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| Analysis and reflection on the ending indexes of clinical trials of Chinese medicine-assisted intervention of pulmonary embolism |
| Hits 292 Download times 117 Received:April 29, 2025 |
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| DOI
10.11656/j.issn.1672-1519.2025.10.11 |
| Key Words
pulmonary embolism;traditional Chinese medicine therapy;randomized controlled trial;outcome indicator;adjuvant therapy |
| Author Name | Affiliation | E-mail | | LI Haiping | Guangzhou Panyu District Hospital of Traditional Chinese Medicine, Guangzhou University of Traditional Chinese Medicine Panyu Hospital, Guangzhou 511400, China | | | ZENG Yanxia | The Second Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou 510120, China | | | LEI Peishan | Guangzhou Panyu District Hospital of Traditional Chinese Medicine, Guangzhou University of Traditional Chinese Medicine Panyu Hospital, Guangzhou 511400, China | leipeishan0207@163.com |
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| Abstract
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| 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. |
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