Department of Pharmacy, Faculty of Science, National University of Singapore, 18 Science Drive 4, Singapore.
Clin Toxicol (Phila). 2012 Jul;50(6):481-9. doi: 10.3109/15563650.2012.700402. Epub 2012 Jun 27.
The use of complementary and alternative medicine (CAM), particularly herbal medicine and their derived products, have been increasing. However, sporadic reports of serious adverse effects associated with the use of these products have become a source of concern. Spontaneous adverse event reporting may be used to monitor the safety of these products.
The objectives of this study is to analyze and describe the patterns of adverse events associated with the use of Chinese Proprietary Medicine, other complementary medicine and health supplements (termed CAM products) in the Singapore Pharmacovigilance database from 1998 to 2009 and to highlight areas of safety concerns.
Adverse events associated with CAM products reviewed by the Vigilance Branch of the Health Sciences Authority for the period 1998-2009 were collated and analyzed. The following information was extracted and collated: patient demographics, type and indication of CAM products, system-organ class affected, seriousness of the adverse event, route of administration, hospitalization status, outcome of adverse event, concomitant use of conventional medicine, adulterant testing and profession of the reporter.
In the period 1998-2009, 627 cases of adverse events due to CAM products were reported. Most of these 627 cases (80.2%) were found to be serious and most of the patients used CAM products for sexual performance enhancement (291, 46.4%), to relieve pain such as joint and neck pain (36, 5.9%) and for slimming purposes (27, 4.3%). Of the 627 cases, endocrine disorders constituted 22.5% and central nervous system disorders constituted 20.6%. Liver was the main organ involved in the serious cases. Twenty-two fatalities were reported and hepatotoxicity was responsible for the deaths of 10 patients during the study period.
In conclusion, 627 adverse event reports associated with CAM products had been successfully analyzed and described. They constituted ~3.8% of the total number of adverse events reported from 1998 to 2009. Outbreaks of severe hypoglycemia in 2008 and 2009 were associated with the use of adulterated and illegal sexual performance enhancement products. Further work to confirm the hepatotoxicity of implicated CAM products is warranted. Reporting of suspected adverse events is strongly encouraged even if the causality is not confirmed because any signs of clustering will allow rapid regulatory actions to be taken. The analysis of spontaneously reported adverse events is important in monitoring the safety of CAM products and helps in the understanding of the benefits and risks associated with the use of such products.
补充和替代医学（CAM）的使用，特别是草药和其衍生产品的使用，一直在增加。然而，与这些产品使用相关的严重不良反应的零星报告已成为关注的问题。自发不良事件报告可用于监测这些产品的安全性。
本研究旨在分析和描述 1998 年至 2009 年期间，在新加坡药物警戒数据库中与中药、其他补充药物和健康补充剂（称为 CAM 产品）使用相关的不良事件模式，并强调安全关注领域。
对 1998 年至 2009 年期间，由卫生科学局监测部门审查的与 CAM 产品相关的不良事件进行了整理和分析。提取并整理了以下信息：患者人口统计学资料、CAM 产品的类型和适应症、受影响的系统器官类别、不良事件的严重程度、给药途径、住院状态、不良事件的结果、与常规药物的同时使用、掺杂物检测和报告人的职业。
在 1998 年至 2009 年期间，报告了 627 例与 CAM 产品相关的不良事件。这些 627 例不良事件中，有 80.2%的不良事件严重，大多数患者使用 CAM 产品用于性功能增强（291 例，占 46.4%）、缓解关节痛和颈部疼痛（36 例，占 5.9%）和减肥目的（27 例，占 4.3%）。在 627 例不良事件中，内分泌紊乱占 22.5%，中枢神经系统紊乱占 20.6%。肝脏是严重不良事件中主要受累的器官。报告了 22 例死亡病例，在研究期间，有 10 例患者的死亡归因于肝毒性。
总之，对与 CAM 产品相关的 627 例不良事件报告进行了成功的分析和描述。它们占 1998 年至 2009 年期间报告的不良事件总数的~3.8%。2008 年和 2009 年的严重低血糖事件暴发与使用掺假和非法性功能增强产品有关。进一步确认有问题的 CAM 产品的肝毒性是必要的。即使因果关系未得到确认，也强烈鼓励报告疑似不良事件，因为任何聚集迹象都将允许迅速采取监管行动。对自发报告的不良事件进行分析对于监测 CAM 产品的安全性非常重要，并有助于了解使用此类产品的益处和风险。
