Biomedical subjects

P J Thuluvath

Publications and source records attributed to P J Thuluvath.

At least 19 recordsLinked to original sources

PubMed2006

Oral V2 receptor antagonist (RWJ-351647) in patients with cirrhosis and ascites: a randomized, double-blind, placebo-controlled, single ascending dose study.

BACKGROUND: RWJ-351647 is a selective V2 receptor antagonist that inhibits vasopressin-induced water reabsorption in the kidney. AIM: To investigate the safety and tolerability of RWJ-351647 compared with placebo after single oral dose administration to patients with cirrhosis and ascites, on a stable treatment with furosemide and spironolactone. METHODS: Single oral doses of 1, 2 and 5 mg of RWJ-351647 were administered to 24 patients with ascites on stable concomitant diuretic treatment. RESULTS: RWJ-351647 had a tmax of 1 to 1.1 h and mean half-life of 10.4-17.4 h. There was no affect on the pharmacokinetics of concomitant diuretics. Increases in cumulative urine volume and free water excretion, and a decrease in urine osmolality were noted in a dose-dependent manner reaching the statistical significance at the 5-mg dose. Four patients exhibited a decrease of > 2 kg in weight in the 24 h after dosing. RWJ-351647 was well tolerated, with no evidence of a dose-related increase in adverse events when compared with placebo. No changes in either serum chemistry or plasma AVP (arginine vasopressin) and renin levels were observed despite the observed aquaresis. CONCLUSION: RWJ-351647 is an effective aquaretic causing dose-dependent increases in urine output and free water clearance, when co-administered with conventional diuretics in patients with cirrhosis and ascites.

Administration, Oral↗

PubMed2005

Biliary complications after liver transplantation: the role of endoscopy.

Biliary complications are important causes of early and late postoperative morbidity and mortality after liver transplantation and are seen in 10-20 % of the patients. The common biliary complications include bile leaks, stones or debris, and anastomotic strictures. Less common complications are hilar strictures, intrahepatic strictures, and papillary stenosis/dysfunction. The complications are similar in living-donor and cadaveric liver transplantations, except for a higher incidence of bile leaks among living-donor transplant recipients. The clinical presentation of post-liver transplant bile duct complications is often subtle, and noninvasive imaging studies may sometimes fail to detect mild but clinically significant stenoses or small leaks. Early recognition and prompt treatment of biliary complications following liver transplantation reduces the morbidity and improves long-term graft and patient survival. In this report, we discuss the role of endoscopy in the diagnosis, treatment options, and the outcome for patients with biliary complications following liver transplantation.

Bile Duct Diseases↗

PubMed2004

Randomised, double blind, placebo controlled trial of interferon, ribavirin, and amantadine versus interferon, ribavirin, and placebo in treatment naïve patients with chronic hepatitis C.

BACKGROUND AND AIM: In this study, we compared the efficacy of triple therapy (interferon alfa, ribavirin, and amantadine) with standard therapy (interferon alfa and ribavirin) in treatment naïve patients with chronic hepatitis C virus (HCV). METHODS: In this prospective, randomised, double blind, placebo controlled, multicentre study, 85 patients (amantadine group) received a three drug regimen of interferon alfa-2b 3 million units three times per week, ribavirin 1000-1200 mg daily in divided doses, and amantadine 100 mg twice daily, and 86 patients (placebo group) received interferon alfa-2b, ribavirin, and identical placebo. Treatment was discontinued at 24 weeks if patients had detectable HCV RNA by polymerase chain reaction (PCR). All patients were followed for 24 weeks after completion of treatment. The primary end point was undetectable HCV-RNA by PCR at 24 weeks (sustained viral clearance) after completion of treatment. RESULTS: At the end of treatment, HCV RNA clearance was seen in 32.9% of the amantadine group and 38.4% of the placebo group (p=0.3). Sustained virological response was seen in 24.7% of the amantadine group and in 27.9% of the placebo group by intention to treat analysis; response rate was 30.4% and 34.8%, respectively, in those who completed 24 weeks of treatment. Poor response was seen in both groups among cirrhotics, African-Americans, genotype 1, and those with a higher viral load. By multivariate analysis, genotype 1, high viral load, and low serum albumin were the only predictors of poor response. Addition of amantadine to the standard regimen did not result in any unexpected side effects. CONCLUSION: Response to triple therapy of interferon alfa, ribavirin, and amantadine was similar to standard therapy of interferon alfa and ribavirin. Our results suggest that amantadine has no role in the management of HCV.

