Association between infection and severe drug adverse reactions: an analysis using data from the Japanese Adverse Drug Event Report database
Association between infection and severe drug adverse reactions: an analysis using data from the Japanese Adverse Drug Event Report database
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DOI：
10.1007/s00228-017-2320-5
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发表时间：
2017-12-01
影响因子：
2.9
通讯作者：
Saito, Yoshiro
中科院分区：
文献类型：
--
作者：
Imatoh, Takuya;Sai, Kimie;Saito, Yoshiro
最近有报道称，免疫反应参与某些类型药物不良反应（ADR）的发病机制。我们的目的是利用日本自发性药物不良事件报告数据库确定感染与药物性间质性肺病（DILD）、横纹肌溶解症、史蒂文斯-约翰逊综合征（SJS）和中毒性表皮坏死松解症（TEN）或药物性肝损伤（DILI）之间的关联。根据是否存在抗感染药物，将报告的病例分为三类（抗感染药物组、合并感染组和非感染组） （作为主要可疑药物或伴随药物）和传染病。我们使用逻辑回归分析评估了四种严重 ADR 与感染的存在和严重性之间的关联。我们确定了研究期间（2009-2013 年）报告的 177,649 例病例。 Logistic回归分析显示感染状态与SJS/TEN或DILI发病之间存在显着正相关（SJS/TEN：抗感染药物组：比值比（OR）2.04，95% CI [1.85-2.24]，伴随感染组：OR 2.44，95% CI [2.21-2.69]，DILI：抗感染药物组：OR 1.27， 95% CI [1.09-1.49]，伴随感染组：OR 1.25，95% CI [1.04-1.49]），与非感染组相比。相比之下，感染与 DILD 或横纹肌溶解症之间存在负相关或无相关。观察到感染与 SJS/TEN 严重性之间存在显着正相关（OR 1.48，95% CI [1.10-1.98]）。这项研究表明，感染在 SJS/TEN 和 DILI 的发展中起着重要作用。对于感染和/或使用抗感染药物的患者，可能需要仔细监测严重的ADR，尤其是SJS/TEN。
It has been reported recently that immune reactions are involved in the pathogenesis of certain types of adverse drug reactions (ADRs). We aimed to determine the associations between infections and drug-induced interstitial lung disease (DILD), rhabdomyolysis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), or drug-induced liver injury (DILI) using a spontaneous adverse drug event reporting database in Japan.The reported cases were classified into three categories (anti-infectious drug group, concomitant infection group, and non-infection group) based on the presence of anti-infectious drugs (either as primary suspected drug or concomitant drug) and infectious disease. We assessed the association between four severe ADRs and the presence and seriousness of infection using logistic regression analysis.We identified 177,649 cases reported in the study period (2009-2013). Logistic regression analysis showed significant positive associations between infection status and onset of SJS/TEN or DILI (SJS/TEN: anti-infectious drug group: odds ratio (OR) 2.04, 95% CI [1.85-2.24], concomitant infection group: OR 2.44, 95% CI [2.21-2.69], DILI: anti-infectious drug group: OR 1.27, 95% CI [1.09-1.49], concomitant infection group: OR 1.25, 95% CI [1.04-1.49]), compared to the non-infection group. By contrast, there were negative or no associations between infection and DILD or rhabdomyolysis. A significantly positive association between infection and SJS/TEN seriousness (OR 1.48, 95% CI [1.10-1.98]) was observed.This study suggested that infection plays an important role in the development of SJS/TEN and DILI. For the patients with infection and/ or anti-infectious drugs, careful monitoring for severe ADRs, especially SJS/TEN, might be needed.