阿司匹林肠溶缓释片与阿司匹林肠溶片抗血小板聚集的药物经济学评价

Pharmacoeconomic Evaluation of Aspirin Enteric-coated Sustained-release Tablets and Aspirin Enteric-coated Tablets in Anti-platelet Aggregation

目的基于医保角度,通过成本-效果分析(CEA)和成本-效用分析(CUA),评价阿司匹林肠溶缓释片与阿司匹林肠溶片抗血小板聚集的经济学优劣。方法采用随机、开放、平行对照多中心实用性临床试验设计,从2016年9月至2017年1月入选来自北京、山东、黑龙江、湖南、内蒙古、山西、湖北、甘肃等19家医院、年龄60岁以上、临床上需要服用阿司匹林防治的符合纳排标准的患高血压、糖尿病、高血脂、冠状动脉粥样硬化性心脏病等受试者。共有796例受试者随机分配至阿司匹林肠溶缓释片50 mg/d组和阿司匹林肠溶片100 mg/d组,分别服用2周不同剂量不同剂型的阿司匹林。通过收集受试者用药期间血小板聚集率、用药安全性、生命质量以及用药成本信息,比较两组药物干预的成本-效果和成本-效用。结果试验前未服用抗血小板药物的受试者中,阿司匹林肠溶缓释片50 mg/d组基线血小板聚集率(79.68±16.03)%,用药14 d后(16.51±24.16)%,降低(63.17±26.67)%;阿司匹林肠溶片100 mg/d组基线血小板聚集率(77.05±19.29)%,用药14 d后(16.11±25.15)%,降低(60.94±30.14)%,降低值两组比较差异无统计学意义(χ^(2)=2.911 8, P=0.233 2)。试验前服用抗血小板药物的受试者中,阿司匹林肠溶缓释片50 mg/d组基线血小板聚集率(14.73±21.33)%,用药14 d后(10.57±15.57)%,降低(4.17±24.04)%;阿司匹林肠溶片100 mg/d组基线血小板聚集率(12.22±17.24)%,用药14 d后(9.32±12.79)%,降低(2.90±21.76)%,降低值两组比较差异无统计学意义(χ^(2)=3.984 6,P=0.136 4)。无论试验前是否使用抗血小板药物,两组人群生命质量在用药前后无明显变化。试验前未服用抗血小板药物的受试者中,用药14 d 50 mg阿司匹林肠溶缓释片药物成本和处理不良反应总费用(6.78±2.56)元,100 mg阿司匹林肠溶片药物成本和处理不良反应总费用(7.61±5.60)元。试验前服用抗血小板药物的受试者中,用药14 d 50 mg阿司匹林肠溶缓释片药物成本和处理不良反应总费用(6.86±5.11)元,100 mg阿司匹林肠溶片药物成本和处理不良反应总费用(7.08±1.60)元。结论 50 mg阿司匹林肠溶缓释片和100 mg阿司匹林肠溶片抗血小板聚集作用相似,前者费用较低,更具成本-效益。

Objective Based on medical insurance perspective, to evaluate the economic superiority and inferiority of Jiening;aspirin enteric coated sustained-release tablets and Bayer aspirin enteric coated tablets against platelet aggregation through cost-effectiveness analysis(CEA) and cost utility analysis(CUA). Methods A randomized, open, parallel-controlled, multicenter pragmatic clinical trial(PCT) was conducted. From September 2016 to January 2017, cases from 19 hospitals in Beijing, Shandong,Heilongjiang, Hunan, Inner Mongolia, Shanxi, Hubei, Gansu, etc, aged over 60 years old, clinically required to take aspirin for prevention and treatment(hypertension, diabetes, hyperlipidemia, coronary heart disease, etc.) and met the inclusion and exclusion criteria were selected. A total of 796 subjects were randomly assigned to the treatment group of Aspirin Enteric-coated Sustained-release Tablets 50 mg/d and the control group of Aspirin Enteric-coated Tablets 100 mg/d, taking aspirin with different doses and different dosage forms for 2 weeks. By collecting information on the platelet aggregation rate, medication safety, quality of life and medication cost of subjects during medication, the cost-effectiveness and cost-utility of drug intervention were compared between the 2 groups. Results Among the subjects who did not take antiplatelet drugs before the trial, the platelet aggregation rate of the treatment group was 79.68±16.03% at baseline and 16.51±24.16% after 14 days of treatment, which decreased by 63.17±26.67%;the platelet aggregation rate of the control group was 77.05±19.29% at baseline and 16.11±25.15% after 14 days of treatment, which decreased by 60.94±30.14%. There was no statistically significant difference in the reduction between the 2 groups(χ^(2)=2.911 8, P=0.233 2). Among the subjects who took antiplatelet drugs before the trial, the platelet aggregation rate of the treatment group was 14.73±21.33% at baseline and 10.57±15.57% after 14 days of treatment, which decreased by 4.17±24.04%;the platelet aggregation rate of the control group was 12.22±17.24% at baseline and 9.32±12.79% after 14 days of treatment, which decreased by 2.90±21.76%. There was no statistically significant difference in the reduction between the 2 groups(χ^(2)=3.9846,P=0.1364). No matter whether antiplatelet aggregation drugs were used before the trial, there was no significant change in the quality of life of the 2 groups before and after the trial. Among the subjects who did not take antiplatelet drugs before the trial, the total drug cost and adverse reaction cost of 14 days of 50 mg JIENING aspirin enteric coated sustained-release tablets and 100 mg BAYER aspirin enteric coated tablets were 6.78±2.56 yuan and 7.61±5.60 yuan respectively. Among the subjects who took antiplatelet drugs before the trial, the total drug cost and adverse reaction cost of 14 days of 50 mg JIENING aspirin enteric coated sustained-release tablets and 100 mg BAYER aspirin enteric coated tablets were 6.86±5.11 yuan and 7.08±1.60 yuan respectively.Conclusion Compared with 100 mg BAYER enteric coated tablets, 50 mg JIENING aspirin enteric coated sustained-release tablets have similar antiplatelet aggregation effect, lower cost and more cost-effective.