中医药联合化疗治疗肺癌的文献质量分析

目的 对肺癌的中医药联合化疗临床治疗性文献进行科研设计质量的分析。方法 采用课题方法学小组统一编制的《中医药治疗性文献评价质量及信息评价表》,对1979—2000年间的肺癌中医药“随机对照试验”文献(共79篇)进行评价。结果 93．7％的文献对随机情况未作任何描述,2．5％的文献其随机化分配存在问题或错误;29．1％文献未述及退出与失访病例情况,未见文献给出病例筛选记录;盲法极少被采用;样本同质性、结论推导等重要环节亦存在着一些问题,影响着随机对照试验的质量。结论 随机对照试验在中医药治疗肺癌研究中的应用逐渐增多,但存在样本量不足等问题,随机对照试验的可信度及质量有待提高。

Qualitative Evaluation on Literatures Related with Treatment of Lung Cancer with Combined Use ofChemotherapy and Chinese Herbs

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. Methods 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. Results 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. Conclusion 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.