阿德福韦酯和拉米夫定治疗乙型肝炎肝硬化失代偿期的临床观察

目的观察阿德福韦酯和拉米夫定治疗肝炎肝硬化失代偿期患者48周的疗效和不良反应。方法采用随机分组法,将62例肝炎肝硬化失代偿期患者,随机分为阿德福韦酯组32例,给予阿德福韦酯10mg/d,拉米夫定组30例,给予拉米夫定100mg/d,疗程均为48周。均给予常规护肝及支持、对症治疗。观察两组患者的肝功能、HBeAg、HBV DNA、肝纤维化标志物Ⅲ型前胶原、Ⅳ型胶原、层黏连蛋白、透明质酸、肾功能及Child-Pugh分级、药物不良反应。结果两组患者肝功能各项指标的复常率、血清HBV DNA下降水平及转阴率、HBeAg转阴率及HBeAg/抗-HBe转换率均随着治疗疗程的延长而增加,但两组比较,差异无统计学意义。治疗至48周时拉米夫定组有2例发生YMDD变异,变异率6.7%,阿德福韦酯组无病毒变异发生。两组患者血清肝纤维化标志物治疗至24周时与治疗前相比明显下降,且随着疗程的延长进一步降低,两组比较差异无统计学意义。两组患者治疗前后Child-Pugh分级比较,差异无统计学意义。两组患者均未发现药物相关的肾功能损害,两组中各有2例患者出现轻度不良反应,但均能耐受。结论肝炎肝硬化失代偿期患者48周的抗病毒治疗,阿德福韦酯的疗效与安全性均与拉米夫定相似,而病毒耐药突变率较拉米夫定低。

A clinical study of adefovir dipivoxil treatment for chronic hepatitis patients with cirrhosis in their decompensation period

OBJECTIVE: To evaluate the efficacy and safety of 48 weeks adefovir dipivoxil (ADV) treatment for chronic hepatitis patients with cirrhosis in their decompensation period. METHODS: Sixty-two chronic hepatitis patients with cirrhosis in their decompensation period were randomly put into two groups. An adefovir dipivoxil (ADV) group: 32 patients treated with 10 mg of ADV a day; and a lamivudine (LMV) group: 30 patients treated with 100 mg of LMV a day. The course of treatment lasted 48 weeks. Serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), Alb, TBil, HBeAg, HBV DNA, PCIII, IVC, LN, and HA, renal function, Child-Pugh scores and drug adverse reactions during the treatment of the two groups were checked, compared and analyzed. RESULTS: The ratios of recovery for liver functions and the negativity rate of HBV DNA, HBeAg, including sero-conversion rate of HBeAg/HBeAb, were increased with prolongation of the treatment period; however, the differences between the two groups were not statistically significant (P > 0.05). Two patients treated with lamivudine suffered from YMDD variation at the 48th week; the ratio of variation was 6.7%. No YMDD variation happened in the ADV group. On the 24th week of the treatment, the levels of the serum markers of hepatic fibrosis declined obviously, compared with those prior to the treatment (P < 0.01). There were no significant statistical differences of those levels between the two groups (P > 0.05). No significant differences of Child-Pugh scores were noticed between the two groups (P > 0.05). No drug related renal function impairment was found during the treatment. Two patients of each group had adverse drug reactions but all were mild. CONCLUSION: The efficacy and safety of adefovir dipivoxil and lamivudine treatment for the above patients were similar, but the ratio of emerging virus-resistant strains was lower in the adefovir dipivoxil treatment group.