1.中国中医科学院 中医临床基础医学研究所,北京 100700
2.中国中医科学院 西苑医院,北京 100091
王萌萌,在读博士,从事中成药疗效精准机制及药物警戒研究,E-mail:mengren2308@163.com
谢雁鸣,主任医师,博士生导师,从事中药上市后评价研究,E-mail:ktzu2018@163.com
王连心,医学博士,研究员,博士生导师,从事中成药疗效精准机制及药物警戒研究,E-mail:wlxing@126.com;
收稿:2024-07-10,
网络出版:2024-08-19,
纸质出版:2025-01-20
移动端阅览
王萌萌,崔鑫,吕健等.冠心静胶囊治疗气虚血瘀型冠心病心绞痛的“6+1”维度临床综合评价[J].中国实验方剂学杂志,2025,31(02):120-128.
WANG Mengmeng,CUI Xin,LYU Jian,et al.Clinical Comprehensive Evaluation of Guanxinjing Capsules in Treating Angina Pectoris of Coronary Heart Disease with Syndrome of Qi Deficiency and Blood Stasis in "6+1" Dimensions[J].Chinese Journal of Experimental Traditional Medical Formulae,2025,31(02):120-128.
王萌萌,崔鑫,吕健等.冠心静胶囊治疗气虚血瘀型冠心病心绞痛的“6+1”维度临床综合评价[J].中国实验方剂学杂志,2025,31(02):120-128. DOI: 10.13422/j.cnki.syfjx.20250192.
WANG Mengmeng,CUI Xin,LYU Jian,et al.Clinical Comprehensive Evaluation of Guanxinjing Capsules in Treating Angina Pectoris of Coronary Heart Disease with Syndrome of Qi Deficiency and Blood Stasis in "6+1" Dimensions[J].Chinese Journal of Experimental Traditional Medical Formulae,2025,31(02):120-128. DOI: 10.13422/j.cnki.syfjx.20250192.
目的
2
系统梳理冠心静胶囊治疗冠心病心绞痛(气虚血瘀证)现有研究,进行涵盖6+1维度及9个方面的临床证据和综合价值评估,明确冠心静胶囊临床定位及优势特点。
方法
2
采用定性与定量相结合的评价方式,应用临床医学、流行病学、循证医学、药物经济学等方法学,通过公开资料、问卷调查、真实世界数据和文献综合评价,构建了对冠心静胶囊的6+1维度等9个方面的评价体系。通过专家为准则层和指标层赋予权重,并利用多准则层决策分析模型(MCDA)和CSC(V2.0)软件对各维度进行了度量,揭示了冠心静胶囊的临床价值。
结果
2
①评估结果显示冠心静胶囊的安全性较高,根据说明书不良反应、临床安全性系统评价和Meta分析、国家药品不良反应监测中心收集等数据显示冠心静胶囊不良反应主要包括胸闷、呼吸困难、头晕和消化系统相关症状,标准化分数为0.75分,安全性良好。②从Meta分析结果中可以看出,在疗效标准一致的情况下,单用冠心静胶囊和冠心静胶囊联合西医常规或中成药来治疗冠心病时的有效性高于单纯西医常规或中成药参芍胶囊治疗,有效性标准化分数为0.57分,仍需一定的证据支持。③以2020年的个人可支配收入作为患者的预期付款假设阈值,与单用常规治疗相比,在一定条件转化下(高于106.91元),冠心病心绞痛患者通过联合冠心静胶囊与常规治疗会有成本效益,经济性较好。④目前已有3个关于冠心静胶囊的发明的专利获得批准,涵盖了临床创新、服务系统革新及产业发展等多个领域,创新性较好。⑤此外,针对医护人员所做的调查问卷涉及5个不同的维度,其统计分数和评价均表现出良好的适应性,适宜性良好。⑥居民报销比例较高,抽样调查发现冠心静胶囊在全国医院内配比较全,可及性良好。⑦源自清朝著名医学家王清任的活血化瘀理论,冠心静胶囊融合了和益气养阴、芳香温通等多种疗法。根据“6+1”维度的分析数据,最终得出冠心静胶囊对冠心病心绞痛(气虚血瘀型)的临床综合评价为0.73分。
结论
2
基于各维度及临床价值综合评价的结果,冠心静胶囊对于冠心病心绞痛(气虚血瘀型)临床证据充足,具备良好的安全性、适宜性和可及性,建议推荐冠心静胶囊按照既定程序纳入基本临床用药管理的相关政策范畴。
Objective
2
To systematically review the available studies about Guanxinjing capsules in treating angina pectoris of coronary heart disease (syndrome of Qi deficiency and blood stasis), evaluate the evidence quality and comprehensive value of Guanxinjing capsules in 6+1 dimensions involving 9 aspects, and clarify the clinical positioning and advantages of this medicine.
