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雷莫司琼治疗腹泻型肠易激综合征:一项随机对照试验的系统评价和荟萃分析

Ramosetron for the treatment of irritable bowel syndrome with diarrhea: a systematic review and meta-analysis of randomized controlled trials.

作者信息

Qi Qingqing, Zhang Yan, Chen Feixue, Zuo Xiuli, Li Yanqing

机构信息

Department of Gastroenterology, Qilu Hospital, Shandong University, 107 Wenhuaxi Road, Jinan, Shandong Province, 250012, China.

出版信息

BMC Gastroenterol. 2018 Jan 8;18(1):5. doi: 10.1186/s12876-017-0734-2.

Abstract

BACKGROUND

Ramosetron is a potent and selective serotonin type 3 receptor antagonist. This meta-analysis aimed to analyze the efficacy and safety of ramosetron for irritable bowel syndrome with diarrhea (IBS-D).

METHODS

Pubmed, MEDLINE, EMBASE and the Cochrane Library were searched for randomized controlled trials investigating the efficacy and safety of ramosetron for IBS-D. Risk of bias was assessed as described in the Cochrane handbook. A random effects model was used to calculate the effects of ramosetron vs placebo on symptomatic improvements, including relief of overall IBS symptoms, relief of abdominal discomfort/pain, improvement in abnormal bowel habits, and improvement in stool consistency, expressed as pooled relative risks (RRs) with 95% confidence interval (CI). Adverse events data were also summarized with RRs.

RESULTS

Four randomized controlled trials involving 1623 participants were included. Compared with placebo, ramosetron could lead to relief of overall IBS symptoms (RR 1.70; 95%CI 1.48, 1.95), relief of abdominal discomfort/pain (RR 1.41; 95%CI, 1.24, 1.59), improvement in abnormal bowel habits (RR 1.72; 95%CI, 1.50, 1.98) and improvement in stool consistency (RR 1.71; 95%CI 1.40, 2.08). Ramosetron could lead to relief of overall IBS symptoms in both male and female patients (RR; 95%CI: 1.94; 1.58, 2.38 and 1.49; 1.25, 1.79). The RR (95%CI) for reported adverse events of ramosetron vs placebo was 1.10 (0.97, 1.26) across all studies. No serious adverse events (e.g., ischemic colitis) were reported. The incidences of hard stool and constipation were higher in ramosetron group compared with placebo group (RR; 95%CI: 4.74; 3.00, 7.51 and 2.53; 1.57, 4.10, respectively).

CONCLUSIONS

Ramosetron had beneficial effects to both male and female IBS-D patients. Treatment with ramosetron could cause more hard stool and constipation, without severe adverse events.

摘要

背景

雷莫司琼是一种强效且选择性的5-羟色胺3型受体拮抗剂。本荟萃分析旨在分析雷莫司琼治疗腹泻型肠易激综合征(IBS-D)的疗效和安全性。

方法

检索了PubMed、MEDLINE、EMBASE和Cochrane图书馆,以查找研究雷莫司琼治疗IBS-D疗效和安全性的随机对照试验。按照Cochrane手册中的描述评估偏倚风险。采用随机效应模型计算雷莫司琼与安慰剂相比在症状改善方面的效果,包括整体IBS症状缓解、腹部不适/疼痛缓解、异常排便习惯改善以及粪便稠度改善,以合并相对风险(RRs)及95%置信区间(CI)表示。不良事件数据也用RRs进行汇总。

结果

纳入了四项涉及1623名参与者的随机对照试验。与安慰剂相比,雷莫司琼可使整体IBS症状缓解(RR 1.70;95%CI 1.48,1.95)、腹部不适/疼痛缓解(RR 1.41;95%CI 1.24,1.59)、异常排便习惯改善(RR 1.72;95%CI 1.50,1.98)以及粪便稠度改善(RR 1.71;95%CI 1.40,2.08)。雷莫司琼可使男性和女性患者的整体IBS症状均得到缓解(RR;95%CI:1.94;1.58,2.38和1.49;1.25,1.79)。在所有研究中,雷莫司琼与安慰剂相比报告的不良事件的RR(95%CI)为1.10(0.97,1.2,6)。未报告严重不良事件(如缺血性结肠炎)。与安慰剂组相比,雷莫司琼组硬便和便秘的发生率更高(RR;95%CI:分别为4.74;3.00,7.51和2.53;1.57,4.10)。

结论

雷莫司琼对男性和女性IBS-D患者均有有益作用。雷莫司琼治疗可能会导致更多硬便和便秘,但无严重不良事件。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70be/5759234/328b8f595c5e/12876_2017_734_Fig1_HTML.jpg

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