Xie Yong, Zhu Yin, Zhou Hong, Lu Zhi-Fa, Yang Zhen, Shu Xu, Guo Xiao-Bai, Fan Hui-Zhen, Tang Jian-Hua, Zeng Xue-Ping, Wen Jian-Bo, Li Xiao-Qing, He Xing-Xing, Ma Jiu-Hong, Liu Dong-Sheng, Huang Cai-Bin, Xu Ning-Jian, Wang Nong-Rong, Lu Nong-Hua
Yong Xie, Yin Zhu, Hong Zhou, Zhi-Fa Lu, Zhen Yang, Xu Shu, Xing-Xing He, Jiu-Hong Ma, Dong-Sheng Liu, Nong-Hua Lu, Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi Province, China.
World J Gastroenterol. 2014 Aug 28;20(32):11415-21. doi: 10.3748/wjg.v20.i32.11415.
To evaluate the efficacy of furazolidone-based triple and quadruple therapy in eradicating Helicobacter pylori (H. pylori) in a multi-center randomized controlled trial.
A total of 720 H. pylori positive patients with duodenal ulcer disease were enrolled at 10 different hospitals in Jiangxi province in China. The patients were randomly assigned to four treatment groups as follows: patients in Groups 1 and 3 received rabeprazole (10 mg), amoxicillin (1000 mg) and furazolidone (100 mg) twice daily for 7 and 10 d, respectively; patients in Groups 2 and 4 received rabeprazole (10 mg), bismuth (220 mg), amoxicillin (1000 mg) and furazolidone (100 mg) twice daily for 7 and 10 d, respectively. The primary outcome measure was H. pylori eradication rate 4 wk after treatment by intention-to-treat and per protocol analysis, while the secondary outcome measures were symptom and sign changes at the end of treatment and 4 wk after the end of treatment, as well as the proportion of patients who developed adverse events.
The demographic data of the four groups were not significantly different. Overall, 666 patients completed the scheme and were re-assessed with the (13)C-urea breath test. The intention-to-treat analysis of the H. pylori eradication rates in Groups 1, 2, 3 and 4 were 74.44%, 82.78%, 78.89% and 86.11%, respectively. The H. pylori eradication rate in Group 4 was significantly higher than that in Group 1. According to the per protocol analysis, the H. pylori eradication rates in Groups 1, 2, 3 and 4 were 81.21%, 89.22%, 85.54% and 92.26%, respectively. The H. pylori eradication rate in Group 4 was significantly higher than that in Group 1. The number of adverse events was 15 (8.3%), 16 (8.9%), 15 (8.3%) and 17 (9.4%) in Groups 1, 2, 3 and 4, respectively, including dizziness, vomiting, diarrhea, nausea, skin rash, itchy skin, and malaise. The symptoms were relieved without special treatment in all of the patients.
Both 7- and 10-d quadruple furazolidone-based therapies achieve satisfactory H. pylori eradication rates.
在一项多中心随机对照试验中评估基于呋喃唑酮的三联和四联疗法根除幽门螺杆菌（H. pylori）的疗效。
在中国江西省10家不同医院共纳入720例幽门螺杆菌阳性的十二指肠溃疡病患者。患者被随机分为四个治疗组，如下：第1组和第3组患者分别每日两次服用雷贝拉唑（10 mg）、阿莫西林（1000 mg）和呋喃唑酮（100 mg），疗程分别为7天和10天；第2组和第4组患者分别每日两次服用雷贝拉唑（10 mg）、铋剂（220 mg）、阿莫西林（1000 mg）和呋喃唑酮（100 mg），疗程分别为7天和10天。主要结局指标是治疗4周后按意向性分析和符合方案分析的幽门螺杆菌根除率，次要结局指标是治疗结束时和治疗结束后4周的症状和体征变化，以及发生不良事件的患者比例。
四组的人口统计学数据无显著差异。总体而言，666例患者完成了方案并接受了（13）C-尿素呼气试验重新评估。第1、2、3和4组幽门螺杆菌根除率的意向性分析分别为74.44%、82.78%、78.89%和86.11%。第4组的幽门螺杆菌根除率显著高于第1组。根据符合方案分析，第1、2、3和4组幽门螺杆菌根除率分别为81.21%、89.22%、85.54%和92.26%。第4组的幽门螺杆菌根除率显著高于第1组。第1、2、3和4组不良事件的例数分别为15例（8.3%）、16例（8.9%）、15例（8.3%）和17例（9.4%），包括头晕、呕吐、腹泻、恶心、皮疹、皮肤瘙痒和不适。所有患者的症状未经特殊治疗均得到缓解。
基于呋喃唑酮的7天和10天四联疗法均能达到令人满意的幽门螺杆菌根除率。
