中医药治疗病毒性心肌炎临床研究指标分析

Analysis of clinical indexes of traditional Chinese medicine treatment of viral myocarditis

关键词:  中医药  病毒性心肌炎  结局指标  核心指标集  随机对照试验

Key words:  traditional Chinese medicine  viral myocarditis  outcome measure  core outcome set  randomized controlled trial

摘要:

[目的] 分析中医药治疗病毒性心肌炎随机对照试验的结局指标，为构建病毒性心肌炎临床试验的核心指标集奠定基础。[方法] 计算机检索中国期刊全文数据库（CNKI）、万方数据库（WanFang Data）、中国生物医学文献数据库（SinoMed）、维普数据库（VIP）、PubMed、The Cochrane Library和EMbase数据库，收集中医药治疗病毒性心肌炎的临床随机对照试验（RCT），检索时限设定为2018年。由两名研究者按照纳入与排除标准独立进行文献筛选和资料提取。[结果] 纳入44个RCT，共计4 077例患者，66种结局指标。单个研究结局指标使用数量为1～16个，平均6个。使用频次排前15位的指标依次为临床疗效、肌酸激酶同工酶、乳酸脱氢酶、肌酸激酶、不良反应、心肌肌钙蛋白I、谷草转氨酶、心电图疗效、肿瘤坏死因子-α、中医症状积分、超氧化物歧化酶、丙二醛、白细胞介素-6、左心室射血分数、白细胞介素-17。[结论] 病毒性心肌炎临床试验结局指标存在差异大、不规范、不实用、缺乏中医特色指标等共性问题，亟需建立病毒性心肌炎核心指标和中医药特色指标。

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.