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| Literature study on outcome indicators of clinical trials of traditional Chinese medicine in the treatment of chronic obstructive pulmonary disease |
| Hits 673 Download times 887 Received:January 12, 2023 |
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| DOI
10.11656/j.issn.1672-1519.2023.04.05 |
| Key Words
chronic obstructive pulmonary disease;traditional Chinese medicine;core indicators |
| Author Name | Affiliation | E-mail | | ZHAO Huiyi | Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | | SUN Xiao | Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | | ZHANG Xiangyu | Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | | MA Luyao | Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | | REN Ming | Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | renming2008@126.com |
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| Abstract
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| [Objective] By analyzing the outcome indicators in the randomized controlled trials of chronic obstructive pulmonary disease(COPD), we can provide a reference for the future construction of the core indicator set of COPD on the basis of clinical staging. [Methods] Eight databases including Chinese Journal Full Text Database(CNKI), Chinese Science and Technology Journal Full Text Database(VIP), Wanfang Data, China Biomedical Abstracts Database(SinoMed), PubMed, Embase, Cochrane Library and Web of Science were searched by computer, and the search time was from November 2020. Two participants independently screened the literature and extracted the information in strict accordance with the preset inclusion and exclusion criteria. Methods eight databases including Chinese Journal Full-text Database (CNKI), Chinese Sci-tech Journal Full-text Database (VIP), Wanfang Data, sinomed, PubMed, EMBASE, Cochrane Library and web of science were searched by computer from the establishment of the database to November 2020. Two participants independently screened the literature and extracted the information in strict accordance with the preset inclusion and exclusion criteria. [Results] The 536 RCT studies in acute exacerbation were included, including 47 379 patients, involving 159 outcome indicators. The number of single study indicators was at least 1 and at most 16.457 stable RCT studies were included. A total of 38 879 patients were included. The sample size ranged from 30 to 331 cases. The average sample size of each RCT study was 85 cases, involving 135 outcome indicators. The number of single study indicators was at least 1 and at most 14. It is found that there are some urgent problems to be solved, such as non-standard, non-uniform and complex types of outcome indicators.[Conclusion] The selection of evaluation outcome indicators in clinical randomized controlled trials of traditional Chinese medicine for COPD generally has such problems as large differences in indicators. It is necessary to carry out research on the core indicator set of COPD on the basis of clinical stages, standardize the evaluation indicators of clinical efficacy of traditional Chinese medicine for COPD, and provide a reference for evaluating the efficacy of traditional Chinese medicine for COPD when selecting outcome indicators. |
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