不同负荷剂量国产氯吡格雷与进口氯吡格雷对冠心病患者血小板抑制率的影响比较

Comparison of the effect of different loading dose of domestic or imported clopidogrel on platelet inhibi⁃tion rate in patients with coronary heart disease

目的比较不同负荷剂量国产氯吡格雷与进口氯吡格雷对冠状动脉粥样硬化性心脏病(冠心病)患者血小板抑制率的影响。方法纳入2017年11月至2018年12月于西京医院心内科住院的115例18~75岁,3个月内未服用氯吡格雷或替格瑞洛的患者。入院后患者按随机数字表法被分为A组(国产氯吡格雷300 mg),B组(国产氯吡格雷600 mg),C组(进口氯吡格雷300 mg),D组(进口氯吡格雷600 mg)4个治疗组。分别于患者服药后2 h和6 h应用血栓弹力图评估氯吡格雷对血小板的抑制效果,主要终点为服药后2 h及6 h二磷酸腺苷(adenosine diphosphate,ADP)及血小板花生四烯酸(arachidonicacid,AA)途径下的血小板抑制率,安全性终点包括1个月内的各种出血、支架内血栓、死亡及心肌梗死。结果A、B、C和D组患者服药后2 h ADP诱导的血小板抑制率分别是42.18%±23.98%、42.76%±29.05%、51.46%±31.11%以及54.56%±25.26%,组间比较差异无统计学意义(P=0.228)。服药后6 h各组ADP诱导的血小板抑制率分别为45.54%±22.72%,44.38%±24.71%,56.54%±27.60%以及59.23%±23.09%,组间比较差异无统计学意义(P=0.068)。D组患者住院期间1例发生鼻出血、1例穿刺部位血肿;各组患者均无死亡、心肌梗死及支架内血栓发生。结论负荷剂量分别为300 mg及600 mg的国产氯吡格雷与进口氯吡格雷在2~6 h内的血小板抑制率无明显差异。

objectives To compare the effect of different loading dose of domestic or imported clopidogrel on platelet inhibition rate in patients with coronary heart disease.Methods A total of 115 patients(aged 18-75 years)without taking clopidogrel or tigreglor in 3 months in Xijing Hospital from November 2017 to December 2018 were randomly divided into 4 treatment groups:group A(patients raking domestic clopidogrel 300 mg),group B(patients raking domestic clopidogrel 600 mg),group C(patients raking imported clopidogrel 300 mg)and group D(patients raking imported clopidogrel 600 mg).Thrombelastography was used to evaluate the inhibition effect of clopidogrel on platelet in patients 2 hours and 6 hours after taking drugs.The primary end points were adenosine diphosphate(ADP)and arachidonicacid(AA)induced platelet inhibition rates in patients 2 hours and 6 hours after taking drugs.The safety end points included all kinds of haemorrhage,stent thrombosis,death and myocardial infarct in 1 month.Results Differences of ADP-induced platelet inhibition rates among A,B,C and D groups 2 hours after taking drugs were not statistically significant(42.18%±23.98%vs.42.76%±29.05%vs.51.46%±31.11%vs.54.56%±25.26%,P=0.228).Differences of ADP induced platelet inhibition rates among the A,B,C and D groups 6 hours after taking drugs were not statistically significant(45.54%±22.72%vs.44.38%±24.71%vs.56.54%±27.60%vs.59.23%±23.09%,P=0.068).There was one patient with nasal hemorrhage and one patient with hematoma at puncture site during hospitalization in D group.There was no death,stent thrombosis and myocardial infarct among the 4 groups.Conclusions There is no significant difference in platelet inhibition rate between domestic clopidogrel and imported clopidogrel at 300 mg and 600 mg loading dosage in 2-6 hours.