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首页> 外文期刊>Current therapeutic research, clinical and experimental. >Postmarketing surveillance of rabeprazole in upper gastrointestinal peptic lesions in Japanese patients with coexisting hepatic disorders
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Postmarketing surveillance of rabeprazole in upper gastrointestinal peptic lesions in Japanese patients with coexisting hepatic disorders

机译：日本合并肝病患者上雷贝拉唑在上消化道消化道病变中的上市后监测

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Many Japanese patients with hepatic disorders confirmed on diagnostic imaging and coexisting upper gastrointestinal (GI) peptic lesions receive treatment with proton pump inhibitors. Some pharmacotherapies used to treat peptic ulcers have been associated with adverse drug reactions (ADRs),including elevated liver enzyme levels.The aim of this study was to determine the tolerability and effectiveness of rabeprazole sodium in treating peptic lesions in patients with coexisting hepatic disorders.This open-label,practice-based,postmarketing surveillance investigation was conducted at 15 centers across Japan. Male and female patients aged ≥18 years with peptic lesions confirmed on upper GI endoscopy and with underlying hepatic disease were enrolled.Patients were randomly assigned to receive rabeprazole 10 or 20 mg PO (tablet) QD after a meal for up to 8 weeks.Tolerability was assessed using monitoring of the incidence of ADRs determined by direct patient questioning, spontaneous reporting,and laboratory assessment. All patients who received at least 1 dose of study drug were included in the tolerability assessment. Effectiveness was assessed at baseline and study end using the rates of achievement of improvement on endoscopy, relief of subjective/objective symptoms (rates of improvement in epigastric pain and heartburn), and global improvement. The effectiveness analysis included all patients with complete data before and after treatment. Subanalyses were conducted to determine the effectiveness of drug by identification of the proportion of patients with coexisting hepatic disorders (cirrhosis, chronic hepatitis, and other hepatic diseases [eg, alcoholic hepatitis, fatty liver]) and by peptic lesion (gastric ulcer, duodenal ulcer, stomal ulcer, and reflux esophagitis) who achieved improvement.A total of 114 patients were enrolled; 108 patients were included in the tolerability analysis (81 men, 27 women; mean age, 59.9 years; 10-mg dose, 90 patients; 20-mg dose, 18 patients) and 98 patients were included in the analysis of effectiveness. Twenty-one ADRs occurred in 11 (10.2%) patients. Serious ADRs occurred in 2 patients (elevated bilirubin level and hepatic encephalopathy, 1 patient each). Administration of rabeprazole was discontinued in 5 patients due to the occurrence of the following ADRs: constipation (1 patient); epigastric pain (1); dyslalia, disorientation, tremor, sleep disorder, and hepatic encephalopathy (1); diarrhea (1);and elevated alkaline phosphatase and y-glutamyl transpeptidase levels (1). On endoscopy, the proportion of patients achieving improvement with either dose was 30/33 (90.9%).The relief rates assessed using subjective symptoms were 47/55 (85.5%) and 47/56 (83.9%) for epigastric pain and heartburn, respectively. The proportion of patients achieving global improvement with either dose was 80/98 (81.6%) patients (49/62 [79.0%] for cirrhosis, 11/16 [68.8%] for chronic hepatitis, and 20/20 [100.0%] for other hepatic diseases [alcoholic hepatitis, fatty liver]).In this study in Japanese patients with hepatic disorders, rabeprazole was well tolerated and appeared effective for the treatment of upper GI peptic lesions.
机译：通过诊断性影像学检查和并存的上消化道（GI）消化道病变证实的许多日本肝病患者接受了质子泵抑制剂治疗。一些用于治疗消化性溃疡的药物治疗与药物不良反应（ADR）有关，包括肝酶水平升高。本研究的目的是确定雷贝拉唑钠在共存肝病患者中治疗消化性病变的耐受性和有效性。这项公开的，基于实践的售后监督调查是在日本15个中心进行的。入选了≥18岁，经上消化道内窥镜检查证实有消化性病变并伴有潜在肝病的男性和女性患者，并随机分配患者接受餐后达8周的雷贝拉唑10或20 mg PO（片剂）QD治疗。通过对患者直接询问，自发报告和实验室评估确定的ADR发生率的监测来评估病情。接受至少1剂研究药物剂量的所有患者均包括在耐受性评估中。在基线和研究结束时使用内窥镜检查的改善率，主观/客观症状的缓解率（上腹痛和胃灼热的改善率）以及总体改善率评估疗效。有效性分析包括所有患者治疗前后的完整数据。通过鉴定并存肝病（肝硬化，慢性肝炎和其他肝病（例如酒精性肝炎，脂肪肝））的患者比例和消化性病变（胃溃疡，十二指肠溃疡）进行亚分析，以确定药物的有效性，气孔溃疡和反流性食管炎）获得改善。共纳入114例患者;耐受性分析包括108例患者（男81例，女性27例;平均年龄59.9岁; 10毫克剂量，90例患者; 20毫克剂量，18例患者），而98例患者纳入了有效性分析。 11例（10.2％）患者发生21例ADR。 2例患者发生了严重的ADR（胆红素水平升高和肝性脑病，每例1例）。由于下列不良反应的发生，有5例患者中止了雷贝拉唑的给药：便秘（1例）;上腹痛（1）;痢疾，迷失方向，震颤，睡眠障碍和肝性脑病（1）;腹泻（1）;碱性磷酸酶和γ-谷氨酰转肽酶水平升高（1）。在内窥镜检查中，无论哪种剂量均可改善的患者比例为30/33（90.9％）。使用主观症状评估的缓解率分别为47/55（85.5％）和47/56（83.9％），用于上腹痛和胃灼热，分别。两种剂量均达到总体改善的患者比例为80/98（81.6％）患者（肝硬化为49/62 [79.0％]，慢性肝炎为11/16 [68.8％]，而20/20 [100.0％]）其他肝病（酒精性肝炎，脂肪肝）。在这项针对日本肝病患者的研究中，雷贝拉唑具有良好的耐受性，对治疗上消化道消化性病变似乎有效。

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