Methods
2
A qualitative combined with quantitative evaluation method was adopted, involving clinical medicine, epidemiology, evidence-based medicine, and pharmacoeconomics. Through public data collection, questionnaire surveys, real-world data collection, and literature comprehensive evaluation, an evaluation system involving 9 aspects in 6+1 dimensions was constructed for Guanxinjing capsules. Experts assigned weights to the criterion layer and indicator layer, and the multi-criteria decision analysis (MCDA) model and CSC (V2.0) were employed to measure each dimension and reveal the clinical value of Guanxinjing capsules.
Results
2
①The evaluation results showed that Guanxinjing capsules are safe. According to the adverse reactions in the instructions, the systematic evaluation and meta-analysis of clinical safety, and the data collected by the National Center for Adverse Drug Reaction Monitoring, the adverse reactions of Guanxinjing capsules mainly include chest tightness, dyspnea, dizziness, and digestive system-related symptoms, with a standardized score of 0.75 points, which suggests good safety. ②The meta-analysis results suggest that according to the same efficacy standards, the effectiveness of Guanxinjing capsules alone and Guanxinjing capsules combined with conventional Western medicine or Chinese patent medicines is higher than that of conventional Western medicine or the Chinese patent medicine Shenshao capsules alone in treating coronary heart disease. The standardized score of effectiveness is 0.57, which indicates that the effectiveness still requires evidence support. ③With the individual disposable income in 2020 as the expected payment assumption threshold, compared with conventional treatment alone, combining Guanxinjing capsules with conventional treatment is cost-effective and economical for the patients with angina pectoris of coronary heart disease under certain conditions (higher than 106.91 yuan), which suggests good economy. ④At present, 3 patents for the invention of Guanxinjing capsules have been approved, covering multiple fields such as clinical innovation, service system innovation, and industrial development, which implies good innovation. ⑤In addition, the questionnaire surveys for medical staff involve five different dimensions, and the statistical scores and evaluation results show good suitability of Guanxinjing capsules. ⑥The reimbursement rate of Guanxinjing capsules by residents is high. The sampling survey results show that Guanxinjing capsules are fully equipped in hospitals across China and have good accessibility. ⑦Derived from the theory of activating blood and resolving stasis proposed by Wang Qingren, a famous physician in the Qing Dynasty, Guanxinjing capsules integrate multiple therapies such as replenishing Qi, nourishing Yin, and aromatic warming and unblocking. According to the analysis data in the "6+1" dimensions, the clinical comprehensive evaluation score of Guanxinjing capsules for angina pectoris of coronary heart disease (syndrome of Qi deficiency and blood stasis) was 0.73.
Conclusion
2
The results of comprehensive evaluation of each dimension and clinical value suggest that Guanxinjing capsules in treating angina pectoris of coronary heart disease (syndrome of Qi deficiency and blood stasis) have sufficient clinical evidence, good safety, suitability, and accessibility. It is recommended that Guanxinjing capsules can be included in the documents of basic clinical medication management in accordance with the established procedure.
MARTIN S S , ADAY A W , ALMARZOOQ Z I , et al . 2024 Heart disease and stroke statistics:A report of US and global data from the American Heart Association [J]. Circulation , 2024 , 149 ( 8 ): e347 - e913 .
