[ Triple therapy regimens involving H2 blockaders for therapy of Helicobacter pylori infections ] . Comparison of ranitidine and lansoprazole in short-term low-dose triple therapy for Helicobacter pylori infection . To evaluate the efficacy and safety of two 1-week low-dose triple-therapy drug regimens involving antisecretory drugs for Helicobacter pylori infection , 99 patients with H. pylori infection were treated with either lansoprazole ( LPZ ) or ranitidine ( RNT ) used together with clarithromycin ( CAM ) and metrinidazole ( MTZ ) . The drug combination and administration periods in the PPI group were LPZ 30 mg , CAM 400 mg , MTZ 500 mg ( LCM group ) . The ranitidine group received RNT 300 mg , CAM 400 mg , MTZ 500 mg ( RCM group ) . The cure rate of H. pylori infection was 88 % in the LCM group ; 95 % CI 79-97 and 92 % in the RCM group ; 95 % CI 84-99 .

H2 blockaders

ranitidine

lansoprazole

antisecretory drugs

lansoprazole

ranitidine

clarithromycin ( CAM )

metrinidazole ( MTZ )

LPZ

CAM

MTZ

ranitidine

RNT

CAM

MTZ

LCM

RCM

Helicobacter pylori infections ]

Comparison

efficacy and safety

cure rate of H.

pylori infection

H. pylori infection


Xylitol for prevention of acute otitis media .

Xylitol

acute otitis media .


Pre-operative short-term pulmonary rehabilitation for patients of chronic obstructive pulmonary disease undergoing coronary artery bypass graft surgery . The role of pre-operative short-term pulmonary rehabilitation in patients with chronic obstructive pulmonary disease who undergo coronary artery bypass graft surgery has been assessed for the first time prospectively . Forty-five patients posted for coronary artery bypass graft surgery were randomised to receive either short-term pulmonary rehabilitation ( group I ) or no such programme ( group II ) . Patients of both the groups were evenly matched with respect to age , sex , body surface area , duration and severity of chronic obstructive pulmonary disease and coronary artery disease . Normal individuals who evenly matched with the study group were assessed for normal respiratory function parameters . Pre-operative and post-operative peak expiratory flow rate , inspiratory capacity , post-operative ventilation time , post-operative pulmonary complication and hospital stay were determined in both the groups . Peak expiratory flow rate ( 220.0 +/- 12.9 and 324.3 +/- 84.3 in group I , 218.0 +/- 16.4 and 260.5 +/- 35.2 in group II ) and inspiratory capacity ( 844.0 +/- 147.4 and 1100.0 +/- 158.1 in group I , 830.0 +/- 117.4 and 1090 +/- 137 in group II ) were significantly lower before and after surgery respectively in both groups compared to normal values . Even though both groups showed a significant rise in post-operative peak expiratory flow rate and inspiratory capacity after surgery , the post-operative peak expiratory flow rate and inspiratory capacity in group I was significantly higher than in group II . In group I , the post-operative ventilation time ( 24.5 +/- 6.00 hours ) , post-operative complications ( n = 4 ) and hospital stay ( 12.4 +/- 3.6 days ) were significantly lower than in group II ( 35.2 +/- 22.3 hours , n = 11 , 18.8 +/- 6.6 days respectively ) . These data suggest that short-term pulmonary rehabilitation is feasible and effective in improving pulmonary functions before and after surgery and in reducing surgical morbidity and cost of medical care significantly .

coronary artery bypass graft surgery

coronary artery

short-term pulmonary rehabilitation

no such programme

inspiratory capacity

post-operative ventilation time

post-operative pulmonary complication

hospital stay

Peak expiratory flow rate

inspiratory capacity

inspiratory capacity after surgery

inspiratory capacity

post-operative ventilation time

post-operative complications

hospital stay

feasible

effective

surgical morbidity

cost of medical care

Forty-five


Anesthesia for in vitro fertilization : the addition of fentanyl to 1.5 % lidocaine . UNLABELLED Ultrasonically guided transvaginal oocyte retrieval is relatively short procedure that is performed on an out-patient basis . The optimal anesthetic technique should allow good surgical anesthesia with minimal side effects , a short recovery time , and , if possible , a high rate of successful pregnancy . Spinal anesthesia is often used in this institution , as well as many others , for this procedure . The addition of fentanyl may be effective for both intraoperative and postoperative pain relief . We assessed the effect of adding fentanyl to 1.5 % lidocaine in women undergoing ultrasonically guided oocyte retrieval . Seventy-eight women were randomized to receive 45 mg of hyperbaric 1.5 % lidocaine with or without 10 microg of fentanyl . Visual analog scale ( VAS ) pain scores were lower in the operating room ( OR ) ( P < 0.05 ) and postanesthesia care unit ( PACU ) ( P < 0.0005 ) for the group that received fentanyl . In addition , the amount of narcotic required in the PACU was less in the fentanyl group ( P < 0.005 ) . There was no difference in VAS scores the evening of or 24 h after the procedure . The amount of analgesics and narcotics required after discharge was the same for both groups . Timed variables , such as time to urination , ambulation , and discharge , were the same for both groups of women . The addition of fentanyl to lidocaine for transvaginal oocyte retrieval results in a more comfortable patient in the OR and PACU . IMPLICATIONS This study demonstrates that when fentanyl is added to a local anesthetic , lidocaine , with spinal anesthesia for egg retrieval procedures , patients are more comfortable during the procedure compared with those who receive lidocaine alone . In addition , the narcotic requirements of patients are less in the postanesthesia care unit .

fentanyl

lidocaine .

Spinal anesthesia

Visual analog scale ( VAS ) pain scores

amount of narcotic required

VAS scores

Timed variables , such as

time to urination

ambulation

, and discharge

in vitro fertilization :

women

ultrasonically guided oocyte retrieval

Seventy-eight

women


Fertility outcome after systemic methotrexate and laparoscopic salpingostomy for tubal pregnancy .

systemic methotrexate

laparoscopic salpingostomy

tubal pregnancy .


Effects of insufficient sleep on blood pressure in hypertensive patients : a 24-h study . The influence of acute sleep deprivation during the first part of the night on 24-h blood pressure monitoring ( ABPM ) was studied in 36 never-treated mild to moderate hypertensive patients . According to a crossover design , they were randomized to have either sleep deprivation or a full night 's sleep 1 week apart , during which they were monitored with ABPM . Urine samples for analysis of nocturnal urinary excretion of norepinephrine were collected . During the sleep-deprivation day , both mean 24-h blood pressure and mean 24-h heart rate were higher in comparison with those recorded during the routine workday , the difference being more pronounced during the nighttime ( P < .01 ) . Urinary excretion of norepinephrine showed a significant increase at night during sleep deprivation ( P < .05 ) . Blood pressure and heart rate significantly increased in the morning after a sleep-insufficient night ( P < .05 ) . These data suggest that lack of sleep in hypertensive patients may increase sympathetic nervous activity during the night and the following morning , leading to increased blood pressure and heart rate . This situation might represent an increased risk for both target organ damage and acute cardiovascular diseases .

insufficient sleep

24-h blood pressure monitoring

sleep deprivation

full night 's sleep

sleep-deprivation

sleep deprivation

sleep-insufficient

blood pressure

blood pressure

excretion of norepinephrine

blood pressure

Urinary excretion of norepinephrine

Blood pressure

heart rate

sympathetic nervous activity

blood pressure

heart rate

hypertensive patients :


Switching patients with asthma from chlorofluorocarbon ( CFC ) albuterol to hydrofluoroalkane-134a ( HFA ) albuterol . Chlorofluorocarbon ( CFC ) propellants deplete stratospheric ozone . Production and use of CFCs , except for certain critical exemptions , has been prohibited by the Montreal Protocol . Use of CFCs as propellants in metered-dose inhalers ( MDIs ) is still allowed , but the U.S. Food and Drug Administration is planning the transition to alternative propellants for use in MDIs . Hydrofluoroalkane-134a ( HFA ) , a non-ozone-depleting propellant , has been used to reformulate albuterol ( HFA albuterol ) . This study evaluates whether comparable safety and efficacy continues for 12 weeks after patients with asthma are switched from CFC albuterol to HFA albuterol . Patients with asthma stabilized on CFC albuterol during a 12-week safety and efficacy trial were randomized to either continue receiving CFC albuterol or to be switched to receive HFA albuterol in a yearlong safety and efficacy trial . Safety and efficacy were compared over the first 12 weeks of the yearlong trial between patients who had remained on CFC albuterol and those who had been switched to HFA albuterol . Bronchodilator efficacy was evaluated by serial spirometry for 6 hr after the patients self-administered the study drug in the clinic . Safety was assessed by measuring changes in pulse rate , blood pressure , and electrocardiogram ( ECG ) intervals after dosing with study drug , monitoring adverse events , and performing prestudy and poststudy laboratory testing and physical examinations . No significant differences in bronchodilator efficacy between the patients continuing to receive CFC albuterol and those switched to HFA albuterol were found in the 12 weeks after the switch . No differences between the two products were found for changes in pulse rate , blood pressure , and ECG intervals . Adverse event profiles were similar for the two products , except the patients remaining on CFC albuterol reported increased asthma symptoms and rhinitis significantly more often than the patients switched to HFA albuterol . No clinically meaningful changes in laboratory tests or physical examinations were found in either treatment group . Patients with asthma switched from CFC albuterol to HFA albuterol receive comparable bronchodilation with a similar safety profile as those continuing to receive CFC albuterol .

