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目的:评价肿瘤坏死因子α(TNF-α)抑制剂(依那西普、英利西单抗和阿达木单抗)治疗类风湿关节炎(RA)患者发生严重感染的风险。方法:通过检索PubMed数据库、EMBASE数据库和Cochrane图书馆,收集已发表的关于TNF-α抑制剂治疗RA时引起严重感染的随机对照试验(RCT)文献。根据入选标准严格筛选文献并按meta分析要求对入选文献进行质量评估,应用Review Manager 4.2软件对其结果进行分析,计算TNF-α抑制剂组与对照组发生严重感染风险的优势比(odds ratio,OR)、95%可信区间(CI)及P值,评价TNF-α抑制剂对严重感染发生风险的影响。结果:本研究共入选1998年1月至2009年1月进行的16项RCT研究,其中依那西普4篇,英利西单抗5篇,阿达木单抗7篇。所有研究共纳入8 541例患者,TNF-α抑制剂组5 812例(依那西普1 347例,英利西单抗2 064例,阿达木单抗2 401例),对照组2 729例。meta分析结果显示,与对照组相比,TNF-α抑制剂组引起严重感染的总体OR为1.43(95%CI为1.08~1.89,P<0.05)。其中,依那西普组,英利西单抗组和阿达木单抗组的OR分别为0.93(95%CI为0.59~1.45,P>0.05)、1.68(95%CI为1.05~2.68,P<0.05)和2.07(95%CI为1.15~3.37,P<0.05)。高剂量TNF-α抑制剂组发生严重感染的风险高于低剂量TNF-α抑制剂组(OR1.62,95%CI1.13~2.33,P<0.01)与对照组(OR1.87,95%CI1.30~2.69,P<0.01),差异有统计学意义。低剂量TNF-α抑制剂组与对照组相比(OR1.31,95%CI0.93~1.85,P>0.05)发生严重感染风险的差异无统计学意义。结论:风湿病患者使用TNF-α抑制剂,尤其在高剂量时,可使严重感染发生的风险有所增加。因此,临床使用TNF-α抑制剂时应对患者严密监测。
PURPOSE: To evaluate the risk of severe infections in patients with rheumatoid arthritis (RA) treated with inhibitors of tumor necrosis factor α (TNF-α) (etanercept, infliximab and adalimumab). METHODS: A randomized controlled trial (RCT) document published on the TNF-α inhibitor-induced RA-induced serious infection was collected by searching the PubMed database, the EMBASE database, and the Cochrane Library. According to the selected criteria, the documents were screened strictly and the quality of the selected documents was evaluated according to the meta-analysis requirements. The results were analyzed with Review Manager 4.2 software to calculate the odds ratio (odds ratio, OR), 95% confidence interval (CI) and P values, to evaluate the effect of TNF-α inhibitors on the risk of serious infection. Results: Sixteen RCTs were enrolled from January 1998 to January 2009, of which 4 were etanercept, 5 were infliximab and 7 were adalimumab. A total of 8 541 patients were enrolled in the study, with 5 812 patients in the TNF-α inhibitor group (1 347 for etanercept, 2 064 for infliximab, and 2 401 for adalimumab) and 2 729 for the control group. The meta-analysis showed that the overall odds ratio for severe infection with the TNF-α inhibitor group was 1.43 (95% CI 1.08-1.89, P <0.05) compared with the control group. The ORs of etanercept group, infliximab group and adalimumab group were 0.93 (95% CI 0.59-1.45, P> 0.05), 1.68 (95% CI 1.05-2.68, P <0.05) ) And 2.07 (95% CI 1.15-3.37, P <0.05). The risk of severe infection in the high-dose TNF-α inhibitor group was significantly higher than that in the low-dose TNF-α inhibitor group (OR 1.62, 95% CI 1.13-2.33, P <0.01) CI1.30 ~ 2.69, P <0.01), the difference was statistically significant. There was no significant difference in the risk of serious infection between the low-dose TNF-α inhibitor group and the control group (OR 1.31, 95% CI 0.93 to 1.85, P> 0.05). Conclusion: The use of TNF-α inhibitors in patients with rheumatism, especially at high doses, may increase the risk of serious infections. Therefore, clinical use of TNF-α inhibitors should be closely monitored in patients.