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[目的]评价CNKI数据库中肿瘤治疗的临床随机对照试验(RCT)文献的质量。[方法]检索2006~2011年CNKI数据库中发表的有关肿瘤治疗的临床随机对照试验的期刊文献,并参考2010年版报告随机临床试验的CONSORT声明,对文献质量进行评价。[结果]共纳入合格文献696篇。其中列举了具体纳入和排除标准的占82.04%;报告了随机分配方法的占14.37%;运用盲法的占0.43%;简单描述随机分配隐藏的占1.15%;具体描述基线资料的占1.87%;有受试者流程图的占0.72%;所有文献中,提及样本量计算的占0.29%;有试验注册的占0.14%;所有文献中均没有记载试验方案和商业资助的内容。[结论]目前肿瘤治疗的临床随机对照试验质量普遍较低,还有待进一步提高,尤其是盲法的使用和样本量的估算方面。
[Objective] To evaluate the quality of clinical randomized controlled trials (RCTs) of oncology treatment in CNKI database. [Methods] We searched the journal articles on clinical randomized controlled trials of cancer treatment published in CNKI database from 2006 to 2011, and evaluated the quality of the literature with reference to the CONSORT statement of randomized clinical trials reported in the 2010 edition. [Results] A total of 696 qualified documents were included. Which lists 82.04% of the specific inclusion and exclusion criteria; 14.37% of the reported random assignment methods; 0.43% of the blinded methods; 1.15% of the random descriptions; 1.87% of the baseline descriptions; There were 0.72% of subjects’ flowcharts; in all references, 0.29% were mentioned for sample size calculations; 0.14% were for trial registrations; and none was documented in the literature in terms of pilot programs and commercial funding. [Conclusions] At present, the quality of clinical randomized controlled trials for cancer treatment is generally low and needs to be further improved, especially in terms of the use of blindness and the estimation of sample size.