Hydrofluoroalkane-134a ( HFA )

either continue receiving

CFC albuterol

to be switched to receive

HFA albuterol

in a yearlong safety and efficacy trial

HFA albuterol

HFA albuterol

Safety and efficacy

Bronchodilator efficacy

serial spirometry

Safety

changes in

pulse rate

blood pressure

, and

electrocardiogram ( ECG )

intervals

monitoring adverse events

bronchodilator efficacy

pulse rate

blood pressure

, and

ECG intervals

. Adverse event profiles

changes


Behavioral and physiological effects of remifentanil and alfentanil in healthy volunteers . BACKGROUND The subjective and psychomotor effects of remifentanil have not been evaluated . Accordingly , the authors used mood inventories and psychomotor tests to characterize the effects of remifentanil in healthy , non-drug-abusing volunteers . Alfentanil was used as a comparator drug . METHODS Ten healthy volunteers were enrolled in a randomized , double-blinded , placebo-controlled , crossover trial in which they received an infusion of saline , remifentanil , or alfentanil for 120 min . The age- and weight-adjusted infusions ( determined with STANPUMP , a computer modeling software package ) were given to achieve three predicted constant plasma levels for 40 min each of remifentanil ( 0.75 , 1.5 , and 3 ng/ml ) and alfentanil ( 16 , 32 , and 64 ng/ml ) . Mood forms and psychomotor tests were completed , and miosis was assessed , during and after the infusions . In addition , analgesia was tested at each dose level using a cold-pressor test . RESULTS Remifentanil had prototypic micro-like opioid subjective effects , impaired psychomotor performance , and produced analgesia . Alfentanil at the dose range tested had more mild effects on these measures , and the analgesia data indicated that a 40:1 potency ratio , rather than the 20:1 ratio we used , may exist between remifentanil and alfentanil . A psychomotor test administered 60 min after the remifentanil infusion was discontinued showed that the volunteers were still impaired , although they reported feeling no drug effects . CONCLUSIONS The notion that the pharmacodynamic effects of remifentanil are extremely short-lived after the drug is no longer administered must be questioned given our findings that psychomotor effects were still apparent 1 h after the infusion was discontinued .

remifentanil

alfentanil

remifentanil

remifentanil

placebo-controlled

saline

remifentanil

alfentanil

STANPUMP

computer modeling software package

remifentanil

Remifentanil

remifentanil

Behavioral and physiological effects

subjective and psychomotor effects

analgesia

pharmacodynamic effects

psychomotor effects

healthy

non-drug-abusing

Ten


Comparison of three solutions of ropivacaine/fentanyl for postoperative patient-controlled epidural analgesia . BACKGROUND Ropivacaine , 0.2 % , is a new local anesthetic approved for epidural analgesia . The addition of 4 microg/ml fentanyl improves analgesia from epidural ropivacaine . Use of a lower concentration of ropivacaine-fentanyl may further improve analgesia or decrease side effects . METHODS Thirty patients undergoing lower abdominal surgery were randomized in a double-blinded manner to receive one of three solutions : 0.2 % ropivacaine-4 microg fentanyl 0.1 % ropivacaine-2 microg fentanyl , or 0.05 % ropivacaine-1 microg fentanyl for patient-controlled epidural analgesia after standardized combined epidural and general anesthesia . Patient-controlled epidural analgesia settings and adjustments for the three solutions were standardized to deliver equivalent drug doses . Pain scores ( rest , cough , and ambulation ) , side effects ( nausea , pruritus , sedation , motor block , hypotension , and orthostasis ) , and patient-controlled epidural analgesia consumption were measured for 48 h. RESULTS All three solutions produced equivalent analgesia . Motor block was significantly more common ( 30 vs. 0 % ) and more intense with the 0.2 % ropivacaine-4 microg fentanyl solution . Other side effects were equivalent between solutions and mild in severity . A significantly smaller volume of 0.2 % ropivacaine-4 microg fentanyl solution was used , whereas the 0.1 % ropivacaine-2 microg fentanyl group used a significantly greater amount of ropivacaine and fentanyl . CONCLUSIONS Lesser concentrations of ropivacaine and fentanyl provide comparable analgesia with less motor block despite the use of similar amounts of ropivacaine and fentanyl . This finding suggests that concentration of local anesthetic solution at low doses is a primary determinant of motor block with patient-controlled epidural analgesia after lower abdominal surgery .

ropivacaine/fentanyl

Ropivacaine

fentanyl

ropivacaine-fentanyl

0.05 % ropivacaine-1 microg fentanyl

ropivacaine

fentanyl

ropivacaine

fentanyl

side effects .

Motor block

severity .

motor block

determinant of motor block


Masticatory performance and chewing experience with implant-retained mandibular overdentures . The relationship between masticatory performance and chewing experience has not yet been explored for patients with implant-retained overdentures . Although many relationships have been found between parameters of objective and subjective oral function , the structure of these relationships remain unclear . Therefore , we studied in a randomized clinical trial the relationship between the comminution of an artificial test food , i.e . masticatory performance , and the subjective chewing experience . The trial involved a comparison between two groups receiving implant treatment and one group receiving conventional complete dentures ( CD ) . The implant treatment involved either a mainly implant-supported mandibular overdenture on a transmandibular implant ( TMI ) or an implant-tissue-supported mandibular overdenture on two IMZ implants ( IMZ ) . Masticatory performance as well as chewing experience were substantially better for the implant-retained overdentures compared with the complete denture group . No significant differences emerged between the TMI and the IMZ group . A multiple regression analysis did not provide any comprehensibility in the relationship between masticatory performance and the variables of chewing experience . In the linear structural relation analysis ( LISREL ) no direct relationship was found between masticatory performance and functional complaints mandibular denture . The results show that an improvement in masticatory performance does not imply the same improvement in chewing experience and vice versa .

implant-retained overdentures

transmandibular implant ( TMI )

masticatory performance and

implant-retained overdentures


Genotyping of CYP21 , linked chromosome 6p markers , and a sex-specific gene in neonatal screening for congenital adrenal hyperplasia . We investigated the feasibility and diagnostic utility of genotyping 9 CYP21 mutations , linked chromosome 6p markers , and a dimorphic X-Y marker from neonatal screening samples . Blood-impregnated filter papers ( Guthrie cards ) from 603 randomly chosen New Zealand neonates were genotyped blind to 17-hydroxyprogesterone ( 17-OHP ) levels . Another 50 samples from Swiss and North American infants with correlative hormonal data were also genotyped . DNA was extracted , and gene-specific PCR was performed . CYP21 PCR products were subjected to ligase detection reaction , simultaneously analyzing 9 CYP21 mutations ; PCR products of other genes were subjected to direct gel analysis . CYP21 genotyping indicated a heterozygote rate of 2.8 % for classic mutations ( excluding CYP21 deletions ) , and 2.0 % for nonclassic mutations in New Zealanders . Ten full-term affected neonates showed a wide range of 17-OHP levels ( 15-1400 nmol/L ) . Sick or preterm infants or infants screened on the first day of life with high 17-OHP proved genetically unaffected . Genetic linkage disequilibrium was found between two CYP21 mutations and chromosome 6p markers . Guthrie cards can be used to accurately genotype CYP21 and other relevant markers , potentially enhancing the specificity and sensitivity of congenital adrenal hyperplasia screening . CYP21 heterozygote frequency for classic mutations is higher than expected based on genotype compared with that predicted by hormonal newborn screening .

Genotyping of CYP21

genotyping 9 CYP21

Blood-impregnated filter papers

CYP21 PCR

feasibility

diagnostic utility

heterozygote rate

17-OHP levels

Genetic linkage disequilibrium

specificity

sensitivity

neonatal

congenital adrenal hyperplasia

neonatal

neonates

Another 50 samples

newborn


Piperacillin/tazobactam plus tobramycin versus ceftazidime plus tobramycin as empiric therapy for fever in severely neutropenic patients . The objective of this trial was to evaluate the potential advantages of the combination of piperacillin and tazobactam in the control of fever in neutropenic patients . In this single-center study , patients who experienced a total of 247 febrile episodes were prospectively randomized to receive either our standard regimen , ceftazidime 3 g/day ( 1 g t.i.d . ) plus tobramycin 3 mg/kg per day ( 1.5 mg/kg b.i.d . ) , or piperacillin 12 g/day plus tazobactam 1.5 g/day ( 4 g+0.5 g t.i.d . ) plus tobramycin 3 mg/kg per day ( 1.5 mg/kg b.i.d. ) . Vancomycin was added in all cases of persistent fever in the ceftazidime arm , but only when there was microbiologically documented resistance in the piperacillin/tazobactam arm . All 247 episodes were evaluable by " intent-to-treat " analysis . The two populations were well matched in terms of age , gender , underlying disease , chemotherapy received , oral decontamination , clinical and bacterial documentation , and severity and duration of neutropenia . Initial antibacterial therapy was successful ( apyrexia at 72 h , without antibiotic change ) more frequently ( P = 0.008 ) with the regimen containing piperacillin/tazobactam ( 54.4 % ) than with the one including ceftazidime ( 37.6 % ) . Fewer ( P = 0.02 ) major infectious events ( infectious death or delay in treatment of underlying disease due to infection ) were observed during piperacillin/ tazobactam treatment ( 2.6 % ) than with the ceftazidime regimen ( 11.3 % ) , despite a lower frequency of glycopeptide addition when piperacillin/tazobactam was used ( 54.4 % versus 77.4 % ) according to the rules adopted . This trial confirmed the efficacy of the piperacillin/tazobactam combination for empirical treatment of febrile neutropenic patients . This antibiotic combination permitted a dramatic decrease in empiric glycopeptide antibiotic administration in such patients .

Piperacillin/tazobactam

tobramycin

ceftazidime plus tobramycin

piperacillin and tazobactam

ceftazidime

tobramycin

piperacillin

tazobactam

tobramycin

Vancomycin

ceftazidime

piperacillin/tazobactam

antibacterial therapy

piperacillin/tazobactam

ceftazidime

piperacillin/ tazobactam

ceftazidime

glycopeptide

piperacillin/tazobactam

piperacillin/tazobactam

empiric glycopeptide antibiotic

fever

fever

successful

glycopeptide addition

efficacy

fever in neutropenic patients .


Independent prognostic information provided by sphygmomanometrically determined pulse pressure and mean arterial pressure in patients with left ventricular dysfunction . OBJECTIVES The purpose of this study was to evaluate the relationship of baseline pulse pressure and mean arterial pressure to mortality in patients with left ventricular dysfunction . BACKGROUND Increased conduit vessel stiffness increases pulse pressure and pulsatile load , potentially contributing to adverse outcomes in patients with left ventricular dysfunction . METHODS Pulse and mean arterial pressure were analyzed for their effect on mortality , adjusting for other modifiers of risk , using Cox proportional hazards regression analysis of data collected from 6,781 patients randomized into the Studies of Left Ventricular Dysfunction trials . RESULTS Pulse and mean arterial pressure were related positively to each other , age , ejection fraction and prevalence of diabetes and hypertension and inversely to prior myocardial infarction and beta-adrenergic blocking agent use . Higher pulse pressure was associated with increased prevalence of female gender , greater calcium channel blocking agent , digoxin and diuretic use , lower heart rate and a higher rate of reported smoking history . Higher mean arterial pressure was associated with higher heart rate , lower calcium channel blocker and digoxin use and lower New York Heart Association functional class . Over a 61-month follow-up 1,582 deaths ( 1,397 cardiovascular ) occurred . In a multivariate analysis adjusting for the above covariates and treatment assignment , higher pulse pressure remained an independent predictor of total and cardiovascular mortality ( total mortality relative risk , 1.05 per 10 mm Hg increment ; 95 % confidence interval , 1.01 to 1.10 ; p = 0.02 ) . Mean arterial pressure was inversely related to total and cardiovascular mortality ( total mortality relative risk , 0.89 ; 95 % confidence interval , 0.85 to 0.94 ; p < 0.0001 ) . CONCLUSIONS One noninvasive blood pressure measurement provides two independent prognostic factors for survival . Increased conduit vessel stiffness , as assessed by pulse pressure , may contribute to increased mortality in patients with left ventricular dysfunction , independent of mean arterial pressure .

