接受来氟米特治疗的类风湿关节炎患者呼吸系统不良事件无增加

作者：Conway R et al. 翻译：金银姬，校对：武东

摘要：目的：评估接受来氟米特（LEF）治疗的类风湿关节炎患者肺疾病的相对风险。

方法：我们检索了PubMed、EMBASE、CENTRAL。所纳入的文献包括成人类风湿关节炎患者中比较来氟米特与安慰剂或有效对照药物的双盲随机对照试验（RCT）。小于50名受试者或少于12周的研究被排除在外。两家调查者独立检索数据库。所有作者回顾了研究。我们采用Mantel-Haenszel随机效应的方法比较相对危险度的差异，评估总呼吸系统不良事件、传染性呼吸系统不良事件、非传染性呼吸系统不良事件，间质性肺疾病和死亡。

结果：我们的文献检索共收到5673例结果。共有8个研究，其中4个研究有安慰剂对照，满足我们研究的纳入标准。4579例受试者中708例患者存在呼吸道不良事件。6例肺炎均发生在对照组。共报告了4例肺死亡，无一例为来氟米特组。来氟米特与总呼吸道不良事件风险增高无相关(相对危险度0.99, 95%可信区间 0.56-1.78)，且与传染性呼吸道不良事件也无相关(相对危险度 0.64, 95%可信区间 0.41-0.97)。来氟米特与非传染性呼吸系统不良事件的风险下降有相关性(相对危险度0.64, 95%可信区间 0.41-0.97)。

结论：我们的研究发现，没有证据表明接受来氟米特治疗的患者呼吸系统不良事件增加。

附原文：AbstractOBJECTIVE:To evaluate the relative risk (RR) of pulmonary disease among patients with rheumatoid arthritis (RA) treated with leflunomide (LEF).METHODS:We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials to April 15, 2014. We included double-blind randomized controlled trials (RCT) of LEF versus placebo or active comparator agents in adults with RA. Studies with fewer than 50 subjects or shorter than 12 weeks were excluded. Two investigators independently searched both databases. All authors reviewed selected studies. We compared RR differences using the Mantel-Haenszel random-effects method to assess total respiratory adverse events, infectious respiratory adverse events, noninfectious respiratory adverse events, interstitial lung disease, and death.RESULTS:Our literature search returned 5673 results. A total of 8 studies, 4 with placebo comparators, met our inclusion criteria. There were 708 respiratory adverse events documented in 4579 participants. Six cases of pneumonitis occurred, all in the comparator group. Four pulmonary deaths were reported, none in the LEF group. LEF was not associated with an increased risk of total adverse respiratory events (RR 0.99, 95% CI 0.56-1.78) or infectious respiratory adverse events (RR 1.02, 95% CI 0.58-1.82). LEF was associated with a decreased risk of noninfectious respiratory adverse events (RR 0.64, 95% CI 0.41-0.97).CONCLUSION:Our study found no evidence of increased respiratory adverse events in RCT of LEF treatment.

引自：Conway R, Low C, Coughlan RJ,et al. Leflunomide Use and Risk of Lung Disease in Rheumatoid Arthritis: A Systematic Literature Review and Metaanalysis of Randomized Controlled Trials. J Rheumatol. 2016 Mar 15. pii: jrheum.150674. [Epub ahead of print]