替比夫定和恩替卡韦治疗慢性乙型肝炎144周的疗效比较

Comparation of the efficacy of telbivudine and entecavir for treating 144 weeks of patients with chronic hepatitis B

目的：替比夫定（LdT）和恩替卡韦（ETV）是我国常用的强效抗病毒药物，探讨其在慢性乙型肝炎（CHB）中实际临床应用的疗效特点及安全性。方法前瞻性随访观察LdT组50例、ETV组52例的慢性乙型肝炎初治患者144周，比较两组患者治疗12、24、36、48、72、96和144周时HBV DNA定量水平及低于检测下限的比率、HBV DNA低于检测下限的中位时间及观察终点时ALT复常率、HBeAg血清学转换率、完全病毒学应答率（CVR）、病毒学突破率（VBT）指标及不良事件的发生率。结果第12、24、36周HBV DNA定量水平LdT组患者均高于ETV组，HBV DNA低于检测下限的比率ETV组高于LdT组，差异均具有统计学意义（均P＜0.05）；而第48、72、96、144周则两组差异均无统计学意义。HBV DNA低于检测下限的中位时间；LdT组为24.0（12.0～92.0）周，大于ETV组的12.0（4.0～52.0）周，差异具有统计学意义（P＜0.001）。LdT组中有9例（18.0%）CK曾大于3倍正常值上限（3＆#215; ULN）以上，而ETV组则仅有2例（3.9%）CK大于3＆#215; ULN，差异具有统计学意义（P=0.003）。观察终点比较ALT复常率、HBeAg血清学转换率、CVR和VBT，两组差异均无统计学意义（均P＞0.05）。结论 ETV初始单药治疗CHB患者比LdT能更快、更强抑制HBV复制且CK升高率较低，但ETV与LdT抑制HBV的远期疗效（大于36周）及ALT复常率、HBeAg血清学转换率、CVR和VBT比较差异无统计学意义。

Objective To compare the clinical efifcacy and safety of telbivudine （LdT） and entecavir （ETV） for nucleos（t）ide analogues （NAs） naive patients with chronic HBV infection. Methods LdT group （50 cases） and ETV group （52 cases） were investigated for 144 weeks, prospectively. Quantitative HBV DNA （qHBV DNA）, the rate of undetectable HBV DNA （uHBV DNA%） and the median time of HBV DNA negative conversion （mHBV DNA） were determined at 12, 24, 36, 48, 72, 96 and 144 weeks. Serum ALT normalization rate, HBeAg seroconversion rate, viral breakthrough （VBT）, the rates of complete viral response （CVR） and the incidences of adverse events of the two groups were determined at the end of follow-up, respectively. Results qHBV DNA and uHBV DNA%were signiifcantly difference at 12, 24 and 36 weeks （all P＆lt;0.05）, but without signiifcantly difference at 48, 72, 96 and 144 weeks （all P＆gt;0.05）. The mHBV DNA in LdT treatment group was 24.0 （12.0-92.0） weeks, signiifcantly longer than that of 12.0 （4.0-52.0） weeks of the ETV treatment group （P＆lt;0.001）. Creatine kinase （CK） in 9 （18.0%） cases of LdT reatment＆amp;nbsp;group was more than 3 times upper limit normal （3 ＆#215; ULN）, while only 2 （3.9%） cases in ETV reatment group more than 3 ＆#215; ULN （P=0.003）. There were no significant difference in serum ALT normalization rate, HBeAg seroconversion rate, VBT and CVR between the two groups （all P＆gt;0.05）. Conclusions ETV monotherapy was faster and more potent in HBV DNA suppression in the early stage （no more than 36 weeks） and showed lower incidences of CK elevated in NAs naive patents when compared to telbivudine, while there is no signiifcant difference in the ALT normalization, HBeAg conversion rate, CVR and VBT.