calcium channel blocking agent

digoxin

diuretic

calcium channel blocker

digoxin

noninvasive blood pressure measurement

pulse pressure

arterial pressure

mortality

Pulse and mean arterial pressure

Higher pulse pressure

Higher mean arterial pressure

deaths

pulse pressure

total and cardiovascular mortality

Mean arterial pressure

total and cardiovascular mortality

survival

Increased conduit vessel stiffness

mortality

left ventricular dysfunction


A comparative study of ofloxacin and cefixime for treatment of typhoid fever in children . The Dong Nai Pediatric Center Typhoid Study Group . BACKGROUND Despite concerns about safety in children , fluoroquinolone antibiotics have become the treatment of choice in patients with multidrug-resistant typhoid fever in Vietnam . However , quinolone-resistant strains of Salmonella typhi have recently been reported from Vietnam ; and if quinolone resistance becomes established , alternative oral treatment options will be needed . OBJECTIVE Cefixime , an orally administered third generation cephalosporin , was compared with ofloxacin for the treatment of uncomplicated typhoid fever in children . METHODS In an open trial children with suspected typhoid fever were randomized to receive either ofloxacin ( 10 mg/kg/day in two divided doses ) for 5 days or cefixime ( 20 mg/kg/day in two divided doses ) for 7 days . RESULTS S. typhi was isolated from 82 patients ( 44 in the cefixime group , 38 in the ofloxacin group ) and 70 ( 85 % ) of the isolates were multidrug-resistant . Median ( 95 % confidence interval , range ) fever clearance times were 4.4 ( 4 to 5.2 , 0.2 to 9.9 ) days for ofloxacin recipients and 8.5 ( 4.2 to 9 , 1.8 to 15.2 ) days for cefixime-treated patients ( P < 0.0001 ) . There were 11 treatment failures ( 10 acute and one relapse ) in the cefixime group and 1 acute treatment failure in the ofloxacin group ( mean difference , 22 % ; 95 % confidence interval , 9 to 36 % ) . CONCLUSION Short course treatment with cefixime may provide a useful alternative treatment in cases of uncomplicated typhoid fever in children , but it is less effective than short course treatment with ofloxacin .

ofloxacin

cefixime

fluoroquinolone antibiotics

Cefixime

cephalosporin

ofloxacin

ofloxacin

cefixime

cefixime

ofloxacin

ofloxacin

cefixime-treated

cefixime

ofloxacin

cefixime

ofloxacin

fever clearance times

treatment failures

acute treatment failure

typhoid fever

children

multidrug-resistant typhoid fever

children

typhoid fever

uncomplicated typhoid fever

children


Epinephrine-induced panic attacks and hyperventilation . To assess the effects of epinephrine on ventilation in patients with panic disorder and in social phobics , analyses were performed on pooled data from two previous infusion studies . Throughout the infusion , changes in transcutaneous PCO2 ( tcPCO2 ) , subjective anxiety , heart rate and blood pressure were recorded continuously . Twenty-nine patients received epinephrine , ten patients received placebo . Thirteen patients ( 45 % ) had a panic attack during epinephrine . The fall in tcPCO2 and the cardiovascular response was greater in panicking patients than patients who did not panic . Although the fall in tcPCO2 associated with panic was not substantial and did not indicate clinically significant acute hyperventilation , it appears to be a sensitive index for epinephrine-induced panic . The fall in tcPCO2 was predicted rather by the frequency of occurrence of anxiety-related somatic symptoms than by the fear of these symptoms . These findings further reduce a role for fear of bodily sensations in epinephrine-induced panic attacks and favor a biological sensitivity to sympathetic stimulation .

epinephrine

epinephrine

placebo .

epinephrine

epinephrine-induced

subjective anxiety

heart rate

blood pressure

fall in tcPCO2

the cardiovascular response

acute hyperventilation

fall in tcPCO2

panic disorder

social phobics

Twenty-nine patients

ten patients


The TOM test : a new instrument for assessing theory of mind in normal children and children with pervasive developmental disorders . This article describes a first attempt to investigate the reliability and validity of the TOM test , a new instrument for assessing theory of mind ability in normal children and children with pervasive developmental disorders ( PDDs ) . In Study 1 , TOM test scores of normal children ( n = 70 ) correlated positively with their performance on other theory of mind tasks . Furthermore , young children only succeeded on TOM items that tap the basic domains of theory of mind ( e.g. , emotion recognition ) , whereas older children also passed items that measure the more mature areas of theory of mind ( e.g. , understanding of humor , understanding of second-order beliefs ) . Taken together , the findings of Study 1 suggest that the TOM test is a valid measure . Study 2 showed for a separate sample of normal children ( n = 12 ) that the TOM test possesses sufficient test-retest stability . Study 3 demonstrated for a sample of children with PDDs ( n = 10 ) that the interrater reliability of the TOM test is good . Study 4 found that children with PDDs ( n = 20 ) had significantly lower TOM test scores than children with other psychiatric disorders ( e.g. , children with Attention-deficit Hyperactivity Disorder ; n = 32 ) , a finding that underlines the discriminant validity of the TOM test . Furthermore , Study 4 showed that intelligence as indexed by the Wechsler Intelligence Scale for Children was positively associated with TOM test scores . Finally , in all studies , the TOM test was found to be reliable in terms of internal consistency . Altogether , results indicate that the TOM test is a reliable and valid instrument that can be employed to measure various aspects of theory of mind .

TOM test

TOM test

TOM test

TOM test

TOM test

TOM test

TOM test

TOM test

TOM test

TOM test

TOM test

TOM test

TOM test

TOM test

interrater reliability

TOM test

TOM test scores

intelligence

TOM test scores

TOM test

pervasive developmental disorders

young children

older children

children

children

PDDs

children

PDDs

children

psychiatric disorders

children


A comparative study of administration methods of granisetron injection used to treat nausea/vomiting induced by cancer chemotherapy without cisplatin in tumors of hematopoietic organs . Keihanshin Study Group of Hematological Malignancies . PURPOSE The antiemetic effect of granisetron injection at a dose of 40 microg/kg used in the treatment of nausea/vomiting induced by multidrug combined cancer chemotherapy excluding cisplatin in patients with tumors of hematopoietic organs was evaluated by comparing a 30-min infusion and a slow intravenous injection given over 30 s. METHODS A two-group random-allocation comparative study was performed with the cooperation of multiple institutions using a central registration system . RESULTS In the treatment of acute clinical symptoms , appetite was described as " similar to that during good health " by 61.1 % of patients ( 55/93 ) in the instillation group and by 47.3 % ( 44/93 ) in the slow injection group , a significant advantage in the infusion group . However , no significant differences in the number of episodes of vomiting , the severity of nausea or clinical efficacy were found . In the final clinical evaluation and assessment of usefulness based on the subjective judgement of physicians throughout the entire therapeutic period , no differences were discernible . No side effects were reported for either method and there was no indication of a sex difference concerning efficacy . However , the efficacy in patients with an anemic tendency was slightly inferior . CONCLUSIONS The maintenance of appetite during the administration of anticancer drugs is very important to maintain patients ' daily activities and quality of life . The present results support the usefulness of infusion of granisetron as an administration method during chemotherapy for malignant hemopathy .

granisetron injection

granisetron injection

granisetron

appetite

clinical efficacy

efficacy in patients

tumors of hematopoietic organs .


Comparison of patient-controlled and nurse-administered analgesia using intravenous fentanyl during labor . Preliminary observations have shown that fentanyl citrate , a potent narcotic , is helpful during labor without undue side effects . This randomized prospective investigation compared the patient-controlled administration of fentanyl with that of administration by nurses on request . Eighty healthy women beginning active labor ( cervical dilation 4 cm ) at term were assigned to receive fentanyl intravenously by either patient-controlled administration ( n=37 ) or nurse administration on demand ( n=43 ) . Pain intensity measurements during early and late labor revealed the degree of analgesia to be the same in both groups . The delay in setting up the infusion system and the short time between requesting analgesia and vaginal delivery were limitations with self-administration . Maternal oversedation and vomiting did not occur . Neonatal naloxone therapy was used infrequently , umbilical serum levels of fentanyl were the same in both groups , and postnatal neuroadaptive testing revealed comparable results in both groups . Despite the usefulness of fentanyl during labor , administration by the patient had no advantages over administration by the nurses in significantly reducing drug use , improving pain relief , or avoiding drowsiness .

fentanyl citrate

administration by nurses on request

fentanyl

patient-controlled administration

nurse administration on demand

administration by the patient

administration by the nurses

Pain intensity measurements

degree of analgesia

Maternal oversedation and vomiting

Neonatal naloxone therapy

umbilical serum levels of fentanyl

postnatal neuroadaptive testing

drug use

improving pain relief

avoiding drowsiness

during labor .


Treatment of polyarteritis nodosa and Churg-Strauss syndrome : indications of plasma exchanges . To define the most effective treatment for polyarteritis nodosa ( PAN ) and Churg-Strauss syndrome ( CSS ) , we undertook 4 consecutive prospective therapeutic trials including 236 patients and tried to answer several important questions : Should cyclophosphamide ( CYC ) be given as the first-line treatment ? What is the place of plasma exchanges ( PE ) in the treatment of systemic vasculitis ? and does hepatitis B virus ( HBV ) related PAN require treatment ? Our first randomized trial in 71 patients ( 1981-1983 ) compared the association of CYC with corticosteroids ( CS ) and PE to CS and PE , in order to evaluate the efficacy of CYC given as the first-line treatment to control disease activity and subsequent survival of PAN and CSS patients . Between December 1983 and December 1988 , we conducted two trials simultaneously : one aimed at patients without HBV markers and the second at patients with HBV markers . In 78 patients without HBV markers , we compared prednisone and PE to prednisone alone as the initial therapeutic regimen . In 33 patients with PAN related to HBV , a new therapeutic strategy was applied as an alternative to long-term steroid and immunosuppressive therapy : short-term steroid therapy and PE were used to control the evolution of PAN and anti-viral therapy was administered to suppress the etiological agent of the vasculitis . In the last protocol including 56 patients and addressed to severe PAN without HBV markers or CSS we have shown that PE did not improve the prognosis and control of the disease . Twelve years after the beginning of the trials on PAN and CSS patients , we think that the therapeutic strategy should be as follows : In PAN without HBV and CSS : prednisone in association with CYC improves the control of the disease despite infectious side effects which may be reduced by better CYC dose adaptation . In PAN related to HBV : The first-line treatment should be the association of anti-viral agents and PE . This treatment was effective and cured a majority of patients within 2 to 3 months ; half of them seroconverted . The length of HBV infection before its diagnosis , delay before initiation of treatment and previous immunosuppressive therapy led to a poor seroconversion rate . The role of PE in the treatment of systemic necrotizing vasculitis : PE are obviously useful in PAN related to HBV where immune complex deposition has been demonstrated . When PAN is not related to HBV and in CSS , even in severe cases , there is presently no argument supporting systematic administration of PE at the time of diagnosis .

cyclophosphamide

plasma exchanges

prednisone and PE

prednisone

steroid and immunosuppressive therapy

short-term steroid therapy and PE

anti-viral therapy

prednisone in association with CYC

anti-viral agents and PE

PE

PE

PE

efficacy

subsequent survival

evolution of PAN

etiological agent of the vasculitis .

prognosis

control of the disease

control of the disease

infectious side effects

effective

length of HBV infection

seroconversion rate .

polyarteritis nodosa

Churg-Strauss syndrome

polyarteritis nodosa

PAN

Churg-Strauss syndrome

CSS

without HBV markers

with HBV markers

without HBV markers

PAN

HBV

severe PAN without HBV markers

PAN


Protocol for the Multicenter Acute Stroke Trial -- thrombolysis study . The rationale for the Multicenter Acute Stroke Trial ( MAST ) is presented in a companion article appearing in this issue . Acute ischaemic stroke is the third major cause of death in developed countries , and a major cause of disability . Despite a very poor prognosis , no treatment has demonstrated an efficacy in lowering the mortality and disability resulting from stroke events . Thrombolysis has been proven to reduce mortality in myocardial infarction , and it has been shown able to induce recanalisation when administered to acute stroke patients . A recent meta analysis of small-sized studies suggests that thrombolysis could offer some benefit to stroke patients , by reducing the mortality and severe invalidity by 56 % ; these results need to be confirmed in adequately designed and sized studies .

