Duo Hong, Yang Yanwei, Zhang Guqing, Chen Yingxin, Cao Yumeng, Luo Linjie, Pan Huaqin, Ye Qifa
Hubei Key Laboratory of Medical Technology on Transplantation, National Quality Control Center for Donated Organ Procurement, Hubei Clinical Research Center for Natural Polymer Biological Liver, Hubei Engineering Center of Natural Polymer-Based Medical Materials, Zhongnan Hospital of Wuhan University, Institute of Hepatobiliary Diseases of Wuhan University, Transplant Center of Wuhan University, Wuhan, Hubei, China.
Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Clinical Research Center of Hubei Critical Care Medicine, Wuhan, China.
Front Pharmacol. 2024 Oct 17;15:1430724. doi: 10.3389/fphar.2024.1430724. eCollection 2024.
Clostridioides difficile infection (CDI) is the most common cause of healthcare-associated infectious diarrhea. A major clinical challenge is recurrent CDI (rCDI) without effective standard drug-based therapy. Additionally, a comprehensive comparison of various therapy effectiveness in rCDI patients is still under investigation.
A Bayesian network meta-analysis (NMA) of randomized control trials up to March 2024 was performed to investigate the efficacy of rCDI interventions.
Seventeen trials were included, comprising 4,148 CDI patients with ten interventions, including fecal microbiota transplantation (FMT) by lower gastrointestinal (LGI), FMT by upper gastrointestinal (UGI), Autologous FMT (AFMT), vancomycin + FMT, vancomycin, placebo, fidaxomicin, Vowst (SER109), Rebyota (RBX2660), and monoclonal antibody. NMA showed that FMT by LGI had the highest efficacy in treating rCDIs with an odds ratio (95% confidence interval) of 32.33 (4.03, 248.69) compared with placebo. FMT by UGI also showed high efficacy, whereas the efficacy comparison between FMT by LGI and UGI was not statistically significant (ORs) (95% CI), 1.72 (0.65, 5.21). The rankogram and surface under the cumulative ranking curve (SUCRA) also showed FMT by LGI ranked at the top and FMT by UGI ranked second in the curative effect.
NMA demonstrates FMT's significant efficacy in rCDI management, regardless of administration route (lower or upper gastrointestinal). Despite its significant benefits, FMT's safety is a concern due to the lack of standardized FDAcompliant manufacturing and oversight. Microbiota-based therapies also exhibit potential. However, limited research mandates further clinical exploration. Antibiotics, in contrast, display comparatively reduced efficacy in rCDI, potentially linked to disruptions in native gut microflora balance.
https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=368435, Identifier CRD42022368435.
艰难梭菌感染(CDI)是医疗保健相关感染性腹泻最常见的病因。一个主要的临床挑战是复发性CDI(rCDI),且缺乏有效的基于标准药物的治疗方法。此外,对于rCDI患者各种治疗效果的全面比较仍在研究中。
对截至2024年3月的随机对照试验进行贝叶斯网络荟萃分析(NMA),以研究rCDI干预措施的疗效。
纳入了17项试验,包括4148例CDI患者,有10种干预措施,包括下消化道(LGI)粪便微生物群移植(FMT)、上消化道(UGI)FMT、自体FMT(AFMT)、万古霉素+FMT、万古霉素、安慰剂、非达霉素、Vowst(SER109)、Rebyota(RBX2660)和单克隆抗体。NMA显示,与安慰剂相比,LGI途径的FMT在治疗rCDI方面疗效最高,优势比(95%置信区间)为32.33(4.03,248.69)。UGI途径的FMT也显示出高疗效,而LGI途径和UGI途径的FMT之间的疗效比较无统计学意义(优势比(95%置信区间)为1.72(0.65,5.21))。排序图和累积排序曲线下面积(SUCRA)也显示,LGI途径的FMT在疗效方面排名第一,UGI途径的FMT排名第二。
NMA证明FMT在rCDI治疗中具有显著疗效,无论给药途径是下消化道还是上消化道。尽管FMT有显著益处,但由于缺乏符合FDA标准的标准化生产和监管,其安全性仍是一个问题。基于微生物群的疗法也显示出潜力。然而,研究有限,需要进一步的临床探索。相比之下,抗生素在rCDI中的疗效相对较低,这可能与肠道原生微生物群平衡的破坏有关。
https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=368435,标识符CRD42022368435。