中国中药杂志

2022, v.47(18) 5088-5096

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近五年中医药干预脓毒症心肌损伤随机对照试验结局指标的分析
Outcome indicators in randomized controlled trials on traditional Chinese medicine intervention of sepsis-induced myocardial injury in recent five years

梁立新;刘子豪;龙德怀;刘红旭;
LIANG Li-xin;LIU Zi-hao;LONG De-huai;LIU Hong-xu;Beijing Hospital of Traditional Chinese Medicine, Capital Medical University;Shunyi Branch, Beijing Hospital of Traditional Chinese Medicine;

摘要(Abstract):

该研究分析了近五年中医药干预脓毒症心肌损伤随机对照试验(RCT)的结局指标,为构建中医药治疗脓毒症心肌损伤的核心指标集提供依据。全面检索4个中文数据库、3个英文数据库、2个临床试验方案注册中心,收集近五年中医药治疗脓毒症心肌损伤的RCT,使用Cochrane的ROB评价表对纳入研究进行质量评价,分析结局指标。最终纳入42项研究,包括2项临床试验注册方案。研究发现,42项研究总体偏倚风险较高,所有纳入研究结局指标包括“临床有效率、中医证候积分、病情程度、炎症、心肌标志物、心脏结构及血流动力学、心电图、免疫功能、代谢及肝肾功能、安全性”等10类共86个结局指标。心肌标志物为出现频次最高的结局指标,其次为心脏结构及血流动力学指标,共8项RCTs报告了中医证候积分。进一步研究发现,中医药干预脓毒症心肌损伤的结局指标选取存在以下问题:结局指标主次不分;轻视终点结局指标,替代指标选取不合理;忽视中医特色指标;缺少对患者免疫状态的评估;对经济学及安全性指标关注不足。因此,应根据有效性试验核心结局指标(COMET)工作组的建议,构建中医药干预脓毒症心肌损伤的临床研究核心指标集,方便临床研究者选取合适的结局指标,便于同类临床研究结论的合并,促进中医药特色治疗措施的推广。
This study aims to analyze the outcome indicators of randomized controlled trial(RCT) on traditional Chinese medicine(TCM) intervention of sepsis-induced myocardial injury(SIMI) in recent five years, which is expected to lay a basis for the construction of core outcome set(COS) for this disease treated by TCM. To be specific, RCT on the treatment of SIMI with TCM was retrieved from 4 Chinese databases, 3 English databases, and 2 clinical trial protocol registries. The quality of the included studies was evaluated with Cochrane risk-of-bias(ROB) tool, and the outcome indicators were analyzed. Finally, 42 RCTs were included, of which 2 were clinical trial registration schemes. The study found that 42 RCTs had a high risk of bias, and reported a total of 86 indicators in "clinical effective rate, disease severity, TCM syndrome score, inflammation, myocardium, cardiac structure and hemodynamics, electrocardiogram, immunology, metabolism and liver and kidney function, and safety". Outcome indicators on myocardium had the highest emergence frequency, followed by indicators on the cardiac structure and hemodynamics. A total of 8 RCTs reported TCM syndrome scores. Further analysis suggested the following problems in the selection of outcome indicators in the RCTs on TCM intervention of SIMI: no classification of primary and secondary indicators, disregard of endpoint indicators, irrational selection of alternative indicators, neglection of TCM characteristics, no assessment of patients′ immune status, and no emphasis on economic indicators and safety indicators. Therefore, according to the recommendations of the core outcome measures in effectiveness trials(COMET) working group, a COS for TCM intervention of TCM for SIMI should be developed, so as to facilitate clinical researchers to select appropriate outcome indicators, the combination of conclusions of similar clinical studies, and the promotion of TCM interventions.

关键词(KeyWords): 中医药;脓毒症;心肌损伤;随机对照试验;结局指标
traditional Chinese medicine;sepsis;myocardial injury;randomized controlled trial;outcome indicator

Abstract:

Keywords:

基金项目(Foundation): 国家中医药管理局中医药循证能力建设项目(2019XZZX-XXG001);; 北京市医院管理局重点医学专业发展计划项目(ZYLX201817)

作者(Authors): 梁立新;刘子豪;龙德怀;刘红旭;
LIANG Li-xin;LIU Zi-hao;LONG De-huai;LIU Hong-xu;Beijing Hospital of Traditional Chinese Medicine, Capital Medical University;Shunyi Branch, Beijing Hospital of Traditional Chinese Medicine;

DOI: 10.19540/j.cnki.cjcmm.20220529.503

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