Liou Jyh-Ming, Chen Chi-Yi, Wu Ming-Shiang, Hsu Ming-Tse, Fang Chien-Chung, Lin Yu-Ling, Chang Ming-Chu, Lin Jaw-Town, Wang Hsiu-Po
Division of Gastroenterology, Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei.
Hepatogastroenterology. 2006 Sep-Oct;53(71):792-6.
BACKGROUND/AIMS: Proton pump inhibitor-based triple therapy containing immediate-release clarithromycin is an important regimen for the eradication of Helicobacter pylori (H. pylori). However, the efficacy of modified-release clarithromycin for the treatment of H. pylori-associated peptic ulcer disease is still unknown. The aims of the study were to compare the efficacy of modified-release clarithromycin and immediate-release clarithromycin on the rates of ulcer healing and eradication of H. pylori.
One hundred and sixty-one patients with Helicobacter pylori-associated peptic ulcer were randomized to receive one-week triple therapy with either modified-release clarithromycin 1000mg once daily (AECMR) or immediate-release clarithromycin 500mg twice daily (AECIR) in combination with amoxicillin 1,000mg twice daily (A) and esomeprazole 40mg once daily (E). Post-treatment ulcer healing status and Helicobacter pylori status was determined by endoscopy and 13C urea-breath test at 16 weeks and 8 weeks after completion of triple therapy, respectively.
Helicobacter pylori eradication rates were 87.5% and 87.7% for AECMR and AECIR, respectively, in the intent-to-treat analysis. Eradication rates in the per-protocol groups were 90.3% and 91.4% for AECMR and AECIR, respectively. In both the intent-to-treat and per-protocol analyses, the eradication rates were comparable in the AECMR and AECIR groups (p= 1.0 and 1.0, respectively). Ulcer healing rates in the intention-to-treat analysis were 81.3% and 77.8% for AECMR and AECIR, respectively. Ulcer healing rates in the per-protocol analysis were 90.3% and 90.0% for AECMR and AECIR groups, respectively. In both the intention-to-treat and per-protocol analyses, the ulcer healing rates were comparable in the AECMR and AECIR groups (p=0.645 and 0.584, respectively).
Modified-release clarithromycin 1000mg once daily can be used as an alternative to immediate-release clarithromycin 500mg twice daily for the treatment of Helicobacter pylori-associated peptic ulcer disease.
背景/目的：含速释克拉霉素的基于质子泵抑制剂的三联疗法是根除幽门螺杆菌（H. pylori）的重要方案。然而，缓释克拉霉素治疗幽门螺杆菌相关性消化性溃疡疾病的疗效仍不明确。本研究的目的是比较缓释克拉霉素和速释克拉霉素在溃疡愈合率和幽门螺杆菌根除率方面的疗效。
161例幽门螺杆菌相关性消化性溃疡患者被随机分为两组，分别接受为期一周的三联疗法，一组为每日一次服用1000mg缓释克拉霉素（AECMR），另一组为每日两次服用500mg速释克拉霉素（AECIR），同时两组均联合每日两次服用1000mg阿莫西林（A）和每日一次服用40mg埃索美拉唑（E）。分别在三联疗法完成后16周和8周通过内镜检查和13C尿素呼气试验确定治疗后溃疡愈合情况和幽门螺杆菌状态。
在意向性分析中，AECMR组和AECIR组的幽门螺杆菌根除率分别为87.5%和87.7%。符合方案组中，AECMR组和AECIR组的根除率分别为90.3%和91.4%。在意向性分析和符合方案分析中，AECMR组和AECIR组的根除率均具有可比性（p值分别为1.0和1.0）。在意向性分析中，AECMR组和AECIR组的溃疡愈合率分别为81.3%和77.8%。在符合方案分析中，AECMR组和AECIR组的溃疡愈合率分别为90.3%和90.0%。在意向性分析和符合方案分析中，AECMR组和AECIR组的溃疡愈合率均具有可比性（p值分别为0.645和0.584）。
每日一次服用1000mg缓释克拉霉素可作为每日两次服用500mg速释克拉霉素的替代方案用于治疗幽门螺杆菌相关性消化性溃疡疾病。