FAN J , WATANABE T . Atherosclerosis:Known and unknown [J]. Pathol Int , 2022 , 72 ( 3 ): 151 - 160 .
CHEN Y , WEI Y , TANG W . The role of hydrogen in the prevention and treatment of coronary atherosclerotic heart disease [J]. Eur J Pharmacol , 2024 , 972 : 176586 .
TU M , JIANG Y , YU J , et al . Acupuncture for treating chronic stable angina pectoris associated anxiety and depression:A systematic review and Meta-analysis [J]. Complement Ther Clin Pract , 2021 , 45 : 101484 .
FERRARO R , LATINA J M , ALFADDAGH A , et al . Evaluation and management of patients with stable angina:Beyond the ischemia paradigm:JACC state-of-the-art review [J]. J Am Coll Cardiol , 2020 , 76 ( 19 ): 2252 - 2266 .
ABBASI M , NEISHABOURY M , KOOHPAYEHZADEH J , et al . National prevalence of self-reported coronary heart disease and chronic stable angina pectoris:Factor analysis of the underlying cardiometabolic risk factors in the SuRFNCD-2011 [J]. Glob Heart , 2018 , 13 ( 2 ): 73 - 82 .
BARBERO U , D'ASCENZO F , NIJHOFF F , et al . Assessing risk in patients with stable coronary disease:When should we intensify care and follow-up? Results from a Meta-analysis of observational studies of the COURAGE and FAME Era [J]. Scientifica (Cairo) , 2016 , 2016 : 3769152 .
XU L , ZHAI X , SHI D , et al . Depression and coronary heart disease:Mechanisms,interventions,and treatments [J]. Front Psychiatry , 2024 , 15 : 1328048 .
LI L , FENG P , ZHOU W , et al . Efficacy and safety of tongxinluo capsule for angina pectoris of coronary heart disease:An overview of systematic reviews and Meta-analysis [J]. Front Cardiovasc Med , 2024 , 11 : 1229299 .
HE X , LIU D , NI S , et al . Efficacy and safety evaluation of Ginkgo biloba dropping pill (GBDP) on stable angina pectoris complicated with depression:A placebo-controlled,randomized,double-blind,multicenter study [J]. Phytomedicine , 2024 , 126 : 155264 .
黄文娟 , 蒋兵 , 赵生俊 . 中成药治疗气滞血瘀型稳定型心绞痛的临床综合评价 [J]. 中国实验方剂学杂志 , 2024 , 30 ( 19 ): 163 - 169 .
HUANG W J , JIANG B , ZHAO S J . Clinical comprehensive evaluation of chinese patent medicines in treatment of stable angina pectoris with Qi stagnation and blood stasis [J]. Chin J Exp Tradit Med Form , 2024 , 30 ( 19 ): 163 - 169 .
高婷婷 , 杨宏昕 , 金锐 . 不同教材/指南冠心病中医分型和治疗中成药对比分析 [J]. 中国医院药学杂志 , 2024 , 44 ( 17 ): 2050 - 2055 .
GAO T T , YANG H X , JIN R . Comparative study of different textbooks/guidelines on the classification of Chinese medicine and treating coronary heart disease with proprietary Chinese medicines [J]. Chin J Hosp Pharm , 2024 , 44 ( 17 ): 2050 - 2055 .
邢雁伟 , 王阶 , 衷敬柏 , 等 . 采用聚类分析和对应相关方法研究1069例冠心病心绞痛证候应证组合规律 [J]. 中华中医药杂志 , 2007 , 22 ( 11 ): 747 - 750 .
XING Y W , WANG J , ZHONG J B , et al . Study on rule of syndrome combination of 1069 cases of angina pectoris by cluster analysis and corresponding-correlation methed [J]. China J Tradit Chi Med Pharm , 2007 , 22 ( 11 ): 747 - 750 .
李军 , 王阶 . 冠心病心绞痛证候要素与应证组合的5099例文献病例分析 [J]. 中国中医基础医学杂志 , 2007 , 13 ( 12 ): 926 - 927,930 .
