序贯疗法与含阿莫西林/四环素的铋剂四联疗法一线根除幽门螺杆菌的比较：一项前瞻性、多中心、随机临床试验。
Comparison of sequential therapy and amoxicillin/tetracycline containing bismuth quadruple therapy for the first-line eradication of Helicobacter pylori: a prospective, multi-center, randomized clinical trial.
作者信息
Lee Ju Yup, Kim Nayoung, Park Kyung Sik, Kim Hyun Jin, Park Seon Mee, Baik Gwang Ho, Shim Ki-Nam, Oh Jung Hwan, Choi Suck Chei, Kim Sung Eun, Kim Won Hee, Park Seon-Young, Kim Gwang Ha, Lee Bong Eun, Jo Yunju, Hong Su Jin
机构信息
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Department of Internal Medicine, Keimyung University School of Medicine, Daegu, South Korea.
出版信息
BMC Gastroenterol. 2016 Jul 26;16(1):79. doi: 10.1186/s12876-016-0490-8.
BACKGROUND
The <80 % Helicobacter pylori eradication rate with sequential therapy is unsatisfactory. Modified bismuth quadruple therapy, replacing metronidazole with amoxicillin, could be promising because H. pylori resistance to tetracycline or to amoxicillin is relatively low. A 14-day modified bismuth quadruple protocol as first-line H. pylori treatment was compared with 10-day sequential therapy.
METHODS
In total, 390 H. pylori-infected subjects participated in the randomized clinical trial: 10-day sequential therapy (40 mg pantoprazole plus 1 g amoxicillin twice a day for 5 days, then 40 mg pantoprazole and 500 mg clarithromycin twice a day and 500 mg metronidazole three times a day for 5 days) or 14-day modified bismuth quadruple therapy (40 mg pantoprazole, 600 mg bismuth subcitrate, 1 g tetracycline, and 1 g amoxicillin, twice a day). (13)C-urea breath test, rapid urease testing, or histology was performed to check for eradication.
RESULTS
Intention-to-treat (ITT) eradication rates of 10-day sequential and 14-day quadruple therapy were 74.6 % and 68.7 %, respectively, and the per-protocol (PP) rates were 84.2 and 76.5 %, respectively. The eradication rate was higher in the sequential therapy group, but neither the ITT nor the PP analyses had a significant difference (P = 0.240 and P = 0.099, respectively). However, the adverse events were significantly lower in the modified bismuth quadruple therapy group than the sequential therapy group (36.9 vs. 47.7 %, P = 0.040).
CONCLUSIONS
Ten-day sequential therapy appears to be more effective despite frequent adverse events. However, both 10-day SQT and 14-day PBAT did not reach the excellent eradication rates that exceed 90 %. Additional trials are needed to identify a more satisfactory first-line eradication therapy.
TRIAL REGISTRATION
ClinicalTrials.gov ( NCT02159976 ); Registration date: 2014-06-03, CRIS ( KCT0001176 ); Registration date: 2014-07-23.
背景
序贯疗法根除幽门螺杆菌的有效率低于80%，效果不尽人意。改良铋剂四联疗法用阿莫西林替代甲硝唑，有望提高疗效，因为幽门螺杆菌对四环素或阿莫西林的耐药率相对较低。本研究比较了14天改良铋剂四联方案作为幽门螺杆菌一线治疗与10天序贯疗法的疗效。
方法
共有390例幽门螺杆菌感染患者参与了这项随机临床试验：10天序贯疗法（40mg泮托拉唑加1g阿莫西林，每日2次，共5天；然后40mg泮托拉唑、500mg克拉霉素和500mg甲硝唑，每日2次，共5天）或14天改良铋剂四联疗法（40mg泮托拉唑、600mg枸橼酸铋钾、1g四环素和1g阿莫西林，每日2次）。采用¹³C尿素呼气试验、快速尿素酶试验或组织学检查判断幽门螺杆菌是否根除。
结果
意向性分析（ITT）显示，10天序贯疗法和14天四联疗法的根除率分别为74.6%和68.7%，符合方案分析（PP）的根除率分别为84.2%和76.5%。序贯疗法组的根除率更高，但ITT分析和PP分析均无显著差异（P分别为0.240和0.099）。然而，改良铋剂四联疗法组的不良事件显著低于序贯疗法组（36.9%对47.7%，P = 0.040）。
结论
尽管不良事件频发，但10天序贯疗法似乎更有效。然而，10天序贯疗法和14天改良铋剂四联疗法的根除率均未达到超过90%的理想水平。需要进一步试验以确定更令人满意的一线根除治疗方案。
试验注册
ClinicalTrials.gov（NCT02159976）；注册日期：2014年6月3日，CRIS（KCT0001176）；注册日期：2014年7月23日。
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