Salliot C, Gossec L, Ruyssen-Witrand A, Luc M, Duclos M, Guignard S, Dougados M
René-Descartes University, Medicine Faculty, AP-HP, Cochin Hospital, Rheumatology B Department, Paris, France.
Rheumatology (Oxford). 2007 Feb;46(2):327-34. doi: 10.1093/rheumatology/kel236. Epub 2006 Jul 31.
To evaluate the rate of infections in rheumatic patients treated with tumour necrosis factor (TNF)-alpha blockers in daily practice and to determine potential risk factors of infections.
Systematic retrospective study was conducted in a tertiary-referral centre of all patients receiving at least one TNF-alpha blocker, between 1997 and December 2004. Serious infections were defined as life-threatening, requiring hospitalization or sequelae. The incidence of infections during the first TNF-alpha blocker course was compared with the incidence during the period just before such therapy, in the same patients and a number needed to harm was calculated. Univariate and multivariate analysis between patients who suffered from at least one infection during treatment or not, was conducted in order to determine potential associated risk factors.
Among the 709 patients treated with at least one TNF-alpha blocker, 57.7% had rheumatoid arthritis; a total of 275 infectious events in 245 patients (34.5%) were reported during all treatment courses. Among these infections, 47 infections in 44 patients (6.2%) fulfilled the definition of serious infections. The incidence rate of serious infections was 3.4 +/- 38.7 per 100 patient-yrs before TNF-alpha blocker therapy vs 10.5 +/- 86.9 during the first TNF-alpha blocker course (P = 0.03, number needed to harm = 14). The single risk factor picked up by multivariate analysis to explain infections was previous joint surgery [odds ratio (OR) = 2.07, 95% confidence interval (CI) = (1.43-2.98), P < 0.0001] and, if surgery was taken out of the model, the cumulative dose of steroids [OR = 1.28 (1.04-1.59), P = 0.02].
The rate of serious infections during TNF-alpha blocker treatment observed in daily practice conditions was much higher than in phase III trials evaluating TNF-alpha blockers. Serious infections are frequent in daily practice and close monitoring is required.
评估在日常临床实践中接受肿瘤坏死因子（TNF）-α阻滞剂治疗的风湿性疾病患者的感染率，并确定感染的潜在危险因素。
在一家三级转诊中心对1997年至2004年12月期间所有接受至少一种TNF-α阻滞剂治疗的患者进行系统回顾性研究。严重感染定义为危及生命、需要住院治疗或留有后遗症。将同一患者在首个TNF-α阻滞剂疗程期间的感染发生率与其在此类治疗前的发生率进行比较，并计算伤害所需人数。对治疗期间至少发生一次感染的患者与未发生感染的患者进行单因素和多因素分析，以确定潜在的相关危险因素。
在709例接受至少一种TNF-α阻滞剂治疗的患者中，57.7%患有类风湿关节炎；在所有治疗疗程中，共报告了245例患者（34.5%）发生275次感染事件。在这些感染中，44例患者（6.2%）发生的47次感染符合严重感染的定义。TNF-α阻滞剂治疗前严重感染的发生率为每100患者年3.4±38.7次，而在首个TNF-α阻滞剂疗程期间为10.5±86.9次（P = 0.03，伤害所需人数 = 14）。多因素分析确定的唯一可解释感染的危险因素是既往关节手术[比值比（OR） = 2.07，95%置信区间（CI） = （1.43 - 2.98），P < 0.0001]，如果将手术因素排除在模型之外，则为类固醇的累积剂量[OR = 1.28（1.04 - 1.59），P = 0.02]。
在日常临床实践中观察到的TNF-α阻滞剂治疗期间严重感染的发生率远高于评估TNF-α阻滞剂的III期试验中的发生率。在日常临床实践中严重感染很常见，需要密切监测。
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