中国医院用药评价与分析2025，Vol.25Issue(2)：143-147,152,6.DOI:10.14009/j.issn.1672-2124.2025.02.004
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
摘要
Abstract
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 lower than those in the original drug group,with statistically significant differences(P<0.05).CONCLUSIONS:There is no significant difference in efficacy and safety between the generic and original Pramipexole dihydrochloride sustained-release tablets,and the economy of generic drug is better than that of original drug.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Key words
Pramipexole dihydrochloride sustained-release tablets/Generic drug/Original drug/Real-world study/National centralized volume-based procurement/Efficacy/Safety/Economy分类
药学引用本文复制引用
王可,王之舟,邢晓璇,刘蕊,花一鸣,董宪喆,张兰..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[J].中国医院用药评价与分析,2025,25(2):143-147,152,6.基金项目
国家医疗保障局委托项目(No.JCS-ZCHT-2023-002) （No.JCS-ZCHT-2023-002）
2022 年度科技智库青年人才计划(No.20220615ZZ07110070) （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) （No.320.6750.2023-06-85）
2024 年度科技智库青年人才计划(No.XMSB20240711099) （No.XMSB20240711099）
