奥替溴铵治疗肠易激综合征的疗效：一项汇总分析。

Efficacy of otilonium bromide in irritable bowel syndrome: a pooled analysis.

作者信息

Clavé Pere, Tack Jan

机构信息

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Hospital de Mataró, Universitat Autònoma de Barcelona, C/ Cirera s/n, 08304, Mataró, Spain.

Translational Research Center for Gastrointestinal Disorders (TARGID), University of Leuven, Belgium Department of Gastroenterology, University Hospital Gasthuisberg, Leuven, Belgium.

出版信息

Therap Adv Gastroenterol. 2017 Mar;10(3):311-322. doi: 10.1177/1756283X16681708. Epub 2017 Jan 16.

DOI:10.1177/1756283X16681708

PMID:28246548

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5305018/

Abstract

BACKGROUND

Otilonium bromide (OB) is a spasmolytic agent acting as an L-type calcium channel antagonist in intestinal and colonic smooth muscle cells (SMCs). We analyzed three independent clinical trials with homogeneous design on patients with irritable bowel syndrome (IBS). After 2 weeks receiving placebo, patients were randomized to receive OB (3 × 40 mg daily) or placebo for 15 weeks. We aimed to perform a pooled analysis of the data from these homogeneous clinical trials to evaluate the efficacy of OB treatment on symptoms and global response of patients.

METHODS

A total of 883 patients with IBS (69.8% women, mean age 46.2 years, 43.8% mixed type) were included, 442 treated with OB and 441 with placebo. The efficacy results from the three studies at weeks 5, 10 and 15 were pooled in an intention-to-treat (ITT) strategy, analyzed with a logistic regression model and described by forest plots.

RESULTS

Despite a placebo effect in all efficacy variables, a significant therapeutic effect of OB was observed at weeks 10 and 15 with reference to: (a) intensity and frequency of abdominal pain; (b) rate of responders as evaluated by patients (71.8% at week 10 and 77.2% at week 15); (c) severity of bloating; (d) rate of responders as evaluated by physicians (55% at week 10 and 63.9% at week 15). No significant OB effect was observed in stool frequency and consistency.

CONCLUSIONS

OB is more effective than placebo in IBS treatment. Therapeutic benefits are significant after 10 weeks and are maximal after 15 weeks of treatment.

摘要

背景

奥替溴铵（OB）是一种解痉剂，在肠道和结肠平滑肌细胞（SMC）中作为L型钙通道拮抗剂发挥作用。我们分析了三项针对肠易激综合征（IBS）患者的设计相同的独立临床试验。在接受2周安慰剂治疗后，患者被随机分为接受OB（每日3次，每次40mg）或安慰剂治疗15周。我们旨在对这些设计相同的临床试验数据进行汇总分析，以评估OB治疗对患者症状和整体反应的疗效。

方法

共纳入883例IBS患者（女性占69.8%，平均年龄46.2岁，43.8%为混合型），442例接受OB治疗，441例接受安慰剂治疗。三项研究在第5、10和15周的疗效结果采用意向性分析（ITT）策略进行汇总，用逻辑回归模型分析并用森林图描述。

结果

尽管在所有疗效变量中均存在安慰剂效应，但在第10周和第15周观察到OB具有显著治疗效果，具体涉及：（a）腹痛强度和频率；（b）患者评估的缓解率（第10周为71.8%，第15周为77.2%）；（c）腹胀严重程度；（d）医生评估的缓解率（第10周为55%，第15周为63.9%）。在大便频率和稠度方面未观察到OB的显著效果。