| 引用本文:苏婉，王立芳，徐振晔.中西医结合治疗非小细胞肺癌随机对照试验文章的规范表述要素研究[J].世界中医药,2015,10(11):. |
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| 中西医结合治疗非小细胞肺癌随机对照试验文章的规范表述要素研究 |
| Literature Quality Evaluation of Randomized Controlled Clinical Trial of the Treatment of Non-Small Cell Lung Cancer with Traditional Chinese Medicine Integrated with Western Medicine |
| 投稿时间：2015-01-12 |
| DOI：10.3969/j.issn.1673-7202.2015.11.041 |
| 中文关键词: 中西医结合 非小细胞肺癌 随机对照试验 文献评价 CONSORT |
| English Keywords:TCM-WM Non-small cell lung cancer RCT Literature quality evaluation CONSORT |
| 基金项目:国家自然科学基金青年基金项目（编号：81202670）；龙华医院国家中医临床研究基地项目（编号：LYTD-18） |
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| 中文摘要: |
| 目的:评价中西医结合治疗非小细胞肺癌的随机对照试验（RCT）的报告质量。方法:计算机检索中文科技期刊数据库（VIP）（1989—2014），并手检相关文献的参考文献。采用CONSORT修订版辅以其他指标对所有纳入的RCT进行质量评价。结果:最初检索到225篇相关文献，最终纳入69篇文献进行评价。结果显示，仅有1篇文献文题含有“随机”字样，46篇文献采用了结构式摘要；研究实施的科学背景与原理的阐述，纳入研究的样本量计算，盲法，受试者流程，意向性分析及辅助分析的使用情况均未报告；统计方法描述不清并存在错误，研究结果均为阳性，仅有19篇文献报告不良反应；讨论中仅有9篇文献根据当前证据对结果进行解释，对研究的局限性，对临床和科研的意义，以及外部真实性的描述均较少。结论:目前有关中西医结合治疗非小细胞肺癌的随机试验质量较低，在试验报告的许多环节都存在不同程度的缺陷。广大临床研究者要加强对RCT各环节的质量控制，加强随机化、对照、盲法等措施的科学严谨性，以提高中医药临床试验文献质量。 |
| English Summary: |
| To evaluate the literature quality of randomized controlled clinical trial related with the treatment of non-small cell lung cancer with traditional Chinese medicine integrated with western medicine (TCM-WM). Methods:The related studies were searched by computer and the references of the included studies by manual method in the database of Chinese Sci Tech Periodicals (VIP Database) during the period of 1989-2014. The quality of the literature of RCTs was evaluated in reference to 22-item checklist of the CONSORT Statement and other self-established criteria. Results:A total of 69 pieces of articles were included among the initial 225. There was only one article with the word “randomization” presenting in its title; 46 of them used a structured abstract. None of them mentioned the scientific background, the rational for the trial, the calculation of the sample size, blinding methods, participant flow, ITT analysis or ancillary analyses. Some haven’t described the statistical methods clearly or used incorrect methods. All 69 trials had positive outcomes, only 19 mentioned adverse effects. Only 9 had general interpretation of the trial’s results in the context of current evidences in their discussion section, and a few of them mentioned the limitations of the study, the clinical and research significance or the external validity of the results. Conclusion:The quality of literature on RCTs of TCM-WM for non-small cell lung cancer is generally poor. It is suggested that the clinical researchers strengthen the quality control throughout the process of RCTs, enhance the scientific preciseness of randomization, controlling and blinding, so that the quality of RCTs of traditional Chinese medicine literature can be improved. |
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