匹伐他汀对超敏C反应蛋白的效应及其影响因素的多水平分析  

Effect and risk factors of pitavastatin on high sensitivity C-reactive protein in patients with hypercholesterolemia： a multilevel models analysis

作　　者：毛勇[1] 余金明[1] 战义强[1] 胡大一[2] 丁荣晶[2] 张芬[1] 李社昌[1] 孔群钰[1] 林凡礼[1] 贾贡献[1] 

机构地区：[1]复旦大学公共卫生学院临床流行病研究中心,公共卫生安全教育部重点实验室,上海200032 [2]北京大学人民医院心脏中心

出　　处：《中华医学杂志》2012年第24期1681-1685,共5页National Medical Journal of China

摘　　要：目的评价广泛使用条件下匹伐他汀对高胆固醇血症患者超敏C反应蛋白（hsCRP）的效应及其影响因素。方法2010年1月113至2011年3月31日我国12个城市的33个研究中心，纳入高胆固醇血症患者429例。以多中心、非盲、不设同类药物平等对照的方式开展为期12周的匹伐他汀Ⅳ期临床试验。结果符合方案集330例受试者，治疗12周时全人群和无入组前调脂治疗组的hsCRP水平分别比基线时下降26．4％（1．20mg／L比1．68mg／L）和27．5％（1．21mg／L比1．97mg／L，均P〈0．05）。多水平模型分析表明，hsCRP的平均水平随治疗时间推移而下降（P〈0．05），每次访视的平均变化率为0．97mg／L（95％CI0．96-0．98）。控制协变量后，基线脉压差和基线白细胞计数对hsCRP值有正效应（P〈0．01）。结论匹伐他汀具有降低高胆固醇血症患者hsCRP的效应，主要影响因素是基线脉压差和基线白细胞计数。Objective To evaluate the effect of pitavastatin on high sensitivity C-reactive protein （hsCRP） in patients with hypercholesterolemia, and determine risk factors for the effect. Methods This study was a 12-week, muhicenter, open-label, without parallel-group comparison, phase IV clinical trail. Results There were 330 subjects in the per protocol set. Contrast to the baseline, the average levels of hsCRP in all of subjects and the group without a history of receiving previous statin medication at week 12 post-treatment decreased respectively 26. 4% （ 1.20 mg/L vs 1.68 mg/L） and 27.5% （ 1.21 mg/L vs 1.97 mg/L, all P 〈 0. 05 ）. The results of muhilevel models indicated that the average levels of hsCRP reduced with the passage of treatment time, the time-varying rate of per-visit was 0. 97 mg/L （95% confidence interval 0. 96 - 0. 98 ）. Controlled individual background covariates, the model predicted that pulse pressure and white blood cell count on the baseline had the significant positive effects on hsCRP（P 〈 0. 01 ）. Conclusions Pitavastatin decreases hsCRP in patients with hypercholesterolemia. The main risk factors for the effect are pulse pressure and white blood cell count on the baseline.

关 键 词：高胆固醇血症 超敏C反应蛋白 匹伐他汀 多水平模型 

分 类 号：R589[医药卫生—内分泌] R9[医药卫生—内科学]