浓缩制剂天花粉不良反应事件通报与检讨

The Reporting and Review of Adverse Reactions Related to Concentrated Preparations of Trichosanthes Root

吴宗修(Tsung-Hsiu Wu)；庄贤业(Hsien-Yeh Chuang)；杨鸿恩(Hong-En Yang)；吴淑娟(Shu-Chuan Wu)

《台北市中医医学杂志》 30卷2期 (2024/09) Pp. 1-11

https://doi.org/10.6718/TJCM.202409_30(2).0001

摘要

2023年1月，某医院陆续有病患使用含有天花粉的中药浓缩制剂後产生肠胃不适。经询问药师此症状是否与服药有关，病人药物谘询後请病人停药并回诊。回诊後由医师改药并停用天花粉，後续不良反应皆已改善，由药师进行药物不良反应通报。根据通报资料13例病例中，男性2例，女性11例，女性远多於男性。年龄分布多集中於40岁以上的中、老年。服用药物剂型为浓缩中药，处方内容皆有天花粉浓缩颗粒，服用日剂量在1至2克，经WHO-UMC药物不良反应之成因相关性（Causality）评估为极有可能，并通报至卫生福利部全国药物不良反应通报中心。本不良反应事件通报後经中医药司追查及食品药物管理署协助下，检测出此通报批号（22L03013）天花粉药材为药厂误用的槭叶栝楼，而非台湾中药典正确基原品种，而该批号已回收销毁。此案件进而显示出中药不良反应通报系统的重要性，在发生更大规模全国灾害不良反应之前，透过通报机制，可以即时阻断损害产生，未来如有类似天花粉造成腹泻不良反应通报案件，可循类似案例请药厂确认是否有误用错误品种，以确保用药安全。

关键字

中药 ； 天花粉 ； 药物不良反应通报 ； 正确基原 ； 用药安全

并列摘要

In January 2023, some patients at a hospital experienced gastrointestinal discomfort after using a concentrated Chinese medicine containing Trichosanthes Root(TR). Upon consultation with a pharmacist, patients were advised to discontinue the medication and return for further evaluation. Upon follow-up, the physician changed the medication and ceased the use of Trichosanthes Root(TR), resulting in improvement of adverse reactions. The pharmacist then proceeded with Adverse Drug Reaction reporting. According to the reported data from 13 cases, there were 2 male and 11 female patients, with a significantly higher number of females. The age distribution was predominantly among middle-aged and elderly individuals, aged 40 and above. The medication involved was in the form of concentrated herbal medicine, with all prescriptions containing concentrated granules of Trichosanthes Root(TR), with daily doses ranging from 1 to 2 grams. The causality assessment by the WHO-UMC regarding adverse drug reactions indicated a very likely correlation, and the cases were reported to the National Adverse Drug Reaction Reporting Center. Following the adverse reaction report, investigation by the Traditional Chinese Medicine Department and assistance from the Food and Drug Administration revealed that the batch number (22L03013) reported was a misused origin of Trichosanthes Root(TR), identified as Trichosanthes laceribracteata Hayata. (TL), rather than the correct origin listed in the Taiwan Herbal Pharmacopoeia. The affected batch has since been recalled and destroyed. This case highlights the importance of the adverse reaction reporting system for herbal medicine. By promptly reporting such incidents before larger-scale national disasters occur, damage can be mitigated. In the future, in cases of adverse reactions such as diarrhea caused by Trichosanthes Root(TR), similar actions can be taken to verify if there has been a misuse of incorrect origin by pharmaceutical companies, ensuring medication safety.

并列关键字

Chinese medicine ； Trichosanthes Root(TR) ； Adverse Drug Reaction reporting ； correct origin ； medication safety