Herbal Medicine Research Division, Korea Institute of Oriental Medicine, Republic of Korea.
Bull World Health Organ. 2013 Aug 1;91(8):569-75. doi: 10.2471/BLT.12.111609. Epub 2013 May 31.
To investigate adverse events attributed to traditional medical treatments in the Republic of Korea.
Adverse events recorded in the Republic of Korea between 1999 and 2010 - by the Food and Drug Administration, the Consumer Agency or the Association of Traditional Korean Medicine - were reviewed. Records of adverse events attributed to the use of traditional medical practices, including reports of medicinal accidents and consumers' complaints, were investigated.
Overall, 9624 records of adverse events attributed to traditional medical practices - including 522 linked to herbal treatments - were identified. Liver problems were the most frequently reported adverse events. Only eight of the adverse events were recorded by the pharmacovigilance system run by the Food and Drug Administration. Of the 9624 events, 1389 - mostly infections, cases of pneumothorax and burns - were linked to physical therapy (n = 285) or acupuncture/moxibustion (n = 1104).
In the Republic of Korea, traditional medical practices often appear to have adverse effects, yet almost all of the adverse events attributed to such practices between 1999 and 2010 were missed by the national pharmacovigilance system. The Consumer Agency and the Association of Traditional Korean Medicine should be included in the national pharmacovigilance system.
调查韩国传统医学治疗相关的不良事件。
对韩国食品药品管理局、消费者机构或韩国传统医学会 1999 年至 2010 年记录的不良事件进行了回顾。调查了归因于传统医学实践的不良事件记录，包括药物事故报告和消费者投诉。
共发现 9624 例归因于传统医学实践的不良事件记录，包括 522 例与草药治疗相关的不良事件。肝脏问题是最常报告的不良事件。只有 8 例不良事件被食品药品管理局运行的药物警戒系统记录。在这 9624 例事件中，1389 例（主要为感染、气胸和烧伤）与物理治疗（n=285）或针灸（n=1104）有关。
在韩国，传统医学实践似乎经常产生不良影响，但 1999 年至 2010 年期间归因于此类实践的几乎所有不良事件都被国家药物警戒系统遗漏。消费者机构和韩国传统医学会应被纳入国家药物警戒系统。
