头颈部鳞癌术后中药治疗的评价──临床随机对照设计的应用

A randomized clinical trial for the evaluation of head and neck squamous cell carcinoma treating with traditional Chinese medicine

作者通过头颈部鳞癌术后中药治疗的研究实例，阐述了临床随机对照研究的科学设计、实施步骤和统计分析的具体方法。结果发现，ｋａｐｌａｎ－Ｍｅｉｅｒ生存曲线，经单因素Ｌｏｇｒａｎｋ检验，治疗组与对照组无统计学差别（Ｐ＞０．０５）。进一步做Ｃｏｘ模型多因素分析，在平衡了性别年龄、服药时间、病理分级、化疗等因素对生存函数的影响后，则发现对照组的死亡危险比是１．９３９，９５％可信限在１．００８～３．７２９之间，Ｐ＜０．０５；在众多预后因素中服药时间对生存函数的影响最大（Ｐ＜０．００１）；提示中药治疗对头颈部鳞癌术后生存具有显著作用，是影响头颈部鳞癌患者术后生存的一项独立的预后因素。

This paper described the research design, research process and statistical analysis of randomized clinical trial by treatment with traditonal chinese medicine in patients with squamous cell carcinoma of the head and neck, At first we found there was no significant difference between treating group and control group (P>0.05) using log-rank test on Kaplan-Meier survival curves. With further multivariate analysis Cox model and after adjusting for sex, age,length of taking the assigned medication,grade of tumor differentiation and using of chemotherapy, the rate of tumor-related death for control group was significantly higher than that for treating group:hazards ratio estimate was 1. 939 (95% confidence interval 1.008-3. 729, P<0. 05). The length of taking chinese medicine was one of the most important prognostic factors (P<0.001). The results suggest that the prescribed medication contributed to the improved survival, and it was an independent prognostic factor.