Liu Yu-long, Xu Kai, Bai Jian-ping, Li Liu-ning, Yang Xiao-bo
The Fourth Department of Internal Medicine, the Second Clinical College of Guangzhou Medical University, Guangzhou 510120.
Zhongguo Zhong Xi Yi Jie He Za Zhi. 2005 Feb;25(2):123-5.
To evaluate the quality of clinical literatures related with treatment of lung cancer with combined use of chemotherapy and Chinese herbs in respect of the scientific research design adapted.
According to the "Scale for Quality and Information Evaluation of TCM Clinical Research Literature" formulated by the group of methodology of this article, the literatures related with lung cancer published between 1979 to 2000 were evaluated in respect of the randomization and controlling of the trial.
The method of randomization was not described in 93.7% of the literatures; problems or mistakes of randomized allocation existed in 2.5%, with no record about the state of dropped out or absconded cases in follow-up study in 29.1%, also no record about case screening was found in all the literatures. Besides, the blind trial method was seldom used, also some problems of key links concerning samples homogeneity and conclusion reasoning presented. All these bugs could influence quality of the randomized control trial.
Randomized control trial has been applied progressively in TCM clinical researches of lung cancer, however, there are still problems such as insufficiency of samples, and improving of the reliability and quality of the trial is needed.
从所采用的科研设计方面评估与肺癌化疗联合中药治疗相关的临床文献质量。
根据本文方法学小组制定的“中医临床研究文献质量与信息评价量表”，对1979年至2000年间发表的与肺癌相关的文献进行试验随机化和对照方面的评估。
93.7%的文献未描述随机化方法；2.5%存在随机分配问题或错误，29.1%的随访研究中未记录失访或退出病例状态，所有文献中均未发现病例筛选记录。此外，很少使用盲法试验，还存在样本同质性和结论推理等关键环节的一些问题。所有这些缺陷都会影响随机对照试验的质量。
随机对照试验已逐渐应用于肺癌的中医临床研究，但仍存在样本不足等问题，需要提高试验的可靠性和质量。
