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| Outcome indicators in clinical trials with traditional Chinese medicine treatment of sepsis |
| Hits 336 Download times 281 Received:December 21, 2023 |
| View Full Text View/Add Comment Download reader |
| DOI
10.11656/j.issn.1672-1519.2024.03.11 |
| Key Words
traditional Chinese medicine;sepsis;outcome indicator;randomized controlled trial |
| Author Name | Affiliation | E-mail | | ZHOU Feng | Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China
Beijing University of Chinese Medicine, Beijing 100029, China | | | XUE Shuzhen | Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China
Capital Medical University, Beijing 100069, China | | | ZHAO Guozhen | Institute of Basic Research in Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China | | | LI Bo | Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China | | | XU Xiaolong | Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China | | | LIU Qingquan | Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China | liuqingquan2003@126.com |
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| Abstract
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| [Objective] This study systematically evaluated the use of outcome indicators in the randomized controlled trials (RCT) with traditional Chinese medicine treatment of sepsis over the last 2 years,in order to lay the foundation for subsequent core outcome set (COS). [Methods] We searched China National Knowledge Network(CNKI),Wanfang Database(Wanfang),Chinese Journal of Science and Technology Database(VIP),China Biomedical Literature Service System(SinoMed),PubMed,Embase,Cochrane Library database and two clinical trial registries. RCTs related to the treatment of sepsis with traditional Chinese medicine were included,and the risk of bias were evaluated by using Cochrane risk bias assessment tool. [Results] Fifty-three studies reported a total of 569 outcome indicators and 161 kinds of outcome indicators. The 15 outcome indicators with the highest frequency of use were APACHEII score,procalcitonin, SOFA score,C-reactive protein,total efficiency rate,28-day mortality,interleukin-6,mean arterial pressure,length of ICU stay,lactic acid,adverse events,tumor necrosis factor-α,CD4,CD8,and traditional Chinese medicine syndrome score. [Conclusion] The selection of outcome indicators was heterogeneous and had a high degree of dispersion;Ignoring TCM characteristic indicators,safety indicators and economic indicators;the outcome indicators report was not standard,the outcome indicators type was arbitrarily converted,the primary and secondary indicators were not distinguishable,and there were crossovers between indicators;the measuring tool and time point is not uniform. Therefore,it is urgent to construct sepsis COS with TCM characteristics and suitable for clinical research in China. |
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