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目的了解恩替卡韦(ETV)对核苷(酸)类药物初治和经治的慢性乙型肝炎患者长期治疗的疗效、安全性和耐药性。方法回顾性分析本院感染科门诊随访恩替卡韦单药治疗的87例慢性乙型肝炎患者,观察肝功能、HBV DNA定量、HBsAg定量、HBeAg阴转、耐药发生率等指标。结果 87例患者中,32例(37%)为恩替卡韦初治患者,55例(63%)为拉米夫定(LAM)或阿德福韦酯(ADV)经治换用恩替卡韦的患者。恩替卡韦初治组,阿德福韦酯经治组和拉米夫定经治组,7年累计病毒学应答率分别为100%(32/32),97%(30/31)和62%(13/21);7年累计耐药率分别为3%(1/32),3%(1/31)和38%(8/21);7年累计HBeAg阴转率为47%(9/19),45%(13/29)和20%(3/15);其中阿德福韦酯经治组有两例患者达到HBsAg清除。在所有的患者中,HBeAg阴性患者较HBeAg阳性患者早期病毒学应答率更高(P=0.012),7年累计病毒学应答率分别为91%(21/23)和89%(57/64)。在恩替卡韦初治患者中,HBeAg阴性患者同样比HBeAg阳性患者早期病毒学应答率高(P=0.001),累计病毒学应答率分别为100%(13/13)和100%(19/19)。3组病毒学应答率比较,恩替卡韦初治患者早期病毒学应答率高于阿德福韦酯经治患者和拉米夫定经治患者(P<0.001)。结论恩替卡韦初治患者长期疗效佳,耐药低,安全性好,阿德福韦酯经治患者序贯恩替卡韦仍能取得较好的长期疗效,但是对于拉米夫定经治患者来说,选用恩替卡韦长期治疗存在较高的耐药风险。
Objective To understand the efficacy, safety and drug resistance of entecavir for long-term treatment of nucleos (s) acid-naive and controlled chronic hepatitis B patients. Methods A retrospective analysis of 87 patients with chronic hepatitis B who were treated with entecavir monotherapy in our infectious clinic was retrospectively analyzed. The indexes of liver function, HBV DNA quantitation, HBsAg quantitation, HBeAg negative conversion and drug resistance were observed. Results Of 87 patients, 32 (37%) were entecavir-naïve and 55 (63%) patients were enrolled with lamivudine (LAM) or adefovir dipivoxil (ADV). The cumulative virological response rates of entecavir-naive group, adefovir dipivoxil-treated group and lamivudine-treated group were 100% (32/32), 97% (30/31) and 62% (1/32), 3% (1/31), and 38% (8/21), respectively. The 7-year cumulative HBeAg negative rate was 47% (9 / 19), 45% (13/29) and 20% (3/15). Among them, two patients in the adefovir dipivoxil group achieved HBsAg clearance. In all patients, HBeAg-negative patients had a higher early virological response rate (P = 0.012) than HBeAg-positive patients and cumulative 7-year virologic response rates were 91% (21/23) and 89% (57/64), respectively . Among the entecavir-naïve patients, HBeAg-negative patients also had higher early virological response rates (p = 0.001) than HBeAg-positive patients, with cumulative virologic response rates of 100% (13/13) and 100% (19/19), respectively. The virological response rates of patients in the newly diagnosed entecavir group were higher than those of adefovir dipivoxil-treated patients and lamivudine-treated patients in the three groups (P <0.001). Conclusion The long-term curative effect, low resistance and safety of the patients with initial treatment of entecavir are good, and the sequential entecavir treatment of adefovir dipivoxil can still achieve better long-term efficacy, but for lamivudine-treated patients, Long-term treatment with entecavir has a high risk of drug resistance.