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与韩国不良事件报告系统数据库中其他药物相比,亚胺培南的信号检测

Signal Detection of Imipenem Compared to Other Drugs from Korea Adverse Event Reporting System Database.

作者信息

Park Kyounghoon, Soukavong Mick, Kim Jungmee, Kwon Kyoung Eun, Jin Xue Mei, Lee Joongyub, Yang Bo Ram, Park Byung Joo

机构信息

Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea.

Medical Research Collaborating Center, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.

出版信息

Yonsei Med J. 2017 May;58(3):564-569. doi: 10.3349/ymj.2017.58.3.564.

Abstract

PURPOSE

To detect signals of adverse drug events after imipenem treatment using the Korea Institute of Drug Safety & Risk Management-Korea adverse event reporting system database (KIDS-KD).

MATERIALS AND METHODS

We performed data mining using KIDS-KD, which was constructed using spontaneously reported adverse event (AE) reports between December 1988 and June 2014. We detected signals calculated the proportional reporting ratio, reporting odds ratio, and information component of imipenem. We defined a signal as any AE that satisfied all three indices. The signals were compared with drug labels of nine countries.

RESULTS

There were 807582 spontaneous AEs reports in the KIDS-KD. Among those, the number of antibiotics related AEs was 192510; 3382 reports were associated with imipenem. The most common imipenem-associated AE was the drug eruption; 353 times. We calculated the signal by comparing with all other antibiotics and drugs; 58 and 53 signals satisfied the three methods. We compared the drug labelling information of nine countries, including the USA, the UK, Japan, Italy, Switzerland, Germany, France, Canada, and South Korea, and discovered that the following signals were currently not included in drug labels: hypokalemia, cardiac arrest, cardiac failure, Parkinson's syndrome, myocardial infarction, and prostate enlargement. Hypokalemia was an additional signal compared with all other antibiotics, and the other signals were not different compared with all other antibiotics and all other drugs.

CONCLUSION

We detected new signals that were not listed on the drug labels of nine countries. However, further pharmacoepidemiologic research is needed to evaluate the causality of these signals.

摘要

目的

利用韩国药品安全与风险管理研究所-韩国不良事件报告系统数据库(KIDS-KD)检测亚胺培南治疗后不良药物事件的信号。

材料与方法

我们使用KIDS-KD进行数据挖掘,该数据库是利用1988年12月至2014年6月间自发报告的不良事件(AE)报告构建而成。我们检测了亚胺培南的信号,计算了比例报告率、报告比值比和信息成分。我们将满足所有三个指标的任何AE定义为一个信号。将这些信号与九个国家的药品标签进行比较。

结果

KIDS-KD中有807582份自发AE报告。其中,与抗生素相关的AE有192510份;3382份报告与亚胺培南有关。最常见的与亚胺培南相关的AE是药物疹,出现了353次。我们通过与所有其他抗生素和药物进行比较来计算信号;58个和53个信号满足这三种方法。我们比较了包括美国、英国、日本、意大利、瑞士、德国、法国、加拿大和韩国在内的九个国家的药品标签信息,发现以下信号目前未包含在药品标签中:低钾血症、心脏骤停、心力衰竭、帕金森综合征、心肌梗死和前列腺增生。与所有其他抗生素相比,低钾血症是一个额外的信号,而与所有其他抗生素和所有其他药物相比,其他信号没有差异。

结论

我们检测到九个国家药品标签上未列出的新信号。然而,需要进一步的药物流行病学研究来评估这些信号的因果关系。

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