| 引用本文: | 高扬,雷文娟,田敏,田金徽,孟敏,葛斌.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[J].中国现代应用药学,2023,40(17):2446-2454. |
| GAO Yang,LEI Wenjuan,TIAN Min,TIAN Jinhui,MENG Min,GE Bin.Meta-analysis of the Clinical Efficacy and Safety of Generic and Original Entecavir in the Treatment of Chronic Hepatitis B[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(17):2446-2454. |
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| 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 |
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高扬1, 雷文娟2,3, 田敏2,3, 田金徽4, 孟敏2,3,5, 葛斌1,2,3
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1.宁夏医科大学药学院, 银川 750004;2.甘肃省药品临床综合评价技术中心, 兰州 730099;3.甘肃省人民医院药剂科, 兰州 730099;4.兰州大学循证医学中心, 兰州 730000;5.甘肃中医药大学药学院, 兰州 730000
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| 摘要: |
| 目的 评价恩替卡韦原研药与仿制药治疗慢性乙型肝炎的临床有效性及安全性。方法 系统梳理国内外相关文献，对恩替卡韦的有效性和安全性开展评价。采用定性、定量相结合的方式进行评价分析。结果 Meta分析结果显示，仿制恩替卡韦与原研恩替卡韦相比，用药12周及48周后，其HBV-DNA阴转率、ALT复常率、血清HBeAg阴转率、HBeAg血清转换率、HBeAg/HBeAb血清转换率及不良反应发生率均无统计学意义。不同疗程的亚组分析显示，各项指标的差异均无统计学意义。结论 本研究结果显示，从临床有效性和安全性考虑，恩替卡韦仿制药和原研药并无明显差异。但受限于纳入文献质量和数量，仍需大样本、多中心的RCT来证实该结论。 |
| 关键词: 恩替卡韦 慢性乙型肝炎 仿制药 有效性 安全性 meta分析 |
| DOI：10.13748/j.cnki.issn1007-7693.20230598 |
| 分类号:R969.3 |
| 基金项目:2021年度甘肃省卫生健康委员会委托课题 |
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| Meta-analysis of the Clinical Efficacy and Safety of Generic and Original Entecavir in the Treatment of Chronic Hepatitis B |
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GAO Yang1, LEI Wenjuan2,3, TIAN Min2,3, TIAN Jinhui4, MENG Min2,3,5, GE Bin1,2,3
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1.College of Pharmacy, Ningxia Medical University, Yinchuan 750004, China;2.Gansu Provincial Drug Clinical Comprehensive Evaluation Technology Center, Lanzhou 730099, China;3.Department of Pharmacy, Gansu Provincial Hospital, Lanzhou 730099, China;4.Evidence-Based Medicine Center, Lanzhou University, Lanzhou 730000, China;5.College of Pharmacy, Gansu University of Chinese Medicine, Lanzhou 730000, China
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| 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. |
| Key words: entecavir chronic hepatitis B generic efficacy safety meta-analysis |
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