ABSTRACT
BACKGROUND: Peginterferon (PEG-IFN) α-2a has been shown to induce a sustained virologic response (SVR) in 20-30% of "hepatitis B e antigen (HBeAg)"-negative patients. AIM: To determine the safety and efficacy of PEG-IFN α-2a in HBeAg-negative, genotype D-naive patients and to analyze the predictors of response. METHODS: This prospective, multicenter, open-label, nonrandomized trial was conducted at four hospitals. A total of 35 consecutive HBeAg-negative naive genotype D patients received PEG-IFN α-2a for 48 weeks. RESULTS: Based on a cutoff of hepatitis B virus (HBV) DNA <400 copies ml(-1), an early virologic response (EVR) at week 12, end of treatment virologic response (ETVR) at week 48, and SVR at week 72 were achieved by 3 (9%), 9 (26%), and 8 patients (23%), respectively. The EVR rate improved to 43%, ETVR to 49%, and SVR to 57%, when a HBV DNA cutoff level of <20,000 copies ml(-1) was used. Pretreatment HBsAg level was not a predictor for SVR on univariate analysis, but correlated with decline in HBV DNA levels at weeks 48 and 72. On multivariate logistic regression analysis, low body weight, high alanine aminotransferase (ALT), low HBV DNA, and low triglyceride levels were identified as baseline predictors of SVR. CONCLUSION: HBeAg-negative genotype D-naive patients treated with PEG-IFN α-2a achieved SVR in 23 (HBV <400 copies ml(-1)) and 57% (HBV <20,000 copies ml(-1)) of patients, a better response than previously reported that might be related to the absence of drug resistance in these naive patients. Pretreatment predictors of SVR were low body weight, high ALT, low HBV DNA, and low triglycerides.
ABSTRACT
BACKGROUND: Blood in the stomach and esophagus in patients with variceal bleeding often obscures the endoscopic view and makes endoscopic intervention difficult to perform. Erythromycin, a motilin agonist, induces gastric emptying. OBJECTIVE: To assess the effect of erythromycin on endoscopic visibility and its outcome in patients with variceal bleeding. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Tertiary care hospital. PATIENTS: Adult patients with liver cirrhosis presenting with hematemesis within the previous 12 hours. INTERVENTION: Either 125 mg erythromycin or placebo administered intravenously 30 minutes before endoscopy. MAIN OUTCOME MEASUREMENTS: Endoscopic visibility during index endoscopy and mean duration of procedure. SECONDARY OUTCOME MEASUREMENTS: Need for repeat endoscopy and blood transfusions within 24 hours, endoscopy-related complications, and length of hospital stay. RESULTS: A total of 102 patients received either erythromycin or placebo (53 erythromycin and 49 placebo). Forty-seven patients in the erythromycin group and 43 in the placebo group had variceal bleeding and were considered for final analysis. A completely empty stomach was seen in 48.9% of the erythromycin group versus 23.3% of the placebo group (P<.01). Mean endoscopy duration was significantly shorter in the erythromycin group than in the placebo group (19.0 minutes vs 26.0 minutes, respectively; P<.005). Length of hospital stay was significantly shorter in the erythromycin group than in the placebo group (3.4 days vs 5.1 days, respectively; P<.002). The need for repeat endoscopy and the mean number of units of blood transfused did not differ significantly in the 2 groups. No adverse events were observed with erythromycin. LIMITATIONS: Sample size not sufficient to measure the need for repeat endoscopy and survival benefit. CONCLUSIONS: Erythromycin infusion before endoscopy in patients with variceal bleeding significantly improves endoscopic visibility and shortens the duration of the index endoscopy. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01060267.).
Subject(s)
Endoscopy, Gastrointestinal/methods , Erythromycin/administration & dosage , Esophageal and Gastric Varices/surgery , Gastric Emptying/drug effects , Gastrointestinal Hemorrhage/surgery , Hemostasis, Endoscopic/methods , Preoperative Care/methods , Dose-Response Relationship, Drug , Double-Blind Method , Female , Follow-Up Studies , Gastrointestinal Agents/administration & dosage , Humans , Injections, Intravenous , Male , Middle Aged , Prospective Studies , Treatment OutcomeSubject(s)
Diabetes Mellitus/therapy , Herbal Medicine , Liver Failure/etiology , Plants, Medicinal/adverse effects , Aged , Anti-Bacterial Agents , Cefuroxime/therapeutic use , Female , Humans , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Liver Failure/diagnosis , Liver Failure/drug therapy , Necrosis/diagnosis , Necrosis/drug therapy , Necrosis/etiology , Vitamin K/therapeutic use , Vitamins/therapeutic useABSTRACT
BACKGROUND: There are a paucity of data available on the exact prevalence of delta hepatitis among HBsAg positive carriers in Saudi Arabia. The aim of this study was to determine the exact prevalence of delta antibody in HBsAg positive carriers in Saudi Arabia. PATIENTS AND METHODS: Between January 1996 and January 1997 the serum of 19,250 patients was tested for HBsAg. HBsAg positive sera were subsequently tested for delta antibody. In addition, 3147 healthy blood donors underwent HBsAg testing. Those who were HBsAg positive had delta antibody testing using the ELISA method. RESULTS: Among 19,250 patients, 780 (4.1 %) were HBsAg positive, of which 67 (8.6%) patients were anti-delta positive and 2 (0.25%) were anti-delta borderline. Among 3147 healthy donors, 60 (1.9%) were HBsAg positive with 2 (3.3%) being delta antibody positive. CONCLUSIONS: The prevalence of delta antibody among hospital- and clinic-based HBsAg positive patients was 8.6% and among healthy blood donors who were HBsAg positive, the prevalence was 3.3%. Furthermore, delta antibody prevalence was 0.06% for "all comers", i.e., healthy blood donors. With decreasing hepatitis B prevalence as a result of universal vaccination, it is expected that delta hepatitis infection among Saudis will decrease with time.