LI J , WANG J . Analysis of 5099 literature cases on the elements and combination of symptoms of coronary heart disease angina pectoris [J]. China J Basic Med Tradit Chin Med , 2007 , 13 ( 12 ): 926 - 927,930 .
赵姣姣 , 董建业 , 柴丽丽 , 等 . 冠心病心绞痛中医证型分布与中药用药规律系统综述 [J]. 实用中医内科杂志 , 2017 , 31 ( 2 ): 1 - 5 .
ZHAO J J , DONG J Y , CHAI L L , et al . Systematic review on TCM syndromes distribution and Chinese medication characteristics in angina pectoris of coronary heart disease [J]. Intern Med J Pract Tradit Chin Med Sci , 2017 , 31 ( 2 ): 1 - 5 .
宋晓龙 , 宋俊 , 王益新 , 等 . 胸痹心痛中医病性证候要素分布特点 [J]. 中国中医急症 , 2014 , 23 ( 1 ): 60 - 62 .
SONG X L , SONG J , WANG Y X , et al . Distribution characteristics of TCM syndrome factors in chest stuffiness and pain [J]. J Emerg Syndromes Tradit Chin Med , 2014 , 23 ( 1 ): 60 - 62 .
王子杨 , 刘美志 , 胡晓贞 , 等 . 脉通君安汤治疗气虚血瘀型冠心病心绞痛的临床疗效及转录组学研究 [J]. 南京中医药大学学报 , 2024 , 40 ( 4 ): 419 - 428 .
WANG Z Y , LIU M Z , HU X Z , et al . Clinical efficacy and transcriptomic study on the treatment of coronary heart disease angina of Qi deficiency and blood sta-sis type with Maitong Jun'an decoction [J]. J Nanjing Univ Tradit Chin Med , 2024 , 40 ( 4 ): 419 - 428 .
范红娟 . 冠心静胶囊治疗气虚血瘀型冠心病心绞痛中医症候疗效观察 [J]. 中西医结合心脑血管病杂志 , 2017 , 15 ( 6 ): 751 - 754 .
FAN H J . Observation on the therapeutic effect of Guanxinjing capsules on traditional Chinese medicine symptoms of angina pectoris in coronary heart disease with qi deficiency and blood stasis type [J]. Chin J Integr Med Cardio /Cerebrovasc Dis , 2017 , 15 ( 6 ): 751 - 754 .
ZHANG G , WANG Q , LIU X , et al . An integrated approach to uncover quality markers of traditional Chinese medicine underlying chemical profiling,network target selection and metabolomics approach:Guan-Xin-Jing capsule as a model [J]. J Pharm Biomed Anal , 2020 , 190 : 113413 .
李文星 , 刘建国 . 冠心静胶囊对冠心病伴焦虑抑郁病人 β -内啡肽及血管内皮功能的影响 [J]. 中西医结合心脑血管病杂志 , 2019 , 17 ( 16 ): 2496 - 2498 .
LI W X , LIU J G . The effect of Guanxinjing capsule on β - endorphin and endothelial function in patients with coronary heart disease accompanied by anxiety and depre ssion [J]. Chin J Integr Med Cardio/Cerebrovasc Dis , 2019 , 17 ( 16 ): 2496 - 2498 .
王坤 , 王彬 , 石奇松 , 等 . 冠心静联合稳心颗粒治疗围绝经期女性心律失常的疗效研究 [J]. 河北医药 , 2021 , 43 ( 3 ): 411 - 414 .
WANG K , WANG B , SHI Q S . Curative effect of Guanxinjing combined with Wenxin granule in treatment of arrhythmia in perimenopausal women [J]. Hebei Med J , 2021 , 43 ( 3 ): 411 - 414 .
戴玉兰 , 白慧荣 . 冠心静胶囊治疗气虚血瘀型心绞痛的临床研究 [J]. 当代医学 , 2021 , 27 ( 22 ): 28 - 30 .
