注射用灯盏花素治疗急性脑梗死和冠心病心绞痛的临床综合评价

Clinical comprehensive evaluation of Breviscapine Injection in treatment of acute cerebral infarction and angina pectoris in coronary heart disease

目的系统梳理注射用灯盏花素(Breviscapine Injection,BI)治疗急性脑梗死和冠心病心绞痛的研究进展,通过临床综合评价的方式,明确BI的临床价值,以推进临床合理用药以及相关政策转化。方法全面搜集BI在安全性、有效性、经济性、创新性、适宜性、可及性(6维度)和药学质量及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、药物经济学评价等方法,利用多准则决策分析模型对各维度进行度量,对BI的临床价值进行综合评价。结果自发呈报系统、不良反应Meta分析、临床研究等表明,BI的不良反应主要为咳嗽、咽痛、气短、呼吸困难等呼吸系统不良反应,严重不良反应发生率判定为罕见,安全性评价为A级,已知风险较小,证据充分;Meta分析结果显示,BI治疗脑梗死及冠心病心绞痛的结局指标可根据等级评价标准判定其有效性等级均为B级,证据比较充分,结果明确;药物经济学评价结果表明,以美国国立卫生研究院卒中量表(national institutes of health stroke scale,NIHSS)评分为结局指标,BI联合常规治疗与单独常规治疗相比更具经济性,增量效应显著,经济性评价为B级,证据比较充分,结果明确;BI治疗急性脑梗死可提高临床总有效率、改善神经功能缺损和血液流变学指标、降低14 d死亡率,且成分单一,质控方便,曾获国家发明专利授权和2017年中国年度设施奖,创新性评价为B级,具有较好的创新性;BI贮运方便,不需个体化治疗方案,无特殊技术和管理要求,适宜性评价为C级,对临床医护及患者具有适宜性;BI药品价格合理,可负担性较好,在全国30个省市有售,可获得性较好,可及性评价为B级,可及性较好;由于该药品为单体中药注射剂,因此,不对其中医药特色进行等级评价。BI的法定信息及非法定信息评价结果显示其各项信息齐全,符合国家标准规定。综合6个维度的等级得分,通过CSC 2.0软件计算得出,BI治疗急性脑梗死和冠心病心绞痛的临床综合评价为A级。结论BI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 of Breviscapine Injection(注射用灯盏花素,BI)in the treatment of acute cerebral infarction and angina pectoris in coronary heart disease,and clarify the clinical value of BI by means of comprehensive clinical evaluation,in order to promote clinical rational drug use as well as relevant policy translation.Methods The evidence on safety,efficacy,economy,innovation,appropriateness,accessibility(six dimensions)and pharmacy quality and information services of BI were comprehensively collected.Evidence-based medicine,questionnaire survey,health technology evaluation,pharmacoeconomic evaluation and other methods were used to measure each dimension by using multi-criteria decision analysis model,and the clinical value of BI was comprehensively evaluated.Results The spontaneous reporting system,adverse reaction Meta-analysis,and clinical studies showed that the adverse reactions of BI were mainly respiratory system adverse reactions such as cough,sore throat,shortness of breath,and dyspnea,and the incidence of serious adverse reactions was ju dged to be rare.The safety evaluation was grade A,with small known risks and sufficient evidence.Meta-analysis results showed that the outcome indicators of BI in the treatment of acute cerebral infarction and angina pectoris in coronary heart disease could be judged as B level of effectiveness according to the grade evaluation criteria,with sufficient evidence and clear results.The pharmacoeconomic evaluation results showed that BI combined conventional treatment was more economical than conventional treatment alone using the national institutes of health stroke scal(NIHSS)score as the outcome index,and the incremental effect was significant.The economic evaluation was grade B,with sufficient evidence and clear results.BI in the treatment of acut e cerebral infarction could improve the total clinical efficiency,improve neurological deficits,improve blood rheological indexes,and reduce 14 d mortality,and had a single composition and convenient quality control.It has been authorized by the national invention patent and the 2017 China Annual Facility Award,and the innovation evaluation was B,with good innovation.BI was convenient to store and transport,does not require individual treatment plans,has no special technical and management requirements,and its suitability evaluation was grade C,which was suitable for clinical care and patients.BI had reasonable prices and good affordability.It was available in 30 provinces and cities across the country with good availability.The accessibility evaluation was grade B with good accessibility.Because it was a monomer injection of traditional Chinese medicine,the grade evaluation of its traditional Chinese medicine characteristics was not carried out.The evaluation results of statutory information and non-statutory information of BI showed that the information was complete and in line with national standards.Based on the grade scores of six dimensions,calculated by CSC 2.0 software,the clinical comprehensive evaluation of BI in the treatment of acute cerebral infarction and angina pectoris in coronary heart disease was grade A.Conclusion The clinical value of BI was good,and it was suggested that it could be directly translated into the relevant policy results of basic clinical drug manag ement.