恩替卡韦长期治疗慢性乙型肝炎的疗效及安全性观察  

Efficacy and safety of entecavir long-term treatment for patients with chronic hepatitis B

作　　者：董庆华[1] 马秀云[1] 徐道振[1] 田敬华[1] 蔡晧东[1] 

机构地区：[1]首都医科大学附属北京地坛医院,北京100015

出　　处：《中华实验和临床感染病杂志（电子版）》2013年第2期48-53,共6页Chinese Journal of Experimental and Clinical Infectious Diseases(Electronic Edition)

摘　　要：目的对使用恩替卡韦长期治疗的慢性乙型肝炎患者进行有效性、安全性和耐药情况的观察。方法纳入3项前瞻性恩替卡韦临床试验(ETV-012、ETV-023和ETV-056)及其后续临床试验(ETV-050)共63例患者,对以上患者进行长达4～8年的观察。结果 63例患者中有3例在治疗2年后失访,1例治疗2.5年时转其他中心治疗;其余59例患者接受长期治疗或随访4～8年,平均(6.16±1.39)年(中位数7.0年),68.3%(43例/63例)的患者用药7～8年。治疗7～8年后,ETV初治组有85.7%的患者保持病毒学应答,LAM经治组有54.5%的患者保持病毒学应答;在7～8年保持HBV DNA持续应答的36例患者中,HBeAg阴转率为36.1%,HBeAg血清学转换率为22.2%;6例患者达到HBeAg血清学转换和(或)HBV DNA完全应答,1例患者达到HBsAg血清学转换;这些患者停药后无1例复发。所有患者未发生与药物相关或可能相关的不良事件,无患者发生肿瘤。有13例(20.6%)患者临床耐药,多为LAM经治患者。结论 ETV长期治疗疗效佳,耐药发生率低,安全性好,尚无导致人类肿瘤发生率增加的证据。Objective To observe the efficacy, safety and tolerability of long-term entecavir （ETV） treatment in patients with chronic hepatitis B. Methods Total of 63 patients were enrolled in three prospective ETV clinical trials （ETV-012, ETV-023 and ETV-056） and subsequent clinical trial （ETV-050）. Efficacy and safety in these patients for up to 4 to 8 years were observed, respectively. Results Among the 63 cases, three patients lost to follow-up after 2 years, one patient turned to another center for treatment after 2.5 years; the other 59 patients received long-term treatment or follow-up of 4 to 8 years （mean 6.16 4- 1.39 years, median 7 years）, 68.3% patients （43/63） were treated for 7-8 years. After treatment for 7-8 years, 85.7% LAM niive patients and 54.5% LAM-treated patients maintained virological response. The rate of HBeAg negative and serological conversion were 36.1% and 22.2% in 36 patients with HBV DNA sustained response for 7-8 years, respectively. There were 6 patients who achieved the HBeAg seroconversion and/or completed HBV DNA suppression, 1 patient achieved the HBsAg serocoversation; and there was no recurrence after withdrawal of ETV therapy. There were no drug-attributed adverse events or hepatocellular carcinoma in all patients. The emergence of drug resistance occured in 13 （20.6%） patients, mostly in patients treated with LAM. Conclusions Long-term ETV treatment was effective, with a low resistance rate and was well tolerated; there were no evidence for the occurrence of cancers in those patients.

关 键 词：肝炎 乙型 恩替卡韦 疗效 安全性 

分 类 号：R512.62[医药卫生—内科学]