Thrombolysis

thrombolysis

death

disability

mortality

disability

mortality in myocardial infarction

recanalisation

mortality

severe invalidity

acute stroke

stroke


Efficacy and safety of mizolastine 10 mg in a placebo-controlled comparison with loratadine in chronic idiopathic urticaria : results of the MILOR Study . BACKGROUND Mizolastine is a novel histamine H1-antagonist registered in Europe for the management of allergic rhinitis and urticaria . OBJECTIVES To compare the clinical efficacy and safety of mizolastine with loratadine and placebo in patients with chronic idiopathic urticaria ( CIU ) . METHODS A multicentre , double-blind , parallel group study was designed in which 247 patients with CIU were randomised after a 1-week placebo run-in period to 10 mg daily mizolastine ( n = 88 ) , 10 mg daily loratadine ( n = 79 ) , or placebo ( n = 80 ) for a 4-week treatment period . RESULTS Mizolastine and loratadine both relieved symptoms of CIU . After 2 weeks ' treatment , the severity of pruritus ( visual analogue score ( VAS ) assessed by patients ) decreased significantly in both the mizolastine and loratadine groups compared with placebo ( mizolastine : -36.7 mm , P = 0.0001 ; loratadine : -29.8 , P = 0.0071 ; placebo : -16.3 ) ; this improvement with both active treatments was maintained throughout the treatment period , the difference being significant only for the mizolastine group ( P = 0.0090 ) . Both active treatments were also associated with reduced weekly episodes of urticaria compared with placebo , which was significant after 2 weeks ' treatment ( mizolastine : 7.9 episodes , P = 0.0061 ; loratadine : 8.3 , P = 0.0221 ; placebo : 13.3 ) . Angioedema was improved to a clinically significant extent with mizolastine , and loratadine compared with placebo in those patients who had this symptom before treatment . Overall tolerability of both treatments was similar to placebo , and there were no clinically relevant effects on cardiac repolarisation with either mizolastine or loratadine . CONCLUSION Mizolastine ( 10 mg daily ) is confirmed as an effective and well tolerated agent , comparable to loratadine and superior to placebo , for the management of CIU . Mizolastine acted as rapidly as loratadine in improving urticarial symptoms from the first day of treatment .

mizolastine

placebo-controlled

loratadine

Mizolastine

mizolastine with loratadine

placebo

placebo

mizolastine

loratadine

placebo

Mizolastine

loratadine

mizolastine and loratadine

placebo

mizolastine

loratadine

placebo

placebo

mizolastine

loratadine

placebo

mizolastine

loratadine

placebo

placebo

mizolastine or loratadine

Mizolastine

placebo

Mizolastine

loratadine

Efficacy and safety

relieved symptoms of CIU

episodes of urticaria

Angioedema

Overall tolerability

effects on cardiac repolarisation

effective and well tolerated

urticarial symptoms

chronic idiopathic urticaria

chronic idiopathic urticaria ( CIU )

CIU


Rett syndrome : randomized controlled trial of L-carnitine . Rett syndrome is a severe neurodevelopmental disorder of unknown etiology , occurring almost exclusively in female patients . The etiology and functional significance of plasma carnitine deficiency seen in some patients with Rett syndrome is unknown . To investigate whether L-carnitine might be of benefit in Rett syndrome , a randomized , placebo-controlled , double-blind crossover trial of L-carnitine has been completed in 35 subjects . Eight-week treatment phases were completed for both a placebo and L-carnitine . Outcome was measured by parents/caregivers and at medical follow-up using three established tools : the Rett Syndrome Motor Behavioral Assessment , the Hand Apraxia Scale , and the Patient Well-Being Index . Analysis comparing change between baseline and week 8 of treatment for L-carnitine and the placebo showed that both parents/caregivers and medical follow-up detected improvements in the subjects ' well-being . In addition , medical review showed an improvement on the Hand Apraxia Scale for a higher proportion of girls on L-carnitine . Identification of predictors of clinical improvement has been limited by the power of the study . These findings suggest that L-carnitine is of benefit in some patients with Rett syndrome . While L-carnitine did not lead to major functional changes in ability , the type of changes reported could still have a substantial impact on the girls and their families . Information is still needed , however , to determine if only subgroups of girls with the disorder are responsive to L-carnitine and the appropriate duration of therapy .

L-carnitine

L-carnitine

placebo-controlled

L-carnitine

placebo

L-carnitine

L-carnitine

placebo

L-carnitine

L-carnitine

L-carnitine

the Hand Apraxia Scale

the

Patient Well-Being Index

well-being

Hand Apraxia Scale

Rett syndrome :

female patients .


High-pressure , rapid-inflation pneumatic compression improves venous hemodynamics in healthy volunteers and patients who are post-thrombotic . PURPOSE Deep vein thrombosis ( DVT ) is a preventable cause of morbidity and mortality in patients who are hospitalized . An important part of the mechanism of DVT prophylaxis with intermittent pneumatic compression ( IPC ) is reduced venous stasis with increased velocity of venous return . The conventional methods of IPC use low pressure and slow inflation of the air bladder on the leg to augment venous return . Recently , compression devices have been designed that produce high pressure and rapid inflation of air cuffs on the plantar plexus of the foot and the calf . The purpose of this study is to evaluate the venous velocity response to high-pressure , rapid-inflation compression devices versus standard , low-pressure , slow-inflation compression devices in healthy volunteers and patients with severe post-thrombotic venous disease . METHOD Twenty-two lower extremities from healthy volunteers and 11 lower extremities from patients with class 4 to class 6 post-thrombotic chronic venous insufficiency were studied . With duplex ultrasound scanning ( ATL-Ultramark 9 , Advanced Tech Laboratory , Bothell , Wash ) , acute DVT was excluded before subject evaluation . Venous velocities were monitored after the application of each of five IPC devices , with all the patients in the supine position . Three high-pressure , rapid-compression devices and two standard , low-pressure , slow-inflation compression devices were applied in a random sequence . Maximal venous velocities were obtained at the common femoral vein and the popliteal vein for all the devices and were recorded as the mean peak velocity of three compression cycles and compared with baseline velocities . RESULTS The baseline venous velocities were higher in the femoral veins than in the popliteal veins in both the volunteers and the post-thrombotic subjects . Standard and high-pressure , rapid-inflation compression significantly increased the popliteal and femoral vein velocities in healthy and post-thrombotic subjects . High-pressure , rapid-inflation compression produced significantly higher maximal venous velocities in the popliteal and femoral veins in both healthy volunteers and patients who were post-thrombotic as compared with standard compression . Compared with the healthy volunteers , the patients who were post-thrombotic had a significantly attenuated velocity response at both the popliteal and the femoral vein levels . CONCLUSION High-pressure , rapid-inflation pneumatic compression increases popliteal and femoral vein velocity as compared with standard , low-pressure , slow-inflation pneumatic compression . Patients with post-thrombotic venous disease have a compromised hemodynamic response to all IPC devices . However , an increased velocity response to the high-pressure , rapid-inflation compression device is preserved . High-pressure , rapid-inflation pneumatic compression may offer additional protection from thrombotic complications on the basis of an improved hemodynamic response , both in healthy volunteers and in patients who were post-thrombotic .

duplex ultrasound scanning

slow-inflation compression devices

Standard and high-pressure

rapid-inflation compression

popliteal and femoral vein velocities

maximal venous velocities

popliteal and femoral veins

velocity response

popliteal and femoral vein velocity

hemodynamic response


A comparison of a non-ionic dimer , iodixanol with a non-ionic monomer , iohexol in low dose intravenous urography . A prospective , double-blind study of 392 patients randomized into four groups was performed to establish whether diagnostic intravenous urograms could be obtained with a lower dose of iodine when using the dimeric , non-ionic contrast medium iodixanol compared with the monomeric , non-ionic iohexol . Patients received iodixanol or iohexol containing either 9 or 12 g of iodine ( gI ) . The primary parameter was the diagnostic quality of the 6 min film , assessed in a blinded fashion , by consensus , by four radiologists . Iodixanol at both doses was diagnostic in over 90 % of cases . Iohexol was only diagnostic in 74 % ( 9 gI ) and 81.8 % ( 12 gI ) . Pairwise comparisons revealed that iodixanol 9 gI was significantly better than both iohexol 9 gI ( p = 0.0005 ) and 12 gI ( p = 0.014 ) . No significant difference was present for different doses within the same contrast medium group . Iodixanol resulted in poorer bladder distension than iohexol . Iodixanol caused significantly less discomfort than iohexol .

non-ionic dimer

iodixanol

a non-ionic monomer , iohexol

non-ionic contrast medium iodixanol

monomeric , non-ionic iohexol

iodixanol or iohexol

iodine

Iodixanol

Iohexol

iohexol

Iodixanol

iohexol . Iodixanol

iohexol .

diagnostic quality

diagnostic

diagnostic

poorer bladder distension

significantly less discomfort

low dose intravenous urography


Isoniazid prophylaxis for tuberculosis in HIV infection : a meta-analysis of randomized controlled trials . OBJECTIVES To evaluate the efficacy of isoniazid for the prevention of tuberculosis in tuberculin skin test-positive and negative individuals with HIV infection . DESIGN Meta-analysis of randomized controlled trials . SETTING Seven trials from Mexico , Haiti , the United States , Zambia , Uganda and Kenya . PATIENTS Individuals free from tuberculosis , 2367 persons in the intervention and 2162 in the control groups . INTERVENTION Comparison of isoniazid with placebo or no prophylaxis . METHODS A systematic search of the literature was carried out from 1985 to October 1997 for randomized controlled trials of isoniazid prophylaxis in HIV-infected persons . Two reviewers evaluated the relevance of each candidate study and the validity of eligible trials . Studies were pooled using a random effect model , conducting secondary analyses for tuberculin skin test-positive and negative persons . RESULTS Mean follow-up in trials varied between 0.4 and 3.2 years . Pooling all seven trials , a risk ratio was found for persons treated with isoniazid for developing tuberculosis of 0.58 [ 95 % confidence interval ( CI ) , 0.43-0.80 ] and 0.94 ( 95 % CI , 0.83-1.07 ) for death . In groups of tuberculin skin test-positive and negative persons , the risk ratio of tuberculosis was 0.40 ( 95 % CI , 0.24-0.65 ) and 0.84 ( 95 % CI , 0.54-1.30 ) , respectively , and the difference in the effectiveness of isoniazid versus placebo between these groups was statistically significant ( P = 0.03 , for the difference of summary estimates ) . Consistency of results was found across trials ( P > 0.10 , heterogeneity value ) for all comparisons . CONCLUSIONS Prophylaxis with isoniazid reduces the risk of tuberculosis in persons with HIV infection . The effect is restricted to tuberculin skin test-positive persons .

