抗TNF制剂治疗RA的疗效和安全性荟萃分析

抗TNF制剂治疗RA的疗效和安全性荟萃分析

        摘要（芬兰）  背景和目的：目前，已上市治疗类风湿关节炎的抗TNF生物制剂有5种：类克、恩利、修美乐、certolizumab pegol和golimumab，国内外很少有临床试验来对比这些生物制剂间的疗效和安全性，因此，我们进行系统综述来间接比较这些制剂。本研究的目标是评估抗TNF制剂在治疗类风湿关节炎中的疗效和安全性，通过综合随机临床试验结果间接对比这5种生物制剂的优劣。

        方法  检索MEDLINE、SCOPUS (包括EMBASE)、Cochrane书库和电子搜索警报中的综述性文献资料。仅选择抗TNF制剂与安慰剂（有或无联合MTX）治疗类风湿关节炎的双盲随机对照试验论文。所收集的资料包括患者信息、干预措施、对照、结果、研究方法和偏倚来源。

        结果  有41篇系统综述和荟萃分析，26篇随机对照研究，其中5篇研究类克、7篇为恩利、8篇为修美乐、3篇为golimumab，3篇为certolizumab。结果显示，抗TNF制剂疗效在所有时间点均优于安慰剂，与MTX相似。抗TNF抑制剂与MTX联合的疗效优于单独的MTX或抗TNF抑制剂，增加剂量不提高疗效。与MTX或安慰剂相比，抗TNF抑制剂是相对安全的。

        结论  虽然尚无研究明确地显示一种生物制剂的疗效肯定优于另一种，但安全性结果分析显示，恩利可能是最安全的抗TNF生物制剂。

        附原文  Abstract  Background and Objectives   Five-tumour necrosis factor (TNF)-blockers (infliximab, etanercept, adalimumab, certolizumab pegol and golimumab) are available for treatment of rheumatoid arthritis. Only few clinical trials compare one TNF-blocker to another. Hence, a systematic review is required to indirectly compare the substances. The aim of our study is to estimate the efficacy and the safety of TNF-blockers in the treatment of rheumatoid arthritis (RA) and indirectly compare all five currently available blockers by combining the results from included randomized clinical trials (RCT). Methods  A systematic literature review was conducted using databases including: MEDLINE, SCOPUS (including EMBASE), Cochrane library and electronic search alerts. Only articles reporting double-blind RCTs of TNF-blockers vs. placebo, with or without concomitant methotrexate (MTX), in treatment of RA were selected. Data collected were information of patients, interventions, controls, outcomes, study methods and eventual sources of bias. Results Forty-one articles reporting on 26 RCTs were included in the systematic review and meta-analysis. Five RCTs studied infliximab, seven etanercept, eight adalimumab, three golimumab and three certolizumab. TNF-blockers were more efficacious than placebo at all time points but were comparable to MTX. TNF-blocker and MTX combination was superior to either MTX or TNF-blocker alone. Increasing doses did not improve the efficacy. TNF-blockers were relatively safe compared to either MTX or placebo. Conclusions  No single substance clearly rose above others in efficacy, but the results of the safety analyses suggest that etanercept might be the safest alternative.

        引自：Kalle J. Aaltonen, Liisa M. Virkki, Antti Malmivaara, Yrjö T.Konttinen, Dan C. Nordström, and Marja Blom. Systematic Review and Meta-Analysis of the Efficacy and Safety of Existing TNF Blocking Agents in Treatment of Rheumatoid Arthritis. PLoS One. 2012; 7(1): e30275