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Analysis of clinical index of Chinese medicine in treatment of unstable angina pectoris
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DOI   10.11656/j.issn.1672-1519.2020.10.17
Key Words   traditional Chinese medicine;unstable angina pectoris;outcome indicator;core index set;randomized clinical trial
Author NameAffiliationE-mail
WANG keyi Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China  
JIN Xinyao Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China  
WANG Hucheng Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China  
ZHANG Mingyan Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China  
LI Nan Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China  
PANG Wentai Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China  
WANG Hui Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China  
ZHANG Junhua Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China zjhtcm@foxmail.com。 
Abstract
    [Objective] To analyze the outcome indexes of the randomized controlled trial of traditional Chinese medicine(TCM) treatment of unstable angina,and to lay a foundation for the establishment of the core index set of the clinical trial of TCM treatment of unstable angina.[Methods] CNKI,WanFang,SinoMed,PubMed,Cochrane library,Embase databases were searched by computer,and the randomized clinical trials (RCTs) of TCM for the treatment of unstable angina pectoris was comprehensively collected. The retrieval time was set in 2018. Literature screening and data extraction were conducted independently by 2 authors according to inclusion and exclusion criteria. [Results] A total of 9778 patients and 119 indicators were included in 90 RCTs. The number of indicators adopted in a single study is 1-16,with an average of 4. The top 15 were clinical efficacy,angina attack frequency,angina duration,adverse reactions,ecg efficacy,TCM symptom score,LDL-C,TC,TG,plasma viscosity,HDL-C,hs-CRP,LVEF,fibrinogen and nitroglycerin dosage. The indexes used in each study differ greatly,and multiple measurement points are adopted for the same index. The combination of indicators is quite random,and there is a lack of significant end-point event indicators and outcome indicators reflecting the characteristics of TCM.[Conclusion] The main problems of indicators include large difference in index selection,large randomness in combination use,non-standard expression of indicators,lack of standardized evaluation standards,large difference in measurement time points,lack of long-term indicators,lack of traditional Chinese medicine characteristic outcome indicators,and use of self-designed outcome indicators. It is urgent to establish the core index set of unstable angina.

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