Wu Meng-Chieh, Wang Yao-Kuang, Liu Chung-Jung, Yu Fang-Jung, Kuo Fu-Chen, Liu Min-Li, Kuo Chao-Hung, Wu Deng-Chyang, Huang Yao-Kang, Wu I-Chen
Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
Department of Internal Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung, Taiwan.
Gastroenterol Res Pract. 2017;2017:5320180. doi: 10.1155/2017/5320180. Epub 2017 Jul 16.
This randomized controlled study aimed to evaluate whether adding bismuth to the standard first-line triple therapy could improve the eradication rate of . A total of 162 patients with infection were randomly assigned to either the 7-day triple therapy group (RAK regimen: rabeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg bid; = 81) or the bismuth plus triple therapy group ( = 81). In the RBAK group, bismuth subcitrate 360 mg twice daily was added to the RAK regimen. A follow-up endoscopy or urea breath test was performed at least 4 weeks after eradication to confirm the treatment efficacy. Comparable compliance and eradication rates were observed in both groups in either intention-to-treat [RAK 72.8% (59/81) versus RBAK 77.8% (63/81); = 0.47] or per protocol analysis [RAK 74.7% (59/79) versus RBAK 81.8% (63/77); = 0.26]. Adverse effects were commonly reported (50.6% for both groups) although most of these did not cause cessation of treatment. The resistance rate was 27.2% for metronidazole and 12.3% for clarithromycin. Adding bismuth to the standard 7-day triple therapy did not substantially increase the eradication rate. Further study is needed clarifying whether extending the duration of RBAK regimen to 10-14 days can lead to a better result.
这项随机对照研究旨在评估在标准一线三联疗法中添加铋剂是否能提高幽门螺杆菌的根除率。共有162例幽门螺杆菌感染患者被随机分为7天三联疗法组（RAK方案：雷贝拉唑20毫克、阿莫西林1克和克拉霉素500毫克，每日两次；n = 81）或铋剂加三联疗法组（n = 81）。在RBAK组中，在RAK方案基础上加用枸橼酸铋360毫克，每日两次。根除治疗后至少4周进行随访内镜检查或尿素呼气试验以确认治疗效果。在意向性分析[RAK组为72.8%（59/81），RBAK组为77.8%（63/81）；P = 0.47]或符合方案分析[RAK组为74.7%（59/79），RBAK组为81.8%（63/77）；P = 0.26]中，两组的依从性和幽门螺杆菌根除率相当。不良反应报告较为常见（两组均为50.6%），尽管大多数不良反应未导致治疗中断。甲硝唑耐药率为27.2%，克拉霉素耐药率为12.3%。在标准7天三联疗法中添加铋剂并未显著提高根除率。需要进一步研究以明确将RBAK方案的疗程延长至10 - 14天是否能取得更好的效果。
