小金丸中成药制剂临床不良反应分析

Analysis of Clinical Adverse Reactions of Xiaojin Pills Patent Medicine

目的:分析小金丸中成药制剂临床不良反应特点及原因。方法:检索CNKI、万方数据,采集小金丸中成药制剂临床研究及不良反应病例报道,分别分析其不良反应发生率、表现特点,并通过关键词共现网络分析其成因。结果:纳入单独应用小金丸并报道了不良反应的临床研究文献14篇,小金丸不良反应病例报道21篇,小金丸中成药制剂不良反应发生率0.73%,以皮肤损害和胃肠道症状为主要表现,且多发生于用药1周以内;毒性药材及动物源性药材的应用,临床超适应症使用,药品说明书安全性警示不充分是其不良反应的主要因素。结论:小金丸不良反应多发生于用药早期,遵循药品说明及辨证施治合理应用、药品必要警示是减少其不良反应的重要途径。

Objective:To analyze the characteristics and causes of clinical adverse reactions of Xiaojin Pills.Methods:Retrieved CNKI and Wanfang data,collected Xiaojinwan proprietary Chinese medicine preparation clinical studies and adverse reaction case reports,analyzed the incidence and performance characteristics of adverse reactions,and analyzed the causes through the keyword co-occurrence network.Results:Included 14 clinical research literatures that used Xiaojin Pills alone and reported adverse reactions,and 21 reports of adverse reactions of Xiaojin Pills.The incidence of adverse reactions of Xiaojin Pills Chinese patent preparations was 0.73%,with skin damage and gastrointestinal symptoms as the main manifestations.It usually occurs within 1 week of medication;the application of toxic medicinal materials and animal-derived medicinal materials,clinical use of over-indications,and insufficient safety warnings in the drug instructions are the main factors for adverse reactions.Conclusion:Adverse reactions of Xiaojin Pills mostly occur in the early stage of medication.Following drug instructions,rational application of syndrome differentiation and treatment,and necessary warnings of drugs are important ways to reduce their adverse reactions.