Adult↗

PubMed2003

Phase II study of the efficacy and safety of cisplatin-epinephrine injectable gel administered to patients with unresectable hepatocellular carcinoma.

PURPOSE: To study the efficacy and safety of percutaneous cisplatin-epinephrine (CDDP-EPI) injectable gel in patients with localized unresectable hepatocellular carcinoma (HCC). PATIENTS AND METHODS: Eligible patients had histologically proven HCC, no prior treatment except for surgery, and no more than three tumors (each measured < or = 7 cm, total tumor volume < or = 200 cm(3)). They were treated percutaneously under ultrasound or computed tomography (CT) guidance, with up to 10 mL of CDDP-EPI gel (1 mL contains 4 mg of CDDP and 0.1 mg of EPI) per treatment and four treatments in 6 weeks to a maximum of eight treatments. The primary end points were tumor response, defined by change of percentage of tumor necrosis according to CT criteria, and safety. Survival parameters were secondary end points. RESULTS: From June 1997 to April 2000, 58 patients (median age, 65 years) entered the study. All patients were assessable for safety, and 51 were assessable for efficacy. The median number of treatments was four (range, one to eight treatments). Objective response rate was 53% (27 of 51 patients), including 16 complete and 11 partial responses. Of the 27 responders, 14 (52%) subsequently developed progressive disease, but in most of them (93%), a new tumor arose at untreated liver sites. Median survival was 27 months (range, 18.4 to 35.7 months). The 1-, 2-, and 3-year survival rates were 79%, 56%, and 14% respectively. The procedure was well tolerated with only minor side effects. CONCLUSION: Percutaneous local ablation with CDDP-EPI injectable gel can induce significant tumor necrosis and local control for localized unresectable HCC, and the treatment is well tolerated.

Adult↗

PubMed2001

Human monocytic ehrlichiosis: an emerging pathogen in transplantation.

BACKGROUND: The spectrum of disease caused by Ehrlichia spp. ranges from asymptomatic to fatal. Awareness and early diagnosis of the infection is paramount because appropriate therapy leads to rapid defervescence and cure. If left untreated, particularly in immunosuppressed patients, ehrlichioses may result in multi-system organ failure and death. METHODS: We report the second case of human monocytic ehrlichiosis (HME) in a liver transplant recipient, and review the literature. RESULTS: The patient presented with fever and headache, had negative cultures, and despite broad-spectrum antimicrobial coverage appeared progressively septic. After eliciting a history of tick exposure we treated the patient empirically with doxycycline. The diagnosis of HME was confirmed by 1) polymerase chain reaction (PCR) for Ehrlichia chaffeensis, 2) acute and convalescent serum titers, and 3) in vitro cultivation of E chaffeensis from peripheral blood. CONCLUSION: Although human ehrlichioses are relatively uncommon, they are emerging as clinically significant arthropod-borne infections. Although epidemiological exposure is responsible for infection, immunosuppression makes patients more likely to succumb to disease. A high index of suspicion and early treatment results in a favorable outcome.

Animals↗

PubMed2001

Prolonged QTc interval and its relationship to autonomic cardiovascular reflexes in patients with cirrhosis.

