中医药辅助干预肺栓塞临床随机对照试验结局指标分析与思考

Analysis and reflection on the ending indexes of clinical trials of Chinese medicine-assisted intervention of pulmonary embolism

关键词:  肺栓塞  中医药疗法  随机对照试验  结局指标  辅助治疗

Key words:  pulmonary embolism  traditional Chinese medicine therapy  randomized controlled trial  outcome indicator  adjuvant therapy

摘要:

目的 分析2020—2025年中医药干预肺栓塞（PE）的临床随机对照试验研究，探讨结局指标的应用现状及存在的问题。方法 本研究系统检索了中国知网（CNKI）、万方数据知识服务平台、中国生物医学文献数据库、PubMed、Web of Science、Embase和Cochrane Library等中英文数据库，纳入中医药联合常规治疗干预PE的随机对照试验（RCTs）。采用Cochrane ROB 2.0工具对纳入文献进行方法学质量评价，并对其结局指标进行系统分类与分析。结果 筛选后纳入25篇文献，其中高风险文献1篇（4%），可能存在风险文献24篇（96%）。共报告76种结局指标，累计使用233次，统计显示理化检测总频次及种类最高（167次，58项），其中凝血指标（76次，18项）、动脉血气（25次，5项）、肺功能（21次，11项）、炎症标志物（15次，8项）、心功能相关指标（15次，7种），心肌损伤标记物（5次，1种），血管内皮功能相关指标（5次，3种），免疫相关指标（2次，2种），肺动脉造影相关指标（1次，1种），其他（2次，2种）。使用率 > 50% 的结局指标有3个，分别是临床总有效率、D-二聚体（D-D）和凝血酶原时间（PT）。结论 临床上常以理化检测作为诊断及进展的重要结局指标。当前中医药治疗PE的临床研究中，结局指标的选择与应用是提升研究质量的关键环节。为更科学、全面地评估疗效，需制定中医药RCT设计规范、明确主次结局的层级、建立复合指标的标准化，并加强对中医证候疗效、安全性及经济学的系统评估。

Abstract:

Objective To analyze the clinical randomized controlled trials(RCTs) on traditional Chinese medicine(TCM) interventions for pulmonary embolism(PE) from 2020 to 2025, and to investigate the current application status and existing issues of outcome indicators.Methods This study systematically searched Chinese and English databases, including CNKI, Wanfang Database, SinoMed, PubMed, Web of Science, Embase, and Cochrane Library, for RCTs evaluating TCM combined with conventional therapy for PE. The methodological quality of included studies was assessed using the Cochrane ROB 2.0 tool, and outcome indicators were systematically categorized and analyzed.Results The 25 studies were included, with 1(4%) classified as high risk and 24(96%) as having some risk of bias. The 76 outcome indicators were reported, cumulatively used 233 times. Physicochemical testing indicators showed the highest frequency and variety(167 times, 58 items), including coagulation parameters(76 times, 18 items), arterial blood gas analysis(25 times, 5 items), pulmonary function(21 times, 11 items), inflammatory markers(15 times, 8 items), cardiac function-related indicators(15 times, 7 items), myocardial injury markers(5 times, 1 item), vascular endothelial function-related indicators(5 times, 3 items), immune-related indicators(2 times, 2 items), pulmonary angiography indicators(1 time, 1 item), and others(2 times, 2 items). Only 3 outcome indicators had a utilization rate > 50%: clinical total effective rate, D-dimer(D-D), and prothrombin time(PT).Conclusion In clinical practice, physical and chemical tests are often used as important outcome measures for diagnosis and progression. In current clinical research on TCM treatment for PE, the selection and application of outcome measures are key factors in improving research quality. To evaluate efficacy in a more scientific and comprehensive manner, it is necessary to establish design standards for TCM RCTs, clarify the hierarchy of primary and secondary outcomes, standardize composite indicators, and strengthen systematic assessments of the efficacy, safety, and economics of TCM syndrome treatment.