isoniazid

isoniazid

placebo

isoniazid

isoniazid

isoniazid

placebo

isoniazid

risk ratio

death

risk ratio of tuberculosis

difference in the effectiveness

tuberculosis in HIV infection :


Behavioral and physiological effects of deep pressure on children with autism : a pilot study evaluating the efficacy of Grandin 's Hug Machine . OBJECTIVE One symptom common to many persons with autism is a high arousal or anxiety level . This study investigated the effects of deep pressure on arousal and anxiety reduction in autism with Grandin 's Hug Machine , a device that allows self-administration of lateral body pressure . METHOD Twelve children with autism were randomly assigned to either an experimental group ( receiving deep pressure ) or a placebo group ( not receiving deep pressure but in the disengaged Hug Machine ) . All children received two 20-min sessions a week over a 6-week period . Arousal was measured behaviorally with the Conners Parent Rating Scale and physiologically with galvanic skin response ( GSR ) readings . RESULTS Behavioral results indicated a significant reduction in tension and a marginally significant reduction in anxiety for children who received the deep pressure compared with the children who did not . Additionally , children in the experimental group , whose GSR measures decreased , on average , after deep pressure , were somewhat more likely to have higher GSR arousal a priori . CONCLUSION These preliminary findings support the hypothesis that deep pressure may have a calming effect for persons with autism , especially those with high levels of arousal or anxiety .

deep pressure

Grandin 's Hug Machine .

deep pressure

Grandin 's Hug Machine

( receiving deep pressure )

placebo

deep pressure

Arousal

significant reduction in tension

GSR measures

GSR arousal

children with autism :


Reduction of stimulus overselectivity with nonverbal differential observing responses . Three individuals with mental retardation exhibited stimulus overselectivity in a delayed matching-to-sample task in which two sample stimuli were displayed on each trial . Intermediate accuracy scores indicated that participants could match one of the samples but not both of them . Accuracy in a baseline condition was compared to accuracy with a differential observing response procedure . This procedure prompted participants to make simultaneous identity-matching responses that required observation and discrimination of both sample stimuli . These observing responses were never followed by differential consequences . When observing responses were prompted , participants ' accuracy scores improved . In a return to the baseline condition , when differential observing responses were no longer prompted , accuracy returned to intermediate levels . The results show that stimulus overselectivity can be greatly reduced by a behavioral intervention that controls observing behavior and verifies discrimination , but that exposure to such procedures alone may be insufficient for lasting benefits .

two sample stimuli

differential observing responses

stimulus overselectivity

accuracy scores

Accuracy

accuracy

accuracy scores

accuracy

lasting benefits

Three

mental retardation


Predictors of survival and eradication of Mycobacterium avium complex bacteremia ( MAC ) in AIDS patients in the Canadian randomized MAC treatment trial . Canadian HIV Trials Network Protocol 010 Study Group . OBJECTIVE To assess the importance of baseline characteristics including medical history , indicators of current disease status , therapeutic drug use , in vitro drug susceptibility , immune status and mycobacterial load on bacteriologic response and survival in HIV-positive patients with Mycobacterium avium complex ( MAC ) bacteremia . DESIGN An observational substudy of an open-label randomized controlled trial of two alternative therapeutic regimens for MAC . SETTING Twenty-four hospital-based HIV clinics in 16 Canadian cities . MAIN OUTCOME MEASURES The main outcome measures were survival and bacteriologic response , defined by consecutive negative blood cultures for MAC at least 2 weeks apart within 16 weeks of study entry . RESULTS Prior AIDS diagnosis , low Karnofsky score , active unstable AIDS-related conditions , absence of antiretroviral therapy and absence of Pneumocystis carinii pneumonia prophylaxis were associated with shorter survival by univariate regression using the proportional hazards model . On multivariate analysis , antiretroviral therapy was not an independent predictor of mortality , and previous rifabutin prophylaxis was independently associated with poor survival outcomes , a result consistent across study treatment . Using a logistic regression model , baseline quantitative mycobacterial load [ relative odds of clearing , 1.97 for a decrease of 1 log10 colony forming count ; 95 % confidence interval ( CI ) , 1.36-2.87 ; P < 0.001 ] and Karnofsky score were the only statistically significant univariate predictors of clearance , although previous prophylaxis with rifabutin was also a significant predictor in a multivariate model ( relative odds of clearing , 0.39 ; 95 % CI , 0.17-0.88 ; P < 0.05 ) . CONCLUSIONS This study indicates that although the level of MAC bacteremia is an important predictor of clearance , it is not associated with survival .

therapeutic regimens

indicators of current disease status

therapeutic drug use

in vitro drug susceptibility

immune status

mycobacterial load

bacteriologic response

survival

survival

bacteriologic response

survival

mortality

Karnofsky score

AIDS

HIV-positive

Twenty-four


Couple-responsible therapy process : positive proximal outcomes . Therapist-couple struggle vs. cooperation is linked to clinical outcome . This research conceptualizes and investigates treatment process as it relates to the occurrence of struggle versus cooperation . Models of couple-responsible and therapist-responsible process in couple therapy were developed . Couple-responsible process consists of enactments , accommodation , and inductive process . Therapist-responsible process consists of primary therapist-couple interaction , therapist interpretation , and direct instruction . In counterbalanced order , 25 couples were exposed to couple-responsible and therapist-responsible episodes during one therapy session . Couples reviewed videotapes of the episodes and completed measures of responsibility , struggle , and cooperation . Perceived responsibility was higher and struggle was lower during couple-responsible episodes . No difference in cooperation was found . Presence or absence of a contrast condition , where couples reported on one therapist process after already experiencing its opposite , led to main effects for responsibility and struggle , and mediated effects of struggle and cooperation . Generally speaking , responsibility was even higher during couple-responsible episodes and even lower during therapist-responsible episodes when contrast was present . Similarly , struggle was even lower during couple-responsible episodes and even higher during therapist-responsible episodes when contrast was present . For both couple-responsible and therapist-responsible episodes , cooperation was negatively affected by a shift from the prior , opposite therapist process . Significant proportions of the variance in responsibility , struggle , and cooperation , however , were not accounted for by therapist process alone .

Couple-responsible therapy process :

couple therapy

couple-responsible episodes .

therapist process

couple-responsible episodes

therapist-responsible episodes

couple-responsible episodes

therapist-responsible episodes

positive proximal outcomes

Perceived responsibility

struggle

cooperation

responsibility

struggle

cooperation

couples


Clinical hypnosis versus cognitive behavioral training for pain management with pediatric cancer patients undergoing bone marrow aspirations . A randomized controlled trial was conducted to compare the efficacy of clinical hypnosis versus cognitive behavioral ( CB ) coping skills training in alleviating the pain and distress of 30 pediatric cancer patients ( age 5 to 15 years ) undergoing bone marrow aspirations . Patients were randomized to one of three groups : hypnosis , a package of CB coping skills , and no intervention . Patients who received either hypnosis or CB reported less pain and pain-related anxiety than did control patients and less pain and anxiety than at their own baseline . Hypnosis and CB were similarly effective in the relief of pain . Results also indicated that children reported more anxiety and exhibited more behavioral distress in the CB group than in the hypnosis group . It is concluded that hypnosis and CB coping skills are effective in preparing pediatric oncology patients for bone marrow aspiration .

pain management

pain and distress

pain

pain-related anxiety

pain

anxiety

relief of pain

anxiety

behavioral distress

effective

pediatric

cancer

age 5 to 15 years


Effects of oral brovincamine on visual field damage in patients with normal-tension glaucoma with low-normal intraocular pressure . PURPOSE To prospectively study the effect of oral brovincamine , a relatively selective cerebral vasodilator , on further deterioration of visual field in patients with normal-tension glaucoma ( NTG ) with low-normal intraocular pressure ( IOP ) . METHODS Fifty-two patients with NTG ( average age 57.7 years ) with an IOP that was consistently less than 15 mmHg were randomly assigned to receive oral brovincamine ( 20 mg three times daily ) or to an untreated control group . The groups were prospectively followed for 2 years with visual field examinations every 4 months , using the 30-2 Humphrey perimeter program . Changes in mean deviation ( MD ) , corrected pattern standard deviation ( CPSD ) , and total deviation ( TD ) at 74 test points were analyzed using regression analysis with linear mixed model . Data from one eye without media opacity of each subject were analyzed . RESULTS There were no differences between groups in age ; sex distribution ; refraction ; blood pressure ; baseline IOP ; MD , CPSD , or TD at each point . Changes in MD ( standard error [ SE ] ) during the study period were -0.778 ( 0.178 ) and -0.071 ( 0.195 ) dB/year in the control and brovincamine groups , respectively ; change in the control group was significantly more negative than in the brovincamine group . Change in CPSD ( SE ) was 0.032 ( 0.015 ) and 0.004 ( 0.016 ) dB/year in the control and brovincamine groups , respectively . Change in the control group was significantly positive , but the intergroup difference was not significant . Change in TD was significantly negative at six test points in the control group , whereas no points showed a significant trend in the brovincamine group ; the intergroup difference was significant . The average IOP was 13.2 mmHg and 13.1 mmHg in the control and brovincamine groups , respectively , and there was no significant intergroup difference . CONCLUSION Oral brovincamine may retard further visual field deterioration in patients with NTG who have low-normal IOP .

brovincamine

oral brovincamine

cerebral vasodilator

oral brovincamine

untreated control group .

visual field examinations

brovincamine

brovincamine

brovincamine

brovincamine

brovincamine

Oral brovincamine

Effects

effect

Changes in mean deviation ( MD )

total deviation ( TD )

refraction

blood pressure

baseline IOP

MD

CPSD

TD

Changes in MD

Change in CPSD ( SE )