BACKGROUND/AIMS: We have previously shown that an abnormality in cardiac autonomic reflexes (AN) is an independent predictor of mortality in patients with chronic liver disease. Aim of this study was to determine whether there was an association between prolonged QTc interval and cardiac AN. METHODS: Cardiac AN and QTc interval were determined in 130 patients (Child A 42, B 53, C 35) with alcoholic and non-alcoholic liver disease. RESULTS: Prolonged QTc (>440ms) was seen in 58 (Child A 30%, B 46%, C 60%, P=0.04) patients. Autonomic tests were normal in 21%, borderline abnormal in 36% and definitely abnormal in 43%. QTc correlated with albumin (P<0.001), prothrombin time (P=0.003) and Child-Pugh score (P<0.001), but not with Valsalva ratio, heart rate variation with 6 breath/min breathing, tilt table or isometric exercise. By logistic regression analysis, QTc correlated only with Child-Pugh score (P<0.001). Mean QTc of 34 who died during the follow up was higher than survivors. Cox regression analysis showed that only Child-Pugh score and AN were independent predictors of mortality. CONCLUSIONS: Prolonged QTc seen in liver disease is independent of their cardiac autonomic function, but is related to the severity of the liver disease.

Adult↗

PubMed2001

Autonomic dysfunction and cholelithiasis in patients with cirrhosis.

Gallstones are seen in 33-46% of patients with cirrhosis, and their prevalence is known to increase with the duration and severity of liver disease. We hypothesized that autonomic neuropathy may contribute to the formation of gallstones or gallbladder disease, as in diabetics with autonomic neuropathy, due to impaired gallbladder emptying. The objective of our study was to determine the prevalence of gallstones or gallbladder disease in cirrhotic patients with and without autonomic neuropathy. We determined autonomic function tests, gallstones, and other gallbladder disease in 123 (male 71) with varying severity of liver disease (Child classes: A, 40; B, 45; C, 35). In all, 54 patients had gallstones and an additional 22 patients had other gallbladder disease (cholecystitis, common bile duct stones, or debris). Autonomic neuropathy was seen in 97 patients (one abnormal test in 48 and two or more in 49). The prevalence of gallstones was similar in Child A (57%), Child B (64%), and Child C (63%) cirrhosis. The gallstones or gallbladder disease was not increased in women, blacks, diabetics, or alcoholic cirrhotics. The prevalence of gallbladder disease was increased in patients with autonomic neuropathy (51% vs 35%, P = 0.08); in patients with Child C cirrhosis, gallstones (P = 0.018) and gallbladder disease (P = 0.03) were seen more commonly in patients with autonomic neuropathy. Our findings suggest that autonomic neuropathy may contribute to the formation of gallstones in patients with advanced cirrhosis, perhaps by impairing gallbladder and sphincter of Oddi dysmotility.

Adult↗

PubMed2001

Outcome of liver transplantation in patients with diabetes mellitus: a case-control study.

The influence of preexisting diabetes mellitus (DM) on outcome after orthotopic liver transplantation (OLT) has not been well defined. The objective of our study was to compare the morbidity and mortality after OLT in 57 patients with preexisting DM (3 type I, 54 type II) with 114 age-, sex-, and race-matched patients without DM (case controls). The demographics were similar in both groups. Pretransplantation serum creatinine was significantly higher in the diabetic group compared with case controls. The incidence of the following complications was significantly higher in the diabetic group after OLT: cardiovascular (61.4% vs. 21.9%, P <.001), major (54.4% vs. 29.8%, P =.002) and minor infections (29.8% vs. 7.9%, P <.0001), renal (59.7% vs. 20.2%, P <.001), ophthalmologic (10.5% vs. 0.9%, P =.01), respiratory (24.6% vs. 7.0%, P =.001), neurologic (31.6% vs. 7.0%, P <.001), hematologic (19.3% vss 2.6%, P =.001), musculoskeletal (24.6% vs. 5.3%, P =.001), and malignancy (22.8% vs. 10.5%, P =.03). The duration of hospital stay, cost of hospitalization, retransplantation, and overall graft survival were similar. Acute rejection was seen in 50.9% of diabetics compared with 25.4% in controls (P =.0009). One-year (87% vs. 77%) and 2-year (81.6% vs. 70.1%) patient survival was similar, but 5-year survival was lower in the DM group (34.4% vs. 67.7%, P =.002). In conclusion, preexisting diabetes is associated with a significant post-OLT morbidity and mortality, and our observations suggest that patients with DM warrant more rigorous pre- and post-OLT evaluation.

