厄贝沙坦氢氯噻嗪片仿制药与原研药治疗轻中度原发性高血压的成本-效果比较

Cost effectiveness comparison of generic irbesartan hydrochlorothiazide tablets and original drugs in the treatment of mild to moderate essential hypertension

目的比较厄贝沙坦氢氯噻嗪片(商品名:倍悦)仿制药与厄贝沙坦氢氯噻嗪片(商品名:安博诺)原研药治疗轻中度原发性高血压的成本-效果(C/E)。方法选择88例新发轻中度高血压患者作为研究对象,采用随机数字表法分为仿制组和原研组,各44例。仿制组患者应用厄贝沙坦氢氯噻嗪片仿制药治疗,原研组患者应用厄贝沙坦氢氯噻嗪片原研药治疗。比较两组治疗效果、治疗前后血压变化、不良反应发生情况、治疗成本。结果仿制组的治疗总有效率95.45%与原研组的97.73%对比,差异无统计学意义(P>0.05)。治疗前后组内收缩压、舒张压对比差异显著(P<0.05),且治疗4、8周后两组收缩压、舒张压显著低于治疗前(P<0.05);两组治疗前后组间的收缩压、舒张压对比,差异无统计学意义(P>0.05)。仿制组的药物不良反应发生率9.09%与原研组的6.82%对比,差异无统计学意义(P>0.05)。仿制组的直接成本(52.27±9.85)元、日均费用(0.93±0.18)元均低于原研组的(374.00±103.18)、(6.68±1.84)元(P<0.05)。仿制组的C/E为0.55,优于原研组的3.83。结论厄贝沙坦氢氯噻嗪片仿制药与原研药治疗轻中度高血压的整体疗效、安全性相当,但仿制药费用更低,更适合长期用药。

Objective To compare the cost effectiveness(C/E)comparison of generic irbesartan hydrochlorothiazide tablets(trade name:Beiyue)and original drugs(trade name:Ambonor)in the treatment of mild to moderate essential hypertension.Methods A total of 88 cases of patients with newly diagnosed mild to moderate hypertension were selected as the study subjects.The patients were divided into the generic group and the original group by random number table method,with 44 cases in each group.The generic group took generic irbesartan hydrochlorothiazide tablets for treatment,and the original group took original drugs for treatment.The treatment effect,blood pressure changes before and after treatment,occurrence of adverse reactions and treatment cost were compared between the two groups.Results The total effective rate of the generic group was 95.45%,and that of the original group was 97.73%,and there was no significant difference between the two groups(P>0.05).There was significant difference in systolic blood pressure and diastolic blood pressure between the two groups before and after treatment(P<0.05).After 4 and 8 weeks of treatment,the systolic blood pressure and diastolic blood pressure in both groups were significantly lower than those before treatment(P<0.05).There was no significant difference in systolic blood pressure and diastolic blood pressure between the two groups before and after treatment(P>0.05).The incidence of adverse drug reactions in the generic group was 9.09%,and that in the original group was 6.82%,and there was no significant difference between the two groups(P>0.05).The generic group had direct cost of(52.27±9.85)yuan and the average daily cost of(0.93±0.18)yuan,which were lower than(374.00±103.18)yuan and(6.68±1.84)yuan in the original group(P<0.05).The generic group had better C/E of 0.55 than 3.83 in the original group.Conclusion The overall efficacy and safety of generic irbesartan hydrochlorothiazide tablets is similar to that of the original drug in the treatment of mild to moderate hypertension,but the cost of the generic drug is lower,and it is more suitable for long-term use.