盐酸普拉克索缓释片仿制药与原研药的疗效、安全性与经济性的真实世界研究  

Real World Study on Efficacy,Safety and Economy of Generic and Original Pramipexole Dihydrochloride Sustained-Release Tablets

作　　者：王可[1] 王之舟[1] 邢晓璇[1] 刘蕊[2] 花一鸣 董宪喆 张兰[1] WANG Ke;WANG Zhizhou;XING Xiaoxuan;LIU Rui;HUA Yiming;DONG Xianzhe;ZHANG Lan(Dept.of Pharmacy,Xuanwu Hospital,Capital Medical University,Beijing 100053,China;Dept.of Pharmacy,the Second Affiliated Hospital of Chongqing Medical University,Chongqing 400010,China)

机构地区：[1]首都医科大学宣武医院药学部,北京100053 [2]重庆医科大学附属第二医院药学部,重庆400010

出　　处：《中国医院用药评价与分析》2025年第2期143-147,152,共6页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家医疗保障局委托项目(No.JCS-ZCHT-2023-002);2022年度科技智库青年人才计划(No.20220615ZZ07110070);吴阶平医学基金会临床科研专项资助基金(No.320.6750.2023-06-85);2024年度科技智库青年人才计划(No.XMSB20240711099)。

摘　　要：目的:比较盐酸普拉克索缓释片国家药品集中带量采购中选仿制药与原研药的疗效、安全性和经济性。方法:提取2021年1月1日至2023年10月31日首都医科大学宣武医院、重庆医科大学附属第二医院使用盐酸普拉克索缓释片原研药或仿制药治疗帕金森病(PD)或帕金森综合征的门诊患者处方数据。纳入识别期使用原研药或仿制药的患者,入组后每3个月进行1次随访。评估患者入组后1年左旋多巴等效剂量(LED)水平随时间的变化程度、普拉克索治疗日费用、PD治疗药物日费用及随访平均处方费用,并且通过识别患者新出现的诊断和伴随用药及其相对时间点来识别入组至随访结束出现的相关不良事件(AE)。结果:共纳入610例患者,其中原研药组247例(39例患者有至少4次随访记录),仿制药组363例(117例患者有至少4次随访记录)。两组患者的一般资料经倾向性评分1∶1匹配后,差异均无统计学意义(P>0.05)。原研药组30例患者发生AE,仿制药组25例患者发生AE;Kaplan-Meier法、Log-rank检验结果显示,两组患者无AE生存率的差异无统计学意义(P=0.295)。Scheirer-Ray-Hare检验结果显示,仿制药组与原研药组患者LED水平随时间的变化程度比较,差异无统计学意义(H=3.032,P=0.553)。仿制药组患者普拉克索治疗日费用、PD治疗药物日费用及随访平均处方费用显著低于原研药组,差异均有统计学意义(P<0.05)。结论:盐酸普拉克索缓释片仿制药与原研药的疗效和安全性无明显差异,仿制药的经济性优于原研药。OBJECTIVE:To compare the efficacy,safety and economy between selected generic and original Pramipexole dihydrochloride sustained-release tablets in national centralized volume-based procurement.METHODS:Prescription data of outpatients using original or generic Pramipexole dihydrochloride sustained-release tablets in the treatment of Parkinson disease(PD)or Parkinson syndrome were extracted from Xuanwu Hospital,Capital Medical University and the Second Affiliated Hospital of Chongqing Medical University from Jan.1st,2021 to Oct.31st,2023.Patients who used the original drug or generic drug during the identification period were enrolled and followed up every 3 months.The change degree of levodopa equivalent dose(LED)level over time,the daily cost of pramipexole treatment,the daily cost of PD treatment drugs and the average prescription cost at follow-up within 1 year after enrollment were evaluated.Adverse events(AE)occurred after enrollment to the end of follow-up were identified by identifying patients’emerging diagnoses,concomitant medications and relative timing.RESULTS:A total of 610 patients were enrolled in the study,including 247 patients in the original drug group(39 patients with at least four follow-up records),and 363 patients in the generic drug group(117 patients with at least four follow-up records).There was no significant difference in general data between two groups after 1∶1 propensity score matching(P>0.05).A total of 30 cases of AE occurred in the original drug group and 25 cases in the generic drug group.Kaplan-Meier method and Log-rank test results showed no statistical significance in the AE-free survival rate between two groups(P=0.295).Scheirer-Ray-Hare test showed that there was no statistical significance in the variation degree of LED level between generic drug group and original drug group over time(H=3.032,P=0.553).The daily cost of pramipexole treatment,the daily cost of PD treatment drugs and the average prescription cost at follow-up in the generic drug group were significantly

关 键 词：盐酸普拉克索缓释片 仿制药 原研药 真实世界研究 集中带量采购 疗效 安全性 经济性 

分 类 号：R971[医药卫生—药品]