目的观察和分析慢性丙型肝炎患者经干扰素联合利巴韦林治疗获得应答后的复发情况及其影响因素。方法收集长期随访资料完整的慢性丙型肝炎患者资料纳入回顾性统计分析。治疗方案为聚乙二醇干扰素或普通干扰素联合利巴韦林治疗,疗程依基因型分别为24周(非1b型)或48周(1b型)。主要观察指标为血清HCVRNA载量,影响因素纳入了年龄、性别、HCV基因型、基线HCVRNA载量及干扰素类型。计量资料用t检验,计数资料用χ2检验,影响因素的分析用二分类logistic回归分析。结果146例慢陛丙型肝炎患者抗病毒治疗结束后平均随访(33.5土16.4)个月,最短12个月,最长85个月,累计复发率为14.8%。随访第1~6个月内复发概率最大,为8.W/O,第7~12个月为1.4%、第13~18个月为1.40/0、第19~24个月为1.6%、第25~30个月为1.1%,30个月后未见复发。65.0%(13/20)的复发病例发生于治疗结束后6个月内,但之后2年内仍有35.0%(7/20)病例复发。HCV基因lb型和非1b型患者复发率分别为20.40/0和12.2%,两组比较,差异无统计学意义(P〉0.05)。复发和未复发患者平均基线HCVRNA载量分别为(6.86±1.01)log。拷贝/ml和(6.60±1.21)logl0拷贝/ml,两组比较,差异无统计学意义(P〉0.05)l聚乙二醇干扰素-2b,聚乙二醇干扰素α-2a及普通干扰素a治疗后复发率分别为12.1%、14.O%及15.O‰组间比较,差异无统计学意义(P〉0.05)l复发患者的平均年龄为(46.15±11.89)岁,高于未复发患者的(37.41±10.65)岁,两组比较,差异有统计学意义(t=3.352,P=0.001)。结论接受病毒基因型指导的标准抗病毒方案的患者,只有年龄与复发显著相关,高龄患者容易复发。基因型指导的抗病毒方案基本上消除了病毒因素对治疗应答的影响。
Objective To investigate viral relapse and the associated risk factors during a long-term follow-up study of chronic hepatitis C (CHC) patients who acheived end-of-treatment response (ETR) after interferon and ribavirin therapy.Methods This retrospective study was conducted on 146 CHC patients treated with a combination of ribavirin and pegylated (PEG) interferon-alpha (IFNα) (n=126) or conventional IFNα (n =20) for 24 (hepatitis C virus (HCV) non-genotype 1b) or 48 (HCV genotype 1b) weeks.The main outcome measure was serum HCV RNA load.The risk factors analyzed included age,sex,HCV genotype,baseline HCV RNA load,and IFN type.Results The mean follow-up time for all patients was 33.45± 16.41months (range:12-85 months).The cumulative relapse rate during follow-up was 14.80%.The relapse rate within six months (8.90%) was significantly higher than other periods during two years of follow-up,and no relapse occmred after 30 months.Of all relapsers (n =20),65% occurred within six months,followed by 35%within 7-24 months after antiviral therapy.The relapse rates in patients with HCV genotype 1b and non-1b were not significantly different (20.37% vs.12.12%,x2 =1.517,P=0.315).The mean baseline HCV RNAload was significantly higher in the relapsers than that in the non-relapsers (t=0.915,P=0.362).Relapse rates were similar in patients treated with PEG-IFNα-2b,PEG-IFNα-2a and IFNα (12.12% vs.13.97% vs.15.00%,respectifively; x2 =0.104,p=0.949).The mean age of relapsers was significantly higher than that of non-relapsers (P<0.005).Conclusion The maximum probability of relapse for CHC patients exists within six months from when ETR is achieved by interferon and ribavirin therapy.A lower risk for relapse persists past this period.Thus,ETR CHC patients,especially older patients,should be carefully monitored during the two years after cessation of antiviral therapy.Standard antiviral therapy based on HCV genotype eliminates the influence of viral factors on treatment-response.