Moving beyond the conventional stratified analysis to estimate an overall treatment efficacy with the data from a comparative randomized clinical study

For a two-group comparative study, a stratified inference procedure is routinely used to estimate an overall group contrast to increase the precision of the simple two-sample estimator. Unfortunately, most commonly used methods including the Cochran-Mantel-Haenszel statistic for a binary outcome and the stratified Cox procedure for the event time endpoint do not serve this purpose well. In fact, these procedures may be worse than their two-sample counterparts even when the observed treatment allocations are imbalanced across strata. Various procedures beyond the conventional stratified methods have been proposed to increase the precision of estimation when the naive estimator is consistent. In this paper, we are interested in the case when the treatment allocation proportions vary markedly across strata. We study the stochastic properties of the two-sample naive estimator conditional on the ancillary statistics, the observed treatment allocation proportions and/or the stratum sizes, and present a biased-adjusted estimator. This adjusted estimator is asymptotically equivalent to the augmentation estimators proposed under the unconditional setting. Moreover, this consistent estimation procedure is also equivalent to a rather simple procedure, which estimates the mean response of each treatment group first via a stratum-size weighted average and then constructs the group contrast estimate. This simple procedure is flexible and readily applicable to any target patient population by choosing appropriate stratum weights. All the proposals are illustrated with the data from a cardiovascular clinical trial, whose treatment allocations are imbalanced.     

大豆甙元—PVP共沉淀物的制备及其体外溶出度的研究

以乙醇为溶媒用溶剂蒸发法制备了大豆甙元—PVP共沉淀物。X-衍射分析和偏光显微镜观察的结果表明,形成共沉淀物所需的PVP比例应大于5:1。体外溶出度试验结果表明,共沉淀物可以显著提高大豆甙元的体外溶出度。大豆甙元:PVP(1:10)的共沉淀物制成片剂后,在1 h内,90%以上的大豆甙元释放于蒸馏水或人工肠液中。     

不同产地和品种淫羊藿中淫羊藿苷的HPLC分析

目的 :对中药淫羊藿中淫羊藿苷的含量分析进行方法学研究 ,并测定淫羊藿的不同产地、不同品种、不同药用部位的淫羊藿苷的含量。方法 :采用RP HPLC技术对 7个品种 2 3个样品进行测定。以PERKIN EIMER SH/5C18柱为分析柱 ,流动相为乙腈 水 36%乙酸 ( 2 5∶73.5∶1 .5)流速 1 .0ml/min。UV检测波长 2 70nm。结果 :本方法测定淫羊藿苷含量在 0 .0 2 1 2～ 0 .1 2 7μg ,0 .53～ 1 .696μg范围内呈良好的线性关系。不同产地、不同品种、不同药用部位的淫羊藿其淫羊藿苷的含量为 0 .0 0 30 7%～ 1 .55%。同一植株不同部位中淫羊藿苷的含量分布叶 >叶茎 >茎 >根。结论 :淫羊藿由于产地不同、品种不同其淫羊藿苷的含量相差悬殊。本测定方法为筛选优良品种和扩大药源提供了简便易行的方法