Adverse Events Associated with Ethical Kampo Formulations: Analysis of the Domestic Adverse-Event Data Reports of the Ministry of Health, Labor, and Welfare in Japan
Adverse Events Associated with Ethical Kampo Formulations: Analysis of the Domestic Adverse-Event Data Reports of the Ministry of Health, Labor, and Welfare in Japan
复制标题
DOI：
10.1155/2019/1643804
复制
发表时间：
2019-01-01
影响因子：
--
通讯作者：
Watari, Hidetoshi
中科院分区：
文献类型：
--
作者：
Shimada, Yutaka;Fujimoto, Makoto;Watari, Hidetoshi
目标。传统的日本汉布药已被纳入日本的国家卫生保健系统。在日本，厚生劳动省的网站公开了药品和医疗器械管理局调查的医务人员报告中获得的药物不良事件数据。利用这些数据，我们调查了与符合伦理的汉布配方相关的不良事件。方法。从2003年7月30日至2018年3月31日的国内不良事件数据中获得了与符合伦理的康普配方相关的不良事件报告。对不良事件进行分类，并分析不良事件类别与原料药的关系。结果。有4232例不良事件报告与符合伦理的汉布配方相关。按类别分类的事件数如下：与肝损伤相关的事件，1193例；肺损伤，1177例；pseudoaldosteronism, 889;肠系膜静脉硬化，223；药疹，185分；其他人，565人。在与肝损伤和肺损伤相关的事件中，大约70%被怀疑是由含有黄芩的汉布配方引起的。假醛固酮相关事件，由甘草酸诱导，包括几个与肌肉损伤、心力衰竭和心律失常有关的事件。在研究期间，与肠系膜静脉硬化相关的事件显著增加，这被认为是由长期使用含有栀子子的汉布配方引起的。在与药疹有关的事件中，大约35%怀疑是由含有麻黄的汉布制剂引起的。结论。汉布药可能引起各种不良事件。从患者安全的角度来看，目前的结果提供了有关与汉布药相关的不良事件的有价值的信息。
Objectives. Traditional Japanese Kampo medicines have been integrated into the Japanese national health-care system. In Japan, the Ministry of Health, Labor, and Welfare's website discloses adverse drug-event data that have been obtained from medical personnel reports investigated by the Pharmaceutical and Medical Devices Agency. Using these data, we investigated adverse events associated with ethical Kampo formulations. Methods. Reports of adverse events associated with ethical Kampo formulations from the domestic adverse-event data were obtained from July 30, 2003, to March 31, 2018. Adverse events were then categorized, and the relationships between categories of adverse events and crude drugs were analyzed. Results. There were 4,232 reported adverse events associated with ethical Kampo formulations. The numbers of events by category were as follows: events related to liver injury, 1,193; lung injury, 1,177; pseudoaldosteronism, 889; mesenteric phlebosclerosis, 223; drug eruption, 185; and others, 565. Among events related to both liver injury and lung injury, approximately 70% were suspected to be induced by Kampo formulations containing Scutellariae Radix. The pseudoaldosteronism-related events, which are induced by Glycyrrhizae Radix, included several events related to muscle injury, heart failure, and arrhythmia. Events related to mesenteric phlebosclerosis, believed to be induced by long-term use of Kampo formulas containing Gardeniae Fructus, increased remarkably during the study period. Among the events related to drug eruption, approximately 35% were suspected to be induced by Kampo formulations containing Ephedrae Herba. Conclusion. Kampo medicines may cause various adverse events. The present results provide valuable information regarding adverse events associated with Kampo medicines from the viewpoint of patient safety.