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| Literature study on outcome index of clinical trial of traditional Chinese medicine in treating chronic pulmonary heart disease |
| Hits 1722 Download times 1144 Received:September 17, 2020 |
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| DOI
10.11656/j.issn.1672-1519.2021.01.13 |
| Key Words
chronic pulmonary heart disease;core outcomes set;traditional Chinese medicine;randomized controlled trial;clinical trial |
| Author Name | Affiliation | E-mail | | NIU Bohan | Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | ZHANG Mingyan | Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | CAI Huizi | Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | LI Kai | Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | PANG Wentai | Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | WANG Hucheng | Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | ZHANG Junhua | Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | zjhtcm@foxmail.com |
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| Abstract
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| [Objective] To provide basic data for the development of the core outcomes set of chronic pulmonary heart disease by sorting out the outcome indexes of the clinical randomized controlled trial of traditional Chinese medicine (TCM) in the treatment of chronic pulmonary heart disease.[Methods] CNKI,WanFang,VIP,SinoMed,PubMed,Cochrane Library and Embase databases were searched by computer to collect the data of randomized controlled trials of traditional Chinese medicine intervention in the treatment of chronic pulmonary heart disease. The publication time of the paper is limited to 2018. The literature was screened independently according to the inclusion and exclusion criteria by two authors,and the data were extracted. If there were differences,it was decided through discussion.[Results] After screening,68 randomized controlled trials of chronic pulmonary heart disease were included,with 49 outcome indicators. According to the functional attributes of indicators,it can be divided into seven indicator fields:symptoms/syndromes,symptoms and signs,physical and chemical examination,quality of life,long-term prognosis,economic evaluation and safety events. The top 15 outcome indicators are:clinical effective rate,blood gas analysis,echocardiography,adverse reactions,brain natriuretic peptide,lung function indicators,TCM syndrome integral,hemorheology,pulmonary artery pressure,quality of life,6-minute walking test,cardiac function classification,serological indicators,symptom relief time and C-reactive protein.[Conclusion] There are some problems in clinical trials of treating chronic pulmonary heart disease with traditional Chinese medicine,such as great difference in outcome index and irregular reports. It is necessary to carry out research on core outcome set to improve the value of clinical research. |
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