仿制药与原研药吸入用布地奈德混悬液治疗AECOPD的药物经济学研究  

Pharmacoeconomics Study on the Treatment of AECOPD with Inhalation Budesonide Suspension between generic preparation and original preparation

作　　者：刘裕婷 林晓峰 林丽敏 施金婉 蓝雁霞 温娟莹 LIU Yu-ting;LIN Xiao-feng;LIN Li-min(Department of pharmacy,Sanshui District People's Hospital,Foshan 528000,China)

机构地区：[1]佛山市三水区人民医院药学部,广东佛山528000

出　　处：《中国处方药》2022年第4期63-65,共3页Journal of China Prescription Drug

基　　金：2020年北京白求恩公益基金会(SCZ282DS)。

摘　　要：目的观察仿制药与原研药布地奈德混悬液在临床上用于治疗慢性阻塞性肺疾病急性加重期患者的临床效果与药物经济学上的差异,以便为广大患者在疗效与费用之间作出权衡。方法将慢性阻塞性肺疾病急性加重的患者52例随机分为两组,分别给予仿制药吸入用布地奈德混悬液(天晴速畅)及原研药吸入用布地奈德混悬液(普米克令舒),1 mg,一天2次,每次15 min,治疗4~7 d后观察临床疗效,运用药物经济学的最小成本分析、成本-效果分析方法进行评价。结果两组总有效率差异无统计学意义(P>0.05);两组肺功能指标及血气分析治疗前后均具有显著性差异(P<0.05),但治疗后两组间血气分析和肺功能差异无统计学意义(P>0.05);成本与效果方面,仿制药吸入用布地奈德混悬液的成本与效果比(C/E)显著小于原研药,且进行敏感性分析后证实结论可信。结论仿制药与原研药吸入用布地奈德混悬液在治疗慢阻塞肺急性加重的临床疗效、不良反应发生率差异均无统计学意义,仿制药吸入用布地奈德混悬液具有较高的经济优势。Objective To observe the difference between the clinical effect and pharmacoeconomics of the generic and original preparation of Inhalation Budesonide Suspension in the treatment of patients with acute exacerbation of chronic obstructive pulmonary disease,so as to considerate the efficacy and cost for the majority of patients.Methods 52 patients since 2020 with acute exacerbation of chronic obstructive pulmonary disease were evaluated.All were divided randomly into two groups,respectively given Inhalation Budesonide Suspension of generic preparation and original preparation(1 mg for 15 minutes,bid).Evaluation and analyze the treatment for 4~7 days with the least cost analysis and cost and effectiveness analysis methods of pharmacoeconomics.Results There was no significant difference of total effective rate between generic preparation and original preparation(P>0.05),but the pulmonary function index and blood gas analysis were significantly different between the two groups before and after treatment(P<0.05);however,there was no significant difference in theabove indexes between the two groups after treatment(P>0.05).In terms of cost-effectiveness,the cost-effectiveness ratio(C/E)of the generic preparation was significantly lower than that of the original preparation,and sensitivity analysis confirmed that the conclusion was credible.Conclusion There is no statistically significant difference between generic preparation and original preparation of Inhalation Budesonide Suspension in the clinical efficacy and adverse reactions for the treatment of acute exacerbation of chronic obstructive pulmonary disease,but the generic preparation has a higher economy advantage.

关 键 词：慢性阻塞性肺疾病急性加重 吸入用布地奈德混悬液 原研药 仿制药 药物经济学 

分 类 号：R563.9[医药卫生—呼吸系统]