Comprehensive clinical evaluation of compound salvia spray for rapid relief of angina pectoris attack in coronary atherosclerotic heart disease

CAI Yun; SUN Chunquan; LU Zhenkai; SU Xinxin; XIE Yanming

doi:10.16025/j.1674-1307.2026.02.005

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Comprehensive clinical evaluation of compound salvia spray for rapid relief of angina pectoris attack in coronary atherosclerotic heart disease

更新时间：2026-04-08

- Comprehensive clinical evaluation of compound salvia spray for rapid relief of angina pectoris attack in coronary atherosclerotic heart disease
- Beijing Journal of Traditional Chinese Medicine Vol. 45, Issue 2, Pages: 172-180(2026)
- 作者机构：
  
  1.中国中医科学院广安门医院济南医院济南市中医医院心血管病科，济南 250012
  2.清华大学玉泉医院清华大学中西医结合医院内分泌科，北京 100084
  3.中国中医科学院中医临床基础医学研究所，北京 100700
- 作者简介：
- 基金信息：
- DOI：10.16025/j.1674-1307.2026.02.005
  CLC：
- Received：08 December 2024，
  
  Published：25 February 2026
- 稿件说明：
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蔡芸，孙春全，路振凯，等.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.

CAI Yun,SUN Chunquan,LU Zhenkai,et al.Comprehensive clinical evaluation of compound salvia spray for rapid relief of angina pectoris attack in coronary atherosclerotic heart disease[J]. Beijing Journal of Traditional Chinese Medicine,2026,45(02):172-180.
蔡芸，孙春全，路振凯，等.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. DOI： 10.16025/j.1674-1307.2026.02.005.

CAI Yun,SUN Chunquan,LU Zhenkai,et al.Comprehensive clinical evaluation of compound salvia spray for rapid relief of angina pectoris attack in coronary atherosclerotic heart disease[J]. Beijing Journal of Traditional Chinese Medicine,2026,45(02):172-180. DOI： 10.16025/j.1674-1307.2026.02.005.

摘要

目的

对复方丹参喷雾剂治疗冠心病心绞痛进行临床证据和综合价值评估，为临床与基础研究提供学术支持。

方法

应用循证医学、问卷调查、真实世界研究、卫生技术评估、药品经济学评价等研究方法，从安全性、有效性、经济性、创新性、适宜性、可及性、中医药特色“6+1”个维度，及药品信息服务评价、临床价值综合评价共9个方面对复方丹参喷雾剂进行临床价值综合评价。

结果

①安全性：从安全性证据的已知风险和证据充分性两方面评价，认为复方丹参喷雾剂风险可控，安全性好，无严重不良反应发生。②有效性：在心绞痛显效率及心电图显效率方面，复方丹参喷雾剂/气雾剂单药疗效优于复方丹参片，与消心痛、复方丹参滴丸治疗效果相同；联合硝酸酯类药物治疗冠心病心绞痛的效果与硝酸酯类药物相同；复方丹参喷雾剂/气雾剂单药治疗冠心病心绞痛在缓解心绞痛的起效时间方面优于复方丹参片。复方丹参喷雾剂的有效性较好，临床意义较大。③经济性：复方丹参喷雾剂已被纳入全国医保乙类目录，从证据质量和经济价值两方面评价，认为复方丹参喷雾剂的经济价值较高，证据比较充分，结果较明确。④创新性：复方丹参喷雾剂在剂型、给药方式、用药配伍方面进行创新，并获得国家发明专利1项，均表明复方丹参喷雾剂的创新性较好。⑤适宜性：问卷调查结果显示，在给药方便度、技术管理及安全性等多个维度，临床医生、护士、药师以及使用本药品的患者认为该药品具有较好的适宜性。⑥可及性：复方丹参喷雾剂每天治疗费用占城镇居民人均可支配日收入的0.76%，占农村居民人均可支配日收入的3.11%，总体可及性较好；但在全国各级医院的配备情况较差，有待于在各级医院进一步推广、加强配备。⑦中医药特色：基于中医药特色评价原则，认为复方丹参喷雾剂药味的配伍精当、效专力宏，有中医药特色。

结论

复方丹参喷雾剂治疗冠心病心绞痛临床价值较高，具有中医药特色。

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

Keywords

references

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