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目的探讨肿瘤坏死因子α(TNF-α)抑制剂是否会增加严重感染风险。设计以全国登记资料为基础的倾向分数匹配队列研究。地点丹麦,2002年12月。参与者获得匹配资格的背景队列包含52 392例炎症性肠炎患者,年龄15~75岁,其中4 300例接受TNF-α抑制剂治疗。为了避免混淆,使用两个阶段匹配法:首先匹配年龄、性别、病程、炎症性肠炎亚型;之后匹配倾向分数(1∶1比例)。最后将接受TNF-α抑制剂治疗的1 543例患者与未接受TNF-α抑制剂治疗的1 543例患者纳入研究。主要结果指标主要结果指标是严重感染,即确诊为入院造成的感染。进行Cox比例风险回归分析,计算两个高危时期(TNF-α抑制剂治疗90 d后和365 d后)的风险率。特定位点严重感染的风险率只在356 d获取。结果在90 d,51例接受TNF-α抑制剂治疗的患者发生感染(发生率14/100人年),33例未接受TNF-α抑制剂治疗的患者发生感染(9/100人年),风险率为1.63〔95%CI(1.01,2.63)〕。在365 d,风险率为1.27〔95%CI(0.92,1.75)〕。特定位点感染分析中,多个亚组的风险率超过2.00,有皮肤和软组织感染者风险率为2.51〔95%CI(1.23,5.12)〕。结论这项全国性倾向分数匹配队列研究证明,开始治疗90 d内使用TNF-α抑制剂会增加严重感染风险,后期风险率会降低。建议临床工作加强对炎症性肠炎患者潜在感染并发症的重视,尤其是在治疗早期。
Objective To investigate whether tumor necrosis factor α (TNF-α) inhibitors may increase the risk of serious infection. Design propensity score matching cohort studies based on national registration data. Location Denmark, December 2002. A background cohort of participants eligible for inclusion included 52 392 patients with inflammatory bowel disease, aged 15-75 years, of whom 4 300 were treated with TNF-α inhibitors. To avoid confusion, two phase matching methods were used: first matching age, gender, course of disease, and inflammatory enteritis subtypes; then matching propensity score (1: 1 ratio). Finally, 1 543 patients who received TNF-α inhibitors and 1 543 who did not receive TNF-α inhibitors were enrolled in the study. The main outcome measures The main outcome measures are serious infections, which are diagnosed as infections caused by admission. Cox proportional hazards regression analysis was performed to calculate the risk for two high-risk periods (after 90 days and 365 days after TNF-α inhibitor treatment). The risk of serious site-specific infection was only obtained at 356 days. Results In the 90 days, 51 patients who received TNF-αinfection (14/100 person-years) and 33 patients who did not receive TNF-αinfection (9/100 person-years) The risk rate was 1.63 [95% CI (1.01, 2.63)]. At 365 days, the risk rate was 1.27 [95% CI (0.92, 1.75)]. In site-specific infection analyzes, the risk for multiple subgroups exceeded 2.00 and the risk for skin and soft tissue infections was 2.51 (95% CI 1.23,5.12). Conclusions This nationwide propensity score matched cohort study demonstrated that the use of TNF-α inhibitors at 90 days after initiation of treatment increases the risk of serious infection with a later risk reduction. Suggested clinical work to strengthen the potential infection complications of inflammatory bowel disease patients attention, especially in the early treatment.