中国中医科学院中医临床基础医学研究所,北京 100700
马雨彤,女,25岁,硕士研究生。研究方向:中药上市后再评价。
谢雁鸣,E-mail:ktzu2018@163.com
收稿:2024-12-10,
纸质出版:2026-01-25
移动端阅览
马雨彤,熊文娟,路振凯,等.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.
MA Yutong,XIONG Wenjuan,LU Zhenkai,et al.Clinical comprehensive evaluation of Xinsuning Capsules in the treatment of ventricular premature contraction (syndrome of phlegm-heat disturbing heart)[J]. Beijing Journal of Traditional Chinese Medicine,2026,45(01):51-58.
马雨彤,熊文娟,路振凯,等.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. DOI: 10.16025/j.1674-1307.2026.01.009.
MA Yutong,XIONG Wenjuan,LU Zhenkai,et al.Clinical comprehensive evaluation of Xinsuning Capsules in the treatment of ventricular premature contraction (syndrome of phlegm-heat disturbing heart)[J]. Beijing Journal of Traditional Chinese Medicine,2026,45(01):51-58. DOI: 10.16025/j.1674-1307.2026.01.009.
目的
2
系统整理心速宁胶囊治疗室性期前收缩的相关研究,明确心速宁胶囊的疗效与特点。
方法
2
通过问卷调查、真实世界数据、已公开发表文献等资料,从有效性、安全性、经济性、创新性、适宜性、可及性、中医药特色“6+1”维度对心速宁胶囊进行临床综合评价。
结果
2
①安全性:心速宁胶囊不良反应包括恶心、呕吐、腹痛、烧心等,本品在上市前的安全性研究中进行了急性毒性试验与长期毒性试验,2项研究的结果均表明,该药品无明显不良反应,药物警戒体系完善。②有效性:心速宁胶囊可以减少室性期前收缩次数,且单用心速宁胶囊或联合抗心律失常常规西药的有效性优于单用常规西药。综合证据质量和证据价值评价,该药品有效性证据充分,结果明确。③经济性:心速宁胶囊为国家医保乙类药物,与同类药相比,其成本较低,服药过程中无相关费用增加。综合质量评价与价值评价,心速宁胶囊具有较好的经济性。④创新性:心速宁胶囊是在古方黄连温胆汤(《六因条辨》)的基础上,结合现代药理对“常山、青蒿”抗心律失常作用的认识化裁而成。⑤适宜性:问卷调查结果显示,该药品在配制、贮运、使用等方面,对医生、护士、患者均具有较好的适宜性。⑥可及性:心速宁胶囊疗程费用为2 370元,限定日费用是79元,销售范围涉及27个省级行政区的3 000家医院。从该品价格水平、可负担性、可获得性三个方面评价,心速宁胶囊具有较好的可及性。⑦中医药特色:心速宁胶囊由古方黄连温胆汤化裁而成,具有清热化痰、宁心定悸等功效,上市后研究例数为1 842例,通过人用经验临床研究及企业提供研究报告,评价其中医药特色维度证据比较充分,结果明确。⑧临床价值综合评价:综合以上“6+1”维度,心速宁胶囊临床价值证据比较充分,结果明确。
结论
2
心速宁胶囊安全性、可及性证据充足;有效性、经济性、创新性、适宜性证据比较充分,结果明确;中医药特色较突出,经临床价值综合评价;本品临床价值证据比较充分,结果明确。
Objective
2
To systematically review research on
Xinsuning Capsules
in the treatment of ventricular premature contraction (VPC) and clarify its efficacy and characteristics.
Methods
2
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 cha
racteristics of traditional Chinese medicine (TCM).
Results
2
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. ⑦ Characteristics 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 obtai
ned 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
2
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.
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