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Analysis of clinical indexes of traditional Chinese medicine treatment of viral myocarditis
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DOI   10.11656/j.issn.1672-1519.2020.08.15
Key Words   traditional Chinese medicine;viral myocarditis;outcome measure;core outcome set;randomized controlled trial
Author NameAffiliationE-mail
WANG Hucheng Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China  
WANG Keyi 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  
PANG Wentai 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  
ZHANG Dong 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 systematically analyze outcome measures in randomized clinical trials ofviral myocarditis with intervention of traditional Chinese medicine(TCM),and to establish the basis for core outcome set(COS) of TCM about viral myocarditis.[Methods] CNKI,WanFang,SinoMed,PubMed,Cochrane library and EMbase databases were searched by computer,and the clinical randomized controlled trial (RCT) of TCM for the treatment of viral myocarditiswas comprehensively collected. The retrieval time was set in 2018.Literature screening and data extraction were conducted independently by 2 system evaluators according to inclusion and exclusion criteria.[Results] A total of 44 RCTs were included,involving 4 077 patients and 66 outcomes. The number of outcomes in one of included RCTs varied from 1 to 16 with the average of 6. After frequency analysis,the top 15 outcomes were rate of clinical efficacy,creatine kinase isoenzyme (CK-MB),lactate dehydrogenase (LDH),creatine kinase (CK),adverse reactions,cardiac troponin Ⅰ(cTnⅠ),aspartate aminotransferase (AST),rate of electrocardiogram(ECG) efficacy,tumor necrosis factor-α (TNF-α),TCM syndrome scores,superoxide dismutase (SOD),malondialdehyde (MDA),interleukin-6 (IL-6),left ventricular ejection fraction (LVEF),Interleukin-17 (IL-17). [Conclusion] There were some common problems about outcomes of clinical trials,such as heterogeneity,non-standardization,impracticability and lack of TCM characteristics,therefore,it is urgent to establish COS-TCM of viral myocarditis.

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