Change in TD

average IOP

normal-tension glaucoma

low-normal intraocular pressure

normal-tension glaucoma ( NTG )

low-normal intraocular pressure

Fifty-two

NTG

NTG


Local injection of bupivacaine after rubber band ligation of hemorrhoids : prospective , randomized study . PURPOSE The aim of this study was to determine if local injection of bupivacaine after hemorrhoidal banding causes a decrease in pain and in the incidence of associated symptoms . METHODS After hemorrhoidal banding , patients were randomly assigned to receive a local injection of bupivacaine with 1:200,000 epinephrine , an injection of normal saline , or no injection , just superior to each band . Pain was graded by the patient and by the study nurse within 30 minutes , and any associated symptoms were recorded . At intervals 6 , 24 , and 48 hours postbanding , the patient recorded pain , limitation of activities , and analgesic requirements . Associated symptoms while at home were recorded . RESULTS Of 115 patients studied , 42 received bupivacaine injection , 42 received normal saline injection , and 31 received no injection . In patients receiving bupivacaine compared with no injection , within 30 minutes postbanding there was a significant reduction in pain graded by the patient ( P = 0.000002 ) and by the nurse ( P = 0.000005 ) and a significant reduction in incidence of nausea ( P = 0.01 ) and shaking ( P = 0.008 ) . However , in the bupivacaine group compared with the other two groups , at the intervals of 6 , 24 , and 48 hours postbanding there was no sustained reduction in the severity of pain and no reduction in analgesic requirements or limitation of normal activities . In the week after banding , there was no difference between groups in symptoms of nausea , shaking , lightheadedness , urinary retention , or bleeding . CONCLUSIONS Bupivacaine injection may be useful for reducing pain and associated symptoms long enough to tolerate a trip home from the outpatient department but does not show a sustained effect .

bupivacaine

bupivacaine

injection of normal saline

no injection , just

bupivacaine

normal saline

no injection

bupivacaine

bupivacaine

Bupivacaine

Pain

associated symptoms

Associated symptoms

reduction in pain

incidence of nausea

severity of pain

hemorrhoids

hemorrhoidal banding


Microbiologic yields and complication rates of vitreous needle aspiration versus mechanized vitreous biopsy in the Endophthalmitis Vitrectomy Study . PURPOSE To compare the microbiologic yields and complication rates associated with vitreous needle tap and vitreous biopsy in the Endophthalmitis Vitrectomy Study ( EVS ) . METHODS Of 420 EVS patients with postoperative endophthalmitis , 201 received immediate vitreous tap or biopsy ( without pars plana vitrectomy ) by random assignment and 193 completed 9-12 months of follow-up . Vitreous specimens were obtained by biopsy with a 20-gauge vitrectomy cutting instrument or by needle tap with a 22-27-gauge needle . If resistance to aspiration by needle tap was noted , a vitreous biopsy was performed . RESULTS Of 201 patients undergoing tap or biopsy , 70 ( 35 % ) had needle tap , 127 ( 63 % ) had mechanized biopsy , and 4 ( 2 % ) had initial needle tap that was aborted to mechanized biopsy ( " abort " eyes ) . Intraoperative hyphema occurred in 2 tap eyes ( 3 % ) , 3 biopsy eyes ( 2 % ) , and 0 ( 0 % ) abort eyes . Postoperative retinal detachment developed in 8 ( 11 % ) tap eyes , 10 ( 8 % ) biopsy eyes , and 0 ( 0 % ) abort eyes ( not significant ) . Respective rates of culture and gram stain positivity were 69 % and 42 % in tap eyes and 66 % and 41 % in biopsy eyes ( not significant ) . The rate of severe visual loss ( final acuity < 5/200 ) was significantly higher in tap eyes ( 16 eyes , 24 % ) compared with biopsy eyes ( 13 eyes , 11 % ) and abort eyes ( 0 eyes , 0 % ; P = 0.043 ) . The difference was largely explained by the greater proportion of virulent organisms in the tap eyes compared with biopsy eyes . When visual acuity outcome was defined by other thresholds ( 20/40 and 20/100 ) , the difference was not significant . CONCLUSIONS This study showed no significant differences between mechanized vitreous biopsy and needle tap with respect to microbiologic yield , operative complications , short-term ( 9-12 months ) retinal detachment risk , or visual outcome . Choice of vitreous sampling procedure must depend on the clinical judgment of the surgeon .

vitreous needle aspiration

mechanized vitreous biopsy

vitreous needle tap

vitreous biopsy

20-gauge vitrectomy

Intraoperative hyphema

Postoperative retinal detachment

rate of severe visual loss

visual acuity outcome

Endophthalmitis Vitrectomy

EVS

postoperative endophthalmitis

immediate vitreous tap

biopsy

tap

biopsy

needle tap

mechanized biopsy

needle tap


Isradipine , raised glycosylated haemoglobin , and risk of cardiovascular events .

Isradipine

cardiovascular events .

risk of cardiovascular events .


Allelic imbalance in the clonal evolution of prostate carcinoma . BACKGROUND To understand better the genetic basis of the clonal evolution of prostate carcinoma , the authors analyzed the pattern of allelic loss in 25 matched primary and metastatic prostate tumors . METHODS Twenty-five cases were selected from the surgical pathology files of the Mayo Clinic from patients who had undergone radical retropubic prostatectomy and bilateral lymphadenectomy between 1987-1991 . All patients had regional lymph node metastases at the time of surgery . DNA samples for the analysis of allelic loss pattern were prepared from primary tumors and matched synchronous lymph node metastases by tissue microdissection . The oligonucleotide primer pairs for the microsatellite DNA markers were D8S133 , D8S136 , D8S137 , ANK1 on chromosome 8p12-21 , LPLTET on chromosome 8p22 , and D17S855 ( intragenic to the BRCA1 gene ) on chromosome 17q21 . One case was not informative at any of the loci tested and was excluded from further analysis . RESULTS The overall frequency of allelic imbalance was 79 % in primary tumors and 88 % in paired metastases . Of 24 informative cases , 14 patients ( 58 % ) showed the same pattern of allelic loss or retention in matched primary and metastatic tumors at all marker locus ; discordant allelic loss was observed in the remaining 10 patients ( 42 % ) . Four patients showed loss of the same allele at one or more marker loci in both primary and metastatic tumors , but discordant allelic loss was observed at other marker loci . Five patients showed allelic loss in at least one genetic marker in the metastatic tumor but not in its matched primary tumor . Five patients displayed loss of one allele at one or more marker loci in a primary tumor but not in the matched metastases . There was no significant difference in the frequency of allelic imbalance between primary and metastatic tumors at any marker analyzed ( P > 0.05 ) . CONCLUSIONS These data suggest that different patterns of allelic deletion may be acquired during cancer progression to metastases . The differences in genetic composition between primary prostate carcinoma and its metastases may be related to intrinsic cancer heterogeneity , overall genetic instability , and clonal divergence .

radical retropubic prostatectomy

bilateral lymphadenectomy

Allelic imbalance

allelic loss

allelic loss

overall frequency of allelic imbalance

allelic loss

allelic loss

allele

allelic loss

allelic loss

loss of one allele

frequency of allelic imbalance

allelic deletion

prostate carcinoma

Twenty-five

regional lymph node metastases


Thrombolysis is superior to heparin for non-obstructive mitral mechanical valve thrombosis . BACKGROUND AND AIM OF THE STUDY Non-obstructive prosthetic valve thrombosis ( PVT ) is a unique subset that features clinical presentation without heart failure , and may be asymptomatic . Thrombolysis has been accepted for obstructive PVT , but treatment strategies of non-obstructive PVT are controversial . This study compared the efficacy and safety of thrombolysis and heparin treatment in these patients . METHODS Between 1993 and 1998 , 20 consecutive patients were found by multiplane transesophageal echocardiography ( TEE ) to have non-obstructive PVT . TEE was performed for peripheral embolism in two patients , stroke or transient ischemic attack in six , stroke and fever in two , fever in one patient , as a routine postoperative examination in two patients , and for other reasons in seven . Patients were allocated to two groups : group I ( n = 8 ) received streptokinase-mediated fibrinolysis ; group II ( n = 12 ) received intravenous heparin by infusion . Treatment was monitored using TEE . RESULTS There was no difference between patient groups with regard to sex , age , type of prosthesis and time since operation , though anticoagulant status was more often inadequate in group II . By TEE , valve motion was normal in all patients . In group I , all thrombi were mobile and 5-13 mm in diameter ; in group II , all thrombi but three were mobile and 3-18 mm in diameter . In group I , thrombolysis was successful in all patients , without complications , within 6-72 h. In group II , heparin treatment was successful in six patients in 3-32 days . In one patient , seven days ' of unsuccessful heparin was followed by two months ' successful coumarin therapy . Among five unsuccessful cases , the thrombus size increased in four ( three became obstructive in 7-35 days ) ; all four patients were switched to fibrinolysis , which was successful without complications in 12-60 h. The fifth patient developed a stroke after nine days of heparin treatment and was subsequently operated on . CONCLUSIONS Non-obstructive PVT may be asymptomatic in one-third of patients . Thrombolysis is an efficient and safe treatment , and may be first-line therapy if there is no contraindication . Heparin treatment was successful in about one-half of our cases in the presence of sessile or small thrombi and inadequate anticoagulant status . In unsuccessful cases , thrombi became obstructive or caused stroke during heparin therapy , the adequate duration of which remains unclear .

transesophageal echocardiography

streptokinase-mediated fibrinolysis ;

intravenous heparin by infusion .

heparin

Heparin

efficacy and safety

valve motion

thrombi

complications

thrombus size

stroke

efficient and safe

stroke

prosthetic valve thrombosis ( PVT )

non-obstructive PVT .


Blood purification for critical care medicine : endotoxin adsorption . Many kinds of blood purifying technologies have been applied to the treatment of critically ill patients since 1979 when plasma exchange with hollow-fiber membranes was developed . These technologies have been applied not only to the removal of toxic substances , but also to the treatment of objective diseases and the removal of the factors relating to the associated inflammation . This article summarizes these methods and their efficacies for critically ill patients , especially those with severe sepsis . Attempts have been made to remove endotoxin , the main cause of sepsis , from the circulation using polymyxin B immobilized fiber , charcoal hemoperfusion , and plasma or whole blood exchange . Attempts have also been made to remove proinflammatory cytokines , eicosanoides , and coagulative factors from the circulation in the human body . Continuous hemofiltration or hemodiafiltration is the representative technology . The efficacy of these methods has been established , but several issues remain unresolved . All methods of the treatment of severe sepsis are discussed with reference to treatment indications , efficacy , and outcome parameters . In particular , the clinical results of endotoxin removal with polymyxin B immobilized fiber are summarized in this article .

Blood purification

blood purifying technologies

polymyxin B immobilized fiber

charcoal hemoperfusion

plasma or whole blood exchange

polymyxin B immobilized fiber

Blood purification

efficacy

indications

efficacy


Naltrexone and communication skills in young children with autism . OBJECTIVE To evaluate the effect of naltrexone on communication skills of young children with autism . METHOD Twenty-four children with autism , 3.0 to 8.3 years old ( mean 5.1 ) who were living at home and attending appropriate school programs , participated in a randomized , double-blind , placebo-controlled , crossover trial . Naltrexone , 1.0 mg/kg , or placebo was administered daily for 2 weeks . Communication was evaluated from videotaped samples of seminaturalistic parent-child interaction . Child and parent language were assessed using similar measures . RESULTS In this heterogeneous sample , the median number of words the child produced on placebo was 9.5 ( range 0-124 ) . The median proportion of utterances with echolalia was 0.16 . No differences were found between the naltrexone and placebo conditions in any of the measures of children or parents ' communication . Significant correlations were found between the child 's number of words and developmental quotient ( Spearman rho = 0.58 , p = .003 ) and between the child 's and parent 's number of words ( rho = 0.55 , p = .005 ) . CONCLUSIONS Previous studies showed that naltrexone was associated with modest reduction in hyperactivity and restlessness in this group of children with autism . In this short-term study , the medication did not lead to improvement in communication , a core deficit of autism .

