北京中医药2026，Vol.45Issue(1)：51-58,8.DOI:10.16025/j.1674-1307.2026.01.009
心速宁胶囊治疗室性期前收缩(痰热扰心证)的临床综合评价
Clinical comprehensive evaluation of Xinsuning Capsules in the treatment of ventricular premature contraction(syndrome of phlegm-heat disturbing heart)
摘要
Abstract
Objective To systematically review research on Xinsuning Capsules in the treatment of ventricular premature contraction(VPC)and clarify its efficacy and characteristics.Methods Data from questionnaires,real-world studies,and published literature were collected.A comprehensive clinical evaluation of Xinsuning Capsules was conducted across the"6+1"dimensions:effectiveness,safety,economy,innovation,suitability,accessibility,and characteristics of traditional Chinese medicine(TCM).Results ① Safety:Adverse reactions of Xinsuning Capsules include nausea,vomiting,abdominal pain,and heartburn.Pre-market safety studies,including acute and long-term toxicity tests,showed no significant adverse effects.The pharmacovigilance system is robust.② Effectiveness:Xinsuning Capsules can reduce the frequency of VPC.Its effectiveness,whether used alone or combined with conventional antiarrhythmic Western medicine,is superior to conventional therapy alone.Comprehensive evaluation of evidence quality and value indicates sufficient effectiveness with clear results.③ Economy:Xinsuning Capsules are included in Category B of the national medical insurance.Compared with similar products,its cost is low,and no additional expenses are incurred during treatment.Comprehensive quality and value evaluation indicate good economic performance.④ Innovation:Xinsuning Capsules are derived from the ancient formula Huanglian Wendan Decoction(Systematic Differentiation of the Six Etiologies),modified according to modern pharmacological research on the antiarrhythmic effects of Dichroae Radix and Artemisiae Annuae Herba.⑤ Suitability:Questionnaire results indicate that the drug has good suitability for clinicians,nurses,and patients in terms of preparation,storage,and use.⑥ Accessibility:The treatment course costs 2 370 yuan,with a defined daily cost of 79 yuan.The product is available in 27 provinces and municipalities and 3 000 hospitals.Evaluation of price,affordability,and availability shows good accessibility.⑦Characteristics of TCM:Xinsuning Capsules,derived from the modified Huanglian Wendan Decoction,clear heat,resolve phlegm,calm the heart,and stabilize palpitations.Based on 1 842 post-marketing cases,clinical studies,and enterprise-provided research reports,sufficient evidence and clear results were obtained for the TCM characteristics dimension.⑧ Comprehensive clinical value evaluation:Based on the above"6+1"dimensions,Xinsuning Capsules demonstrates sufficient evidence of clinical value with clear results.Conclusion Xinsuning Capsules have sufficient evidence for safety and accessibility;effectiveness,economy,innovation,and suitability have relatively sufficient evidence with clear results;TCM characteristics are prominent.Comprehensive clinical value evaluation indicates sufficient evidence and clear outcomes.关键词
心速宁胶囊/室性期前收缩/痰热扰心证/临床综合评价/多准则决策分析Key words
Xinsuning Capsule/ventricular premature contraction/syndrome of phlegm-heat disturbing heart/clinical comprehensive evaluation/multi-criteria decision analysis引用本文复制引用
马雨彤,熊文娟,路振凯,谢雁鸣..心速宁胶囊治疗室性期前收缩(痰热扰心证)的临床综合评价[J].北京中医药,2026,45(1):51-58,8.基金项目
国家中医药管理局岐黄学者支持项目(国中医药人教函[2022]6号) （国中医药人教函[2022]6号）
全国名老中医药专家传承工作室建设项目(国中医药人教函[2022]175号) （国中医药人教函[2022]175号）
