一清胶囊治疗热毒证的药品临床综合评价  

Comprehensive Clinical Evaluation of Yiqing Capsules in Treating Heat-toxin Syndrome

作　　者：王雅星 苏鑫鑫 黄艳丽 崔鑫 黎元元[1] 谢雁鸣[1] WANG Yaxing;SU Xinxin;HUANG Yanli;CUI Xin;LI Yuanyuan;XIE Yanming(Institute of Basic ResearchMedicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中国实验方剂学杂志》2024年第6期126-133,共8页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家中医药管理局岐黄学者支持项目(国中医药人教函[2022]6号);国家重点研发计划项目(2018YFC1707400)。

摘　　要：目的:通过系统梳理一清胶囊治疗热毒证咽炎、扁桃体炎、牙龈炎、口腔溃疡的现有研究,明确其内在优势价值及治疗特点,为国家卫生医药决策相关部门提供参考,同时为临床和基础的研究提供基础和线索。方法:采用定性和定量相结合的评价方法,基于多准则决策(MCDA)模型,应用CSC v2.0软件从多方面对一清胶囊进行临床综合评价。结果:一清胶囊自发呈报系统(SRS)监测数据中严重不良反应包括瘙痒、皮疹、腹泻等,均好转或痊愈,无加重或转院治疗。文献数据显示临床不良反应主要表现为腹痛、腹泻等,急性毒性和长期毒性均显示安全性较好,一清胶囊安全性评为B级;Meta分析结果显示,一清胶囊单用或者联合治疗伴有热毒证咽炎、扁桃体炎、牙龈炎、口腔溃疡在症候改善情况、疾病主症消失率、口疮复发率等方面优于牛黄解毒胶囊或西药治疗,药理药效学显示一清胶囊具有抗菌、抗病毒、抗炎等作用,有效性评为B级;从卫生体系角度出发,采用决策树模型,根据增量效应水平分析,以1倍人均国内生产总值(GDP)作为阈值条件下,一清胶囊在治疗热毒证牙龈炎以牙龈炎疼痛消失率为指标,与牛黄解毒胶囊组采用增量成本效果比为0.39元/%,相比更具有经济性优势,且成本可接受,经济性评为B级;一清胶囊既能清气分热,又能泻血分火毒,为清下并行,以下为清的代表方剂,适用于热毒证,同时结合企业产业服务体系和企业创新性,综合得创新性评为B级;本品一般不需要个体化治疗方案,供应贮运方便,政策宣传和药品信息规范,医护、患者都易操作;中成药信息齐全,符合国家标准,适宜性评为A级;一清胶囊价格水平低,可获得性及可负担性较好,可及性评为A级;一清胶囊的原经方“三黄泻心汤”源于古医书,且真实世界研究较丰富,中医药特色评为C级。结论:综合“6+1”维度,采用CSC v2.0�Objective:To systematically review the studies about Yiqing Capsules in the treatment of pharyngitis,tonsillitis,gingivitis,and oral ulcers with heat-toxin syndrome and clarify the advantages and therapeutic characteristics of Yiqing capsules,thus providing reference for the decision-making by relevant departments and clues for the clinical and basic research.Method:The multi-criteria decision analysis(MCDA)model and CSC v2.0 were employed to comprehensively evaluate Yiqing capsules from multiple aspects.Result:The serious adverse reactions in the spontaneous reporting system(SRS)monitoring data of Yiqing capsules included pruritus,rash,an ddiarrhea,all of which were relieved or cured,without aggravation or interhospital transfer for treatment.Literature data showed that the main clinical adverse reactions were abdominal pain,diarrhea,etc.Both acute toxicity and long-term toxicity tests showed good safety,and thus the safety of Yiqing capsules was rated as grade B.The results of Meta-analysis showed that Yiqing capsules used alone or in combination with other medicines outperformed Niuhuang Jiedu capsules or Western medicine in the treatment of pharyngitis,tonsillitis,gingivitis,and oral ulcers with heat toxin in terms of symptom alleviation,disappearance rate of main symptoms,and recurrence rate of aphtha.Pharmacological and pharmacodynamic studies showed that Yiqing capsules had antimicrobial,antiviral,and anti-inflammatory effects,with the effectiveness rated as grade B.The decision tree model was adopted to analyze the incremental cost-effectiveness ratio.With the threshold of 1 fold per capita GDP and the disappearing rate of pain in gingivitis as the indicator,Yiqing capsules had an economic advantage in the treatment of gingivitis due to heat-toxin compared with Niuhuang Jiedu capsules,and the incremental cost-effectiveness ratio was 0.39 yuan/%,which indicated acceptable cost,with the economy rated as grade B.Yiqing capsules can not only clear heat from Qi aspect but also purge blood fire,serving as the r

关 键 词：一清胶囊 热毒证 证候改善 临床综合评价 多准则决策分析 

分 类 号：R242[医药卫生—中医临床基础] R2-031[医药卫生—中医学] R287R286