分层线性模型对中药新药多中心临床试验重复测量数据的分析

Analysis of Repeated Data of Multi-center Clinical Trial for Traditional Chinese Medicine by Hierarchical Linear Model

目的将分层线性模型应用于中药新药多中心临床评价中,对重复测量数据的适用性与可行性进行探究。方法理论研究部分对分层线性模型的基本概念和原理进行阐述,并对传统统计学方法和分层线性模型应用条件进行比较;实证研究部分采用某中药新药多中心临床试验的具体数据,应用分层线性模型对中医证候积分这一指标进行分析。结果最终结果分层线性模型将重复测量时间(time)与组别(group)的交互作用(group×time)作为随机变量带入模型,统计结果中组别、重复测量时间和交互作用变量均有统计学意义,交互作用结果 t=2.65,P=0.0081。在整个治疗过程中试验组均值降低8.5分,对照组降低7.47分。治疗结束时,试验组的中医证候积分均值为2.46分,对照组为3.31分,试验组低于对照组。将统计结果结合中医证候积分均值变化趋势可认为,试验组的疗效不低于对照组。结论通过对比数据要求、应用条件和分析结果,分层线性模型可作为一种有效模型引入中药新药多中心临床评价中。

Objective To explore the applicability and feasibility of the hierarchical linear model in dealing with the repeated measurement data by applying it into multi-center clinical trials’ evaluation of new Chinese medicine. Methods The theoretical research described the basic concepts and principles of hierarchical linear model and compared the applying conditions of traditional statistical methods with hierarchical linear model. In the empirical study, the hierarchical linear model was used into a real multicenter clinical trial research of traditional Chinese medicine, with the TCM syndrome score as the analysis indicator. Results The hierarchical linear model added time, group and time＆#215;group as random variables into the model to get the final result. All of the three variables were significant in the result. The interaction （time×group） statistical result was t=2.65, P=0.008 1. During the whole treatment, the TCM syndrome mean score of trial group reduced 8.5 and the control group reduced 7.47. At the end of treatment, the TCM syndrome mean score of trial group was 2.46, and the control group was 3.31, which was higher than trail group. For this result, combining with the TCM syndrome score’s developing trend, we can see that the efficacy of trial group is not worse than the control group. Conclusion By comparing the data requirements, applying conditions and analysis results, the hierarchical linear model could be an effective method which can be used in multi-center trial to evaluate traditional Chinese drug.