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.中国中医科学院 中医临床基础医学研究所,北京 100700
牛英硕,女,38岁,博士研究生,副主任医师。研究方向:中医药治疗心血管疾病的临床研究。
谢雁鸣,E-mail: ktzu2018@163.com
收稿:2024-12-08,
纸质出版:2025-09-25
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牛英硕,魏瑞丽,王志飞,等.芪冬颐心口服液治疗病毒性心肌炎气阴两虚证的临床综合评价[J].北京中医药,2025,44(9):1207-1213.
NIU Yingshuo,WEI Ruili,WANG Zhifei,et al.Clinical comprehensive evaluation of Qidong Yixin Oral Liquid in the treatment of viral myocarditis with qi and yin deficiency syndrome[J]. Beijing Journal of Traditional Chinese Medicine,2025,44(09):1207-1213.
牛英硕,魏瑞丽,王志飞,等.芪冬颐心口服液治疗病毒性心肌炎气阴两虚证的临床综合评价[J].北京中医药,2025,44(9):1207-1213. DOI: 10.16025/j.1674-1307.2025.09.025.
NIU Yingshuo,WEI Ruili,WANG Zhifei,et al.Clinical comprehensive evaluation of Qidong Yixin Oral Liquid in the treatment of viral myocarditis with qi and yin deficiency syndrome[J]. Beijing Journal of Traditional Chinese Medicine,2025,44(09):1207-1213. DOI: 10.16025/j.1674-1307.2025.09.025.
目的
2
综合评价芪冬颐心口服液治疗病毒性心肌炎气阴两虚证的临床价值。
方法
2
使用多准则决策分析模型,从安全性、有效性、经济性、创新性、适宜性、可及性和中医药特色“6+1”维度,进行多源证据收集和价值评估,对芪冬颐心口服液进行临床综合评价。
结果
2
安全性维度:基于被动监测、临床文献报道、药物质量和警戒管理的证据提示,芪冬颐心口服液无严重不良反应病例报告。有效性维度:指南推荐芪冬颐心口服液用于治疗病毒性心肌炎迁延期或慢性期气阴两虚证;随机对照试验的系统评价提示,联用本品治疗病毒性心肌炎,较对照组能显著提高临床疗效,下调心肌酶指标。经济学维度:基于系统评价对下调肌酸激酶同工酶的成本-疗效进行分析,联用本品更具有经济性。创新性维度:本品为全国第一个获批在说明书中将病毒性心肌炎纳入适应证的中成药,创新性较好。适宜性维度:医护版和患者版的调查问卷显示,本品在药品使用方面适宜性较好。可及性维度:药品可获得性、价格水平和可负担性较好。中医药特色维度:本品源于国医大师任继学教授治疗病毒性心肌炎的经验方,针对气阴两虚的核心病机,重剂益气养阴以治本,行气活血、清热解毒以治标,兼通阳气以“先安未受邪之地”,中医药特色比较突出。综合评价认为,该药安全性和中医药特色突出,有效性、经济性、创新性、适宜性和可及性维度比较均衡;使用CSC v2.0软件计算,芪冬颐心口服液治疗病毒性心肌炎的临床价值证据比较充分。
结论
2
基于临床综合评价结果,芪冬颐心口服液治疗病毒性心肌炎气阴两虚证的临床价值较好,安全性和中医药特色突出。
Objective
2
To comprehensively evaluate the clinical value of
Qidong Yixin Oral
Liquid
in the treatment of viral myocarditis with
qi
and
yin
deficiency syndrome.
Method
2
A Multi-Criteria Decision Analysis (MCDA) model was used to collect multi-source evidence and evaluate the value of
Qidong Yixin Oral
Liquid
across the "6+1" dimensions: safety, effectiveness, economy, innovation, suitability, accessibility, and traditional Chinese medicine (TCM) characteristics. A comprehensive clinical evaluation was then conducted.
Result
2
Safety: Evidence from passive monitoring, clinical literature, drug quality assessments, and alert management indicates that no serious adverse reactions induced by
Qidong Yixin Oral
Liquid
have been reported. Effectiveness: Guidelines recommend
Qidong Yixin Oral
Liquid
for viral myocarditis in the prolonged or chronic stage with
qi
and
yin
deficiency syndrome. Systematic reviews of randomized controlled trials suggest that, when combined with conventional treatment, the product significantly improves clinical efficacy and downregulates myocardial enzyme indicators compared with control therapy. Economy: Cost-effectiveness analysis based on creatine kinase isoenzyme reduction shows that combination therapy including
Qidong Yixin Oral
Liquid
is more economical. Innovation:
Qidong Yixin Oral
Liquid
is the first Chinese patent medicine approved in China with viral myocarditis included in its indications, demonstrating good innova
tion. Suitability: Surveys among clinicians and patients indicate good suitability for clinical use. Accessibility: The drug shows favorable accessibility, price level, and affordability. TCM characteristics: Derived from Professor REN Jixue's empirical formula against viral myocarditis, the product targets the core pathogenesis of
qi
and
yin
deficiency syndrome. It uses a heavy dose to tonify
qi
and nourish
yin
to treat the root cause, promotes
qi
circulation and clears heat to alleviate symptoms, and supports
yang
qi
to protect vulnerable areas. The TCM characteristics are prominent. The comprehensive evaluation indicates that safety and TCM characteristics are outstanding, while effectiveness, economy, innovation, suitability, and accessibility are relatively balanced. CSC v2.0 software calculations support the clinical value of
Qidong Yixin Oral
Liquid
in viral myocarditis.
Conclusion
2
Based on the comprehensive clinical evaluation,
Qidong Yixin Oral
Liquid
demonstrates good clinical value in treating viral myocarditis with
qi
and
yin
deficiency syndrome, with outstanding safety and distinctive TCM characteristics.
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