Review of Registered Clinical Trials on Traditional Chinese Medicine for Cardiovascular Diseases During 2007 and 2020

Jingyuan MAO; Shanshan LIN; Jiaying WANG; Xianliang WANG; Zhiqiang ZHAO; Boli ZHANG

doi:10.13288/j.11-2166/r.2022.07.001

您当前的位置：

首页 >

文章列表页 >

Review of Registered Clinical Trials on Traditional Chinese Medicine for Cardiovascular Diseases During 2007 and 2020

更新时间：2022-03-29

- Review of Registered Clinical Trials on Traditional Chinese Medicine for Cardiovascular Diseases During 2007 and 2020
- Journal of Traditional Chinese Medicine Vol. 63, Issue 7, Pages: 601-607(2022)
- 作者机构：
  
  1.天津中医药大学第一附属医院/国家中医针灸临床医学研究中心，天津市西青区昌凌路88号，300381
  2.天津中医药大学
  3.南京医科大学附属无锡人民医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2022.07.001
  CLC：
- Received：09 October 2021，
  
  Revised：2022-01-10，
  
  Published：02 April 2022
- 稿件说明：
移动端阅览
毛静远,林姗姗,王家莹等.2007-2020年中医药治疗心血管疾病临床试验注册情况述评[J].中医杂志,2022,63(07):601-607.

Jingyuan MAO, Shanshan LIN, Jiaying WANG, et al. Review of Registered Clinical Trials on Traditional Chinese Medicine for Cardiovascular Diseases During 2007 and 2020[J]. Journal of Traditional Chinese Medicine, 2022, 63(7): 601-607.
毛静远,林姗姗,王家莹等.2007-2020年中医药治疗心血管疾病临床试验注册情况述评[J].中医杂志,2022,63(07):601-607. DOI： 10.13288/j.11-2166/r.2022.07.001.

Jingyuan MAO, Shanshan LIN, Jiaying WANG, et al. Review of Registered Clinical Trials on Traditional Chinese Medicine for Cardiovascular Diseases During 2007 and 2020[J]. Journal of Traditional Chinese Medicine, 2022, 63(7): 601-607. DOI： 10.13288/j.11-2166/r.2022.07.001.

摘要

梳理中国临床试验注册中心和美国ClinicalTrials.gov注册平台中中医药治疗心血管疾病临床试验的注册现状，汇总高质量研究成果并分析存在的问题，为把握相关研究发展动态提供参考。共纳入分析489项已注册的中医药治疗心血管疾病的临床试验，包括干预性研究409项（83.64%）、观察性研究80项（16.36%）；所研究疾病类型以冠心病相关研究为主（256项，52.35%），其次为高血压病相关研究（81项，16.56%）、心力衰竭相关研究（67项，13.70%）等；干预性研究涉及的中医药疗法以中成药（214项，52.32%）、中药汤剂（114项，27.87%）为主。注册研究在冠心病、心力衰竭、隐匿性高血压等疾病方面已获得高质量研究证据，但部分临床试验仍存在科研概念混淆、研究方法归类错误、注册信息缺失等问题，基于以上问题提出真实世界研究可为中医药治疗心血管疾病研究领域中进一步验证及补充随机对照试验研究证据的有效方法之一，并主张未来应有必要探索能够展现中医药特色优势的更多的临床研究方法。

Abstract

This study analyzed the registration status of clinical trials on traditional Chinese medicine （TCM） for treatment of cardiovascular diseases in the Chinese Clinical Trial Registry and the ClinicalTrials.gov， summarized the results of high-quality researches， and analyzed the existing problems， so as to provide a reference for relevant researches. A total of 489 registered clinical trials on TCM for cardiovascular diseases were included and analyzed， including 409 （83.64%） interventional trials and 80 （16.36%） observational studies. The main diseases studied were coronary heart disease （256 studies， 52.35%）， hypertension （81 studies， 16.56%） and heart failure （67 studies， 13.70%）. The main TCM therapies studied were proprietary Chinese medicine （214 studies， 52.32%） and decoctions （114 studies， 27.87%）. Currently， certain registered studies on coronary heart disease， heart failure， and occult hypertension have been finished and published as high-quality research evidence. However， there are still problems such as confusion of scientific research concepts， wrong classification of research methods and lack of certain registration items. Based on the existed problems， it is proposed that real-world study can be one effective approach to further verify and supplement the evidence from randomized controlled trials in the field of TCM treatment of cardiovascular diseases， and that it is necessary to explore more TCM-specific clinical research methods in the future.

关键词

Keywords

references

郝盼盼，张运 . 中西医结合治疗心血管病临床试验的回顾与展望［J］. 中华心血管病杂志， 2019 ， 47 （ 9 ）： 697 - 702 .

吴泰相，李幼平，刘关键，等 . 中国临床试验注册中心及中国循证医学中心提高我国临床试验质量的策略和措施［J］. 中国循证医学杂志， 2010 ， 10 （ 11 ）： 1243 - 1248 .

中国临床试验注册中心 . 中国临床试验注册中心公告［J］. 中国循证医学杂志， 2007 ， 7 （ 8 ）： 557 - 558 .

