集采仿制药文拉法辛缓释胶囊有效性和安全性真实世界研究  

Real-world Study on the Efficacy and Safety of Eeneric Venlafaxine Extended-release Capsules in Centralized Procurement

作　　者：杨敏[1] 彭莉蓉[1] 白荷荷[1] 韩小年[1] 王金萍[1] 王可[2] 董宪喆 张兰[2] YANG Min;PENG Lirong;BAI Hehe;HAN Xiaonian;WANG Jinping;WANG Ke;DONG Xianzhe;ZHANG Lan(Department of Pharmacy,Xi’an Central Hospital,Xi’an 710004,China;Department of Pharmacy,Xuanwu Hospital,Capital Medical University,Beijing 100053,China)

机构地区：[1]西安市中心医院药剂科,西安710004 [2]首都医科大学宣武医院药学部,北京100053

出　　处：《医药导报》2025年第4期584-589,共6页Herald of Medicine

摘　　要：目的采用真实世界临床数据,评估国家组织集采中选仿制药文拉法辛缓释胶囊与原研药在临床实际使用中的有效性、安全性和经济性。方法采取多中心、回顾性的真实世界研究。收集2021年10月—2022年10月西安市中心医院等7家医疗机构使用文拉法辛缓释胶囊的门诊患者信息,包括处方数据和实验室检查数据,将患者分为仿制药组和原研药组。倾向性评分匹配后,比较两组患者的处方日剂量,血药浓度,药物持有率,药物持续治疗3、6、9个月率,换药率,不良反应发生率,用药频度,日均费用,药品人均年费用及年均费用占比。结果仿制药组的处方日剂量、药物持有率(MPR≥0.8)高于原研药组,差异有统计学意义(P<0.05);两组患者的血药浓度,差异无统计学意义(P=0.294);仿制药组的药物持续治疗3、6、9个月率均高于原研药组,差异有统计学意义(P<0.01);原研药组的单次换药率高于仿制药组,差异有统计学意义(P=0.032);两组患者的二次换药率,差异无统计学意义(P=1.000);两组患者丙氨酸氨基转移、天冬氨酸氨基转移酶、总胆固醇、电解质钠、活化部分凝血活酶时间、血小板计数异常发生率,差异无统计学意义(P>0.05);仿制药组的日均费用低于原研药组;仿制药组的药品人均年费用及年均费用占比均低于原研药组,差异有统计学意义(P<0.01)。结论在真实世界临床诊疗患者中,未发现国家组织集采中选药品文拉法辛缓释胶囊仿制药与原研药在有效性和安全性方面存在有临床意义的差异,而仿制药的经济性优于原研药。Objective To evaluate the effectiveness,safety and economy of generic venlafaxine sustained-release capsules and the original drug in clinical practice based on real world clinical data.Methods This is a multicenter,retrospective real-world study.The information of outpatients who used venlafaxine sustained-release capsules in 7 hospitals from October 2021 to October 2022 was collected,including prescription data and laboratory data.They were divided into generic drug group and original drug group.After the baseline level was corrected by propensity score match method,the prescription daily dose,plasma concentration,medication possession ratio,the continuous medication rate for 3,6 and 9 months,dressing change rate,the incidence of adverse reactions,the frequency of drug use,the average daily cost,the annual cost per capita and the proportion of the average annual cost of drugs were compared between the two groups.Results After the baseline level was corrected by propensity score matching method,the prescription daily dose and medication possession ratio(MPR≥0.8)in the generic drug group were higher than that of the original drug group(P<0.05).There was no statistically difference in plasma concentration between the two groups(P=0.294).The continuous medication rate for 3,6 and 9 months in the generic drug group were statistically higher than those in the original drug group(P<0.01).The single dressing change rate of the generic drug group was lower than that of the original drug group(P=0.032).There was no significant difference in the rate of secondary dressing change between the two groups(P=1.000).There were no significant differences in the incidence of abnormal ALT,AST,TC,Na,APTT,and PLC between two groups(P>0.05).The average daily cost of the generic drug group was lower than that of the original drug group.The per capita annual cost of drugs and the proportion of average annual cost of drugs in the generic drug group were significantly lower than those in the original drug group(P<0.01).Conclusion In th

关 键 词：文拉法辛 抗抑郁药 仿制药 原研药 真实世界研究 

分 类 号：R954[医药卫生—药学]