The Safety of Pharmacotherapy for Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis.

While many studies include the number needed to treat to highlight therapeutic benefits, adding the number needed to harm (NNH), a measure we evaluate herein, could enable more comprehensive risk-benefit assessments.

虽然许多研究包括治疗效果的数字需要治疗(NNT)来突出治疗益处，但在此评估的我们添加了数字需要伤害(NNH)，一个我们评估的措施，可以实现更全面的风险-效益评估。

Methods

PubMed, Web of Science, and Cochrane databases were searched through October 2024.

检索了截至2024年10月的PubMed、Web of Science和Cochrane数据库。

Clinical trials investigating IBS pharmacotherapies including discontinuation rates because of adverse events (AEs) were included.

包括因不良事件（AEs）导致的停药率在内的研究肠易激综合征（IBS）药物治疗的临床试验被纳入。

Data were pooled using a random-effects model.

数据使用随机效应模型进行汇总。

The primary outcome was NNH for each pharmacotherapy, defined as the reciprocal of the absolute difference in risk of AEs leading to treatment discontinuation between the experimental and placebo groups.

主要结果是每种药物治疗的不良事件导致治疗中断的需治疗人数（NNH），定义为实验组与安慰剂组之间导致治疗中断的不良事件风险绝对差异的倒数。

Secondary outcomes included the relative risk of withdrawing because of an AE and the most common AEs for each drug.

次要结果包括因不良事件（AE）撤回的相对风险以及每种药物最常见的不良事件。

Results

Fifty-four trials met inclusion criteria.

共有54项试验符合纳入标准。

For constipation-predominant IBS pharmacotherapies, the NNH for linaclotide, lubiprostone, plecanatide, tegaserod, and tenapanor was 35 ( P < 0.01), 53 ( P = 0.59), 59 ( P < 0.01), 58 ( P = 0.03), and 16 ( P < 0.01), respectively.

对于便秘型肠易激综合征的药物治疗，利那洛肽、卢比前列酮、普乐卡尼肽、替加色罗和特那帕诺的需治疗人数分别为35（P<0.01）、53（P=0.59）、59（P<0.01）、58（P=0.03）和16（P<0.01）。

For diarrhea-predominant IBS pharmacotherapies, the NNH for alosetron and eluxadoline was 14 ( P < 0.01) and 32 ( P < 0.01) whereas the NNH for both rifaximin and ramosetron was a negative, although statistically insignificant, value.

对于腹泻型肠易激综合征的药物治疗，阿洛司琼和艾鲁司特的需治疗人数分别为14（P<0.01）和32（P<0.01），而利福霉素和拉莫司特的需治疗人数为负值，尽管统计上不显著。

For IBS global symptom pharmacotherapies, the tricyclics, the NNH was 24 ( P < 0.01).

对于IBS全球症状的药物治疗，三环类药物的不良事件发生数为24（P<0.01）。

Many AEs were transient without long-term sequela.

许多不良事件是短暂的，没有长期的后遗症。

Discussion

Among pharmacotherapies for IBS, tricyclics (especially at elevated doses), tenapanor, and alosetron have the highest absolute risk of discontinuation because of an AE when compared with rifaximin, the safest pharmacotherapy studied.

在治疗肠易激综合症（IBS）的药物治疗中，三环类药物（特别是高剂量时）、tenapanor和alosetron因不良事件导致的停药绝对风险最高，与研究中安全性最高的药物利福霉素相比。