中国药物警戒 ›› 2017, Vol. 14 ›› Issue (2): 75-77.

• 基础与临床研究 • 上一篇    下一篇

核苷（酸）类似物治疗慢性乙型肝炎的临床观察

陈保生，刘宏菊，刘冰，郭秀英，王海英，马丽萍*   

  1. 北京大学首钢医院,北京 100144
  • 收稿日期:2017-03-10 修回日期:2017-03-10 出版日期:2017-02-20 发布日期:2017-03-10
  • 通讯作者: 马丽萍,女,硕士,主管药师,抗感染临床药学和慢病药物治疗管理。E-mail:applemary18@163.com
  • 作者简介:陈保生,男,硕士,副主任医师,感染性疾病的诊疗。

Clinical Observation of Nucleotide Analogues in Treating Patients with Chronic Hepatitis B

CHEN Bao-sheng, LIU Hong-ju ,LIU Bing, GUO Xiu-ying ,WANG Hai-ying, MA Li-ping*   

  1. Peking University Shougang Hospital, Beijing 100144, China
  • Received:2017-03-10 Revised:2017-03-10 Online:2017-02-20 Published:2017-03-10

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摘要： 目的 探讨核苷（酸）类似物（阿德福韦酯、拉米夫定、恩替卡韦）治疗慢性乙型肝炎的有效性和安全性。方法 选取2012年10月至2013年2月期间就诊的慢性乙型肝炎患者94例进行开放性观察研究。阿德福韦酯组30例、拉米夫定组28例和恩替卡韦组36例;3组患者均连续服药96周;观察3组患者给药后不同时期的生物化学应答率、病毒学应答率和HBeAg血清学转换率等,并比较3组患者的临床疗效及不良反应。结果 第4和8周时3组患者的ALT均有明显改善,3组间ALT改善无统计学差异（P﹥0.05）。病毒学应答率第12周和24周,3组患者第12和24的病毒学应答率存在显著性差异（P﹤0.05）,其中阿德福韦酯组显著低于恩替卡韦组（P﹤0.017）;第48周和96周3组间比较无统计学差异（P﹥0.05）。HBeAg血清学转换率第96周3组间HBeAg血清学事件发生率无显著差异（P﹥0.05）。结论 核苷（酸）类似物治疗慢性乙型肝炎患者安全性较高,适合长期使用;其中恩替卡韦宜作为慢性乙型肝炎患者初始治疗选择。

关键词: 慢性活动性乙型肝炎, 核苷（酸）类似物, 生物化学应答率, 病毒学应答率, HBeAg血清学转换率

Abstract: Objective To explore the efficacy and safety of nucleos(t)ide analogs (NAs) in treatment of patients with chronic hepatitis B(CHB).Methods 94 outpatients with CHB from December 2012 to February 2013 were recruited to the open observational study. The adefovir dipivoxil (ADV) group, lamivudine (LAM) group and entecavir (ETV) group included 30 patients, 28 patients and 36 patients respectively. All included patients continuously took ADV, LAM or ETV for 96 weeks. We observed and compared the aminotransferase (ALT) normalization rate, virological response rate, HBeAg seroconversion rate, and adverse drug event (ADE) incidence.Results At 4th week and 8th week, ALT of three groups had been significantly improved, but there were no statistical differences（P﹥0.05）. At 12th week and 24th week, there were significant differences in virological response rate (P﹤0.05), among which the ADV group was significantly lower than the ETV group（P﹤0.017）. At 48th week and 96th week, there were no statistical differences（P﹥0.05）in virological response rate. There were no significant differences in HBeAg seroconversion rate among three groups（P﹥0.05）.Conclusion NAs are suitable for long-term use for the treatment of CHB patients with high safety, of which ETV should be as an initial choice.

Key words: chronic hepatitis B, nucleos(t)ide analog, biochemical response rate, virological response rate, HBeAg seroconversion rate

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