Case-Control Studies↗

PubMed2001

Liver transplantation in patients with severe portopulmonary hypertension treated with preoperative chronic intravenous epoprostenol.

Portopulmonary hypertension (PPHTN) is no longer an absolute contraindication to orthotopic liver transplantation (OLT). The pre-OLT management of patients with PPHTN requires early diagnosis and chronic therapy with intravenous epoprostenol to decrease pulmonary vascular resistance (PVR). Close follow-up is necessary to reassess pulmonary artery pressures (PAPs) and evaluate right ventricular (RV) function. This assists in the optimal timing of OLT. Successful management also necessitates reassessment of pulmonary artery hemodynamics just before OLT, with clearly defined parameters used to determine whether to proceed. Even with the intraoperative and postoperative availability of potent pulmonary vasodilators, clinical management may be suboptimal in reducing PAP. Adequate reduction in PVR and improvement in RV function in response to chronic epoprostenol therapy may facilitate successful OLT. We present a case report and review the limited experience with this treatment.

Adult↗

PubMed2001

Vaccination, screening for malignancy, and health maintenance of the liver transplant recipient.

Transplant recipients are highly motivated to maintain their recovered health status and are generally compliant with pharmacotherapy and medical follow-up. As well as routine blood tests and monitoring of immunosuppressant drug levels, recipients require immunization updates and regular screening for malignancy, diabetes, hypertension, hyperlipidemia, and ophthalmologic complications. Little information is available about the consistent implementation of these health maintenance strategies in this population. A telephone survey of liver transplant recipients was conducted using a 20-item questionnaire. It was designed to assess the frequency and adequacy of health maintenance screening, immunizations, and screening tests for malignancy, which are specific to the liver transplant population. We contacted 60 liver recipients transplanted at our institution between 1992 and 1996. The mean age of the patients (31 men and 29 women) was 48 years (range, 42-56 years). Before transplantation, pneumococcal and hepatitis B vaccination occurred in 13% and 18%, respectively. After transplantation, 27% had received pneumococcal vaccination and none had received primary vaccination for hepatitis B. Forty-eight percent received yearly influenza vaccination. Of 60 questioned recipients, 2 were aware of their varicella exposure status or a possible need for varicella immunoglobulin if a primary exposure to chickenpox were to occur. Two were aware of the need for the recipient's children or grandchildren who were undergoing polio vaccination to receive an inactivated intramuscular polio preparation. Yearly screening for dermatologic or oral malignancies was provided to only 40% of patients. Physician-performed breast examination or screening mammograms was done in 38% of the surveyed women. Eleven percent of the women had received a gynecologic examination with a cervical cytologic examination within the prior 2 years. Of the male recipients, 68% received either digital prostate examination or serum prostate specific antigen determinations or both. Of 60 recipients, 30 had had either flexible sigmoidoscopy or colonoscopy within the previous 2 years. Yearly dental examinations were performed on 75% of patients, and more than 90% had at least yearly blood pressure and weight determinations. Of 60 patients, 41 were aware of cholesterol and lipid profiles having been performed within the past 2 years. Ophthalmologic screening was performed in 83% of surveyed recipients. This survey suggests that routine health maintenance management is less than optimal in this population. Follow-up based on a standard protocol may improve the health care of these patients.

Adult↗

PubMed2001

Features of recurrent primary sclerosing cholangitis in two consecutive liver allografts after liver transplantation.

