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| Literature review of outcome in clinical trials of traditional Chinese medicine injections for non-small cell lung cancer |
| Hits 1009 Download times 648 Received:December 07, 2020 |
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| DOI
10.11656/j.issn.1672-1519.2021.02.15 |
| Key Words
core outcome set;traditional Chinese medicine injection;lung cancer;randomized controlled trial |
| Author Name | Affiliation | E-mail | | LI Kai | 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 | | | CAI Huizi | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | 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 | 1056081969@qq.com |
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| Abstract
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| [Objective] To analyze the outcome measures of randomized controlled trials (RCTs) of Chinese herbal injections for non-small cell lung cancer (NSCLC),so as to provide a basis for the establishment of a core outcome set for clinical trials of lung cancer. [Methods] The 8 databases including CNKI,WanFang,VIP,SinoMed,Embase,Cochrane Library,Web of Science and PubMed were searched electronically. Two authors independently screened the literatures and extracted the data in strict accordance with the inclusion and exclusion criteria from literatures published in 2018. Any differences were discussed and resolved. [Results] A total of 8 450 patients were included in 94 RCTs,retrieving a total of 64 outcome measures. The number of outcomes from a single study ranged from 1 to 10,with an average number of outcomes at 3.3. The top 10 outcome measures frequently used were clinical efficacy,adverse events,quality of life,immune function,tumor marker level,KPS score,toxicity and side effects,T cell subpopulation change,traditional Chinese medicine(TCM) syndrome score and overall survival. Among the 94 RCT studies,there were existing problems such as poor clinical correlation of outcome measures,lack of TCM characteristic outcomes,random combination of outcomes,diverse measurement time points,large time span and inconsistent measurement tools. [Conclusion] There are problems seen in outcomes reported in clinical trials of non-small cell lung cancer for TCM,hence it is necessary to establish a set of core indexes to improve the quality of relevant clinical studies. |
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