Real-world Study on the Efficacy and Safety of Eeneric Venlafaxine Extended-release Capsules in Centralized Procurement
10.3870/j.issn.1004-0781.2025.04.014
- VernacularTitle: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
- Author:
Min YANG
1
;
Lirong PENG
;
Hehe BAI
;
Xiaonian HAN
;
Jinping WANG
;
Ke WANG
;
Xianzhe DONG
;
Lan ZHANG
Author Information
1. 西安市中心医院药剂科,西安 710004
- Publication Type:Journal Article
- Keywords:
Venlafaxine;
Antidepressant drugs;
Generic drug;
Original-patented drug;
Real world study
- From:
Herald of Medicine
2025;44(4):584-589
- CountryChina
- Language:Chinese
-
Abstract:
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 the actual clinical diagnosis and treatment,no clinically significant differences in effectiveness and safety were found between the generic venlafaxine sustained-release capsule and the original-patented,while the economic advantages of the generic drug were better than that of the original-patented drug.