Naltrexone

naltrexone

Naltrexone

placebo

naltrexone

placebo

naltrexone

children or parents ' communication

child 's number of words

developmental quotient

autism

young children

with autism .

Twenty-four

autism


Long term response to therapy of chronic anti-HBe-positive hepatitis B is poor independent of type and schedule of interferon . OBJECTIVE The response rate to alpha interferon ( IFN ) of chronic anti-HBe-positive hepatitis B is variable . We studied whether type , dose , and schedule of IFN , and type and frequency of posttreatment monitoring , influence the response rate . METHODS Seventy-two consecutive anti-HBe-positive chronic hepatitis B patients ( 59 male and 13 female , median age 41 yr ) stratified by sex and histology were randomly allocated to three treatment arms . Twenty-seven patients ( A ) received 10 million units alpha-N1 IFN i.m . t.w . for 24 wk ( total dose : 720 million units ) ; 21 ( B ) received 9 million units alpha-2a IFN i.m . t.w . for 4 wk , followed by 18 million units for 12 wk and 9 million units for 8 wk ( 972 million units ) ; 24 ( C ) received 2 alpha-2a IFN courses ( 9 million units i.m . t.w . for 16 and 12 wk separated by a 6-month interval [ 756 million units ] ) . Primary response was defined by normal ALT and serum HBV-DNA levels below 10 pg/ml at the end of therapy and sustained response by normal ALT ( tested monthly ) , undetectable HBV-DNA and IgM anti-HBc ( < 7 I.U . Paul Ehrlich Institute ) ( tested every 3 months ) during the posttreatment follow-up . RESULTS At the end of treatment , 12 , 8 , and 13 patients from groups A , B , and C , respectively , were responders . At the 18-month follow-up , two patients in group A and only one in groups B and C maintained the response . Overall , after 34 months ( median posttreatment follow-up ) , three patients were long term responders , whereas three showed a sustained remission after relapse . CONCLUSIONS The rate of long term response to interferon of anti-HBe-positive chronic hepatitis B is poor , independent of IFN type , dose , or schedule ; the more stringent the monitoring , the higher the relapse rate .

alpha interferon ( IFN )

IFN

alpha-N1 IFN i.m .

alpha-2a IFN i.m .

2 alpha-2a IFN

normal ALT

serum HBV-DNA levels

normal ALT

undetectable HBV-DNA

remission

rate of long term response

chronic anti-HBe-positive hepatitis B

Seventy-two

male

female

41 yr


Getting a high response rate of sexual behavior survey among the general population in Japan : three different methods of survey on sexual behavior . The purpose of this study was to specify the most accurate , reliable and valid technique for a general sexual behavioral survey in Japan . This pilot study was conducted to assure a high response rate and to keep respondents ' privacy confidential by using an anonymous questionnaire survey technique . The sample ( 360 potential respondents ) was selected randomly from basic resident registers in two geographically different areas . From the registries , 90 residents , aged 20 to 49 years old , were randomly selected to represent each sex from each area . The subjects were randomly assigned to three groups each having a different procedure of requesting the completion of the survey and providing the questionnaires : ( 1 ) Postal Group , ( 2 ) Telephone Group , and ( 3 ) Face-to-face Group . The survey was carried out from October 1995 to February 1996 . Effective response rates for the above mentioned three groups were 69.2 % , 69.2 % and 55.8 % , respectively . It is difficult to determine the best method when only considering the effective response rates . However , judging from our effort and expense , the mail survey is the best possible procedure and would be a reasonable method for a national sexual behavior survey .

Postal Group

Telephone Group

Face-to-face Group

mail survey

Effective response rates

effective response rates

360 potential respondents

90 residents


Comparative evaluation of olopatadine ophthalmic solution ( 0.1 % ) versus ketorolac ophthalmic solution ( 0.5 % ) using the provocative antigen challenge model . OBJECTIVE This study was conducted to compare the efficacy and safety of olopatadine ophthalmic solution ( 0.1 % ) with ketorolac ophthalmic solution ( 0.5 % ) in a clinical model of acute allergic conjunctivitis . Olopatadine is a dual acting H1 histamine receptor antagonist and a mast cell stabilizer , shown to be effective in treating allergic conjunctivitis . Ketorolac is a non-steroidal anti-inflammatory drug approved in the United States for the relief of ocular itching associated with seasonal allergic conjunctivitis . METHODS The provocative antigen challenge model was used in this randomized , double-blind , single-center , crossover study . The allergen and concentration that consistently elicited a positive allergic reaction was used for challenge . After at least 14 days , subjects were randomized to receive either olopatadine in one eye and placebo in the contralateral eye , or ketorolac in one eye and placebo in the contralateral eye . Twenty-seven minutes after drug instillation subjects were challenged with allergen . At 3 , 10 , and 20 minutes following allergen challenge , subjects graded ocular itching and were assessed for hyperemia in conjunctival , ciliary , and episcleral vessel beds . Approximately 14 days later , subjects received the alternate treatment in one eye and placebo in the contralateral eye . They were again challenged with allergen and their responses were rated in the same manner . RESULTS Olopatadine significantly ( p < 0.0001 ) reduced both ocular itching and hyperemia in all three vessel beds compared to placebo at all time points tested following allergen challenge . Ketorolac did not significantly reduce itching and showed a trend of increased hyperemia compared to placebo . Olopatadine was significantly ( p < 0.001 ) more effective than ketorolac in reducing hyperemia and ocular itching at all time points and was also significantly ( p < 0.05 ) more comfortable than ketorolac as reported by subjects immediately following drug instillation . CONCLUSION The study demonstrated that olopatadine is effective and safe in preventing and treating ocular itching and hyperemia associated with acute allergic conjunctivitis and is more effective and more comfortable than ketorolac .

olopatadine ophthalmic solution

ketorolac ophthalmic solution

olopatadine ophthalmic solution

ketorolac ophthalmic solution

Olopatadine

Ketorolac

olopatadine

placebo

ketorolac

placebo

placebo

Olopatadine

placebo

Ketorolac

placebo

Olopatadine

ketorolac

ketorolac

olopatadine

ketorolac

efficacy and safety

graded ocular itching

ocular itching

hyperemia

itching

effective

hyperemia

ocular itching

comfortable

ocular itching

hyperemia

acute allergic conjunctivitis .

allergic conjunctivitis .


Effect of total androgen ablation on pathologic stage and resection limit status of prostate cancer . Initial results of the Italian PROSIT study . The likelihood of finding organ-confined untreated prostate cancer ( PCa ) by pathological examination at the time of radical prostatectomy ( RP ) is only 50 % in patients with clinically organ-confined disease . In addition , tumour is present at the resection margin in approximately 30 % of clinical T2 ( clinical stage B ) cases . The issue of clinical " understaging " and of resection limit positivity have led to the development of novel management practices , including " neoadjuvant " hormonal therapy ( NHT ) . The optimal duration of NHT is unknown . We undertook the present analysis to evaluate the effect of NHT on pathologic stage of PCa and resection limit status in patients with prostate cancer and treated with total androgen ablation either for three or six months before RP . Between January 1996 and February 1998 , 259 men with prostate cancer underwent radical retropubic prostatectomy and bilateral pelvic node dissection in the 26 centres participating in the Italian randomised prospective PROSIT study . Whole mount sectioning of the complete RP specimens was adopted in each centre for accurately evaluating the pathologic stage and resection limit status . By February 1998 , haematoxylin and eosin stained sections from 155 RP specimens had been received and evaluated by the reviewing pathologist ( RM ) . 64 cases had not been treated with total androgen ablation ( e.g . NHT ) before RP was performed , whereas 58 and 33 had been treated for three and six months , respectively . 114 patients were clinical stage B whereas 41 were clinical stage C. After three months of total androgen ablation , pathological stage B was more prevalent among patients with clinical B tumours , compared with untreated patients ( 57 % in treated patients vs. 36 % in untreated ) . The percentage of cancers with negative margins was statistically significantly greater in patients treated with neoadjuvant therapy than those treated with immediate surgery alone ( 69 % vs. 42 % , respectively ) . After six months of NHT therapy the proportion of patients with pathological stage B ( 67 % vs. 36 % , respectively ) and negative margins was greater than after 3 months ( 92 % vs. 42 % , respectively ) . For clinical C tumours , the prevalence of pathological stage B and negative margins in the patients treated for either 3 or 6 months was not as high as in the clinical B tumours , when compared with the untreated group ( pathological stage B : 31 % and 33 % vs. 6 % in the clinical C cases , respectively . Negative margins : 56 % and 67 % vs. 31 % , respectively ) . The initial results of this study suggest that total androgen ablation before RP is beneficial in men with clinical stage B because of the significant pathological downstaging and decrease in the number of positive margins in the RP specimens . These two effects are more pronounced after six months of NHT than after three months of therapy . The same degree of beneficial effects are not observed in clinical C tumours .

total androgen ablation

radical prostatectomy ( RP )

total androgen ablation

total androgen ablation

NHT

total androgen ablation

neoadjuvant therapy

immediate surgery alone

total androgen ablation before

RP

NHT

pathological stage B

negative margins

pathological downstaging

positive margins in the RP specimens

beneficial effects

prostate cancer


Problem-solving counseling for caregivers of the cognitively impaired : effective for whom ? BACKGROUND Individualized problem-solving counseling for caregivers of cognitively impaired relatives is thought to help caregivers cope with the stress and burden of caregiving . Few studies have shown the effectiveness of counseling for these caregivers . OBJECTIVES To determine the effectiveness of individualized problem-solving counseling by nurses for caregivers and the expenditures of health care utilization . METHOD Caregivers ( n = 77 ) of the cognitively impaired living at home were randomized to receive nurse counseling or not . Psychosocial adjustment to their relative 's illness , psychological distress , burden , coping skills , and expenditures were measured after 6 months and 1 year . RESULTS Although on average , all caregivers receiving nurse counseling indicated no improvement in psychosocial adjustment to their relative 's illness , psychological distress , or caregiver burden , they found counseling very helpful and it was effective for a subgroup of caregivers . Those with poor logical analysis coping skills at baseline had decreased psychological distress ( F ( 1,53 ) = 9.7 , p = .003 ) and improved psychosocial adjustment ( F ( 1,53 ) = 4.7 , p = .035 ) after 1 year . Caregivers in control and counseling groups whose relatives entered a nursing home improved their psychosocial adjustment 23 % on average whereas those continuing to live in the community decreased by 8 % . Almost half as many relatives entered nursing homes in the counseling group ( n = 9 vs. n = 5 ) but these compared to control group relatives had greater annualized per person expenditures for health and social services ( Cdn $ 23,437 vs. Cdn $ 15,151 ) . CONCLUSIONS Caregivers found nurse counseling most helpful . Those indicating infrequent use of logical analysis coping skills showed benefits .

