原研与仿制莫西沙星注射液在治疗社区获得性肺炎中的成本-效果分析  

Cost-effectiveness analysis of original andgeneric moxifloxacin injection in the treatment of community acquired pneumonia

作　　者：张亮 侯文洁[2] 周秋云[2] 张宇[3] 方中坚 邵蓉[1] ZHANG Liang;HOU Wen-jie;ZHOU Qiu-yun;ZHANG Yu;Fang Zhong-jian;SHAO Rong(School of International Pharmaceutical Business,China Pharmaceutical University,Jiangsu Nanjing 211198,China;Department of Pharmacy,Nanjing Municipal Chest Hospital,Jiangsu Nanjing 210029,China;Department of Respiratory Medicine,Nanjing Municipal Chest Hospital,Jiangsu Nanjing 210029,China)

机构地区：[1]中国药科大学国际医药商学院,江苏南京211198 [2]南京市胸科医院药学部,江苏南京210029 [3]南京市胸科医院呼吸内科,江苏南京210029

出　　处：《中国医院药学杂志》2021年第3期246-250,共5页Chinese Journal of Hospital Pharmacy

基　　金：国家社科基金重大项目《我国创新药物政策环境研究》(编号:15ZDB167);中国药科大学"双一流"学科创新团队建设项目(编号:CPU2018GY39);江苏省药学会-奥赛康医院药学科研基金(编号:A201909)。

摘　　要：目的:研究原研莫西沙星对比仿制莫西沙星治疗社区获得性肺炎中的有效性和经济性。方法:采用前瞻性研究方法,选取2018年1月—2019年12月收治的85例社区获得性肺炎患者,根据患者治疗意愿分为原研组45例和仿制组40例。均连续给药7 d。比较两组患者临床疗效和不良反应发生情况。以治疗总费用为成本,采用成本-效果分析方法评价两组患者用药方案的成本-效果(C/E)和增量成本-效果比(ICER,ΔC/ΔE),并通过下降15%的不同费用进行敏感性分析。结果:原研组和仿制组患者的有效率分别为84.4%、82.5%,差异无统计学意义(P>0.05)。仿制组患者药物过敏和血糖异常的发生率显著高于原研组,差异有统计学意义(P<0.05)。原研组和仿制组的平均总费用分别为9 648.72元和8 403.11元(P>0.05),有效率的C/E分别为114.32、101.86,原研组对于仿制组的ΔC/ΔE为655.58。敏感性分析支持成本-效果分析的结果。结论:原研莫西沙星和仿制莫西沙星治疗社区获得性肺炎的疗效相当,考虑到不良反应的发生率和支付意愿,仿制莫西沙星的经济学优势不明显。OBJECTIVE To explore the efficacy and economics of original and generic moxifloxacin injection in the treatment of community acquired pneumonia(CAP). METHODS For this prospective study,85 CAP patients were selected from January 1,2018 to December 31,2019.They were divided into original group(n=45) and generic group(n=40) according to the patient’s treatment intention.Treatment lasted for 7 days in both groups.Effective rate and occurrence of adverse drug reaction(ADR) were compared between two groups.Cost-effectiveness analysis was performed for evaluating the cost-effectiveness ratio(C/E) and incremental cost-effectiveness ratio(ICER,ΔC/ΔE) of two groups using total cost of treatment.Sensitivity analysis was performed by reducing different cost by 15%. RESULTS Effective rate of two groups was 84.4% and 82.5% respectively.There was no statistical significance(P>0.05).The incidence of drug allergy and abnormal blood glucose was higher in generic group than those in original group.There was no statistical significance(P<0.05).The total cost of original and generic groups was 9648.72 and 8403.11 yuan respectively(P>0.05).C/E of effective rate was 114.32 and 101.86 and ΔC/ΔE of effective rate between original and generic groups 655.58.Sensitivity analysis supported the results of cost-effectiveness analysis. CONCLUSION Original and generic moxifloxacin have a similar efficacy for CAP.However,considering the incidence of adverse reactions and willingness to pay,the economic advantage of generic moxifloxacin is unobvious.

关 键 词：社区获得性肺炎 莫西沙星 仿制药 有效率 成本-效果分析 

分 类 号：R969[医药卫生—药理学]