国产阿德福韦酯治疗HBeAg阳性慢性乙型肝炎患者的疗效及持久性

Efficacy and durability of generic adefovir dipivoxil in patients with HBeAg positive chronic hepatitis

目的探讨国产阿德福韦酯（ADV）治疗HBeAg阳性慢性乙型肝炎患者的疗效及持久性。方法采用前瞻性双盲对照的方法研究初治的HBeAg阳性慢性乙型肝炎患者，随机接受国产ADV10mg/d或安慰剂治疗12周，此后为开放研究，所有患者接受96周ADV治疗后停止试验，随访观察12周，观察治疗期间以及停药后肝肾功能、乙型肝炎病毒脱氧核糖核酸（HBVDNA）水平、HBeAg变化。结果（1）54例患者随机接受ADV（38例）或安慰剂（16例）治疗，经治疗12周ADV组ALT由（135.84±10.63）U／L降至（58.92±4.95）U／L（组内P〈0.001），优于安慰剂组由（145.56±17.19）U／L降至（159.50±37.05）U／L（组间P〈0.001）；lgHBV-DNA下降幅度ADV组为2.51、安慰剂组为1.04（P〈0.001）；（2）ADV治疗48、96周ALT复常率为63.30％、70.50％，AST复常率为87.80％、88.60％，HBVDNA低于检测值（〈103拷贝／ml）比例分别为53.06％、54.55％，96周HBeAg转阴率11.36％；（3）在96周试验中止后17例患者停止ADV治疗，12周的随访过程中HBVDNA全部转阳，伴随88.24％（15／17）患者肝功异常。结论国产ADV治疗慢性乙型肝炎有效，但96周停药病情极易复发：

Objective To study the efficacy and durability of generic adefovir dipivoxil（ADV） in patients with HBeAg positive chronic hepatitis. Methods 54 nucleosides-naǐve patients with HBeAg positive chronic hepatitis were enrolled in this randomized, double-blinded, placebo-controlled, prospective study. 38 patients received ADV（10mg once daily） and the others received placebo. Then all the patients were treated with ADV for 96 weeks and were followed up for 12 weeks. Results （1） At week 12, the level of ALT declined significantly in ADV group（135.84±10.63 U/L to 58.92±4.95 U/L, P 〈 0.001） compared with placebo group（145.56± 17.19U/L to 159.50±37.05 U/L） （ P 〈 0.001）. The HBV-DNA level also declined significantly in adefovir group compared with placebo group（2.51 vs 1.04 log 10 copies/ml, P 〈 0.001） . （2） The rates of normal ALT, normal of AST and undetectable HBV-DNA at 48 and 96 weeks of therapy with ADV were 63.30%, 70.50%, 87.80%, 88.60% , 53.06%, 54.55 %, respectively. （3） There were 17 patients discontinuated ADV after 96 weeks. The follow-up results showed that HBV-DNA became positive again in all these 17 patients and abnormal liver function developed in 88.24% （15/17）patients. Conclusions Treatment of chronic hepatitis B with generic ADV was effective and well tolerated, but relapse may develop when treatment was discontinued.