TNF治疗早期类风湿关节炎患者严重感染和恶性肿瘤的风险: 随机对照研究的荟萃分析

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TNF therapy and the risk of serious infection and malignancy in patients with early rheumatoid arthritis: A meta-analysis of randomized controlled trials 1.       Andrew E Thompson,†, 2.       Scott W Rieder, 3.       Janet E Pope Arthritis & Rheumatism DOI: 10.1002/art.30310 Abstract Objective: To conduct a meta-analysis of the rates of serious infection and malignancy in patients with early rheumatoid arthritis who have started anti-TNF therapy and are naïve to DMARD/Methotrexate therapy. Methods: A systematic literature search was conducted through the summer of 2009. All studies included were randomized, double-blind, placebo-controlled of patients with early rheumatoid arthritis who were started on anti-TNF therapy without prior DMARD/Methotrexate use. Six trials met our inclusion criteria that included 2183 patients receiving biologic therapy and 1236 patients receiving methotrexate therapy. Data extracted were from published trials. Results: A pooled odds ratio (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 methotrexate. The pooled odds ratio for serious infections was 1.16 (95% CI, 0.75-1.77) and for malignancies was 1.07 (95% CI, 0.52-2.23). There was no significant difference between the anti-TNF therapy and the control therapy in both serious infection rates and malignancy rates. Conclusions: While other meta-analyses have shown an increased risk of serious infection and malignancy in patients taking anti-TNF therapy, our results show that there is not an increased risk when the patients have early disease and haven't previously failed DMARD/Methotrexate therapy.

TNF治疗早期类风湿关节炎患者严重感染和恶性肿瘤的风险: 随机对照研究的荟萃分析   目的: 对早期类风湿关节炎未用过DMARD /甲氨喋呤并开始接受抗-TNF治疗的患者进行严重感染和恶性肿瘤的汇萃分析。   方法: 对截至2009年夏季的文献进行系统检索。所有研究包括早期类风湿关节炎未用过DMARD /甲氨喋呤并开始接受抗-TNF治疗患者的随机、双盲、安慰剂对照研究。有6项试验符合我们的入选标准,包括2183例接受生物治疗和1236例接受甲氨喋呤治疗的患者。从已发表的研究中提取数据。   结果: 计算抗-TNF与甲氨喋呤相比的严重感染（需要住院治疗）和恶性肿瘤的汇总比值比(Mantel-Haenszel方法对稀疏数据进行连续修正)。严重感染的汇总比值比为1.16(95%可信区间,0.75-1.77)，而恶性肿瘤为1.07(95%可信区间,0.52-2.23)。两组间在严重感染和恶性肿瘤发生率上没有显著差异。     结论: 有荟萃分析表明应用抗-TNF治疗的患者发生严重感染和恶性肿瘤风险增加,而我们的结果显示, 早期类风湿关节炎未用过DMARD /甲氨喋呤并开始接受抗-TNF治疗的患者严重感染和恶性肿瘤的发生风险并未增加。