DAI Y L , BAI H R . Clinical study on Guanxinjing capsule in treating angina pectoris of Qi deficiency and blood stasis type [J]. China Contemp Med , 2021 , 27 ( 22 ): 28 - 30 .
张强 , 王志飞 , 谢雁鸣 , 等 . 中成药临床综合评价报告规范 [J]. 中国中药杂志 , 2021 , 46 ( 23 ): 6062 - 6067 .
ZHANG Q , WANG Z F , XIE Y M , et al . Report standards for clinical comprehensive evaluation of Chinese patent medicine [J]. China J Chin Mater Med , 2021 , 46 ( 23 ): 6062 - 6067 .
路振凯 , 谢雁鸣 . 痛泻宁颗粒治疗腹泻型肠易激综合征肝气犯脾证的临床综合评价 [J]. 中国实验方剂学杂志 , 2024 , 30 ( 11 ): 139 - 149 .
LU Z K , XIE Y M . Clinical Comprehensive evaluation of Tongxiening granules in treatment of diarrhea-predominant irritable bowel syndrome with liver Qi invading spleen syndrome [J]. Chin J Exp Tradit Med Form , 2024 , 30 ( 11 ): 139 - 149 .
陈子佳 , 张强 , 雷超 , 等 . 喜炎平注射液治疗社区获得性肺炎:1项基于多准则决策分析的临床证据与价值评估研究 [J]. 中草药 , 2024 , 55 ( 5 ): 1641 - 1651 .
CHEN Z J , ZHANG Q , LEI C , et al . Xiyanping injection for community-acquired pneumonia:A clinical evidence and value evaluation study based on multi-criteria decision analysis [J]. Chin Tradit Herb Drug , 2024 , 55 ( 5 ): 1641 - 1651 .
李文星 , 刘建国 , 李雪清 , 等 . 冠心静胶囊治疗冠心病伴焦虑抑郁的临床疗效 [J]. 中西医结合心脑血管病杂志 , 2018 , 16 ( 24 ): 3694 - 3695 .
LI W X , LIU J G , LI X Q , et al . Clinical efficacy of Guanxinjing capsules in the treatment of coronary heart disease with anxiety and depression [J]. Chin J Integr Med Cardio/Cerebrovasc Dis , 2018 , 16 ( 24 ): 3694 - 3695 .
李文星 , 刘建国 , 李雪清 , 等 . 冠心静胶囊治疗冠心病心绞痛伴有焦虑抑郁临床观察 [J]. 临床合理用药杂志 , 2018 , 11 ( 4 ): 90 - 91 .
LI W X , LIU J G , LI X Q , et al . Clinical observation of Guanxinjing capsules in the treatment of coronary heart disease angina pectoris with anxiety and depression [J]. Chin J Clin Ration Drug Use , 2018 , 11 ( 4 ): 90 - 91 .
范红娟 , 李书瑞 , 康凯宁 , 等 . 冠心静胶囊治疗稳定型劳力性心绞痛的疗效观察 [J]. 现代药物与临床 , 2016 , 31 ( 7 ): 1016 - 1019 .
FAN H J , LI S R , KANG K N , et al . Clinical observation of Guanxinjing capsules in treatment of stable exertional angina pectoris [J]. Drug Clin , 2016 , 31 ( 7 ): 1016 - 1019 .
王海兵 , 张天豪 , 张学斌 . 冠心静胶囊治疗冠心病心绞痛的临床疗效及经济学评价 [J]. 中国药物评价 , 2017 , 34 ( 1 ): 62 - 66 .
WANG H B , ZHANG T H , ZHANG X B . Clinical efficacy and economic evaluation of Guanxinjing capsule for angina pectoris of coronary heart disease [J]. Chin J Drug Eval , 2017 , 34 ( 1 ): 62 - 66 .
姜俊玲 , 李新军 . 冠心静治疗冠心病抑郁症的疗效观察 [J]. 中国中医药科技 , 2014 , 21 ( 3 ): 316 - 317 .
