大剂量泮托拉唑对氯吡格雷作用的影响

目的:观察大剂量泮托拉唑对氯吡格雷作用的影响。方法:选择18～65岁的健康男性22名为研究对象,根据试验设计交叉进行3个阶段的试验。第1阶段:所有研究对象单独服用氯吡格雷1周(CLOP组);第2阶段:研究对象随机均分为2组,第1组服用氯吡格雷的同时服用泮托拉唑(CONC组),第2组服用氯吡格雷后8～12h再服用泮托拉唑(STAG组);第3阶段:CONC组和STAG组交换服药方式。每阶段的服药时间为1周,各阶段间隔时间为4周(药物清除期)。氯吡格雷服药剂量为首剂600mg.d-1,维持用量为每天75mg.d-1;泮托拉唑剂量为80mg.d-1。通过血样的采集评价血小板功能。结果:完成试验的20名研究对象血小板基线功能和服用氯吡格雷后24h测量的血小板功能无显著性差异(P>0.05);在服用氯吡格雷1周后,CONC组与STAG组患者血小板反应性指数(PRI)分别为(56.0±3.9)%和(56.1±3.9)%,2组比较差异无统计学意义(P=0.974)。单独服用氯吡格雷时,PRI高于同时服用泮托拉唑(vs.CONC组,P=0.100;vs.STAG组,P=0.107),但差异无统计学意义。结论:大剂量泮托拉唑对氯吡格雷的药效影响较小。

Effects of Pantoprazole on Therapeutic Efficacy of Clopidogrel

OBJECTIVE:To observe the effects of large dose of pantoprazole on therapeutic efficacy of clopidogrel.METH-ODS:22 healthy male volunteers aged 18～65 years old were divided into 3 period in crossover design study.First stage:all patients received clopidogrel alone(CLOP group);second stage:The volunteers weer randomly divided into 2 groups.The first group were given clopidogrel and pantoprazole at the same time(CONC group),and the second group were given clopidogrel first-ly and 8～12 hours later given pantoprazole(STAG group);third stage:medication methods of CONC group and STAG group were exchanged.Medication duration of each stage lasted for 1 weeks,and medical interval was 4 weeks(drug clearance period).The initial dose(ID)of clopidogrel was 600 mg every day,maintenance dose(MD)was 75 mg every day.The dose of pantopra-zole was 80 mg.d-1.Blood samples were collected to evaluate the function of platelet.RESULTS:There were no significant differ-ence in basic function of platelet and the function of platelet in 20 healthy volunteers in 24 h after given clopidogrel(P>0.05).1 weeks later,PRI of 2 groups were(56.0±3.9)%and(56.1±3.9)%(P=0.974).PRI of volunteers receiving clopidogrel alone(P=0.100)was higher than that of volunteers receiving clopidogrel and pantoprazole(P=0.107).CONCLUSION:Large dose of pantoprazole shows small effect on therapeutic efficacy of clopidogrel,and it is a safe therapy method.