Alhifany Abdullah A, Almutairi Abdulaali R, Almangour Thamer A, Shahbar Alaa N, Abraham Ivo, Alessa Mohammed, Alnezary Faris S, Cheema Ejaz
Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia.
Pharmacy, University of Arizona, Tucson, Arizona, USA.
BMJ Open. 2019 Nov 7;9(11):e031145. doi: 10.1136/bmjopen-2019-031145.
The risk of recurrent infections (RCDIs) is high when treated with standard antibiotics therapy (SAT) alone. It is suggested that the addition of faecal microbiota transplantation (FMT) or bezlotoxumab after SAT reduces the risk of RCDI. In the absence of head-to-head randomised controlled trials (RCTs), this review attempts to compare the efficacy and safety of bezlotoxumab with FMT in reducing the risk of RCDI in hospitalised patients.
A systematic review and Bayesian network meta-analysis.
A comprehensive search from inception to 30 February 2019 was conducted in four databases (Medline/PubMed, Embase, Scopus, ClinicalTrials.gov).
RCTs reporting the resolution of diarrhoea associated with RCDI without relapse for at least 60 days after the end of treatments as the primary outcome.
We extracted author, year of publication, study design and binomial data that represented the resolution of diarrhoea or adverse events of monoclonal antibodies and FMT infusion. Random-effects models were used for resolution rate of RCDI and adverse events. The Cochrane Risk of Bias tool was used to assess the quality of included RCTs.
Out of 1003 articles identified, seven RCTs involving 3043 patients contributed to the review. No difference was reported between single or multiple infusions of FMT and bezlotoxumab in resolving RCDI, (OR 1.53, 95% credible interval (CrI) 0.39 to 5.16) and (OR 2.86, 95% CrI 1.29 to 6.57), respectively. Patients treated with SAT alone or bezlotoxumab with SAT showed significantly lower rates of diarrhoea than FMT (OR 0, 95% CrI 0 to 0.09) and (OR 0, 95% CrI 0 to 0.19), respectively. There was no difference in terms of other adverse events.
This is the first network meta-analysis that has compared the recently Food and Drug Administration-approved monoclonal antibody bezlotoxumab with FMT for resolving RCDI. The quality of the included RCTs was variable. The findings of this study suggested no difference between single or multiple infusions of FMT and bezlotoxumab. However, FMT was associated with a higher rate of non-serious diarrhoea as opposed to SAT used alone or in combination with bezlotoxumab.
单独使用标准抗生素疗法（SAT）治疗时，复发性艰难梭菌感染（RCDI）风险很高。有人提出，在SAT后加用粪便微生物群移植（FMT）或贝佐妥单抗可降低RCDI风险。在缺乏直接头对头随机对照试验（RCT）的情况下，本综述试图比较贝佐妥单抗与FMT在降低住院患者RCDI风险方面的疗效和安全性。
系统评价和贝叶斯网络荟萃分析。
对四个数据库（Medline/PubMed、Embase、Scopus、ClinicalTrials.gov）进行了从创刊到2019年2月28日的全面检索。
将报告与RCDI相关的腹泻在治疗结束后至少60天内未复发作为主要结局的RCT纳入。
我们提取了作者、发表年份、研究设计以及代表腹泻缓解或单克隆抗体和FMT输注不良事件的二项式数据。随机效应模型用于RCDI缓解率和不良事件分析。采用Cochrane偏倚风险工具评估纳入RCT的质量。
在检索到的1003篇文章中，7项RCT（涉及3043例患者）纳入本综述。在缓解RCDI方面，单次或多次输注FMT与贝佐妥单抗之间未报告有差异，分别为（比值比1.53，95%可信区间（CrI）0.39至5.16）和（比值比2.86，95%CrI 1.29至6.57）。单独接受SAT或接受SAT联合贝佐妥单抗治疗的患者腹泻发生率显著低于接受FMT治疗的患者，分别为（比值比0.95%CrI 0至0.09）和（比值比0.95%CrI 0至0.19）。在其他不良事件方面无差异。
这是第一项将美国食品药品监督管理局最近批准的单克隆抗体贝佐妥单抗与FMT用于缓解RCDI进行比较的网络荟萃分析。纳入的RCT质量参差不齐。本研究结果表明，单次或多次输注FMT与贝佐妥单抗之间无差异。然而，与单独使用SAT或SAT联合贝佐妥单抗相比，FMT与较高的非严重腹泻发生率相关。
