北京中医药2026，Vol.45Issue(2)：172-180,9.DOI:10.16025/j.1674-1307.2026.02.005
复方丹参喷雾剂缓解冠心病心绞痛发作的临床综合评价
Comprehensive clinical evaluation of compound salvia spray for rapid relief of angina pectoris attack in coronary atherosclerotic heart disease
摘要
Abstract
Objective To evaluate the clinical evidence and comprehensive value of compound salvia spray in the treatment of angina pectoris in coronary heart disease,and to provide academic support for clinical and basic research.Method Using research methods including evidence-based medicine,questionnaire surveys,real-world studies,health technology assessment,and pharmacoeconomic evaluation,the clinical value of compound salvia spray was comprehensively assessed from nine aspects:safety,effectiveness,economy,innovation,appropriateness,accessibility,and characteristics of traditional Chinese medicine(TCM)within a"6+1"framework,as well as drug information service evaluation and overall clinical value evaluation.Result ① Safety:Based on the evaluation of known risks and the adequacy of safety evidence,compound salvia spray was considered to have controllable risks and good safety,with no serious adverse reactions reported.② Effectiveness:In terms of angina symptom markedly effective rate and electrocardiogram(ECG)markedly effective rate,compound salvia spray/aerosol monotherapy was superior to compound salvia tablets and equivalent to isosorbide dinitrate and compound salvia dripping pills.When combined with nitrate drugs,its efficacy in treating angina pectoris of coronary heart disease was comparable to that of nitrate drugs alone.In addition,compound salvia spray/aerosol monotherapy showed a faster onset in relieving angina compared with compound salvia tablets.Overall,compound salvia spray demonstrated good effectiveness with significant clinical value.③ Economy:Compound salvia spray has been included in the National Medical Insurance Class B Catalog.Based on evaluations of evidence quality and economic value,it was considered to have high economic value,with relatively sufficient evidence and clear results.④ Innovation:Compound salvia spray shows innovation in dosage form,route of administration,and formulation compatibility,and has been granted one national invention patent,indicating good innovation.⑤ Appropriateness:Questionnaire survey results indicated that clinicians,nurses,pharmacists,and patients considered the drug to have good appropriateness in terms of ease of administration,technical management,and safety.⑥ Accessibility:The daily treatment cost of compound salvia spray accounts for 0.76%of the per capita daily disposable income of urban residents and 3.11%of that of rural residents,indicating good overall accessibility.However,its availability across hospitals at different levels nationwide remains limited and requires further promotion and wider adoption.⑦ TCM characteristics:Based on evaluation principles of TCM,the formulation demonstrates appropriate compatibility of medicinal components and strong targeted efficacy,reflecting distinctive characteristics of TCM.Conclusion Compound salvia spray demonstrates high clinical value in the treatment of angina pectoris in coronary heart disease and possesses distinctive characteristics of TCM.关键词
多准则决策分析/复方丹参喷雾剂/冠心病心绞痛/临床综合评价/中医药特色Key words
multi-criteria decision analysis(MCDA)/compound salvia spray/angina pectoris in coronary heart disease/clinical comprehensive evaluation/characteristics of traditional Chinese medicine引用本文复制引用
蔡芸,孙春全,路振凯,苏鑫鑫,谢雁鸣..复方丹参喷雾剂缓解冠心病心绞痛发作的临床综合评价[J].北京中医药,2026,45(2):172-180,9.基金项目
国家重点研发计划"中医药现代化研究"项目(2018YFC1707400) （2018YFC1707400）
济南市卫生健康委员会科技发展计划项目(2024310021) （2024310021）
济南市医疗卫生行业高层次人才专项经费资助(202512) （202512）