Problem-solving counseling

problem-solving counseling

nurse counseling or

not

nurse counseling

control

counseling

counseling

control

nurse counseling

relative 's illness

psychological distress

burden

coping skills

expenditures

improvement

relative 's illness

psychological distress

caregiver burden

psychological distress

psychosocial adjustment

psychosocial adjustment

health and social services

77 )

cognitively impaired


Oral and parenteral glutamine in bone marrow transplantation : a randomized , double-blind study . BACKGROUND Total parenteral nutrition ( TPN ) supplemented with glutamine ( GLN ) has been reported to be effective for patients with bone marrow transplantation ( BMT ) . Our aim was to evaluate enteral and parenteral glutamine in patients undergoing BMT . METHODS For evaluation of GLN in BMT , 66 patients with 43 hematologic and 23 solid malignancies ( 21 breast carcinomas ) , were randomized , double-blinded , to either oral GLN ( n = 35 ) or glycine-control ( GLY ) ( n = 31 ) , 10 g three times daily . When TPN became necessary , patients who received GLN orally were given TPN with GLN ( 0.57 g/kg ) . Those who received GLY received standard TPN , isocaloric and isonitrogenous . Patients with hematologic malignancies received high-dose chemotherapy , total body irradiation , and either allogeneic ( ALLO ) BMT ( n = 18 ) or autologous ( AUTO ) stem cell transplantation ( n = 25 ) . Patients with solid malignancies ( n = 23 ) received AUTO . RESULTS There were 14 in-hospital deaths without relationship to GLN administration . For respective comparisons of ALLO and AUTO transplants in the GLN and GLY hematologic groups and AUTO in the solid tumor groups , there were no significant differences in hospital stay , duration of stay after BMT , TPN days , neutrophil recovery > 500/mm3 , incidence of positive blood cultures , sepsis , mucositis , and diarrhea . Acute graft us host disease occurred in 1 of 10 hematologic patients receiving GLN and in 3 of 8 patients receiving GLY placebo ( p > .05 ) . Possible reduction in need for TPN and a suggestion of improved long-term survival were associated with GLN . CONCLUSIONS Oral and parenteral GLN seemed to be of limited benefit for patients having AUTO or ALLO BMT for hematologic or solid malignancies . Further study of long-term effects of GLN in BMT seems warranted .

glutamine

oral GLN

glycine-control

TPN

GLN

TPN

GLN

TPN

stem cell transplantation

AUTO

GLN

sepsis , mucositis , and diarrhea

Acute graft us host disease

improved long-term survival

patients undergoing BMT

66 patients

Patients with hematologic malignancies

relationship to GLN administration .

1 of 10


Gender differences in response to nicotine replacement therapy : objective and subjective indexes of tobacco withdrawal . K. A. Perkins ( 1996 ) recently proposed that nicotine reinforcement controls smoking to a greater degree among men than women and that consequently , nicotine replacement therapy ( NRT ) during smoking cessation should benefit men more than women . The authors tested this hypothesis . Polysomnographic measures of sleep and self-report indexes of tobacco withdrawal were collected pre- and postcessation from an active nicotine patch group and a placebo patch group in a randomized , double-blind clinical trial ( N = 34 ) . Objective sleep parameters supported Perkins 's hypothesis and indicated that among women , NRT may be less effective at suppressing certain withdrawal responses compared with men and may produce some iatrogenic effects . Valid and reliable self-report measures of withdrawal did not reveal gender differences in response to NRT .

nicotine replacement therapy

nicotine reinforcement

nicotine replacement therapy ( NRT )

nicotine patch

placebo patch

NRT

NRT

sleep and self-report indexes

may produce some iatrogenic effects


Amphotericin B in children with malignant disease : a comparison of the toxicities and pharmacokinetics of amphotericin B administered in dextrose versus lipid emulsion . In a prospective , randomized clinical trial , the toxicity of 1 mg of amphotericin B ( AmB ) per kg of body weight per day infused in 5 % dextrose was compared with that of AmB infused in lipid emulsion in children with malignant disease . In an analysis of 82 children who received a full course of 6 days or more of AmB ( 117 courses ) , it was shown that there were significant increases in plasma urea and creatinine concentrations and in potassium requirement after 6 days of therapy with both AmB infused in dextrose and AmB infused in lipid emulsion , with there being no difference between the two methods of AmB administration . An intent-to-treat comparison of the numbers of courses affected by acute toxicity ( fever , rigors ) and chronic toxicity ( nephrotoxicity ) also indicated that there was no significant difference between AmB infused in dextrose ( 78 courses ) and AmB infused in lipid emulsion ( 84 courses ) . The pharmacokinetics of AmB were investigated in 20 children who received AmB in dextrose and 15 children who received AmB in lipid emulsion . Blood samples were collected up to 24 h after administration of the first dose , and the concentration of AmB in plasma was analyzed by a high-performance liquid chromatography assay . The clearance ( CL ) of AmB in dextrose ( 0.039 +/- 0.016 liter . h-1 . kg-1 ) was significantly lower ( P < 0.005 ) than the CL of AmB in lipid emulsion ( 0.062 +/- 0 . 024 liter . h-1 . kg-1 ) . The steady-state volume of distribution for AmB in dextrose ( 0.83 +/- 0.33 liter . kg-1 ) was also significantly lower ( P < 0.005 ) than that for AmB in lipid emulsion ( 1.47 +/- 0.77 liter . kg-1 ) . Although AmB in lipid emulsion is apparently cleared faster and distributes more widely than AmB in dextrose , this study did not reveal any significant advantage with respect to safety and tolerance in the administration of AmB in lipid emulsion compared to its administration in dextrose in children with malignant disease .

Amphotericin B

amphotericin B administered in dextrose

lipid emulsion

amphotericin B ( AmB )

dextrose

AmB infused in lipid emulsion

AmB

AmB

dextrose

AmB

lipid emulsion

AmB

AmB

dextrose

AmB infused in lipid emulsion

AmB

AmB

dextrose

AmB in lipid emulsion

AmB

AmB in dextrose

AmB in lipid emulsion

AmB in lipid emulsion

AmB in lipid emulsion

AmB in dextrose

AmB

dextrose

pharmacokinetics of AmB

concentration of AmB in plasma

clearance ( CL ) of AmB in dextrose

AmB in lipid emulsion

AmB in dextrose

safety and tolerance

children

malignant disease :

children

malignant disease

children

malignant disease


Effect of granulocyte/colony-stimulating factor on the onset of the adult respiratory distress syndrome . To evaluate the effect of granulocyte/colony-stimulating factor ( G-CSF ) on the onset of the adult respiratory distress syndrome ( ARDS ) , we investigated whether the incidence of ARDS due to pulmonary infection differed between the G-CSF group which received chemotherapy with G-CSF and historical controls without G-CSF . We evaluated 132 patients with hematological malignancy in complete remission without any main organ dysfunction who had been treated between April 1983 and December 1997 . We compared the incidence of ARDS due to pulmonary infection between those who received G-CSF and those who did not . There was no remarkable difference in the number of patients , gender , age , or distribution of primary diseases between the two groups . The intensity of chemotherapy was not considered to significantly differ between the two groups , though the chemotherapy regimens administered differed slightly . In the G-CSF group , the duration of neutropenia was significantly shorter and the frequency of documented infection was significantly decreased . We could not find any relationship between ARDS due to pulmonary infection and any anticancer agent or antibiotics . There was no relationship between the kind of G-CSF and the incidence of ARDS due to pulmonary infection ( per chemotherapy session ; p > 0.10 , per case ; p > 0.30 , chi2 test ) . The incidence of ARDS due to pulmonary infection per chemotherapy session was 4.21 % , and showed a higher tendency in the G-CSF group ( p < 0.100 , chi2 test ) . The incidence of ARDS due to pulmonary infection per case was 25.4 % and was significantly higher in the G-CSF group ( p < 0.025 , chi2 test ) . The incidence of ARDS due to pulmonary infection was higher in the G-CSF group than in the controls , suggesting that G-CSF promotes the development of ARDS due to pulmonary infection .

granulocyte/colony-stimulating factor

chemotherapy with G-CSF

historical controls without G-CSF

G-CSF

G-CSF

G-CSF

G-CSF

G-CSF

G-CSF

G-CSF

intensity of chemotherapy

duration of neutropenia

pulmonary infection

pulmonary infection

respiratory distress syndrome

historical controls without G-CSF


Low-dose growth hormone treatment with diet restriction accelerates body fat loss , exerts anabolic effect and improves growth hormone secretory dysfunction in obese adults . Growth hormone ( GH ) can induce an accelerated lipolysis . Impaired secretion of GH in obesity results in the consequent loss of the lipolytic effect of GH . Dietary restriction as a basic treatment for obesity is complicated by poor compliance , protein catabolism , and slow rates or weight loss . GH has an anabolic effect by increasing insulin-like growth factor ( IGF ) -I . We investigated the effects of GH treatment and dietary restriction on lipolytic and anabolic actions , as well as the consequent changes in insulin and GH secretion in obesity . 24 obese subjects ( 22 women and 2 men ; 22-46 years old ) were fed a diet of 25 kcal/kg ideal body weight ( IBW ) with 1.2 g protein/kg IBW daily and were treated with recombinant human GH ( n = 12 , 0.18 U/kg IBW/week ) or placebo ( n = 12 , vehicle injection ) in a 12-week randomized , double-blind and placebo-controlled trial . GH treatment caused a 1.6-fold increase in the fraction of body weight lost as fat and a greater loss of visceral fat area than placebo treatment ( 35.3 vs. 28.5 % , p < 0.05 ) . In the placebo group , there was a loss in lean body mass ( -2.62 +/- 1.51 kg ) and a negative nitrogen balance ( -4.52 +/- 3.51 g/day ) . By contrast , the GH group increased in lean body mass ( 1.13 +/- 1.04 kg ) and had a positive nitrogen balance ( 1.81 +/- 2.06 g/day ) . GH injections caused a 1.6-fold increase in IGF-I , despite caloric restriction . GH response to L-dopa stimulation was blunted in all subjects and it was increased after treatment in both groups . GH treatment did not induce a further increase in insulin levels during an oral glucose tolerance test ( OGTT ) but significantly decreased free fatty acid ( FFA ) levels during OGTT . The decrease in FFA area under the curve during OGTT was positively correlated with visceral fat loss . This study demonstrates that in obese subjects given a hypocaloric diet , GH accelerates body fat loss , exerts anabolic effects and improves GH secretion . These findings suggest a possible therapeutic role of low-dose GH with caloric restriction for obesity .

Growth hormone

diet

recombinant human GH

placebo

GH

GH

GH injections

GH

GH

accelerated lipolysis

lipolytic effect of GH

insulin-like growth factor ( IGF ) -I

lipolytic and anabolic actions

insulin

GH secretion

lean body mass

negative nitrogen balance

lean body mass

positive nitrogen balance

increase in IGF-I

GH response to L-dopa stimulation

insulin levels

free fatty acid ( FFA ) levels

FFA area

visceral fat loss

body fat loss

exerts anabolic effects

GH secretion

obese

adults

obesity

obese

women

men

22-46 years

obese