真实世界数据分析评估支架植入术后带量集采与原研硫酸氢氯吡格雷抗血小板效果

Real-world Data Analysis to Evaluate the Antiplatelet Efficacy of Clopidogrel Bisulfate After Stent Implantation with Volume Collection and Original Research

目的探讨在真实世界中国家带量集采与原研硫酸氢氯吡格雷治疗急性冠脉综合征(acute coronary syndrome,ACS)患者支架植入术后抗血小板效果。方法基于真实世界建立ACS患者支架植入术后患者数据库。在患者支架植入术后将患者分为带量集采组和原研对照组,构建基线变量和结局变量,通过倾向性评分按1∶1匹配入组,比较2组研究对象口服等强化双倍剂量的氯吡格雷(75 mg,BID),1个月后调整为一般维持剂量(75 mg,QD)的抗血小板效果以及连续服用1 a后的药物不良反应发生情况。结果(1)2组在口服强化剂量第5天二磷酸腺苷(adenosine diphosphate,ADP)抑制率比较差异无统计学意义(P>0.05);1个月后改为维持剂量第5天ADP抑制率均较前升高,组内前后比较均有统计学差异(P<0.05);维持剂量第5天与强化剂量第5天的ADP抑制率升高幅度比较差异无统计学意义(P>0.05)。(2)2组在口服强化剂量第5天MA-ADP比较差异无统计学意义(P>0.05);1个月后改为维持剂量第5天2组MA-ADP同样无统计学差异(P>0.05),组内前后比较均有统计学差异(P<0.05);2组MA-ADP在2次不同时间点是否落在正常治疗窗内均无统计学差异(P>0.05)。(3)集采氯吡格雷(C/E=0.840)与原研氯吡格雷(C/E=2.124)进行比较具有更佳的平均成本-效果药物经济学效应。结论集采与原研氯吡格雷在治疗PCI术后抗血小板的强化剂量期或是维持剂量期表现的抗血小板疗效、安全性无明显差异。

Objective To explore the anti-platelet efficacy of national bulk collection and original clopidogrel bisulfate after stent implantation in patients with acute coronary syndrome(ACS)in the real world.Methods We established a real-world database of patients with acute coronary syndrome(ACS)after stent implantation.After stent implantation,the patients were divided into the group with dose collection and the control group,and the baseline variables and outcome variables were constructed,and the two groups were matched according to the propensity score of 1∶1.The antiplatelet effects and adverse drug reactions were compared between the two groups after oral administration of double doses of clopidogrel(75 mg,BID)for one month and then adjusted to the general maintenance dose(75 mg,QD)for one year.Results 1.There was no significant difference in the ADP inhibition rate between the two groups on the 5th day after oral intensive dose(P>0.05),but the ADP inhibition rate on the 5th day after oral maintenance dose was increased after one month,and there was significant difference between the two groups before and after oral intensive dose(P<0.05).There was no significant difference in the increase of ADP inhibition rate between the maintenance dose and the intensive dose on the 5th day(P>0.05).2.There was no significant difference in MA-ADP between the two groups on the fifth day of oral intensive dose(P>0.05),and there was no significant difference in MA-ADP between the two groups on the fifth day of oral maintenance dose after one month(P>0.05),but there was significant difference within the group(P<0.05);There was no significant difference in whether MA-ADP fell within the normal therapeutic window at two different time points between the two groups(P>0.05).3.Compared with the original clopidogrel(C/E=2.124),the pooled clopidogrel(C/E=0.840)had a better average cost-effectiveness pharmacoeconomic effect.Conclusion There is no significant difference in antiplatelet efficacy and safety between pooled clopidogrel and original clopidogrel in the intensive dose period or maintenance dose period of antiplatelet after PCI.