Recurrence of primary sclerosing cholangitis (PSC) after liver transplantation is very uncommon. The true incidence of recurrence is unknown, mainly because of the difficulty in differentiating ischemic strictures from that of recurrent disease. Primary sclerosing cholangitis and ischemic strictures have identical histopathologic and cholangiographic features. We report a young man who had recurrence of PSC in two allografts and report our experience in 32 patients who had liver transplantation for PSC. Six patients (18%) had evidence of non-anastomotic strictures and, of these, only one patient (reported here) had unequivocal evidence of true recurrence. The strictures in other five patients happened because of ischemia. The recurrence of the disease in two allografts in an immunosuppressed patient, in the absence of ischemia, chronic rejection, or any known pathogen, raises the question of the role of an unidentified infectious agent in the etiopathogenesis of PSC.

Adult↗

PubMed2001

Postoperative morbidity, mortality, costs, and long-term survival in severely obese patients undergoing orthotopic liver transplantation.

OBJECTIVE: Severely obese patients who undergo orthotopic liver transplantation are likely to have higher morbidity, mortality, costs, and a lower long-term survival. METHODS: This case-control study was done at a university hospital. One hundred twenty-one consecutive patients who underwent liver transplantation between 1994 and 1996 were studied. Severe obesity was defined as body mass index (BMI) more than 95th percentile (>32.3 for women and >31.1 for men), and moderate obesity was defined as BMI between 27.3 and 32.3 for women and 27.8 and 31.1 for men. The outcome measures were intraoperative complications, postoperative complications (wound infections, bile leak, vascular complications), length of hospital stay, costs of transplantation, and long-term survival RESULTS: The baseline characteristics, UNOS status, and cause of liver disease at the time of transplantation were similar in severely obese (n = 21, BMI = 37.4+/-4.8 kg/m2), obese (n = 36, BMI 28.7+/-0.9 kg/m2), and nonobese patients (n = 64, BMI 23.8+/-2.5 kg/m2). The intraoperative complications and transfusion requirements were similar in all three groups. The postoperative complications such as respiratory failure (p = 0.009) and systemic vascular complications (p = 0.04) were significantly higher in severely obese patients. The overall perioperative complication rate was 0.61 (39 of 64 patients) in nonobese patients, 0.77 (28 of 36 patients) in obese patients, and 1.43 (30 of 21 patients) in severely obese patients (p = 0.01). Infections were the leading cause of death in all groups accounting for 57-66% of deaths. The length of hospital stay was significantly higher in obese patients. The hospital costs of transplantation were higher ($30,000-$40,000) in severely obese patients than in nonobese patients. The long-term patient survival was similar between the groups (Kaplan-Meier analysis). CONCLUSIONS: Despite higher postoperative complications, severely obese patients have an acceptable long-term survival, which is comparable to nonobese patients. The cost of transplantation is higher among severely obese patients. There was no increased incidence of cardiovascular mortality among severely obese patients during the follow-up period.

Adult↗

PubMed2001

Spontaneous bacterial peritonitis--in-hospital mortality, predictors of survival, and health care costs from 1988 to 1998.

OBJECTIVES: Spontaneous bacterial peritonitis (SBP) is a complication of end-stage liver disease with a reported mortality of 30-50%. In this study, we investigated the outcome of all patients admitted to Maryland hospitals with SBP from 1988 to 1998. Main outcomes considered included trends in survival rates over time, changes in the length of stay, total health care costs, and variables that predicted survival rates. METHODS: We used the Maryland Health Services Cost Review database of all patients admitted to Maryland hospitals with an International Classification of Diseases (Ninth Revision) code for both peritonitis and cirrhosis from 1988 to 1998. RESULTS: A total of 348 patients were admitted with an in-hospital mortality of 32.6%; there was no significant change in mortality rate during this period. The survival rate was similar in the university and community hospitals. In the logistic regression analysis, age (p = 0.001) and intensive care unit stay (p = 0.0001) were found to significantly influence the survival rates; those patients who had an intensive care unit stay were 2.8 times more likely to die than those who did not have an intensive care unit stay, controlling for age. The average length of hospital stay remained unchanged (13.5 +/- 12.7 days) during the study period. Although the median hospital charge (excluding professional fees) remained unchanged, mean inflation-adjusted charges increased from $7,897 in 1988 to $25,902 in CONCLUSIONS: The mortality rate associated with SBP has remained unchanged over an 11-yr period from 1988 to 1998. The mortality showed a strong correlation with age and intensive care unit stay. The median hospital stay and median charges remained unchanged during this period, but mean costs increased significantly because of increased use of resources by a few patients.

