Dai Jianfeng, Gong Jing, Guo Rui
College of Agroforestry and Health, The Open University of Sichuan, Chengdu, China.
Department of Gastroenterology, Eastern Hospital, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, 585 Honghebei Street, Chengdu, Sichuan Province, 610101, China.
Eur J Clin Pharmacol. 2022 Nov;78(11):1727-1737. doi: 10.1007/s00228-022-03376-1. Epub 2022 Sep 3.
There is a lack of real-world evidence of the comparative effectiveness of fidaxomicin versus vancomycin or metronidazole for treating patients with Clostridium difficile (CDI) infection. No systematic evidence comparing these treatment regimens using real-world observational studies was published up to date. The goal of this study is to compare the fidaxomicin and vancomycin/metronidazole regimens in terms of treatment outcomes in CDI patients.
Systematic and comprehensive search was carried out in the following databases and search engines: EMBASE, Cochrane, MEDLINE, ScienceDirect, and Google Scholar from 1954 until January 2022. Newcastle-Ottawa (NO) scale was used to assess the risk of bias. Meta-analysis was carried out using random effects model, and pooled odds ratios (OR) with 95% confidence interval (CI) were reported.
A total of 10 studies satisfied the inclusion criteria, most of them were with poorer quality. The pooled OR was 0.40 (95% CI: 0.09-1.68; I = 82.4%) for clinical cure and 2.02 (95% CI: 0.36-11.39; I = 88.4%) for sustained cure. We reported pooled OR of 0.69 (95% CI: 0.40-1.20; I = 65.7%) for the recurrence rate, 2.81 (95% CI: 1.08-7.29; I = 70.6%) for the treatment failure, and 0.73 (95% CI: 0.50-1.07; I = 0%) for all-cause mortality between patients that received fidaxomicin and vancomycin. The pooled OR was 0.71 (95% CI: 0.05-9.47; I = 69.6%) in terms of recurrence between patients receiving fidaxomicin and metronidazole.
Fidaxomicin and vancomycin/metronidazole regimens did not have significant difference in terms of treatment outcomes, such as clinical cure, sustained cure, recurrence, and all-cause mortality. However, there was significantly higher risk of treatment failure in CDI patients taking fidaxomicin.
缺乏关于非达霉素与万古霉素或甲硝唑治疗艰难梭菌(CDI)感染患者的比较有效性的真实世界证据。截至目前,尚未发表使用真实世界观察性研究比较这些治疗方案的系统性证据。本研究的目的是比较非达霉素与万古霉素/甲硝唑方案在CDI患者治疗结局方面的差异。
在以下数据库和搜索引擎中进行了系统全面的检索:1954年至2022年1月期间的EMBASE、Cochrane、MEDLINE、ScienceDirect和谷歌学术。使用纽卡斯尔-渥太华(NO)量表评估偏倚风险。采用随机效应模型进行荟萃分析,并报告合并比值比(OR)及95%置信区间(CI)。
共有10项研究符合纳入标准,其中大多数质量较差。临床治愈的合并OR为0.40(95%CI:0.09 - 1.68;I = 82.4%),持续治愈的合并OR为2.02(95%CI:0.36 - 11.39;I = 88.4%)。我们报告接受非达霉素和万古霉素治疗的患者复发率合并OR为0.69(95%CI:0.40 - 1.20;I = 65.7%),治疗失败的合并OR为2.81(95%CI:1.08 - 7.29;I = 70.6%),全因死亡率的合并OR为0.73(95%CI:0.50 - 1.07;I = 0%)。接受非达霉素和甲硝唑治疗的患者复发方面的合并OR为0.71(95%CI:0.05 - 9.47;I = 69.6%)。
非达霉素与万古霉素/甲硝唑方案在临床治愈、持续治愈、复发和全因死亡率等治疗结局方面无显著差异。然而,服用非达霉素的CDI患者治疗失败风险显著更高。