濃縮製劑天花粉不良反應事件通報與檢討

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

吳宗修(Tsung-Hsiu Wu)；莊賢業(Hsien-Yeh Chuang)；楊鴻恩(Hong-En Yang)；吳淑娟(Shu-Chuan Wu)

《台北市中醫醫學雜誌》 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，某醫院陸續有病患使用含有天花粉的中藥濃縮製劑後產生腸胃不適。經詢問藥師此症狀是否與服藥有關，病人藥物諮詢後請病人停藥並回診。回診後由醫師改藥並停用天花粉，後續不良反應皆已改善，由藥師進行藥物不良反應通報。根據通報資料13例病例中，男性2例，女性11例，女性遠多於男性。年齡分佈多集中於40歲以上的中、老年。服用藥物劑型為濃縮中藥，處方內容皆有天花粉濃縮顆粒，服用日劑量在1至2克，經WHO-UMC藥物不良反應之成因相關性（Causality）評估為極有可能，並通報至衛生福利部全國藥物不良反應通報中心。本不良反應事件通報後經中醫藥司追查及食品藥物管理署協助下，檢測出此通報批號（22L03013）天花粉藥材為藥廠誤用的槭葉栝樓，而非臺灣中藥典正確基原品種，而該批號已回收銷毀。此案件進而顯示出中藥不良反應通報系統的重要性，在發生更大規模全國災害不良反應之前，透過通報機制，可以即時阻斷損害產生，未來如有類似天花粉造成腹瀉不良反應通報案件，可循類似案例請藥廠確認是否有誤用錯誤品種，以確保用藥安全。

關鍵字

中藥 ； 天花粉 ； 藥物不良反應通報 ； 正確基原 ； 用藥安全

並列摘要

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.

並列關鍵字

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