替比夫定治疗慢性乙型肝炎患者3年的临床观察

Three years clinical observation on Telbivudine in the treatment of chronic hepatits B LIU Xiaoqin，ZHANG Dazhi，GUO Shuhua

摘要:

目的：观察替比夫定治疗慢性乙型肝炎（Chronic hepatitis B，CHB）患者3年的临床疗效及安全性。方法：随机选择重庆医科大学附属第二医院感染科门诊单一接受替比夫定治疗的CHB患者，给予口服替比夫定 600 mg，1次/d，连续治疗156周，观察患者治疗前、后病毒学、血清学及生化学指标的变化。其中有62例患者达到3年疗程，根据24周时的乙型肝炎病毒（Hepatitis B virus，HBV）DNA水平将患者分为＜lg3拷贝/ml和≥lg3拷贝/ml 2组，比较其在治疗156周时的抗病毒疗效，观察其安全性。疗效比较采用卡方检验或校正卡方检验。结果：替比夫定治疗156周时，HBV DNA不可测（＜lg3拷贝/ml）率为79.0％，丙氨酸氨基转移酶（Alanine aminotransferase，ALT）复常（≤1.0×ULN）率为72.6％，HBeAg血清转换率为39.7％，耐药率为11.3％。24周时HBV DNA＜lg3拷贝/ml的HBeAg阳性患者，156周时的HBV DNA不可测率显著高于HBV DNA≥lg3拷贝/ml的患者（ χ2=13.98，P＜0.005），HBeAg血清学转换率亦较高（P ＞0.05），而耐药发生率较低（ χ2=4.17，P＜0.05）；因HBeAg阴性患者数量少（n=4），无法分组进行统计比较。治疗156周过程中，37.1％患者曾出现肌酸激酶（Creatine kinase，CK）升高，无1例发生严重不良事件而停药。结论：3年的临床试验表明替比夫定是强效的抗HBV药物，具有抑制HBV复制强，HBeAg血清转换率较高的优点，3年耐药率较低，是一种安全有效的抗病毒药物。替比夫定治疗24周时HBV DNA水平可较好的预测156周疗效。

Abstract:

Objective：To investigate the efficacy and safety of applying Telbivudine in the treatment of chronic hepatitis B（CHB） for consecutive 3 years. Methods：Totally 62 patients with CHB who received monotherapy of Telbivudine in the department of infectious diseases in the second affiliated hospital of Chongqing medical university took Telbivudine 600 mg orally once per day. The virology，serology and biochemical indicators of 62 patients were detected and analyzed before and at the 156th week after the treatment. The 62 patients who received the treatment for 3 years were divided into two groups according to the hepatitis B virus（HBV） DNA level（＜lg3 copy/ml and ≥lg3 copy/ml） and comparison was made at the 156th week during the treatment in order to know the ef－ficacy and safety of the treatment. Chi-square test or calibration chi-square test was applied to do the efficacy comparison. Results：After 156 weeks of treatment，HBV DNA negative rate was 79.0％，Alanine aminotransferase（ALT） normalization rate was 72.6％，HBeAg seroconversion rate was 39.7％ and drug resistant rate was 11.3％. In HBeAg-positive patients（with HBV DNA