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目的:比较替比夫定与拉米夫定长期治疗慢性乙型肝炎患者的疗效及安全性。方法:2004年3月至2005年2月符合入选标准的39例慢性乙型肝炎患者纳入研究。39例患者随机分为2组进入双盲治疗:替比夫定组(22例),男18例,女4例,平均年龄(30.9±7.8)岁,口服替比夫定600mg,1次/d,治疗104周;拉米夫定组(17例),男13例,女4例,平均年龄(30.4±8.5)岁,口服拉米夫定100mg,1次/d,治疗104周。104周后2组患者均进入替比夫定开放治疗,口服替比夫定600mg,1次/d,继续治疗104周。每8周检测患者血清HBV DNA水平、完全应答率和ALT水平,观察2组患者治疗104周后HBeAg血清转换情况、治疗期间病毒学反弹率及替比夫定的不良反应。结果:双盲治疗阶段,替比夫定组和拉米夫定组患者治疗52周和104周时HBV DNA的完全应答率分别为72.2%(16/22)、77.3%(17/22)和47.1%(8/17)、47.1%(8/17);ALT的复常率分别为100%(22/22)、86.4%(19/22)和82.3%(14/17)、76.5%(13/17)。替比夫定组治疗60周、104周和第3年HBV DNA反弹率分别为4.5%(1/22)、18.2%(4/22)和28.6%(6/21),第4年未增加反弹的病例;拉米夫定组治疗52周、104周HBV DNA的反弹率分别为23.5%(4/17)和41.2%(7/17)。2组共有4例耐药者加用阿德福韦酯联合治疗8~24周后HBV DNA下降至可检测值下限。双盲治疗阶段替比夫定组有5例患者发生9例次肌酸激酶(CK)升高(1065~4915U/L),但无肌肉症状;开放治疗阶段有6例患者发生9例次CK升高(1036~45984U/L),均出现肌肉症状。结论:替比夫定对慢性乙型肝炎患者的疗效优于拉米夫定;患者对替比夫定的耐受性较好。
Objective: To compare the efficacy and safety of telbivudine and lamivudine in the treatment of chronic hepatitis B patients. METHODS: Thirty-nine patients with chronic hepatitis B that met the inclusion criteria between March 2004 and February 2005 were included in the study. 39 patients were randomly divided into two groups and entered into double-blind treatment: telbivudine group (22 cases), 18 males and 4 females, average age (30.9 ± 7.8) years, telbivudine 600mg, 1 / d for 104 weeks; lamivudine group (17 cases), 13 males and 4 females, mean age (30.4 ± 8.5) years, oral lamivudine 100 mg once a day for 104 weeks. After 104 weeks, the two groups of patients entered telbivudine open treatment, telbivudine 600mg, 1 time / d, continue treatment for 104 weeks. Serum HBV DNA levels, complete response rates, and ALT levels were measured every 8 weeks. HBeAg seroconversion was observed in 104 patients at 2 weeks after treatment, and virologic rebound rates and telbivudine adverse reactions were observed during treatment. RESULTS: At the double-blind treatment phase, the complete response rate of HBV DNA was 72.2% (16/22) and 77.3% (17/22) in the telbivudine and lamivudine groups at 52 and 104 weeks, respectively 47.1% (8/17), respectively. The recovery rates of ALT were 100% (22/22), 86.4% (19/22) and 82.3% (14/17), 76.5% 13/17). The rebound rates of HBV DNA in telbivudine-treated group were 4.5% (1/22), 18.2% (4/22) and 28.6% (6/21) at 60 weeks, 104 weeks and 3 years respectively, In the lamivudine group, after 52 weeks of treatment, the rebound rates of HBV DNA at week 104 were 23.5% (4/17) and 41.2% (7/17), respectively. A total of 4 drug-resistant patients in 2 groups with adefovir dipivoxil combined treatment 8 to 24 weeks after the HBV DNA decreased to a detectable value of the lower limit. During the double-blind treatment period, 5 patients in the telbivudine group had 9 episodes of creatine kinase (CK) elevation (1065-4915 U / L), but no muscular symptoms. Of the 6 patients in the open treatment group, 9 were CK Increased (1036 ~ 45984U / L), all showed muscle symptoms. CONCLUSION: Telbivudine is superior to lamivudine in patients with chronic hepatitis B; patients are more tolerant to telbivudine.