CAJ | 학술논문

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1日至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％(1.20 mg/L比1.68 mg/L)和27.5％(1.21 mg/L比1.97 mg/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0.97 mg/L(95％CI 0.96～0.98).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.
목적 평개엄범사용조건하필벌타정대고담고순혈증환자초민C반응단백(hsCRP)적효응급기영향인소.방법 2010년1월1일지2011년3월31일아국12개성시적33개연구중심,납입고담고순혈증환자429례.이다중심、비맹、불설동류약물평등대조적방식개전위기12주적필벌타정Ⅳ기림상시험.결과 부합방안집330례수시자,치료12주시전인군화무입조전조지치료조적hsCRP수평분별비기선시하강26.4％(1.20 mg/L비1.68 mg/L)화27.5％(1.21 mg/L비1.97 mg/L,균P＜0.05).다수평모형분석표명,hsCRP적평균수평수치료시간추이이하강(P＜0.05),매차방시적평균변화솔위0.97 mg/L(95％CI 0.96～0.98).공제협변량후,기선맥압차화기선백세포계수대hsCRP치유정효응(P＜0.01).결론 필벌타정구유강저고담고순혈증환자hsCRP적효응,주요영향인소시기선맥압차화기선백세포계수.
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,multicenter,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 multilevel 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.