冠心舒通胶囊治疗冠心病心绞痛心血瘀阻证的临床综合评价

Clinical comprehensive evaluation of Guanxin Shutong Capsules in treatment of coronary heart disease angina pectoris with heart blood stasis syndrome

通过系统梳理冠心舒通胶囊治疗冠心病心绞痛心血瘀阻证的现有资料,采用定性与定量相结合的评价方法,基于多准则决策分析(MCDA)模型,参照《药品临床综合评价管理指南(2021年版试行)》对冠心舒通胶囊“6+1”维度的多元证据和价值进行临床综合评价,突出冠心舒通胶囊的临床治疗特点和优势,以期为医疗卫生决策部门提供参考依据。各维度评价结果分为A、B、C、D 4个等级。安全性方面,冠心舒通胶囊开展了国家不良反应监测中心自发呈报系统(SRS)监测和安全性文献分析,临床表现主要有恶心、腹泻、皮疹、心悸、头痛等,多为轻、中度不良反应,临床预后良好,但由于监测到该药品上市后有严重不良反应上报,只开展了SRS监测和文献安全性分析,因此该药品的安全性证据充分性需进一步提升,安全性评为B级。Meta分析结果显示,冠心舒通胶囊联合常规治疗冠心病心绞痛在提高心绞痛、心电图疗效等优于单用常规治疗,有效性评为A级。药物经济学评价研究显示,基于2020年人均可支配收入作为患者意愿支付阈值的假设,冠心病心绞痛患者使用冠心舒通胶囊联合常规治疗比单用常规治疗更具有经济性,但基于现有的临床效果参数尚无法支持2组患者间接成本的差异,干预方案成本的精确性需进一步提升,经济性评为B级。冠心舒通胶囊获国家发明专利13项,实用新型专利1项,有良好的企业服务体系和产业创新性,创新性评为A级。适宜性问卷调查结果显示,冠心舒通胶囊用药信息的宣传推广对患者的选择用药有一定影响,需进一步加强药品信息宣传,适宜性评为B级。冠心舒通胶囊的疗程费用与同类中成药价格相当,在城镇、农村居民中可负担性良好,无季节供应和产地限制,可及性评为A级。冠心舒通胶囊是蒙古族医治疗心刺痛的经验方,具有活血化瘀、通经活络、行气止痛的功效,上市后积累了2000例以上的人用经验证据,中医药特色较突出,评为B级。综合各维度证据评价,基于MCDA模型和CSC v2.0软件计算,冠心舒通胶囊治疗冠心病心绞痛心血瘀阻证的临床价值综合评为A类,建议可按程序转化为基本临床用药管理的相关政策结果。

This study aims to comprehensively summarize articles on the treatment of coronary heart disease angina pectoris with heart blood stasis syndrome(CHD-AP-HBSS)by Guanxin Shutong Capsules(GSC),and comprehensively evaluate the evidence and value of the formula in"6+1"dimensions based on multi-criteria decision analysis(MCDA)model and Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021)with quantitative and qualitative methods,which is expected to highlight the clinical characteristics and advantages of the prescription and serve as a reference for medical and health departments.The dimensions are grade A,B,C,or D.In terms of safety,according to the reports from the spontaneous reporting system of National Center for ADR Monitoring,and literature analysis,GSC mainly results in the adverse reactions of mild or moderate nausea,diarrhea,rash,palpitation,and headache,with favorable prognosis in patients.Nevertheless,severe adverse reactions have been reported after marketing.Thus,additional evidence for its safety should be accumulated,and the current safety is grade B.Meta-analysis proves that GSC in combination with conventional treatment is superior to conventional treatment alone in alleviating AP and symptoms indicated by electrocardiogram(ECG).Therefore,the effectiveness of the medicine is grade A.As for the pharmacoeconomic value,based on the assumption that the per capita disposable income in 2020 is the willingness-to-pay threshold,it is more economical for CHD-AP patients to use GSC combined with conventional treatment than conventional treatment alone.However,as the currently available clinical parameters fail to support the difference in indirect cost between the two groups,the accuracy in the cost of intervention plan needs to be further improved.Therefore,the economy of the prescription is grade B.GSC has been awarded 13 national invention patents and 1 utility model patent,and won a lot of national and provincial patent awards,marking the enterprise service awareness and innovativeness.As a result,it is grade A in aspect of innovation.A questionnaire on the suitability of GSC suggests that publicity and promotion influence patients′choice and thus additional efforts should be made in this aspect.The suitability of this formula is grade B.Both rural and urban residents can afford the medicine for the whole course and the price is close to that of similar Chinese patent medicines.In addition,it is accessible regardless of season and place,so accessibility is grade A.As a Mongolian empirical formula destined to treat heart stabbing pain,it has the effects of activating blood and resolving stasis,dredging channels and activating collaterals,and moving Qi to relieve pain,and boasts the empirical evidence of more than 2000 human cases.With prominent characteristics of traditional Chinese medicine,it is grade B.Based on the MCDA model and CSC v2.0,GSC is comprehensively class A in the treatment of CHD-AP-HBSS.The result can serve as a reference for basic clinical medication management.