Peg-IFNα-2b联合利巴韦林治疗基因1/6型慢性丙型肝炎患者临床研究*

目的 探讨应用聚乙二醇化干扰素α（Peg-IFNα）联合利巴韦林（RBV）治疗基因1/6型慢性丙型肝炎（CHC）患者的临床疗效。方法 随机将246例慢性丙型肝炎（CHC）患者分为观察组123例和对照组123例,分别接受Peg-IFNα-2b 80 μg或Peg-IFNα-2a 180 μg皮下注射,1次/w,两组均同时口服利巴韦林,治疗48 w,随访24 w。采用罗氏公司COBAS Taqman HCV实时定量PCR试剂检测血清HCV RNA,采用Abbott RealTime HCV Genotype II试剂检测HCV基因型。结果 观察组和对照组基线基因1型感染者分别为104例（84.6%）和108例（87.8%）,基因6型感染者分别为19例（15.4%）和15例（12.2%,P>0.05）,血清HCV RNA水平分别为（7.17±0.89） lg copies/ml和（7.19±0.88） lg copies/ml,白细胞计数分别为（6.6±1.3）×10⁹/L和（6.6±1.5）×10⁹/L,血小板计数分别为（154.1±21.1）×10⁹/L和（157.2±19.2）×10⁹/L,血清ALT水平分别为（83.4±26.3） U/L和（80.3±29.4）U/L,均无显著性相差（P>0.05）;观察组快速病毒学应答率（RVR）、早期病毒学应答率（EVR）、治疗结束时病毒学应答率（ETVR）和持续病毒学应答率（SVR）分别为45.5%、82.1%、83.7%和85.4%,与对照组的43.1%、78.9%、79.7%和78.0%比,无显著性差异（P>0.05）,两组停药后复发率分别为14.6%和22.0%,也无显著性相差（P>0.05）;在治疗过程中,观察组与对照组发热（58.5%对61.0%）、肌肉酸痛（48.8%对51.2%）、乏力（41.5%对44.7%）、头痛（30.9%对34.1%）、厌食（25.2%对30.1%）、脱发（26.8%对30.9%）、失眠（20.3%对25.2%）、白细胞下降（27.6%对31.7%）、红细胞下降（23.6%对28.5%）、血小板下降（13.8%对17.9%）和血清T3/T4/TSH异常（8.9%对10.6%）等不良反应发生率比较,均无显著性差异（P>0.05）。结论 应用Peg-IFNα-2b或Peg-IFNα-2a治疗基因1/6型CHC患者,疗效较好,且两种干扰素治疗效果相当,安全性较好,值得临床应用。

Clinical efficacy of peg-IFNα and ribavirin combination in treating patients with chronic hepatitis C and genotype one and six infection

Objective To investigate the clinical efficacy of peg-IFNα and ribavirin combination in treating patients with chronic hepatitis C（CHC） and genotype one and six infection. Methods A total of 246 patients with CHC were enrolled in this study,and the patients were randomly divided into observation group （n=123） and control group （n=123）,receiving peg-IFNα-2b 80 μg,or peg-IFNα-2a 180 μg subcutaneously once a week,respectively,and the patients with CHC in both groups received ribavirin orally for 48 weeks. All patients were followed-up for 24 weeks after discontinuation of the regimen. Serum HCV RNA and HCV genotypes were detected routinely by Abbott RealTime HCV Genotype II kits. Results At baseline, the genotype one of HCV infection in the observation and control groups were 84.6% and 87.8%,and genotype six infection were 15.4% and 12.2% （P>0.05）,serum HCV RNA levels were（7.17±0.89） lg copies/ml and （7.19±0.88） lg copies/ml,white blood cell counts were （6.6±1.3）×10⁹/L and （6.6±1.5）×10⁹/L,platelet counts were （154.1±21.1）×10⁹/L and （157.2±19.2）×10⁹/L,serum ALT levels were（83.4±26.3） U/L and （80.3±29.4） U/L,all without significant differences （P>0.05）;the rapid virologic response（RVR）,early virologic response（EVR）,end-treatment virologic response（ETVR） and sustained virologic response rates（SVR） in the observation group were 45.5%, 82.1%,83.7% and 85.4%,no significant differences as compared to 43.1%,78.9%,79.7% and 78.0%,respectively in the control （P>0.05）,and the relapse rates in the two groups were 14.6% and 22.0%（P>0.05）;during the injection of interferon-α,there were no significant differences as compared to the side effects such as the fever （58.5% vs. 61.0%）,muscle aches（48.8% vs. 51.2%）,fatigue （41.5% vs. 44.7%）,headaches （30.9% vs. 34.1%）,anorexia（25.2% vs. 30.1%）,hair loss （26.8% vs. 30.9%）,insomnia（20.3% vs. 25.2%）,leukopenia（27.6% vs. 31.7%）,declined erythrocyte counts（23.6% vs. 28.5%）,thrombocytopenia （13.8% vs. 17.9%） and serum T3/T4/TSH level abnormal （8.9% vs. 10.6%,all P>0.05）. Conclusions Application of peg-IFNα-2b and peg-IFNα-2a show similar efficacy and safety in the treatment of patients with CHC with genotype 1/6 infection,which is worthy of further clinical observation.