摘要
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 80μg或Peg-ⅠFNα-2a 180μg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 Real Time 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)×10~9/L和(6.6±1.5)×10~9/L,血小板计数分别为(154.1±21.1)×10~9/L和(157.2±19.2)×10~9/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。
ObjectiveTo investigate the clinical efficacy of peg-ⅠFNαand ribavirincombination in treating patients with chronic hepatitis C(CHC)and genotype one and six infection.Methods A total of 246patients 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 80μg,or peg-ⅠFNα-2a 180μg 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%and12.2%(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 wereandcounts wereand(157.2±19.2)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 to43.1%,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.
作者
侯春阳
马玉梅
李方治
Hou Chunyang;Ma Yumei;Li Fangzhi(Second Department of Infectious Diseases,Sixth People's Hospital,Shenyang 110006,Liaoning Province,China)
出处
《实用肝脏病杂志》
CAS
2019年第1期53-56,共4页
Journal of Practical Hepatology
基金
辽宁省科技惠民计划专项资金资助项目(编号:2013GS210102)
