阿德福韦酯联合拉米夫定治疗拉米夫定耐药的 HBeAg 阳性慢性乙型肝炎患者临床疗效观察

目的：探讨阿德福韦酯（ADV）联合拉米夫定（LAM）治疗 LAM 耐药的 HBeAg 阳性慢性乙型肝炎（CHB）患者的临床疗效及安全性。方法将100例确诊为 LAM 耐药的 HBeAg 阳性 CHB 患者随机分为单药治疗组（ADV）和联合治疗组（ADV 联合 LAM），每组50例，观察治疗12个月；在治疗的3、6、9和12 m 末，观察比较两组患者 ALT 复常率、血清 HBV DNA 载量、HBeAg 血清学转换和不良反应情况。结果在治疗3、6、9和12 m 末，两组患者 HBV DNA 载量均较治疗前显著降低（P＜0.05），而联合治疗患者在6、9和12 m 末 HBV DNA 载量较 ADV单药治疗患者下降更加明显分别为（3.94±1.16）、（3.37±1.19）和（3.14±1.18） lg copies/ml 对（4.51±1.37）、（4.07±1.14）和（3.85±1.16）lg copies/ml，P＜0.05]；在治疗6、9和12 m 末，联合治疗患者 HBV DNA 转阴率分别为56.0%、64.0%和76.0%，显著高于 ADV 单药治疗患者（分别为32.0%、44.0%和56.0%，P＜0.05）；在治疗6、9和12 m 末，联合治疗患者 ALT 复常率分别为72.0%、80.0%和92.0%，显著高于单药治疗患者（52.0%、60.0%和76.0%，P＜0.05）；两组患者血清 HBeAg 阴转率及 HBeAg 血清学转换率无差异，治疗期间均未出现严重的不良反应。结论 ADV 联合LAM 治疗 LAM 耐药的 HBeAg 阳性 CHB 患者临床疗效和安全性好。

Adefovir dipivoxil alone or in combination with lamivudine in the treatment of patients with lamivu-dine-resistant hepatitis Be antigen-positive chronic hepatitis B

Objective To investigate the efficacy and safety of adefovir dipivoxil（ADV）alone or in combi-nation with lamivudine（LAM） in the treatment of patients with LAM-resistant hepatitis Be antigen（HBeAg）-pos-itive chronic hepatitis B（CHB）. Methods One hundred patients with LAM-resistant HBeAg-positive CHB were randomly divided into ADV treatment group （n=50） and combinational therapy group （LAM plus ADV,n=50）;The treatment was carried on for 12m;At the end of 3,6,9 and 12m,the normalization rate of ALT,serum HBV DNA viral load, seroconversion rate of HBeAg,and adverse events were observed. Results At the end of 3,6,9 and 12m of treatment,serum HBV DNA load in patients receiving ADV alone or in combinational therapy decreased significantly as compared to their baselines levels （P〈0.05）;Furthermore,at the end of 6,9 and 12m, serum HBV DNA load in combinational therapy patients were lower than those in patients receiving ADV alone （3.94±1.16）,（3.37±1.19） and（3.14±1.18） lg copies/ml vs.（4.51±1.37）,（4.07±1.14） and（3.85±1.16）lg copies/ml, respectively,P〈0.05];At the end of 6,9 and 12m of treatment,the negative conversion rates of serum HBV DNA in combinational group were 56.0%,64.0% and 76.0%,respectively,significantly higher than those in patients re-ceiving ADV alone （32.0%,44.0%,and 56.0%,respectively,P〈0.05）,while the normalization rates of ALT in com-binational group were 72.0%,80.0%,and 92.0%,respectively,significantly higher than those in patients with ADV treatment alone （52.0%,60.0%,and 76.0%,respectively,P〈0.05）;There was no significant difference in negative conversion rates of HBeAg or seroconversion rate of HBeAg to anti-HBe between the two groups;Serious adverse events did not occur in both groups. Conclusions ADV in combination with LAM in treatment of patients with LAM-resistant HBeAg-positive CHB is effective and safe and is promising in dealing with nucleos（t）ide-resistant patients with CHB.