硫酸氯吡格雷的抗血小板聚集临床研究

Study of the clinical anti aggregating effect of clopidogrel on platelet

目的 :验证硫酸氯吡格雷抗血小板聚集作用的临床疗效。方法 :将筛选具有血小板高聚集性的 2 40例患者随机分入氯吡格雷组 (CPG组 )与噻氯匹定组 (TCP组 ) ,分别服用CPG 5 0mg和TCP 2 5 0mg ,或TCP片2 5 0mg和CPG安慰片 5 0mg ,总疗程 4周。分别于服药前、服药后d8与 4周末检测ADP诱导的血小板聚集率 ,并分别于服药前与服药后 4周末检查出凝血时间、肝肾功能及血、小便常规。结果 :服药后CPG组患者ADP诱导的血小板聚集率显著降低 (P <0 .0 1) ,出凝血时间均延长。服药后d8与 4周末 ,ADP 0 .5 μmol/L诱导率分别降低(2 8.7± 2 2 .5 )与 (2 8.8± 2 3.4) ;ADP 1.0 μmol/L诱导率分别下降 (35 .4± 2 3 .8)与 (34.3± 2 5 .6 )。TCP组于服药后的d8与 4周末 ,其ADP 0 .5 μmol/L诱导率分别降低 (2 8.3± 2 3 .8)与 (32 .8± 2 3 .1) ;ADP 1.0 μmol/L诱导率分别下降 (35 .3± 2 0 .8)与 (37.2± 2 5 .4)。两组间无显著性差别。CPG组与TCP组的不良反应发生率分别为 8.85 %与12 .17%。结论 :CGP与TCP具有等效的抗血小板聚集作用 ,但前者不良反应少 ,可广泛应用于具有血小板高聚集状态的心。

Objective:To evaluate the clinical anti aggregating effect of clopidogrel on platelet.Method:240 patients with high platelet aggregating activity were randomized equally into following groups: clopidogrel group(CPG group) and ticlopidine group(TCP group).Each patient received treatment of clopidogrel 50mg qd or ticlopidine 250mg qd for four weeks and was scheduled for clinical visit and reperformed the ADP induced platelet aggregation on days 8 and 28 after treatment.Result: The ADP induced platelet aggregation of CPG group was reduced significantly in comparison to pretreatment( P <0.01).On days 8 and 28,the reduction of ADP (0.5μmol/L) induced platelet aggregation was (28.7±22.5) and (28.8±23.4),and the descent of ADP(1.0μmol/L) induced aggregation was (35.4±23.8) and (34.3±25.6),respectively.These effects were non statistically different from those of TCP group. In TCP group, the reduction of ADP (0.5μmol/L) induced platelet aggregation was (28.3±23.8) and(32.8±23.1), and the descent of ADP(1.0μmol/L) induced aggregation was (35.3±20.8) and (37.2±25.4) on days 8 and 28,individually.The rate of adverse events in CPG group was 8.85 percent.TCP group was of 12.17 percent adverse event rate and higher bleeding rate in bulbar conjunctiva and skin.Conclusion:The clinical anti aggregating effect of clopidogrel on platelet is similar to theeffect of ticlopidine.Clopidogrel is of less adverse events than ticlopidine and can be used in the prevent and treatment of cardiocerebrovascular diseases.