雄黄的临床不良反应分析

Clinical Adverse Reactions of Realgar

目的:探讨含雄黄制剂致不良反应相关规律和特点,分析使用含雄黄制剂相关的风险因素,为临床安全合理用药提供参照。方法:以"牛黄解毒丸""牛黄解毒片""六神丸""安宫牛黄丸""含雄黄制剂""不良反应"为检索词,检索中国期刊网全文数据库和PubMed医学文献检索服务系统,按纳入与排除标准共纳入72篇文献,并对文献资料进行提取、归纳、分析。结果:10.9%的病例涉及砷的毒性反应。发现明确砷中毒有关的案例,均涉及长期使用雄黄比例较高的制剂。累及系统器官主要为皮肤(剥落性皮炎)、血和尿砷超标、消化系统损害等。其他不良反应主要为过敏反应,表现为皮疹、药疹、过敏性休克、心律失常等,但这些不良反应可能与雄黄制剂中其他药物有关,尚不能确定是雄黄引起的。结论:重视含雄黄制剂引起的不良反应,规范雄黄的摄入剂量与时间,加强临床合理用药,防范不良反应发生。

Objective： To explore the regularity and feature of the adverse reactions of realgar preparations, and to analyze the risk factors associated with realgar preparations, thus to provide references for its clinical safety and rational use. Methods： “Niuhuang Jiedu Tablets”, “Liushen Pill”, “Angong Niuhuang Pill”, “realgar preparations”, and “adverse reaction” were taken as the key words to retrieve articles in the CNKI and Pubmed database. 72 literatures which met the inclusion and exclusion criteria were extracted and analyzed. Results： 10.9% of the cases involved the toxic reaction of arsenic. It was found that the cases related to arsenic poisoning were related to long-term use of realgar. Adverse reactions were mainly involved in skin（exfoliative dermatitis）, excessive arsenic in blood and urine, and damage of gastrointestinal system. Other adverse reactions were mainly allergic reactions, characterized by skin rashes, drug eruption, allergic shock, and arrhythmia; which may be associated with other medicinal in realgar preparations. Conclusion： Preventing the adverse reactions caused by realgar preparations, standardizing the intake dose and intake time of realgar and strenghening the rational use should be paid more attention to.