Meta-analysis of the Clinical Efficacy and Safety of Generic and Original Entecavir in the Treatment of Chronic Hepatitis B
10.13748/j.cnki.issn1007-7693.20230598
- VernacularTitle:恩替卡韦仿制药与原研药治疗慢性乙型肝炎的临床有效性和安全性meta分析
- Author:
GAO Yang
1
;
LEI Wenjuan
2
;
TIAN Min
2
;
TIAN Jinhui
3
;
MENG Min
4
;
GE Bin
5
Author Information
1. College of Pharmacy, Ningxia Medical University, Yinchuan 750004, China;
2. Gansu Provincial Drug Clinical Comprehensive Evaluation Technology Center, Lanzhou 730099, China;Department of Pharmacy, Gansu Provincial Hospital, Lanzhou 730099, China;
3. Evidence-Based Medicine Center, Lanzhou University, Lanzhou 730000, China;
4. Gansu Provincial Drug Clinical Comprehensive Evaluation Technology Center, Lanzhou 730099, China;Department of Pharmacy, Gansu Provincial Hospital, Lanzhou 730099, China;College of Pharmacy, Gansu University of Chinese Medicine, Lanzhou 730000, China
5. College of Pharmacy, Ningxia Medical University, Yinchuan 750004, China;Gansu Provincial Drug Clinical Comprehensive Evaluation Technology Center, Lanzhou 730099, China;Department of Pharmacy, Gansu Provincial Hospital, Lanzhou 730099, China;
- Publication Type:Journal Article
- Keywords:
entecavir;
chronic hepatitis B;
generic;
efficacy;
safety;
meta-analysis
- From:
Chinese Journal of Modern Applied Pharmacy
2023;40(17):2446-2454
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To evaluate the clinical efficacy and safety of original and generic entecavir(ETV) in the treatment of chronic hepatitis B. METHODS Domestic and foreign literatures were systematically reviewed to evaluate the efficiency and safety. Qualitative combined with quantitative methods were used to evaluate and analyze. RESULTS Meta-analysis results showed that there were no significant differences in HBV-DNA negative conversion rate, ALT normalization rate, serum HBeAg negative conversion rate, HBeAg serum conversion rate, HBeAg/HBeAb serum conversion rate and incidence of adverse reactions between generic and original ETVs after 12 and 48 weeks of medication. Subgroup analysis of different treatment courses showed no statistical significance in each index. CONCLUSION The results of this study shows no significant differences between the two drugs in terms of clinical efficacy and safety considerations. However, limited by the quality and quantity of included literature, a large sample and multicenter RCT is still needed to confirm the conclusion.
