摘要
目的:对痫愈胶囊治疗癫痫风痰闭阻证进行临床综合评价,为临床合理用药及中药上市后研究提供方法学参考。方法:基于循证医学、临床流行病学、临床医学、循证药学、药物经济学等,利用公开数据、文献数据、药学研究、问卷调查等信息,采用定性与定量相结合的评价方式,从安全性、有效性、经济性、创新性、适宜性、可及性和中医药特色“6+1”个维度进行临床综合评价。采用多准则决策分析(MCDA)模型及CSC软件V2.0版评价痫愈胶囊的临床价值,各维度评价结果分为A、B、C、D 4个等级。结果:自发呈报系统(SRS)监测数据、文献报道、临床研究等多源安全性证据表明,该药品的主要不良反应为头晕、嗜睡、恶心等,未见严重不良反应。证据较充分,风险可控,安全性评价为B级。Meta分析表明痫愈胶囊联合常规西药治疗癫痫在减少癫痫发作频数(次/月)、提高临床总有效率方面优于单用常规西药治疗,有效性评为B级。药物经济学研究结果表明,痫愈胶囊联合常规西药(丙戊酸镁缓释片)治疗癫痫比单独使用丙戊酸镁缓释片更具有成本-效果优势,但增量效应水平不显著,经济性评为B级。痫愈胶囊是目前国家医保目录中芳香豁痰开窍剂名录下仅有的可以治疗癫痫的中成药,针对风痰闭阻证而设,证型明确;公司基于现代科学技术对经典名方进行传承创新,获得多项发明专利,创新性评为A级。调查问卷结果表明,痫愈胶囊使用可满足临床医患用药需求,说明书、标签等宣传资料准确完整,无夸大误导现象;药品说明书、标签及包装的信息服务规范,综合调查问卷及中成药信息服务结果,适宜性评为A级。与同类药价格比较,痫愈胶囊价格水平居中;治疗费用占人均可支配收入较高,可负担性一般;药品销售覆盖范围广,药材资源可持续,可获得性较好,可及性评为B级。该药品源于经典名方“牵正散”和“天麻钩藤饮”的合方,针对风痰闭阻证而设,人用经验较丰富,中医特色评为B级。综合痫愈胶囊“6+1”维度的证据评价结果,临床价值综合评价为B类。结论:痫愈胶囊治疗癫痫(风痰闭阻证)临床价值较好,中医药特色较突出,建议按程序转化为基本临床用药管理的相关政策结果。
Objective:To perform a clinical comprehensive evaluation of Xianyu capsules in the treatment of epilepsy with wind-phlegm obstruction syndrome to provide methodological references for clinical rational medication and post-marketing research on Chinese medicine.Method:Based on evidence-based medicine,clinical epidemiology,clinical medicine,evidence-based pharmacy,and pharmacoeconomics,the clinical comprehensive evaluation was carried out from the"6+1"dimensions of safety,effectiveness,economy,innovation,suitability,and accessibility,as well as characteristics of traditional Chinese medicine(TCM)using public data,literature data,pharmaceutical research,questionnaire survey,and other information by qualitative and quantitative evaluation methods in combination.Multi-criteria decision analysis(MCDA)model and CSC software V2.0 were adopted to evaluate the clinical value of Xianyu capsules.The evaluation results of each dimension were divided into four grades,i.e.,A,B,C,and D.Result:Multiple sources of safety evidence such as spontaneous reporting system(SRS)monitoring data,literature reports,and clinical studies showed that the main adverse reactions of Xianyu capsules were dizziness,drowsiness,and nausea,and there were no serious adverse reactions.Due to the sufficient evidence and the controllable risk,they were graded B for the safety.Meta-analysis showed that Xianyu capsules combined with conventional western medicine in the treatment of epilepsy were better than conventional western medicine alone in reducing the frequency of seizures(times/month)and improving the total clinical effective rate,and they were graded B for the effectiveness.The results of pharmacoeconomic research showed that Xianyu capsules combined with conventional western medicine(magnesium valproate sustained-release tablets)had cost-effectiveness advantages over magnesium valproate sustained-release tablets alone in the treatment of epilepsy,but the level of incremental effect was not significant.Therefore,they were graded B for economy.Xianyu capsules are the only Chinese patent medicine that can treat epilepsy under the list of phlegm-eliminating and orifices-opening agents with aromatics in the current national medical insurance catalogue.They are designed for the syndrome of wind-phlegm obstruction with clear syndrome type.The company has insisted on inheritance and innovation based on the classic famous prescriptions by virtue of modern science and technology,and obtained a number of patents for invention.Hence,they were graded A for the innovation.The questionnaire results showed that the use of drugs could meet the medication needs of clinical doctors and patients,and the publicity materials such as instructions and labels were accurate and complete without exaggeration and misleading.The information service of drug instructions,labels,and packaging was normative.According to the comprehensive questionnaire and the information service results of Chinese patent medicine,they were graded A for the suitability.Compared with the price of similar drugs,the price of Xianyu capsules is moderate.The cost of treatment accounts for a high proportion of per capita disposable income and is generally affordable.Because of a wide sales scope,sustainable medicinal material resources,and good availability,they were graded B for the accessibility.Xianyu capsules are derived from the combination of the classic prescriptions Qianzhengsan and Tianma Goutengyin,which are designed for the syndrome of wind-phlegm obstruction with rich experience in human use.Hence,they were rated as grade B for TCM characteristics.Based on the evidence evaluation results of"6+1"dimensions of Xianyu capsules,the comprehensive evaluation of clinical value was B.Conclusion:The clinical value of Xianyu capsules in the treatment of epilepsy with wind-phlegm obstruction syndrome is high,and the TCM characteristics are prominent.It is suggested to convert into the relevant policy results of basic clinical medication management according to the procedure.
作者
雷超
谭畅
张强
崔鑫
王志飞
谢雁鸣
LEI Chao;TAN Chang;ZHANG Qiang;CUI Xin;WANG Zhifei;XIE Yanming(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2023年第3期117-126,共10页
Chinese Journal of Experimental Traditional Medical Formulae
基金
中国中医科学院科技创新工程重大攻关项目(CI2021A00702)
国家重点研发计划项目(2018YFC1707400)。
关键词
痫愈胶囊
癫痫
风痰闭阻证
临床综合评价
多准则决策分析
牵正散
天麻钩藤饮
Xianyu capsules
epilepsy
wind-phlegm obstruction syndrome
clinical comprehensive evaluation
multi-criteria decision analysis
Qianzhengsan
Tianma Goutengyin
作者简介
第一作者:雷超,在读博士,从事中药上市后再评价研究,E-mail:chaolei2021@163.com;通信作者:王志飞,博士,研究员,从事中药上市后再评价工作,E-mail:wzhftcm@163.com;通信作者:谢雁鸣,首席研究员,从事中药上市后评价研究,E-mail:ktzu2018@163.com。
