Mo Guo-sheng, Wu Zi-long, Zhang Jin-long, Hhang Zhi-guang, Cai Jian-gang, Jie Zhong-hua, Wu Xu-guang, Shi Jun-ping
Zhejiang Provincial Corps Hospital of Chinese People's Armed Police Forces, Jiaxing 314000, China.
Zhonghua Shi Yan He Lin Chuang Bing Du Xue Za Zhi. 2011 Apr;25(2):129-31.
To evaluate the efficacy and potential renal impairment of one-year combination therapy de novo of adefovir dipivoxil (ADV) and lamivudine (LMV) for decompensated cirrhosis related to HBV.
A total of 36 patients with decompensated cirrhosis related to HBV, nobody had nucleos(t)ide analogs (NAs) treatment history, were recruited and were divided into two group (control group and observation group) randomly. A monotherapy of LMV (100 mg per day) was selected to individuals in control group (n = 18), in contrast, a combination therapy de novo of ADV (10 mg per day) and LMV (100 mg per day) was applied to those in observation group (n = 18). Basic approaches including liver protection, symptom-driven intervention, and supporting therapy, were given to all of the individuals. A course of one year was applied to all. Liver function, Child-Pugh score, serum creatinine (sCr) level, virological response (VR) rate, and virological breakthrough rate were observed pro- and post- treatment, differences between the two populations were analysed statistically.
(1) The averages of gender, age, HBeAg status, HBV viral load, sCr level, and Child-Pugh score were all compatible in the two groups at baseline (P > 0.05 for all). (2) At the endpoint of treatment, none of deaths was reported. Comparing with the status before treatment in each group itself, liver function, Child-Pugh score, and viral load were improved statistically (P < 0.01 for all), especially in observed group (P < 0.01 for all variables, vs control group), as for VR rate, result is significant superior to that of control group too (88.89% vs 66.67% , P < 0.05). (3) Virological breakthrough occurred to none in observed group and three cases (16.67%) in control group, all of them were confirmed to be rtM204V variant in the following detection of direct sequencing. (4) Elevated level of sCr didn't arised at the end of treatment in two groups.
Present study reveals that in populations with decompensated cirrhosis related to HBV, one-year combination therapy de novo of ADV and LMV is superior to monotherapy of LMV, and the renal safety is favorable within one year.
评估阿德福韦酯（ADV）与拉米夫定（LMV）起始联合治疗1年对乙型肝炎病毒（HBV）相关失代偿期肝硬化的疗效及潜在的肾损害。
共纳入36例HBV相关失代偿期肝硬化患者，均无核苷（酸）类似物（NAs）治疗史，随机分为两组（对照组和观察组）。对照组（n = 18）患者采用拉米夫定单药治疗（每日100 mg），观察组（n = 18）患者采用阿德福韦酯（每日10 mg）与拉米夫定（每日100 mg）起始联合治疗。所有患者均给予包括保肝、对症干预及支持治疗等基本治疗措施。疗程均为1年。观察治疗前后的肝功能、Child-Pugh评分、血清肌酐（sCr）水平、病毒学应答（VR）率及病毒学突破率，并对两组间差异进行统计学分析。
（1）两组患者基线时的性别、年龄、HBeAg状态、HBV病毒载量、sCr水平及Child-Pugh评分的均值均具有可比性（均P > 0.05）。（2）治疗终点时，均无死亡病例报告。与各组自身治疗前相比，肝功能、Child-Pugh评分及病毒载量均有统计学改善（均P < 0.01），尤其是观察组（各变量均P < 0.01，与对照组相比），VR率也显著优于对照组（88.89% 对66.67%，P < 0.05）。（3）观察组无病毒学突破发生，对照组有3例（16.67%）发生病毒学突破，后续直接测序检测均证实为rtM204V变异株。（4）两组治疗结束时sCr水平均未升高。
本研究表明，在HBV相关失代偿期肝硬化患者中，阿德福韦酯与拉米夫定起始联合治疗1年优于拉米夫定单药治疗，且1年内肾脏安全性良好。
