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比较生物制剂、托法替尼和粪菌移植治疗溃疡性结肠炎的有效性和安全性:系统评价和网络荟萃分析。

Comparative of the Effectiveness and Safety of Biological Agents, Tofacitinib, and Fecal Microbiota Transplantation in Ulcerative Colitis: Systematic Review and Network Meta-Analysis.

机构信息

Department of Epidemiology and Biostatistics, School of Public Health, Anhui Medical University, Hefei, Anhui, China.

Anhui Province Key Laboratory of Major Autoimmune Diseases, Anhui Medical University, Hefei, Anhui, China.

出版信息

Immunol Invest. 2021 May;50(4):323-337. doi: 10.1080/08820139.2020.1714650. Epub 2020 Feb 2.

Abstract

BACKGROUND

Biological agents are commonly used for the treatment of ulcerative colitis (UC). As new treatments, tofacitinib, and fecal microbiota transplantation (FMT) have demonstrated efficacy in treating UC. This network meta-analysis aims to determine the efficacy and safety of biological agents, tofacitinib, and FMT.

METHODS

A network meta-analysis was conducted by systematically searching the PubMed, Embase, and Cochrane Libraries. According to strict inclusion and exclusion criteria, we included randomized controlled trials (RCTs) of biological agents, tofacitinib, and FMT in UC. A random-effect model was chosen by the network meta-analysis and sensitivity analysis. Heterogeneity test and publication bias test were performed to determine the efficacy of treatments.

RESULTS

Data were extracted from 16 RCTs and we found that all treatments were more effective than the placebos. A total of 21 comparisons were made to determine efficiency. We found that infliximab, vedolizumab, and FMT performed better curative effect in terms of absolute effects and relative ranks. Furthermore, there was no statistical difference in the efficacy of biological agents, tofacitinib, and FMT. Moreover, no treatments were found to increase the occurrence of adverse events when compared with placebos, except infliximab. However, vedolizumab seemed to reduce the occurrence of adverse events compared with infliximab.

CONCLUSION

Of the biological agents, vedolizumab and infliximab were the most effective, suggesting that biological agents are still a better choice. Nevertheless, tofacitinib and FMT may be promising alternatives with high efficacies. However, more safety and maintenance studies need to be conducted in future for the acquisition of more accurate results. FMT: Fecal microbiota transplantation; UC: Ulcerative colitis; RCTs: Randomized controlled trials; IBD: Inflammatory bowel disease; CD: Crohn's disease; IBS: Irritable bowel syndrome; CDI: infections; ITT: Intention-to-treat; : Relative risk; : Confidence interval; : Credible intervals; IFX: Infliximab; ADA: Adalimumab; TFB: Tofacitinib; GLM: Golimumab; VDZ: Vedolizumab; PBO: Placebo; wk: week; F: Female; M: Male; AEs: Adverse events; SAEs: Serious adverse events; anti-TNF: Anti-tumor necrosis factors.

摘要

背景

生物制剂常用于治疗溃疡性结肠炎(UC)。作为新的治疗方法,托法替尼和粪便微生物移植(FMT)已被证明在治疗 UC 方面有效。本网络荟萃分析旨在确定生物制剂、托法替尼和 FMT 的疗效和安全性。

方法

通过系统地搜索 PubMed、Embase 和 Cochrane 图书馆,进行网络荟萃分析。根据严格的纳入和排除标准,我们纳入了 UC 中生物制剂、托法替尼和 FMT 的随机对照试验(RCT)。通过网络荟萃分析和敏感性分析选择随机效应模型。进行异质性检验和发表偏倚检验以确定治疗效果。

结果

从 16 项 RCT 中提取数据,我们发现所有治疗方法均优于安慰剂。共进行了 21 次比较以确定疗效。我们发现英夫利昔单抗、维得利珠单抗和 FMT 在绝对效果和相对排名方面具有更好的疗效。此外,生物制剂、托法替尼和 FMT 的疗效没有统计学差异。此外,与安慰剂相比,除英夫利昔单抗外,没有发现其他治疗方法会增加不良反应的发生。然而,与英夫利昔单抗相比,维得利珠单抗似乎降低了不良反应的发生。

结论

在生物制剂中,英夫利昔单抗和维得利珠单抗是最有效的,表明生物制剂仍然是更好的选择。然而,托法替尼和 FMT 可能是具有高效的有前途的替代品。然而,未来需要进行更多的安全性和维持性研究,以获得更准确的结果。FMT:粪便微生物移植;UC:溃疡性结肠炎;RCTs:随机对照试验;IBD:炎症性肠病;CD:克罗恩病;IBS:肠易激综合征;CDI:感染;ITT:意向治疗;RR:相对风险;CI:置信区间;CrI:可信区间;IFX:英夫利昔单抗;ADA:阿达木单抗;TFB:托法替尼;GLM:古利木单抗;VDZ:维得利珠单抗;PBO:安慰剂;wk:周;F:女性;M:男性;AE:不良反应;SAE:严重不良反应;抗 TNF:抗肿瘤坏死因子。

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