脱氧核苷酸联合聚乙二醇化干扰素α-2a治疗病毒性肝炎合并肝功能异常的有效性与安全性的临床研究

摘要

目的：观察脱氧核苷酸联合聚乙二醇化干扰素α-2a(PEG-IFNα-2a)治疗慢性乙型病毒性肝炎(CHB)合并肝功能异常的临床疗效与安全性。方法84例CHB合并肝功能异常患者，随机分为治疗组42例，给予PEG-IFNα-2a联合脱氧核苷酸注射液治疗，对照组42例仅给予PEG-IFNα-2a治疗，两组连续治疗24周后评估疗效。结果治疗组乙肝病毒脱氧核糖核酸(HBV-DNA)阴转率(66.7% VS 42.9%)，乙肝e抗原(HBeAg)阴转率(45.2% VS 19.0%)，乙肝s抗原(HBsAg)阴转率(35.7% VS 16.7%)， HBeAg/抗-HBe血清学转换率(35.7% VS 14.3%)， HBsAg/抗-HBs血清学转换率(19.0% VS 2.4%)均高于对照组(P<0.05)。治疗组谷丙转氨酶(ALT)、谷草转氨酶(AST)、总胆红素(TBiL)、碱性磷酸酶(ALP)、血清总蛋白(TP)、血清白蛋白(ALB)水平与对照组比较，差异均具有统计学意义(P<0.05)。治疗组白细胞减少发生率为7.1%(3/42)，血小板减少发生率4.8%(2/42)。对照组发生率则分别为28.6%(12/42)、23.8%(10/42)。两组比较，差异具有统计学意义(P<0.05)。结论脱氧核苷酸联合聚乙二醇化干扰素α-2a可提高CHB治疗的转阴率，减少干扰素的骨髓抑制、肝损伤等不良反应。%Objective To observe the clinical effect and safety of deoxynucleotide combined with pegylated interferon α-2a(PEG-IFNα-2a)in the treatment of chronic viral hepatitis B (CHB) complicated with abnormal liver function.Methods A total of 84 patients of CHB complicated with liver injury were randomly divided into treatment group with 42 cases, receiving PEG-IFN α-2a combined with deoxynucleotide injection for treatment, and control group with 42 cases receiving PEG-IFN α-2a alone. After 24 weeks of treatment, curative effects of the two groups were evaluated. Results The treatment group had higher hepatitis B virus-deoxyribonucleic acid (HBV-DNA) negative rate (66.7% VS 42.9%), hepatitis Be antigen (HBeAg) negative rate (45.2% VS 19.1%), hepatitis B surface antigen (HBsAg) negative rate (35.7% VS 16.7%), HBeAg/anti-HBeserologic negative rate (35.7% VS 14.3%), andHBsAg/anti-HBs serologic negative rate (19.0% VS 2.4%) than the control group (P<0.05). The treatment group had statistically significant differnces of alanine aminotransferase (ALT), aspartate transaminase (AST), total bilirubin (TBiL), alkaline phosphatase (ALP), total serum protein (TP), and serum albumin (ALB), compared with the control group (P<0.05). The incidence of leucopenia was 7.1% (3/42), and incidence of thrombocytopenia was 4.8% (2/42) in the treatment group. Those in the control group were respectively 28.6% (12/42) and 23.8% (10/42). The difference between the two groups had statistical significance (P<0.05).Conclusion Combination of deoxynucleotide and pegylated interferon α-2a can improve the negative rate in treatment for CHB, and reduce myelosuppression of interferon and adverse reactions as liver injury.