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目的分析恩替卡韦单药与拉米夫定联合阿德福韦酯两种治疗方案对代偿期乙型肝炎肝硬化疗效比较研究中入组1年时的患者基线数据特点。方法疗效比较研究的方案为对临床或病理诊断为代偿期乙肝肝硬化的患者进行随访,每3个月检测一次血常规、肝功能、肾功能、HBV DNA,每半年检测一次甲胎蛋白、凝血功能、腹部超声和肝脏弹性,比较两种治疗方案的疗效。结果至2013年8月,共入组通过临床诊断代偿期乙肝肝硬化患者382例,截至数据统计时可获得240例患者的随访资料。随访的中位数时间为6个月。恩替卡韦单药治疗患者为200例(83.3%),拉米夫定联合阿德福韦治疗组为40例(16.7%)。两组在患者年龄、性别、HBeAg及HBV DNA水平分布方面具有可比性。所有入组患者中男性176例(73.3%),女性64例(26.7%),平均年龄为(44.6±11.6)岁,HBeAg阳性占58%,HBV DNA的中位数为5.94(4.33,6.87)log10 IU/ml。上述特点与经典的4 006研究中肝穿证实的肝硬化人群特征相似。结论本研究入组患者1年时,通过临床诊断的代偿期乙肝肝硬化患者的基线特征与既往研究中肝穿证实的代偿期乙肝肝硬化患者基线特征相似,恩替卡韦单药组与拉米夫定联合阿德福韦联合用药组偏组明显。
Objective To analyze the characteristics of baseline data of patients enrolled in the study on the efficacy of entecavir monotherapy combined with lamivudine and adefovir dipivoxil in decompensated hepatitis B cirrhosis. Method Comparison of the efficacy of the program for clinical or pathological diagnosis of compensated hepatitis B cirrhosis patients were followed up every 3 months to detect blood, liver function, renal function, HBV DNA, alpha-fetoprotein detected once every six months, Coagulation, abdominal ultrasound and liver elasticity, the efficacy of the two treatment options. Results By August 2013, a total of 382 patients with decompensated hepatitis B cirrhosis were enrolled in the cohort. As of the data statistics, 240 patients were followed up. The median follow-up time was 6 months. 200 patients (83.3%) were entecavir monotherapy, 40 patients (16.7%) were treated with lamivudine and adefovir. The two groups were comparable in terms of patient age, gender, HBeAg and HBV DNA distribution. The average age was 44.6 ± 11.6 years, with 58% of HBeAg positive and the median of HBV DNA was 5.94 (4.33,6.87). There were 176 males (73.3%) and 64 females (26.7% log10 IU / ml. These characteristics are similar to those of the classic liver cirrhosis population who were confirmed by liver biopsy. Conclusions The baseline characteristics of patients with decompensated hepatitis B cirrhosis who were clinically diagnosed in this study at one year were similar to those of patients with compensated hepatitis B cirrhosis confirmed by liver puncture in previous studies. Fufang combined adefovir combination group partial group obvious.