Liang Hua, Zou Guohua
Department of Biostatistics and Computational Biology, University of Rochester Medical Center, 601 Elmwood Avenue, Box 630, Rochester, NY 14642, USA.
Biom J. 2007 Jun;49(3):406-15. doi: 10.1002/bimj.200610294.
In this article we propose to use a semiparametric mixed-effects model based on an exploratory analysis of clinical trial data for a study of the relation between virologic responses and immunologic markers such as CD4+ and CD8 counts, and host-specific factors in AIDS clinical trials. The regression spline technique, used for inference for parameters in the model, reduces the unknown nonparametric components to parametric functions. It is simple and straightforward to implement the procedures using readily available software, and parameter inference can be developed from standard parametric models. We apply the model and the proposed method to an AIDS clinical study. Our findings indicate that viral load level is positively related to baseline viral load level, negatively related to CD4+ cell counts, but unrelated to CD8 cell counts and patient's age neither.
在本文中，我们建议基于对临床试验数据的探索性分析，使用半参数混合效应模型来研究艾滋病临床试验中病毒学反应与免疫标志物（如CD4 +和CD8计数）以及宿主特异性因素之间的关系。用于模型参数推断的回归样条技术将未知的非参数成分简化为参数函数。使用现成的软件来实施这些程序既简单又直接，并且可以从标准参数模型进行参数推断。我们将该模型和所提出的方法应用于一项艾滋病临床研究。我们的研究结果表明，病毒载量水平与基线病毒载量水平呈正相关，与CD4 +细胞计数呈负相关，但与CD8细胞计数和患者年龄均无关。
