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首页> 外文期刊>Clinical Pharmacology and Therapeutics >Active safety monitoring of newly marketed medications in a distributed data network: Application of a semi-automated monitoring system
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Active safety monitoring of newly marketed medications in a distributed data network: Application of a semi-automated monitoring system

机译：分布式数据网络中新上市药品的主动安全监控：半自动化监控系统的应用

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摘要

We developed a semi-automated active monitoring system that uses sequential matched-cohort analyses to assess drug safety across a distributed network of longitudinal electronic health-care data. In a retrospective analysis, we show that the system would have identified cerivastatin-induced rhabdomyolysis. In this study, we evaluated whether the system would generate alerts for three drug-outcome pairs: rosuvastatin and rhabdomyolysis (known null association), rosuvastatin and diabetes mellitus, and telithromycin and hepatotoxicity (two examples for which alerting would be questionable). Over >5 years of monitoring, rate differences (RDs) in comparisons of rosuvastatin with atorvastatin were -0.1 cases of rhabdomyolysis per 1,000 person-years (95% confidence interval (CI): -0.4, 0.1) and -2.2 diabetes cases per 1,000 person-years (95% CI: -6.0, 1.6). The RD for hepatotoxicity comparing telithromycin with azithromycin was 0.3 cases per 1,000 person-years (95% CI: -0.5, 1.0). In a setting in which false positivity is a major concern, the system did not generate alerts for the three drug-outcome pairs.
机译：我们开发了一种半自动化主动监控系统，该系统使用顺序匹配的队列分析来评估纵向电子医疗数据的分布式网络中的药物安全性。在回顾性分析中，我们表明该系统将确定西立伐他汀诱导的横纹肌溶解。在这项研究中，我们评估了该系统是否会针对三对药物治疗结果产生警报：瑞舒伐他汀和横纹肌溶解症（已知为无效关联），瑞舒伐他汀和糖尿病，telithromycin和肝毒性（对于两个可能引起警觉的例子）。在超过5年的监测中，罗舒伐他汀与阿托伐他汀的比较率差异（RD）为每1000人年-0.1例横纹肌溶解症（95％置信区间（CI）：-0.4、0.1）和-2.2糖尿病/千例人年（95％CI：-6.0，1.6）。泰利霉素与阿奇霉素比较的肝毒性RD为每1000人年0.3例（95％CI：-0.5，1.0）。在假阳性是一个主要问题的情况下，系统没有为三个药物结果对生成警报。

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