难辨梭菌感染复发菌群恢复的临床试验解决率:最新的系统综述和荟萃分析。

IF 4.2 3区医学

Therapeutic Advances in Gastroenterology Pub Date : 2023-05-30 eCollection Date: 2023-01-01 DOI:10.1177/17562848231174293

Raseen Tariq, Darrell S Pardi, Sahil Khanna

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引用次数: 1

摘要

背景:在观察性研究中，微生物群恢复对治疗复发性艰难梭菌感染(CDI)非常有效(治愈率>90%)，但在对照临床试验中的疗效似乎较低。目的:进行一项更新的荟萃分析，以评估开放标签注册前瞻性临床试验中微生物群恢复对复发性CDI的疗效，并与随机对照试验(rct)进行比较。设计:进行系统回顾和荟萃分析。数据来源和方法:截至2022年7月，对各种数据库进行了系统搜索，以确定感兴趣的研究。临床试验的微生物群恢复复发性CDI临床解决一次剂量。我们以95%置信区间(ci)计算加权合并率(wpr)。结果:共纳入19项临床试验，1176例复发性CDI患者。在接受微生物群修复治疗的患者中，897例患者通过单一微生物群修复治疗获得临床治愈(WPR, 78%;95% ci, 71-85%)。研究间存在显著异质性，I2为88%。对照组(非微生物群恢复)的试验分析显示，523例患者中有373例CDI消退(WPR, 72%;95% CI, 60-82%)，微生物群恢复。在9项开放标签临床试验中，653名患者中有524名患者在初始微生物群恢复后出现CDI缓解(WPR, 84%;95% ci, 74-92%)。比较随机对照试验和开放标签试验之间的解决率显示，与开放标签试验相比，随机对照试验的治愈率较低(WPR, 73%对84%，p)。结论:与开放标签和观察性试验相比，随机对照环境中的微生物群恢复导致的解决率较低，可能是由于更严格的定义和纳入标准。开放标签研究的解决率与观察性研究相似。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Resolution rates in clinical trials for microbiota restoration for recurrent Clostridioides difficile infection: an updated systematic review and meta-analysis.

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Resolution rates in clinical trials for microbiota restoration for recurrent Clostridioides difficile infection: an updated systematic review and meta-analysis.

Background: Microbiota restoration is highly effective to treat recurrent Clostridioides difficile infection (CDI) in observational studies (cure rates >90%) but efficacy in controlled clinical trials appears to be lower.

Objectives: To perform an updated meta-analysis to assess the efficacy of microbiota restoration for recurrent CDI in open-label registered prospective clinical trials compared to randomized controlled trials (RCTs).

Design: A systematic review and meta-analysis was conducted.

Data sources and methods: A systematic search of various databases was performed up to July 2022 to identify studies of interest. Clinical trials of microbiota restoration for recurrent CDI with clinical resolution with one dose were included. We calculated weighted pooled rates (WPRs) with 95% confidence intervals (CIs).

Results: In all, 19 clinical trials with 1176 recurrent CDI patients were included. Of the patients treated with microbiota restoration, 897 experienced a clinical cure with a single microbiota restoration therapy (WPR, 78%; 95% CI, 71-85%). There was significant heterogeneity among studies with an I² of 88%. Analysis of trials with a control arm (non-microbiota restoration) revealed CDI resolution in 373 of 523 patients (WPR, 72%; 95% CI, 60-82%) with microbiota restoration. Among the nine open-label clinical trials, CDI resolution was seen in 524 of 653 patients after initial microbiota restoration (WPR, 84%; 95% CI, 74-92%). Comparison of resolution rates between RCTs and open-label trials revealed a lower cure rate in RCTs compared to open-label trials (WPR, 73 versus 84%, p < 0.0001).

Conclusions: Microbiota restoration in a randomized controlled setting leads to lower resolution rates compared to open label and observational settings, likely due to stricter definitions and inclusion criteria. Resolution rates in open-label studies were similar to observational studies.

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来源期刊

Therapeutic Advances in Gastroenterology Medicine-Gastroenterology

自引率

2.40%

发文量

103

期刊介绍： Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area. The editors welcome original research articles across all areas of gastroenterology and hepatology. The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.