摘要

目的：本研究探討服用本院栝樓根濃縮中藥引起腹瀉不良事件起因，並討論現行中藥管理政策的侷限及未來可精進目標。

方法：採用回溯性分析方法，篩選曾服用含濃縮中藥栝樓根處方且多次腹瀉症狀的患者，與患者訪談及運用WHO-UMC Causality Criteria 來評估藥物與不良事件之間的相關性，確定其關聯性後，透過薄層層析法 (thin-layer chromatography, TLC)

與高效液相層析法 (high-performance liquid chromatography, HPLC) 比對懷疑藥品與標準品之間差異。

結果：追溯該批懷疑藥品開藥區間，共計13 位患者回報腹瀉不良事件，另經比對懷疑藥品與標準品之高效液相層析 (HPLC) 指紋圖譜，該批懷疑藥品成分含量與標準品不同。

結論：本案例確認懷疑藥品的成分與標準品不符，可能源於基原不同，凸顯現行中藥管理政策在危害成分標準、基原鑑定及品質控管上的不足。此外，中藥品回收資訊公開程度不及西藥，將影響安全性監測與應對速度。未來若能強化監管與品質控管，將有助於降低基原誤用風險，並有效處理不合格藥品，以確保患者安全及有效性。

 

ABSTRACT

Objective: This study aims to investigate the causes of adverse diarrhea events associated with Trichosanthes root herbal extract and to evaluate the limitations and potential improvements in current traditional Chinese medicine management policies.

Methods: A retrospective analysis was conducted to select patients who exhibited recurrent diarrhea symptoms after ingesting prescriptions containing concentrated Trichosanthes root herbal extract. Patient interviews and the WHO-UMC Causality Criteria were employed to assess the association between the medication and the adverse events. Once the association was established, thin-layer chromatography (TLC) and high-performance liquid chromatography (HPLC) were utilized to compare the suspected pharmaceutical product with standard references.

Results: During the dispensing period of the suspected medicinal products, 13 patients reported adverse events of diarrhea. Furthermore, the HPLC fingerprint profiles of the suspected products differed from the reference standards, indicating a discrepancy in the ingredient content. 

Conclusion: This case confirmed discrepancies in the composition of suspected medicinal products compared to the reference standard, likely due to differences in botanical origin. This finding highlights deficiencies in the current regulatory framework for Chinese medicine, particularly in hazard standards, origin identification, and quality control. Additionally, Chinese medicine recall information is less transparent than that of Western medicines, which may affect safety monitoring and response time. Enhancing regulatory oversight and quality control in the future will help reduce the risk of raw material misidentification and effectively address substandard drugs, ensuring patient safety and efficacy.

 

 

Submitted for publication: 2025.02.08; Accepted for publication: 2025.07.04