首页|仿制与原研左乙拉西坦注射用浓溶液疗效、安全性与经济性比较的真实世界研究

仿制与原研左乙拉西坦注射用浓溶液疗效、安全性与经济性比较的真实世界研究

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目的 比较国家集中带量采购中标药品左乙拉西坦注射用浓溶液仿制药与原研药的疗效、安全性与经济性。方法 回顾性收集带量采购政策实施后(2021年11月—2022年3月)首都医科大学宣武医院使用原研的左乙拉西坦注射用浓溶液的住院患者病历资料(原研药组)和皖南医学院第一附属医院(弋矶山医院)使用仿制的左乙拉西坦注射用浓溶液的住院患者病历资料(仿制药组)，比较2组在预防和治疗癫痫方面的疗效、安全性及经济性。结果 原研药组和仿制药组治疗用药的患者分别纳入18，17例，有效率为50。00％和58。82％，均未发生药品不良反应，原研药组与仿制药组日均费用的中位数(四分位数间距)分别为255。00(255。00，510。00)元和131。78(131。78，131。78)元。倾向性评分匹配后，原研药组和仿制药组预防用药的患者各76例，有效率分别为97。37％和100。00％(P＞0。05)，药品不良反应发生率均为0％，原研药组与仿制药组日均费用的中位数(四分位数间距)分别为170。00(170。00，170。00)元和131。78(131。78，131。78)元，差异有统计学意义(P＜0。01)。结论 仿制与原研左乙拉西坦注射用浓溶液在预防癫痫方面的临床疗效基本一致，安全性相当，经济性优于原研药;治疗癫痫时，两药的有效率相近，但需进一步扩大样本量，验证结果。
Comparison of effectiveness,safety,and economy of generic and original levetiracetam concentrated solution for injection:a real-world study
Objective To evaluate the effectiveness,safety and economy of the clinical application of levetiracetam(LEV)concentrated solution for injection generic drug and the original drug in the national centralized volume-based procurement.Methods The information of inpatients using original LEV concentrated solution for injection in the Xuanwu Hospital of Capital Medical University(original drug group)and inpatients using generic LEV concentrated solution for injection in the First Affiliated Hospital of Wannan Medical College(generic drug group)was retrospectively analyzed after the implementation of the procurement policy(from November 2021 to March 2022).To compare the effectiveness,safety and economy of the two in the prevention and treatment of epilepsy.Results In the original drug group and the generic drug group,18 and 17 patients were enrolled in the treatment of epilepsy respectively,the effective rates were 50.00％and 58.82％,the incidence of adverse reactions were both 0％,and the median daily cost was 255.00(255.00,510.00)yuan and 131.78(131.78,131.78)yuan.After propensity score matching,both the original drug group and the generic drug group had 76 patients each received preventive medication,the effective rates were 97.37％and 100％(P＞0.05),and the incidence of adverse reactions were both 0％.The median daily fee for the original the generic drug group was 170.00(170.00,170.00)yuan and 131.78(131.78,131.78)yuan,there were significant difference(P＜0.01).Conclusion The clinical effect of generic and original LEV concentrated solution for injection in preventing epilepsy is basically the same,the clinical safety are equivalent,the generic has better economy than the original.The effective rate of the treatment of epilepsy is similar,while the sample size needs to be further expanded to verify the results.

Levetiracetam concentrated solution for injectionGeneric drugsOriginal drugsEffectivenessSafetyEconomyDrug centralized procurementReal-world study

冯英楠、董宪喆、彭静、王可、王之舟、栾家杰、张兰、岳小林

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首都医科大学宣武医院药学部(北京 100053)

皖南医学院第一附属医院(弋矶山医院)药学部(安徽芜湖 241001)

左乙拉西坦注射用浓溶液 仿制药 原研药 疗效 安全性 经济性 药品集中带量采购 真实世界研究

"重大新药创制"科技重大专项北京市医院管理中心"登峰"计划专项中国科协科技智库青年人才计划首都卫生发展科研专项北京市中医药局市级中医药专家学术经验传承工作项目(第六批)

2017ZX09101001-002-044DFL2019080320220615ZZ07110070首发2022-2Z-20113

2024

10.12173/j.issn.1005-0698.202312037

药物流行病学杂志
中国药学会 武汉医药（集团）股份有限公司

药物流行病学杂志

CSTPCD
影响因子：0.746
ISSN：1005-0698
年,卷(期)：2024.33(2)
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