摘要
目的探讨低剂量替格瑞洛在中国健康人群中抗血小板的有效性与安全性。方法随机选取20例健康受试者,其中,10例接受标准剂量替格瑞洛(标准剂量组),10例接受低剂量替格瑞洛(低剂量组)。所有受试者第1天接受负荷剂量,用药后0、0.5、1、2、4、8 h采血;第2天(24 h)、第3天(48 h)、第4天(72 h)接受维持剂量,用药前采血。应用Verify NowP2Y12系统进行血小板功能检测并观察两组受试者主要不良反应。结果用药后0、0.5、1、2、4、8、24、48及72 h,两组P2Y12反应单位(PRU)值与血小板聚集率差异无统计学意义(P>0.05)。用药后0.5 h,标准剂量组与低剂量组血小板聚集率分别为58.5%与53.9%;用药后2~4 h,标准剂量组与低剂量组血小板聚集率达到峰值,分别为98.7%与97.1%,且在8、24、48 h均维持在较高水平。受试者对替格瑞洛均耐受,无严重不良反应发生。标准剂量组出现2例轻微出血事件,低剂量组出现1例轻微出血事件,两组差异无统计学意义(P>0.05)。结论在中国健康人群中,低剂量与标准剂量替格瑞洛均有着较快、较强的血小板抑制作用,且不增加出血风险。
Objective To investigate the effectiveness and safety of low dose ticagrelor in population of China. Methods Twenty healthy subjects were randomly selected, of which ten were treated with standard dose of ticagrelor and ten received low-dose ti- cagrelor. Blood was collected at 0 hour,0. 5 hour, 1 hour,2 hours,4 hours and 8 hours, respectively. Blood was collected the next day (24 hours)before taking the dose. After the third day (48 hours)and the fourth day (72 hours), blood was taken before taking the med- icine. The platelet function of whole blood was detected by VerifyNow-P2Y12 system and the main adverse reactions were observed. Results There was no significant difference of platelet aggregation rate and PRU between the two groups and the standard dose ti- cagrelor at 0. 5 hour, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours after administration ( P 〉 0. 05 ). After 0. 5 hour,the average platelet aggregation rate was 58.5% and 53. 9% in the standard and low dose groups,respectively. The platelet ag- gregation rate reached the peak at 2 to 4 hours after the administration, and the PAl was 98.7% and 97. 1%, which were maintained at a high level at 8 hours ,24 hours and 48 hours. Subjects were resistant to ticagrelor and no serious adverse events occurred. Two cases of mild bleeding occurred in the standard dose of ticagrelor group,one case occurred in the low maintenance dose of ticagrelor group, and the incidence of bleeding between the two groups had not statistically significant difference ( P 〉 0. 05 ). Conclusion In the healthy population of China,low dose tieagrelor and standard dose of ticagrelor have a faster,stronger platelet inhibition,and does not increase the risk of bleeding.
出处
《临床军医杂志》
CAS
2017年第6期575-578,共4页
Clinical Journal of Medical Officers
关键词
中国健康人
替格瑞洛
低剂量
标准剂量
Chinese healthy population
Ticagrelor
Low dose
Standard dose