芪龙胶囊治疗缺血性中风病气虚血瘀证的临床综合评价

Clinical comprehensive evaluation of Qilong Capsules in treatment of ischemic stroke with Qi deficiency and blood stasis syndrome

系统梳理芪龙胶囊治疗缺血性中风病气虚血瘀证现有研究,对其临床证据与价值综合评价,以体现产品的优势和特色,为国家医药管理部门决策提供参考。该研究基于循证医学、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”维度,运用多准则决策分析(MCDA)模型对各维度进行评价,应用CSC v2.0软件计算芪龙胶囊的临床价值。各维度评价结果分为A、B、C、D 4个等级。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口干、恶心、皮疹等,未见明显严重不良反应,证据较充分,已知风险较小,风险可控,安全性评为A级。Meta分析表明芪龙胶囊联合常规西药治疗缺血性中风病急性期在改善神经功能缺损评分、提高临床总有效率和患者日常生活活动能力、改善血液流变学指标方面优于单用常规西药治疗,证据级别较高,临床意义明显,有效性评为A级。药物经济学研究结果表明,芪龙胶囊联合常规西药相比单独使用常规西药治疗缺血性中风病更具有成本-效果优势,但增量效应水平不显著,药物经济学报告的质量评价结果基本明确,经济性评为B级。芪龙胶囊针对社会重大脑血管病,充分发挥中药优势,注重经典传承,科学技术革新,创新性评为B级。问卷调查结果表明,药品技术特点和使用可满足临床医生和患者用药需求,适宜性评为B级。与同类药价格比,该药品价格水平偏高;治疗费用占人均可支配收入小,可负担性好;药品销售覆盖范围广,产能充足,药材资源可持续,可获得性好,可及性评为B级。该药品源于经典名方“补阳还五汤”,补气与活血并调,人用经验较丰富,中医药特色评为B级。综合芪龙胶囊“6+1”维度的证据评价结果,临床价值综合评价为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。

The present study systematically sorted out the existing research on Qilong Capsules in the treatment of ischemic stroke with Qi deficiency and blood stasis syndrome and comprehensively evaluated its clinical evidence and value to highlight the advantages and characteristics of products and provide references for the decision-making of national pharmaceutical management departments.Based on the evidence-based medicine,epidemiology,clinical medicine,evidence-based pharmacy,and pharmacoeconomics,the qualitative and quantitative evaluation of"6+1"dimensions of safety,effectiveness,economy,innovation,suitability,and accessibility,as well as characteristics of traditional Chinese medicine(TCM)was performed with multi-criteria decision analysis(MCDA)mo-del using the information,such as public data,literature data,pharmaceutical research,and questionnaire survey,and CSC v2.0 was used to calculate the clinical value of Qilong Capsules.The evaluation results were grade A,B,C,or D.Spontaneous reporting system(SRS)monitoring data,literature reports,clinical trials,and other multi-source safety evidence showed that the main adverse reactions of this drug included dry mouth,nausea,and rash,and no severe adverse reactions was found.The evidence was sufficient with small and controllable known risks,and the safety was grade A.Meta-analysis showed that Qilong Capsules combined with conventional western medicine in the treatment of acute ischemic stroke was superior to the control group in improving neurological deficits,clinical total response rate,patients′activities of daily living,and hemorheological indexes.The level of evidence was high with manifest clinical significance,and the effectiveness was grade A.The results of pharmacoeconomic research showed that Qilong Capsules combined with conventional western medicine in the treatment of ischemic stroke were advantageous in cost-effectiveness as compared with conventional western medicine alone,but the incremental effect was not significant.The quality evaluation results of the economic report were comparatively clear,and the economy was grade B.Aiming at major cerebrovascular diseases in the society and giving full play to the advantages of TCM,Qilong Capsules focused on the inheritance of classics and scientific and technological innovation,and innovation was grade B.The results of the questionnaire survey showed that the technical characteristics and drug application could meet the medication needs of clinical doctors and patients,and the suitability was grade B.The price level of this drug was comparatively high and the affordability was good since the treatment cost accounted for a small proportion of disposable income.The drug accessibility was good with a wide range of drug sales,sufficient production capacity,and sustainable medicinal materials resources,and was grade B.This drug was derived from the classic prescription Buyang Huanwu Decoction with rich experience of human application,which could regulate Qi and blood circulation,and the section of TCM characteristics was grade B.Based on the evidence evaluation results of"6+1"dimensions of Qilong Capsules,the comprehensive evaluation of clinical value was class A.It is suggested that it can be transformed into relevant policy results of basic clinical medication management according to procedures.