Adult↗

PubMed2000

Heart rate variability as a predictor of autonomic dysfunction in patients awaiting liver transplantation.

Chronic liver disease, both alcoholic and nonalcoholic, has been shown to be associated with autonomic neuropathy, as well as other hemodynamic and circulatory disturbances. In a longitudinal study, the presence of autonomic neuropathy and the severity of liver disease were independent risk factors for mortality. The aim of this study was to determine whether the severity of liver disease correlated with measures of heart rate variability. We studied 21 patients being evaluated for liver transplantation to determine if severity of disease correlated with heart rate variability and compared them to seven healthy controls. Heart rate variability was determined for a series of 500 consecutive R-R intervals during quiet breathing. Standard deviation, pNN50, a marker of parasympathetic function, and approximate entropy (ApEn), a recently described measure of regularity, were calculated. Four standard tests of autonomic function were also performed. pNN50 was significantly reduced in all liver disease patients compared to controls (P < 0.05). Both standard deviation and ApEn were significantly reduced in Child's class C patients suggesting a generalized dysfunction in cardiovascular homeostasis. ApEn was significantly lower in the nonsurvivors during follow-up than the survivors (P < 0.05). In conclusion, increasing severity of liver failure is associated with a reduction in total heart rate variability and regularity. Measurement of heart rate variability offers a simple, noninvasive means of assessing the cardiovascular and autonomic effects of liver disease, particularly in those awaiting liver transplantation.

Adult↗

PubMed2000

Prevalence of obesity and diabetes in patients with cryptogenic cirrhosis: a case-control study.

It has recently been suggested that nonalcoholic steatohepatitis (NASH) is an under-recognized cause of cryptogenic cirrhosis (CC) on the basis of higher prevalence of obesity and type II diabetes among these patients. To test this hypothesis, we studied 65 consecutive patients with advanced cirrhosis (Child-Pugh Score >/= 7) of undetermined etiology (CC) from our active waiting list for liver transplantation in January 1993, 1996, and 1999. For each patient, we selected 2 age- and sex-matched controls from the corresponding lists. The prevalence of obesity (defined as body mass index [BMI] >/= 30) and diabetes were compared between the groups. Sixteen patients (and their 32 controls) with CC were excluded as further review of records suggested other possible etiologies. Thus, the final analysis included 49 patients and 98 controls. The etiology of cirrhosis in the control group was alcohol in 16.3%, chronic viral hepatitis in 30.6%, autoimmune hepatitis in 8.2%, and primary biliary cirrhosis (PBC) or primary sclerosing cholangitis in 35.7%. The prevalence of obesity (55% vs. 24%) and type II diabetes (47% vs. 22%) was significantly higher in patients with CC compared with controls. Twenty-three percent of patients with CC had both obesity and diabetes compared with 5% among controls (P =.002). There was no difference in the prevalence of hypercholesterolemia (serum cholesterol > 200 mg/dL) between the groups. In conclusion, patients with advanced CC are more likely to be obese and diabetic compared with age- and sex-matched patients with advanced cirrhosis. This supports the hypothesis that NASH may be an etiological factor in some of the patients with CC.

Adult↗

PubMed1999

Autonomic and peripheral (sensorimotor) neuropathy in chronic liver disease: a clinical and electrophysiologic study.

