基于临床的含黄连中药汤剂安全性主动监测研究

Active Safety Monitor on Traditional Chinese Medicine Decoction Containing Copits based on Clinical Study

目的:探索中药汤剂安全性主动监测方法,并对含黄连的中药汤剂进行安全性主动监测,了解含中药黄连的汤剂不良反应发生情况和不良反应特征。方法:以访谈方式,对使用含黄连的中药汤剂的门诊患者进行用药调查,记录患者一般资料以及不良反应发生情况,计量资料用Excel表进行统计分析。结果:使用含黄连的中药汤剂的201例患者中,不良反应发生率为8.95%(18/201)。排便次数增多10例,便秘4例,恶心反胃4例,但症状较轻微,均未影响药物继续治疗。其不良反应发生与用药剂量、患者体质、药物配伍密切相关。结论:本项研究探讨了中药汤剂不良反应与患者体质寒热虚实、药物配伍的关系,为探讨中药不良反应发生规律、探讨符合中医药特点的不良反应监测方法提出了新思路。

Objective：To explore the active monitoring method on the safety of traditional Chinese medicine decoction, and discuss the occurrence characters of the adverse drug reactions（ADR） of decoction containing Coptis. Methods： Patients who were prescribed the Traditional Chinese medicine decoction containing Coptis were interviewed, and the common data and the ADR characteristics were collected. All the data were analyzed with Excel software. Results：Among the 201 patients who were followed up ,8.95% （ 1 8/201 ）presented with ADR, which included 10cases of defecate number increase ,4 cases of constipation, and 4 cases of nausea. But the treatment continued because of the slight symptom. And the ADR rate of Coptis was closely connected with the dose, the medical compatibility, and the patients condition. Conclusion：This study explores the relationship between the ADR and the medical compatibility, as well as the heatcold, deficiency-excess condition of patients. It points out a new way to study the rules of the occurrence, and the monitoring method of the ADR,which is in accordance with the characteristics of traditional Chinese medicine.