注射用血栓通(冻干)治疗急性脑梗死的临床综合评价

Comprehensive Clinical Evaluation of Xueshuantong for Injection(Lyophilized)in Treatment of Acute Cerebral Infarction

目的:系统梳理注射用血栓通(冻干)治疗急性脑梗死(ACI)的现有研究,通过临床综合评价的方式,明确注射用血栓通(冻干)的临床价值,以推进临床合理用药及相关政策转化。方法:搜集注射用血栓通(冻干)在安全性、有效性、经济性、创新性、适宜性、可及性、中医药特色(“6+1”维度)和信息服务等方面的证据,应用循证医学、问卷调查、卫生技术评估、药品经济学评价等研究方法,利用多准则决策分析模型对各维度进行度量,以综合评价注射用血栓通(冻干)的临床价值。结果:安全性主动监测研究、自发呈报系统、不良反应Meta分析等结果表明,注射用血栓通(冻干)的不良反应主要为皮疹、瘙痒、胸闷、头痛、头晕等一般不良反应,严重不良反应发生率判定为罕见,已知风险较小,证据充分,安全性评价为A级;Meta分析结果显示,注射用血栓通(冻干)联合常规治疗ACI在改善神经功能缺损评分、提高日常活动能力评分及临床疗效方面优于常规治疗,有效性评价为B级;药物经济学评价结果表明,以临床总有效率为效果参数,注射用血栓通(冻干)联合常规治疗与单用常规治疗相比具有相对经济性,但增量效应不显著,经济性评价为B级;该药品与其他成分的活血类中药注射剂相比,除ACI、冠心病不稳定型心绞痛外,在视网膜中央静脉阻塞方面也有良好的临床疗效,适应证更广泛,荣获专利16件,创新性评价为B级;医护人员和患者的适宜性较好,无特殊技术和管理要求,适宜性评价为B级;注射用血栓通(冻干)药品价格合理,可负担性较好,有一定的处方使用限制,可获得性一般,可及性评价为B级;由于该药品为中药有效部位制备而成的注射剂,因此,不对其中医药特色进行等级评价。注射用血栓通(冻干)法定信息及非法定信息评价结果显示,各项信息齐全,符合国家标准的规定。综合6个维度的等级得分,通过CSC 2.0计算得出注射用血栓通(冻干)治疗ACI的临床综合评价为B类。结论:注射用血栓通(冻干)的临床价值较好,建议可直接转化为基本临床用药管理的相关政策结果。

Objective:To systematically review the existing studies on Xueshuantong for injection(lyophilized)in the treatment of acute cerebral infarction(ACI),and to clarify the clinical value of Xueshuantong for injection(lyophilized)through comprehensive clinical evaluation,so as to promote clinical rational drug use and relevant policy transformation.Method:Evidence of Xueshuantong for injection(lyophilized)in terms of safety,effectiveness,economy,innovation,suitability,accessibility,traditional Chinese medicine(TCM)characteristics(6+1 dimensions)and information service was comprehensively collected.Evidence-based medicine,questionnaire survey,health technology assessment,pharmacoeconomic evaluation and other research methods were used,and the multi-criteria decision analysis model was used to measure each dimension,in order to comprehensively evaluate the clinical value of Xueshuantong for injection(lyophilized).Result:Spontaneous reporting system,Meta-analysis of adverse reactions,and active safety monitoring study showed that the main adverse reactions of Xueshuantong for injection(lyophilized)were rash,pruritus,chest tightness,headache,dizziness and other general adverse reactions,the incidence of serious adverse reactions was judged to be rare,the known risk was small,the evidence was sufficient,and the safety evaluation was grade A.The results of Meta-analysis showed that Xueshuantong for injection(lyophilized)combined with conventional treatment for ACI was superior to conventional treatment in terms of improving neurological deficit score,improving daily activity score and clinical efficacy,and the effectiveness evaluation was grade B.The results of pharmacoeconomic evaluation showed that Xueshuantong for injection(lyophilized)combined with conventional treatment was relatively economic compared with conventional treatment alone,with the total clinical effective rate as the effect parameter,but the incremental effect was not significant,the economic evaluation was grade B.In addition to ACI and unstable angina of coronary heart disease,the drug also had good clinical efficacy in central retinal vein occlusion,and had a wider range of indications and awarded 16 patents,and its innovation evaluation was grade B.The suitability of medical personnel and patients was good without special technical and management requirements,and the suitability was evaluated as grade B.Xueshuantong for injection(lyophilized)had reasonable price,good affordability,certain prescription restrictions and general availability,the accessibility evaluation was grade B.Since the drug is an injection of effective parts of TCM,no grade evaluation of its TCM characteristics is conducted.The legal and non-legal information evaluation results of Xueshuantong for injection(lyophilized)showed that all the information was complete and in accordance with the requirements of national standards.Based on the grade scores of the 6 dimensions,the clinical comprehensive evaluation of Xueshuantong for injection(lyophilized)in the treatment of ACI was calculated as category B by CSC 2.0.Conclusion:The clinical value of Xueshuantong for injection(lyophilized)is good,and it is suggested that it can be directly translated into relevant policy outcomes for basic clinical medication management.