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中国中医科学院中医临床基础医学研究所,北京 100700
Received:09 December 2024,
Published:25 August 2025
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路振凯,张旭明,崔鑫,等.愈风宁心滴丸治疗稳定型心绞痛的临床综合评价[J].北京中医药,2025,44(8):1075-1081.
LU Zhenkai,ZHANG Xuming,CUI Xin,et al.Comprehensive clinical evaluation of Yufeng Ningxin Dripping Pills in the treatment of stable angina pectoris[J]. Beijing Journal of Traditional Chinese Medicine,2025,44(08):1075-1081.
路振凯,张旭明,崔鑫,等.愈风宁心滴丸治疗稳定型心绞痛的临床综合评价[J].北京中医药,2025,44(8):1075-1081. DOI: 10.16025/j.1674-1307.2025.08.027.
LU Zhenkai,ZHANG Xuming,CUI Xin,et al.Comprehensive clinical evaluation of Yufeng Ningxin Dripping Pills in the treatment of stable angina pectoris[J]. Beijing Journal of Traditional Chinese Medicine,2025,44(08):1075-1081. DOI: 10.16025/j.1674-1307.2025.08.027.
目的
2
对愈风宁心滴丸治疗稳定型心绞痛进行临床综合评价,明确其临床优势,推进临床合理用药和相关政策转化。
方法
2
全面收集愈风宁心滴丸治疗稳定型心绞痛的研究数据与相关资料,从安全性、有效性、经济性、创新性、适宜性、可及性以及中医药特色“6+1”维度进行系统分析,采用Meta分析、决策树模型、问卷调查等方法,结合多维决策分析(MCDA)模型及CSC v2.0软件,对愈风宁心滴丸的临床价值进行综合评价。
结果
2
安全性:不良反应监测中心自发呈报系统共报告本品不良反应17例次,不良反应为皮疹、心慌胸闷、腹部不适、乏力等,均为一般不良反应,安全性证据充足;有效性:Meta分析结果显示,相较于单纯西药治疗,联用愈风宁心滴丸能够减少稳定型心绞痛患者的心绞痛发作频率和持续时间,降低心电图ST段异常发生率,有效性证据比较充分;经济性:愈风宁心滴丸有经济性证据支持,经济性相对较好;创新性:临床、企业服务体系和产业创新性证据充足;适宜性:医护人员及患者对于愈风宁心滴丸的适宜性较好;可及性:可获得性以及可负担性整体较好,可及性证据比较充分;中医药特色:愈风宁心滴丸的中医药特色有证据支持。综合“6+1”维度的结果,认为愈风宁心滴丸治疗稳定型心绞痛证据比较充分。
结论
2
愈风宁心滴丸治疗稳定型心绞痛的临床价值证据充分。
Objective
2
To conduct a comprehensive clinical evaluation of
Yufeng
Ningxin
Dripping Pills
in the treatment of stable angina pectoris, clarify its clinical advantages, and promote rational clinical use and related policy translation.
Methods
2
Comprehensive research data and related information on the use of
Yufeng
Ningxin
Dripping Pills
for treating stable angina pectoris were collected. A systematic analysis was conducted across six dimensions, including safety, efficacy, economy, innovation, suitability, accessibility, and one traditional Chinese medicine (TCM) characteristic dimension, referred to as the "6+1" dimensions. Methods such as meta-analysi
s, decision tree models, questionnaire surveys, and the Multi-Criteria Decision Analysis (MCDA) model combined with CSC v2.0 software were used to conduct a comprehensive clinical value evaluation.
Results
2
Safety: The Adverse Reaction Monitoring Center reported 17 cases of adverse reactions, including rash, palpitations, chest tightness, abdominal discomfort, and fatigue, all classified as mild. The safety evidence is sufficient. Efficacy: Meta-analysis results indicated that, compared to Western medicine alone, the combined use of
Yufeng
Ningxin
Dripping Pills
reduced the frequency and duration of angina episodes in patients with stable angina pectoris and decreased the incidence of ST-segment abnormalities on electrocardiograms. The efficacy evidence is robust. Economy:
Yufeng
Ningxin
Dripping Pills
are supported by economic evidence and show relatively good cost-effectiveness. Innovation: There is abundant evidence supporting the clinical application, enterprise service system, and industrial innovation of
Yufeng
Ningxin
Dripping Pills
. Suitability: Healthcare professionals and patients rated the suitability of the product highly. Accessibility: The product is well available and affordable, with sufficient evidence supporting its accessibility. TCM characteristics: The TCM characteristics of
Yufeng
Ningxin
Dripping Pills
are well-supported by relevant evidence. Synthesizing the results from the "6+1" dimensions, there is substantial evidence supporting the use of
Yufeng
Ningxin Dripping Pills
for treating stable angina pectoris.
Conclusion
2
Yufeng
Ningxin
Dripping Pills
demonstrate substantial clinical value for the treatment of stable angina pectoris.
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