脱氧核苷酸联合聚乙二醇化干扰素α-2a治疗慢性乙型病毒性肝炎合并肝功能异常随机安慰剂对照的临床研究

A randomized,placebo-controlled trial of deoxynucleotide and pegylated interferon α-2a in treatment of chronic hepatitis B(CHB) with abnormal liver function

目的评价脱氧核苷酸联合聚乙二醇化干扰素α-2a治疗慢性乙型肝炎(CHB)合并肝损伤的临床疗效的协同性。方法入选92例CHB合并肝损伤患者,治疗组46例给予PEG-IFNα-2a的同时联合脱氧核苷酸注射液200 mg/次静脉滴注。对照组46例仅给予PEG-IFNα-2a皮下注射,两组连续治疗48周后评估CHB血清标志物及肝功能指标。结果治疗组HBV-DNA阴转率(60.7%vs 39.2%)、HBe Ag阴转率(34.8%vs 15.2%)、HBs Ag阴转率(28.3%vs 10.8%)更高。治疗组ALT、AST、TBi L、ALP水平分别为(51.6±12.4)U/L、(51.8±12.8)U/L、(23.5±7.6)μmol/L、(87.2±24.2)U/L。对照组分别为(72.3±15.3)U/L、(70.8±13.4)U/L、(33.4±6.8)μmol/L、(158.4±28.7)U/L,即治疗组更低。另外治疗组血清总蛋白水平、血清白蛋白、A/G水平分别为(76.2±9.2)g/L、(37.5±8.3)g/L、(1.8±0.3)。对照组分别为(65.2±8.2)g/L、(32.3±7.9)g/L、(1.4±0.3)。两组具有明显的差异(P<0.05)。治疗过程中,治疗组白细胞减少发生率为6.5%,血小板减少发生率4.3%。对照组发生率则分别为26.1%、23.9%,两组比较具有统计学差异(P<0.05)。结论脱氧核苷酸联合PEG-IFNα-2a具有协同性,同时可减少干扰素的血液不良反应。

Objective To evaluate the clinical efficacy of deoxynucleotide combined with pegylated interferon α-2a in the treatment of chronic hepatitis B （CHB﹚ with liver injury. Methods All 92 cases of CHB with liver injury patients were selected in our clinical study. All patients were randomly divided into treatment group（n=46, treated with PEG-IFNα-2a and deoxynucleotide acid injection, 200 mg/d, intravenous drip﹚and control group （n=46, treated with PEG-IFNα-2a﹚.Then assessment of CHB serum markers and liver function after 48 weeks continuous treatment. Results There were significant differences between the two groups in the HBV-DNA negative rate （60.7% v s 39.2%﹚, the HBeAg se roconversion rate （34.8%vs 15.2%﹚, the HBsAg negative rate （28.3% vs 10.8%﹚, the ALT levels（51.6±12.4 vs 72.3± 15.3﹚U/L, the AST levels（51.8±12.8 vs 70.8±13.4﹚U/L, the TBiL levels（23.5±7.6 vs 33.4±6.8﹚μmol/L, the ALP lev-els（87.2±24.2 vs 158.4±28.7﹚U/L, the serum levels of total protein （76.2±9.2 vs 65.2±8.2﹚g/L, albumin （37.5±8.3 vs 32.3±7.9﹚g/L, and the A/G levels （1.8±0.3 vs 1.4±0.3﹚（P〈0.05﹚. What’s more, during the course of treatment, the neutropenia rate（6.5%vs 26.1%﹚,thrombocytopenia incidence rate （4.3% vs 23.9%﹚also had significant difference be-tween the treatment group and control group （P〈0.05﹚. Conclusion There is synergistic clinical efficacy of deoxynu-cleotide combined pegylated interferonα-2a, and less adverse events during treatment.