JIANG J L , LI X J . Observation of the therapeutic effect of Guanxinjing on depression caused by coronary heart disease [J]. Chin J Tradit Med Sci Technol , 2014 , 21 ( 3 ): 316 - 317 .
王彬 . 观察冠心静胶囊治疗冠心病伴焦虑抑郁的临床疗效 [J]. 养生保健指南 , 2019 ( 46 ): 20 .
WANG B . Observation of the clinical efficacy of Guanxinjing capsules in the treatment of coronary heart disease with anxiety and depression [J]. Health Guide , 2019 ( 46 ): 20 .
宋书江 , 魏凤菊 , 魏腾瑶 , 等 . 冠心静胶囊治疗气虚血瘀型冠心病的疗效观察 [J]. 中国药物经济学 , 2014 , 9 ( S1 ): 133 - 134 .
SONG S J , WEI F J , WEI T Y , et al . Observation of the therapeutic effect of Guanxinjing capsules on coronary heart disease of Qi deficiency and blood stasis type [J]. China J Pharm Econ , 2014 , 9 ( S1 ): 133 - 134 .
李晓卉 . 冠心静胶囊治疗气虚血瘀型冠心病心绞痛中医症候疗效观察 [J]. 当代医学 , 2018 , 24 ( 34 ): 48 - 50 .
LI X H . Observation on curative effect of Guanxinjing capsule in treating coronary heart disease and angina pectoris due to Qi deficiency and blood stasis [J]. China Contemp Med , 2018 , 24 ( 34 ): 48 - 50 .
陈雨 , 张小琼 , 王伟红 , 等 . 冠心静胶囊在女性心律失常中的运用 [J]. 大家健康:中旬版 , 2017 , 11 ( 6 ): 188 - 189 .
CHEN Y , ZHANG X Q , WANG W H , et al . Application of Guanxinjing capsules in female arrhythmia [J]. Everybody Health: Midmonth , 2017 , 11 ( 6 ): 188 - 189 .
王彬 , 陈雨 , 陈伟 , 等 . 冠心静胶囊对围绝经期女性心律失常的疗效研究 [J]. 河北医药 , 2021 , 43 ( 5 ): 712 - 715 .
WANG B , CHEN Y , CHEN W , et al . Therapeutic effects of Guanxinjing capsule on arrhythmia in perimenopausal women [J]. Hebei Med J , 2021 , 43 ( 5 ): 712 - 715 .
王彬 , 陈雨 , 陈伟 , 等 . 冠心静联合美托洛尔治疗围绝经期女性心律失常的临床研究 [J]. 河北医药 , 2020 , 42 ( 23 ): 3584 - 3586,3590 .
WANG B , CHEN Y , CHEN W , et al . Therapeutic effects of Guanxinjing capsule combined with metoprolol on arrhythmia in women patients at perimenopausal period [J]. Hebei Med J , 2020 , 42 ( 23 ): 3584 - 3586,3590 .
杨硕 , 谢雁鸣 , 王连心 , 等 . 夏荔芪胶囊治疗前列腺增生(本虚标实证)的临床综合评价 [J]. 中草药 , 2023 , 54 ( 9 ): 2879 - 2888 .
YANG S , XIE Y M , WANG L X , et al . Clinical comprehensive evaluation of Xialiqi capsules in treatment of prostatic hyperplasia with deficiency in origin and excess in superficiality [J]. Chin Tradit Herb Drug , 2023 , 54 ( 9 ): 2879 - 2888 .
王连心 , 谢雁鸣 , 王志飞 , 等 . 天舒胶囊治疗偏头痛(瘀血阻络证、肝阳上亢证)的临床综合评价 [J]. 中国中药杂志 , 2022 , 47 ( 6 ): 1501 - 1508 .
WANG L X , XIE Y M , WANG Z F , et al . Clinical comprehensive evaluation of Tianshu capsules in treatment of migraine(syndrome of blood stasis blocking collaterals and syndrome of ascendant hyperactivity of liver Yang) [J]. China J Chin Mater Med , 2022 , 47 ( 6 ): 1501 - 1508 .
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