GE JB ， FAN WH ， ZHOU JM ， et al . Efficacy and safety of Shexiang Baoxin pill （MUSKARDIA） in patients with stable coronary artery disease： a multicenter， double-blind， placebo-controlled phase Ⅳ randomized clinical trial ［J］. Chin Med J （Engl）， 2020 ， 134 （ 2 ）： 185 - 192 .

GUO M ， WANG P ， DU J ， et al . Xinyue capsule in patients with stable coronary artery disease after percutaneous coronary intervention： a multicenter， randomized， placebo-controlled trial ［J］. Pharmacol Res ， 2020 ， 158 ： 104883 . doi： 10.1016/j.phrs.2020.104883 http://dx.doi.org/10.1016/j.phrs.2020.104883 .

LI X ， ZHANG J ， HUANG J ， et al . A multicenter， randomized， double-blind， parallel-group， placebo-controlled study of the effects of Qili Qiangxin capsules in patients with chronic heart failure ［J］. J Am Coll Cardiol ， 2013 ， 62 （ 12 ）： 1065 - 1072 .

MAO JY ， ZHANG J ， LAM CSP ， et al . Qishen Yiqi dripping pills for chronic ischaemic heart failure： results of the CACT-IHF randomized clinical trial ［J］. ESC Heart Fail ， 2020 ， 7 （ 6 ）： 3881 - 3890 .

ZHANG DY ， CHENG YB ， GUO QH ， et al . Treatment of masked hypertension with a Chinese herbal formula： a randomized， placebo-controlled trial ［J］. Circulation ， 2020 ， 142 （ 19 ）： 1821 - 1830 .

HUA W ， GAO RL ， ZHAO BC ， et al . The efficacy and safety of Wenxin Keli in patients with frequent premature ventricular contractions： a randomized， double-blind， placebo-controlled， parallel-group， multicenter trial ［J］. Chin Med J （Engl）， 2015 ， 128 （ 19 ）： 2557 - 2564 .

JIA W ， LI Y ， WAN J ， et al . Effects of Xuezhitong in patients with hypertriglyceridemia： a multicentre， randomized， double-blind， double simulation， positive drug and placebo parallel control study ［J］. Cardiovasc Drugs Ther ， 2020 ， 34 （ 4 ）： 525 - 534 .

SCHULZ KF ， CHALMERS I ， ALTMAN DG . The landscape and lexicon of blinding in randomized trials ［J］. Ann Intern Med ， 2002 ， 136 （ 3 ）： 254 - 259 .

MURAD MH ， ASI N ， ALSAWAS M ， et al . New evidence pyramid ［J］. Evid Based Med ， 2016 ， 21 （ 4 ）： 125 - 127 .

SNIDERMAN AD ， LACHAPELLE KJ ， RACHON NA ， et al . The necessity for clinical reason in gin the era of evidence-based medicine ［J］. Mayo Clin Proc ， 2013 ， 88 （ 10 ）： 1108 - 1114 .

唐立，康德英，喻佳洁，等 . 实效性随机对照试验：真实世界研究的重要设计［J］. 中国循证医学杂志， 2017 ， 17 （ 9 ）： 999 - 1004 .

杨松，马龙腾，张菁菁 . 中国临床医学真实世界研究施行规范［J］. 解放军医学杂志， 2018 ， 43 （ 1 ）： 1 - 6 .

吴阶平医学基金会，中国胸部肿瘤研究协作组 . 真实世界研究指南（2018年版）［R/OL］. （ 2018-08-03 ）［ 2022-01-07 ］. http：//guide.medlive.cn/guideline/16342 http://guide.medlive.cn/guideline/16342 .

田峰，谢雁鸣 . 真实世界研究：中医干预措施效果评价的新理念［J］. 中西医结合学报， 2010 ， 8 （ 4 ）： 301 - 306 .

查看原文

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Identification and Control Strategies for Immortal Time Bias in Traditional Chinese Medicine Cohort Studies

Advantages，Challenges，and Implementation Pathways of Natural Experiments in Evaluating the Efficacy of Traditional Chinese Medicine

Effect of Xingeng No.Ⅱ Granules （心梗2号颗粒剂） on Left Ventricular Remodeling in Patients of ST-Segment Elevation Myocardial Infarction with Qi Deficiency and Blood Stasis Syndrome after PCI：An Open-Labbled Randomized-Controlled Trial

Construction and Application of a Real-World Cohort of Community-Acquired Pneumonia Based on a Multimodal Large-Scale Traditional Chinese Medicine Big Data Platform

Challenges and Recommendations for Implementing Key Technologies in Decentralized Clinical Trials of Traditional Chinese Medicine

Related Author

CHEN Yuhan

LI Runting

YUAN Ziyi

WEI Shuwen

LIU Kai

WEN Yaqian

LIU Jianping

LIU Zhaolan

Related Institution

Center for Evidence-Based Medicine，Beijing University of Chinese Medicine

School of Management Science and Engineering，Nanjing University of Finance and Economics

School of Acupuncture-Moxibustion and Tuina，Beijing University of Chinese Medicine

Center for Evidence-Based Medicine，Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Center for Evidence-Based Medicine，Hospital of Chengdu University of Traditional Chinese Medicine

Address：No.16, Nanxiao street, Dongzhimen, Dongcheng District, Beijing Postal code：100700
Tel：010-64035632 Email：jtcmcn@188.com
Technical support is provided by Beijing Founder electronics co., LTD 京ICP备09064830号-19 京公网安备11010102007558号
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