达托霉素治疗皮肤及软组织感染的疗效和安全性网状Meta分析

摘要/Abstract

摘要： 目的：通过对皮肤和皮肤结构感染（Skin and skin structure infections，SSSI）的治疗方法进行系统回顾和网状Meta分析(Network meta-analysis，NMA)，旨在评价新型的环脂肽类药物达托霉素的疗效和安全性。方法：按照预先制定的检索策略，检索Pubmed、Embase、The Cochrane Library、The ClinicalTrials.gov Website和中国期刊全文数据库（CNKI）、万方数据库（WANFANG）、维普数据库（VIP），检索时间从建库开始至2020年7月31日，建立严格的文献纳入和排除标准，应用Revman评价文献质量，筛选出高质量的随机对照试验(Randomized Clinical Trials，RCTs)，提取文献基本信息及数据，应用R软件的GEMTC包联合JAGS软件进行贝叶斯网状Meta分析。采用相对风险比（Relative risk，RR）及95%置信区间（95% Confidence interval，95%CI）评估达托霉素的临床治愈率、微生物清除率以及严重不良反应。结果：本研究使用R软件调用GEMTC程序包来进行网状Meta分析，在皮肤软组织感染的情况下，达托霉素对比几种抗菌药物，其疗效和安全性没有统计学差异。排序结果显示，临床治愈率、微生物清除率排在首位的分别是特拉万星、达托霉素。严重不良反应发生率最低的是特拉万星。结论：对于皮肤和软组织感染的治疗，达托霉素对比万古霉素、利奈唑胺、替加环素、替考拉宁、奥利万星、特拉万星、达巴万星，其疗效和安全性没有统计学差异。在微生物结局上达托霉素略有优势；安全性方面，达托霉素较万古霉素、利奈唑胺、替加环素等药物严重不良反应的发生率相对较小。但是鉴于本次Meta分析的局限性和异质性，我们的结论需要谨慎解读，未来需要更大规模的前瞻性研究与更严格的研究设计予以验证。

关键词: font-size:medium, ">达托霉素；网状Meta分析；皮肤和皮肤结构感染；随机对照试验font-size:medium, ">R911.2

Abstract: Objective： The objective was to conduct a systematic review and Network meta-analysis (NMA) of existing treatments for SSSI focusing on the recently approved agent from a new class of antibiotics， the cyclic lipopeptides Daptomycin. Methods： This network meta-analysis is used to determine direct and indirect evidence of relevant trials. We search for Pubmed， Embase， The Cochrane Library， The ClinicalTrials.gov Website， and China National Knowledge Infrastructure(CNKI)， WANFAG Database (WANFANG)， and VIP Database (VIP) according to a pre-defined search strategy. Establish strict literature inclusion and exclusion criteria and evaluate the quality of the included studies in Revman.The Bayesian Network meta-analysis was performed using R software through gemtc package. The clinical success rate， microbial success rate， and safety of several antimicrobial drugs were assessed using relative risk ratio (RR) and 95% confidence interval (95% CI). Results： In this study， the Bayesian Network meta-analysis was performed using R software through gemtc package. In the case of skin soft tissue infection， Daptomycin compared to several antibacterial drugs， its efficacy and safety were not statistically different. The results of the ranking showed that the clincal success rate， microbial success rate， and success rate of treatment of MRSA ranked first in the first place are Telavancin， Daptomycin， Daptomycin. The lowest incidence of severe adverse reactions was Telavancin. Conclusions： In the case of skin and soft tissue infections， Daptomycin compared to several antibacterial drugs， its efficacy and safety were not statistically different.In the microbial outcome， Daptomycin has a slight advantage. In terms of safety， the incidence of severe adverse reactions of Daptomycin is relatively small compared with Vancomycin， Linezolid， Tigecycline.However， given the limitations and heterogeneity of this meta-analysis， our conclusions need to be interpreted cautiously. The future requires larger prospective studies and more rigorous research designs to test these conclusions.

Key words: font-size:medium, ">Daptomycin； Network Meta-analysis； Skin and skin structure infections； Randomized Clinical Trial

中图分类号:

周俊凝, 徐晓艳, 秦元, 宋沧桑, 张阳. 达托霉素治疗皮肤及软组织感染的疗效和安全性网状Meta分析[J]. 中国药物评价, 2020, 37(6): 483-496.

ZHOU Jun-ning, XU Xiao-yan, QIN Yuan, SONG Cang-sang, ZHANG Yang. Efficacy and Safety of Daptomycin in the Treatment of Skin and Soft Tissue Infections： Network Meta-analysis[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2020, 37(6): 483-496.

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