Drug-induced liver injury associated with Complementary and Alternative Medicine: a review of adverse event reports in an Asian community from 2009 to 2014.
Drug-induced liver injury associated with Complementary and Alternative Medicine: a review of adverse event reports in an Asian community from 2009 to 2014.
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DOI：
10.1186/s12906-016-1168-z
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发表时间：
2016-07-07
影响因子：
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通讯作者：
Cheong HH
中科院分区：
文献类型：
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作者：
Teo DC;Ng PS;Tan SH;Lim AT;Toh DS;Chan SY;Cheong HH
多年来，补充和替代医学（CAM）的使用不断增加。最近对新加坡 CAM 相关不良事件报告 (AER) 的审查发现，提交的 AER 数量相当多。本研究的目的是根据向健康科学局 (HSA) 报告的自发不良事件，分析新加坡与 CAM 相关的肝毒性病例，并强调特定草药成分的安全信号。编制了 2009 年至 2014 年提交给 HSA 警戒与合规部门 (VCB) 的与 CAM 和肝毒性相关的 AER。提取并分析了以下信息： 人口统计信息；发病时间；住院情况；结果;肝毒性的类型； CAM的成分和每日总剂量（TDD）；兼用西药及保健品；以及记者详细信息。 57 份报告符合分析条件。 35 起 (61.4%) 案件涉及中医 (TCM)。其中 29 例（82.9%）应用了 Roussel Uclaf 因果关系评估方法，中位数得分为 4（范围：1-8）。 11 例 (31.4%) 病例中疑似柴胡（Radix bupleuri）。大部分成分的TDD均在中国药典推荐剂量范围内。对药物引起的肝损伤仍然知之甚少，需要进行更客观的评估。应大力提倡报告不良事件，以促进未来分析和了解 CAM 的风险效益概况。
The use of Complementary and Alternative Medicine (CAM) has been increasing over the years. A recent review of adverse event reports (AERs) associated with CAM in Singapore found a notable number of AERs submitted. The objectives of this study are to analyse hepatotoxicity cases associated with CAM in Singapore based on spontaneous adverse event reporting to the Health Sciences Authority (HSA), and to highlight safety signals for specific herbal ingredients. AERs associated with CAM and hepatotoxicity submitted to the Vigilance and Compliance Branch (VCB) of the HSA from 2009 to 2014 were compiled. The following information was extracted and analysed: Demographic information; time to onset; hospitalisation status; outcome; type of hepatotoxicity; ingredients of CAM, and the total daily doses (TDD); concurrent western medicines and health supplements; and reporter details. Fifty-seven reports were eligible for analysis. Thirty-five (61.4 %) cases involved Traditional Chinese Medicine (TCM). The Roussel Uclaf Causality Assessment Method was applied in 29 (82.9 %) of these cases, and the median score was 4 (range: 1–8). Chai Hu (Radix bupleuri) was suspected in 11 (31.4 %) cases. TDDs of most ingredients were within recommended doses of the Chinese Pharmacopoeia. Drug-induced liver injury is still poorly understood and more objective assessments are warranted. Reporting of adverse events should be strongly advocated to facilitate future analyses and the understanding of risk-benefit profiles of CAM.