Peripheral neuropathy has been reported in association with chronic liver disease. However, the precise incidence, severity and characteristics of neuropathy, and the relationship of neuropathy to different etiologies of liver disease have not been defined. In this study, 58 patients with advanced liver disease were evaluated in detail for the presence of neuropathy. Peripheral (sensorimotor) neuropathy was found in 71% and autonomic neuropathy was found in 48% of the patients. Although the majority of patients were asymptomatic, neurological examination showed distal sensory loss to pain, or vibration or distal loss of reflexes in 17 patients (29%). Sensory neuropathy was seen more commonly than motor axonal polyneuropathy on nerve conduction studies. Quantitative sensory testing was frequently abnormal (62%) and cooling thresholds were more affected than vibration thresholds. Overall, the pattern of neuropathy in patients with liver disease conformed to the pattern expected in "dying back" or length-dependent neuropathy. The neuropathy was most severe in patients with advanced hepatic decompensation. Comparison of causes of liver disease showed no significant differences in the severity of neuropathy among the different etiologies. In conclusion, axonal sensory-motor polyneuropathy and autonomic neuropathy are commonly seen in patients with end-stage liver disease of different causes.

Adult↗

PubMed1999

Cognitive impairment in alcoholic and nonalcoholic cirrhotic patients.

Cognitive impairment is common in patients with advanced liver disease. It has been suggested that patients with alcoholic liver disease (ALD) have more impaired cognition than nonalcoholics. The objective of this study was to characterize any differences in cognitive functions between alcoholic cirrhotic patients and non-alcoholic cirrhotic patients of similar age, education, and severity of liver disease. We assessed cognitive functions in 117 patients with alcoholic cirrhosis and 163 patients with nonalcoholic cirrhosis using a brief battery of neuropsychological tests. In addition, all patients had standard psychiatric examinations to assess the effect of the disease severity, alcoholism, anxiety, and depression on the test scores. The study showed a higher proportion of patients with cognitive impairment in the alcoholic group. Alcoholics performed poorly in tests of memory and motor speed compared with nonalcoholics, despite similar premorbid IQ and education. Because patients with alcoholic cirrhosis had more severe liver disease (Child-Pugh score 8.5 +/- 2.2 vs. 7.6 +/- 2.2, P =.03) than nonalcoholics, the results were reanalyzed after adjusting for the linear effects of Child-Pugh score on cognitive test scores. We also used two-way analysis of variance to examine the interaction between Child class and alcoholism. Finally, the test scores were compared within each Child class. These analyses revealed no primary or interaction effect of alcoholism and confirmed that the differences in the test scores observed in alcoholics reflect the greater severity of their liver disease. The severity of cognitive impairment is similar in both alcoholic and non-alcoholic cirrhotic patients when adjusted for the severity of liver disease.

Adult↗

PubMed1998

A prospective, randomized, double-blind trial evaluating the efficacy of ursodeoxycholic acid in prevention of liver transplant rejection.

Acute cellular rejection (ACR) after orthotopic liver transplantation occurs in 50% to 80% of patients despite the recent advances in immunosuppressive therapy. Adjuvant use of ursodeoxycholic acid (UDCA) is theoretically attractive, but studies have shown conflicting results. In this randomized, controlled study, we evaluated the efficacy of UDCA in reduction of the incidence of ACR. Thirty patients were randomized to receive either UDCA (15 mg/kg) or placebo in addition to the standard triple-drug regimen; 14 patients received UDCA, and the rest received placebo, for 3 to 6 months. The diagnosis of ACR was based on histologic criteria. Three patients withdrew from the study within 1 month of therapy, all because of capsule size. There was no difference in the total incidence of ACR between the placebo and UDCA groups, with 12 and 11 episodes within 6 months, respectively; the overall incidence of rejection was 77%. There were also no differences in the incidence of recurrent rejection, in the number of rejection episodes occurring after 5 days of therapy, or in the use of OKT3. There was no difference in 1-year survival between groups. This study shows that adjuvant therapy with UDCA in addition to standard triple-drug immunosuppressive therapy does not reduce the incidence of ACR.

Acute Disease↗