论文部分内容阅读
目的评价聚乙二醇化干扰素(PEG-IFN)α-2a治疗慢性乙型肝炎(CHB)的疗效和安全性。方法72例CHB患者随机分配到治疗组和对照组。治疗组(30例)予PEG-IFNα2a 180μg皮下注射,每周1次,疗程48周。对照组(42例)予普通干扰素500MU,皮下注射,隔日1次,疗程48周,治疗结束后随访48周。结果治疗12周时,治疗组乙型肝炎e抗原(HBeAg)的阴转率达到30%,明显高于对照组,x~2=4．162,P＜0．05,HBeAg定量及乙型肝炎病毒(HBV DNA)定量对数值明显低于治疗前水平,t值分别为2．689、4．080,P＜0．01,而对照组治疗12周时与治疗前相比,差异无统计学意义,t值分别为1．229、1．009,P＞0．05；治疗24周时,治疗组乙型肝炎e抗原(HBeAg)阴转率明显高于对照组,x~2=6．190,P＜0．05,HBeAg定量和HBV DNA定量的对数值均明显低于对照组,t值分别为2．215、2．122,P＜0．05；治疗48周时,治疗组除上述观察指标优于对照组外,HBeAg/抗-HBe血清转换率、丙氨酸氨基转移酶的复常率及完全应答率也明显高于对照组,x~2值分别为5．771、5．617、5．308,P＜0．05；治疗结束后随访48周时,治疗组HBeAg的阴转率、HBeAg定量、HBV DNA定量对数值、HBeAg/抗-HBe血清转换率、丙氨酸氨基转移酶的复常率及完全应答率均明显优于对照组,分别为x~2=11．943、t=3．439、t=6．111、x~2、9．930、x~2=9．522、x~2=7．920,P值均＜0．01,而且保持持续应答,而对照组的应答率则有所下降；治疗组9例患者于治疗前后做2次肝活组织检查,治疗前肝组织中的乙型肝炎表面抗原及核心抗原阳性率分别为88．89%和66．67%,治疗结束时分别为22．22%和33．33%,乙型肝炎表面抗原较治疗前明显减少,x~2=8．001,P＜0．01；治疗前后肝组织的炎症活动度、纤维化程度及胶原表达无明显差异。治疗组有3例出现HBsAg阴转,阴转率为10%,其中2例出现在治疗后32周,1例出现在治疗结束后24周,对照组无一例阴转。PEG-IFNα-2a的不良反应与对照组相似。结论PEG IFNα-2a治疗慢性乙型肝炎能有效地抑制其病毒复制,且能持续应答,治疗48周内安全且耐受性良好。
Objective To evaluate the efficacy and safety of pegylated interferon (PEG-IFN) α-2a in the treatment of chronic hepatitis B (CHB). Methods 72 CHB patients were randomly assigned to treatment group and control group. The treatment group (30 cases) was given PEG-IFNα2a 180μg subcutaneously once a week for 48 weeks. The control group (n = 42) received 500MU of common interferon, injected subcutaneously once every other day for 48 weeks and followed up for 48 weeks after the end of treatment. Results At 12 weeks of treatment, the negative conversion rate of HBeAg in the treatment group was 30%, which was significantly higher than that in the control group (x ~ 2 = 4.162, P <0.05). The HBeAg and hepatitis B The logarithmic value of HBV DNA was significantly lower than that before treatment (t = 2.689, 4.080, P <0.01), while there was no significant difference between the two groups Significance, t value were 1.229,1.009, P> 0.05; At 24 weeks of treatment, the negative conversion rate of HBeAg in treatment group was significantly higher than that in control group, x ~ 2 = 6. 190, P <0.05, HBeAg quantitative and HBV DNA quantitative logarithm were significantly lower than the control group, t values were 2.215,2.122, P <0.05; 48 weeks after treatment, the treatment group except The above indexes were better than the control group, the HBeAg / anti-HBe seroconversion rate, alanine aminotransferase recovery rate and complete response rate were also significantly higher than the control group, x ~ 2 values were 5.771,5 .617,5.308, P <0.05; After 48 weeks of treatment, the negative rate of HBeAg, HBeAg, HBV DNA, HBeAg / anti-HBe serine conversion, Aminotransferase complex recovery rate and complete response rate were significantly better In the control group, x2 = 11.943, t = 3.439, t = 6.111, x2,9. 930, x2 = 9.522, x2 = 7.920, P values were less than 0.01, and sustained response, while the control group, the response rate decreased; 9 patients in the treatment group before and after treatment to do 2 liver biopsy before treatment in the liver surface of hepatitis B The positive rates of antigen and core antigen were 88.89% and 66.67%, respectively. The end of treatment was 22.22% and 33.33% respectively. The surface antigen of hepatitis B was significantly reduced than that before treatment, x ~ 2 = 8. 001, P <0.01. There was no significant difference in the degree of inflammation, the degree of fibrosis and the expression of collagen in the liver before and after treatment. In the treatment group, 3 cases had HBsAg negative conversion rate of 10%, of which 2 cases appeared after 32 weeks of treatment, and 1 case appeared 24 weeks after the end of treatment, and none of the control group had negative conversion. Adverse reactions to PEG-IFNα-2a were similar to those in the control group. Conclusion PEG IFNα-2a treatment of chronic hepatitis B can effectively inhibit the virus replication, and sustainable response, safe and well-tolerated within 48 weeks of treatment.