Zhao Lei, Peng Fu, Guan Binghe, Li Xia, Wu Wei, Chen Jianping, Shen Jiangang
School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong, China.
Biol Trace Elem Res. 2015 Jul;166(1):41-8. doi: 10.1007/s12011-015-0318-3. Epub 2015 Apr 2.
"Angong Niuhuang Pill" (AGNH Pill) has been used as patented herbal formula for treatment of acute brain disorders including ischemic stroke, hemorrhage stroke, and trauma brain injury in traditional Chinese medicine for a thousand years. It is widely used in treatment of many diseases. As AGNH Pill contains metal elements named realgar and cinnabar, whether AGNH Pill is safe attracts great concerns. To address this question, we reviewed adverse drug reactions (ADR) and adverse events (AE) to assess the safety of AGNH Pill clinically. We searched PubMed, Embase, Cochrane library, TOXNET, and Chinese databases CNKI and Wanfang for articles published between January 1974 and January 2015. A total of 49 cases contained in 10 articles were included in this study. We were unable to determine the frequency of ADR/AE induced by AGNH Pill due to the lack of complete production and market information provided by pharmaceutical manufacturers and hospitals. Based on current literature data, we estimated that the risk of ADR/AE from AGNH Pill administration was low. The majority of ADR/AE was attributed to the improper use of AGNH Pill, such as use in children with overdosage or use with incompatible drugs. We were unable to distinguish whether incidents were ADR or AE because of the poor reports. To date, published evidence indicates that AGNH Pill appears to carry a relatively low risk of ADR/AE. As the quality of clinical assessment for the safety of AGNH Pill is poor, it is desirable to conduct well-designed randomized clinical trials to assess its safety for the treatment of acute brain disorders.
安宫牛黄丸作为一种专利中药配方，在中医领域用于治疗包括缺血性中风、出血性中风和创伤性脑损伤在内的急性脑部疾病已有千年历史。它被广泛用于多种疾病的治疗。由于安宫牛黄丸含有雄黄和朱砂等金属元素，其安全性备受关注。为解决这一问题，我们回顾了药物不良反应（ADR）和不良事件（AE），以临床评估安宫牛黄丸的安全性。我们检索了PubMed、Embase、Cochrane图书馆、TOXNET以及中国数据库知网和万方，查找1974年1月至2015年1月发表的文章。本研究共纳入10篇文章中的49例病例。由于制药厂商和医院提供的生产及市场信息不完整，我们无法确定安宫牛黄丸引起的ADR/AE发生率。基于当前文献数据，我们估计服用安宫牛黄丸出现ADR/AE的风险较低。大多数ADR/AE归因于安宫牛黄丸使用不当，如儿童过量服用或与不相容药物联用。由于报告质量差，我们无法区分事件是ADR还是AE。迄今为止，已发表的证据表明安宫牛黄丸出现ADR/AE的风险相对较低。鉴于安宫牛黄丸安全性的临床评估质量较差，有必要开展精心设计的随机临床试验来评估其治疗急性脑部疾病的安全性。
