荟萃分析随机对照临床试验显示抗TNF治疗未增加早期RA病人的严重感染和肿瘤发生风险

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Arthritis Rheum. 2011 Jun;63(6):1479-85.   Tumor necrosis factor therapy and the risk of serious infection and malignancy in patients with early rheumatoid arthritis: a meta-analysis of randomized controlled trials.   Thompson AE, Rieder SW, Pope JE.   Source University of Western Ontario and St. Joseph's Health Care, London, Ontario, Canada. andy.thompson@sjhc.london.on.ca   Abstract OBJECTIVE: To conduct a meta-analysis of the rates of serious infection and malignancy in patients with early rheumatoid arthritis (RA) who have started anti-tumor necrosis factor (anti-TNF) therapy and had not received treatment with disease-modifying antirheumatic drugs (DMARDs) or methotrexate (MTX). METHODS: A systematic literature search was conducted through the summer of 2009. All studies included were randomized, double-blind, placebo-controlled trials involving patients with early RA who were started on anti-TNF therapy without prior DMARD/MTX use. Six trials met the inclusion criteria for the meta-analysis, comprising a total of 2,183 patients receiving biologic therapy and 1,236 patients receiving MTX. The data extracted were from published trials. RESULTS: A pooled odds ratio (OR) (determined using Mantel-Haenszel methods, with a continuity correction designed for sparse data) was calculated for serious infections (requiring hospitalization) and malignancies, comparing anti-TNF therapy to MTX control. The pooled OR for serious infections was 1.28 (95% confidence interval [95% CI] 0.82-2.00) and that for malignancies was 1.08 (95% CI 0.50-2.32). There was no significant difference in either the rate of serious infections or the rate of malignancies between the anti-TNF therapy group and the control group. CONCLUSION: Whereas other meta-analyses have shown an increased risk of serious infection and malignancy in patients receiving anti-TNF therapy, the results of the present meta-analysis show that there is not an increased risk when the patients have early disease and have not previously been treated with DMARDs and/or MTX.   PMID: 21360522

荟萃分析随机对照临床试验显示抗TNF治疗未增加早期RA病人的严重感染和肿瘤发生风险   Arthritis Rheum. 2011; 63: 1479-85.   目的：利用荟萃分析了解早期RA病人的严重感染和恶性肿瘤发生率，在这些临床试验中，之前未经包括MTX在内的DMARDs治疗的RA病人将接受肿瘤坏死因子拮抗剂治疗。 方法：系统性检索截至2009年夏天的相关文献。所纳入研究是随机、双盲、安慰剂对照临床试验，研究对象是之前未经DMARDs/MTX治疗而将启用抗TNF治疗的早期RA患者。共发现6项符合荟萃分析纳入条件的临床试验，共有2183例患者接受生物制剂治疗，使用MTX的患者有1236例。所纳入研究均已公开发表。 结果：本研究应用汇总比值比(OR)来比较抗TNF和MTX的严重感染(需住院治疗)和肿瘤发生风险，相关计算使用Mantel-Haeszel方法（针对罕见事件的连续校正而设计）。严重感染的汇总OR是1.28（95%CI: 0.82-2.00），肿瘤的汇总OR是1.08（95%CI: 0.50-2.32）。抗TNF治疗组与对照组之间的严重感染和恶性肿瘤发生率并无显著差异。 结论：尽管有些荟萃分析显示抗TNF治疗会增加严重感染和恶性肿瘤发生发现，而本文的荟萃分析显示在病程早期且之前未接受过传统DMARDs治疗的病人中上述风险并未见增加。