Leeds Institute of Medical Research at St. James's, University of Leeds, Leeds, UK.
Leeds Gastroenterology Institute, St. James's University Hospital, Leeds, UK.
Gut. 2020 Jan;69(1):74-82. doi: 10.1136/gutjnl-2018-318160. Epub 2019 Apr 17.
OBJECTIVE: Over half of patients with IBS have either diarrhoea (IBS-D) or a mixed stool pattern (IBS-M). The relative efficacy of licenced pharmacological therapies is unclear in the absence of head-to-head trials. We conducted a network meta-analysis to resolve this uncertainty. DESIGN: We searched MEDLINE, Embase, Embase Classic, the Cochrane central register of controlled trials, and Clinicaltrials.gov through January 2019 to identify randomised controlled trials (RCTs) assessing the efficacy of licenced pharmacological therapies (alosetron, eluxadoline, ramosetron and rifaximin) in adults with IBS-D or IBS-M. Trials included in the analysis reported a dichotomous assessment of overall response to therapy, and data were pooled using a random effects model. Efficacy and safety of all pharmacological therapies were reported as a pooled relative risk with 95% CIs to summarise the effect of each comparison tested. Treatments were ranked according to their p score. RESULTS: We identified 18 eligible RCTs (seven alosetron, five ramosetron, two rifaximin and four eluxadoline), containing 9844 patients. All were superior to placebo for the treatment of IBS-D or IBS-M at 12 weeks, according to the Food and Drug Administration (FDA)-recommended endpoint for trials in IBS. Alosetron 1 mg twice daily was ranked first for efficacy, based on the FDA-recommended composite endpoint of improvement in both abdominal pain and stool consistency, effect on global symptoms of IBS and effect on stool consistency. Ramosetron 2.5µg once daily was ranked first for effect on abdominal pain. Total numbers of adverse events were significantly greater with alosetron 1 mg twice daily and ramosetron 2.5µg once daily, compared with placebo. Rifaximin 550 mg three times daily ranked first for safety. Constipation was significantly more common with all drugs, except rifaximin 550 mg three times daily. CONCLUSION: In a network meta-analysis of RCTs of pharmacological therapies for IBS-D and IBS-M, we found all drugs to be superior to placebo, but alosetron and ramosetron appeared to be the most effective.
目的：半数以上的 IBS 患者要么患有腹泻（IBS-D），要么患有混合性粪便模式（IBS-M）。在没有头对头试验的情况下，许可的药物治疗的相对疗效尚不清楚。我们进行了一项网络荟萃分析以解决这一不确定性。
设计：我们检索了 MEDLINE、Embase、Embase Classic、Cochrane 对照试验中心注册库和 Clinicaltrials.gov，以查找评估 IBS-D 或 IBS-M 成人许可药物治疗（阿洛司琼、埃鲁索多林、雷莫司琼和利福昔明）疗效的随机对照试验（RCT）。分析中纳入的试验报告了对治疗的总体反应的二分评估，并且使用随机效应模型对数据进行了汇总。使用汇总相对风险（95%CI）报告所有药物治疗的疗效和安全性，以总结每个测试比较的效果。根据 p 评分对治疗方法进行排名。
结果：我们确定了 18 项符合条件的 RCT（阿洛司琼 7 项、雷莫司琼 5 项、利福昔明 2 项和埃鲁索多林 4 项），包含 9844 名患者。根据食品和药物管理局（FDA）推荐的 IBS 试验终点，所有药物在 12 周时均优于安慰剂，用于治疗 IBS-D 或 IBS-M。根据 FDA 推荐的改善腹痛和粪便一致性、IBS 全球症状的疗效和粪便一致性的综合终点，阿洛司琼 1mg 每日两次被评为疗效最佳。雷莫司琼 2.5μg 每日一次被评为治疗腹痛的疗效最佳。与安慰剂相比，阿洛司琼 1mg 每日两次和雷莫司琼 2.5μg 每日一次的不良反应总数显著增加。利福昔明 550mg 每日三次被评为安全性最佳。除利福昔明 550mg 每日三次外，所有药物的便秘发生率均显著增加。
结论：在一项 IBS-D 和 IBS-M 药物治疗 RCT 的网络荟萃分析中，我们发现所有药物均优于安慰剂，但阿洛司琼和雷莫司琼似乎最有效。
Lancet Gastroenterol Hepatol. 2019-12-16
Cochrane Database Syst Rev. 2007-10-17
Cochrane Database Syst Rev. 2020-10-19
Cochrane Database Syst Rev. 2017-12-22
Cochrane Database Syst Rev. 2021-4-19
Cochrane Database Syst Rev. 2020-1-9
Lancet Gastroenterol Hepatol. 2019-8-29
Cochrane Database Syst Rev. 2004
Gastroenterol Hepatol (N Y). 2025-7
J Clin Med. 2025-6-5
Nat Rev Gastroenterol Hepatol. 2025-4-25
J Neurogastroenterol Motil. 2025-4-30
World J Gastroenterol. 2025-2-28
Nat Rev Gastroenterol Hepatol. 2025-3
Zhongguo Dang Dai Er Ke Za Zhi. 2024
Zotero 插件