观察国产聚乙二醇化重组集成干扰素变异体注射液（PegIFN-SA）联合利巴韦林（RBV）治疗慢性丙型病毒性肝炎（CHC）患者时甲状腺功能异常（TD）或甲状腺自身抗体（TAs）产生情况及对疗效影响。

前瞻性观察2013年9月至2015年12月于本中心接受国产PegIFN-SA联合RBV治疗的CHC病例45例。试验组患者给予PegIFN-SA皮下注射（1.5 μg/kg、1次/周），对照组患者给予聚乙二醇化干扰素α-2a（PegIFN-α-2a）皮下注射（派罗欣180 μg、1次/周），两组患者均联合口服利巴韦林（000~1 200 mg/d），HCV基因2、3型患者治疗24周，非HCV基因2、3型患者治疗48周，停药后均随访6个月。在治疗前、治疗后每3个月及停药后6个月监测两组患者甲状腺功能及HCV RNA水平。

试验组慢性丙型肝炎患者30例，其中男性14例，女性16例，平均年龄为（36.5 ± 12.0）岁（19~56岁），HCV基因2、3型患者6例，HCV非基因2、3型患者24例。治疗结束停药半年后HCV持续应答率为83.3%（25/30），共13例患者出现TD或TAs，其发生率为43.3%（13/30）；9例发生TD患者中4例（44.4%）丙型肝炎复发，高于未出现TD者（1/21，4.8%），差异具有统计学意义（P = 0.02）。

国产PegIFN-SA联合RBV治疗慢性丙型病毒性肝炎患者甲状腺功能异常及抗体阳性较为常见，发生甲状腺功能异常者CHC更易复发。

To investigate the incidence and long-term outcomes of thyroid dysfunction (TD) in patients with chronic hepatitis C (CHC) who received pegylated recombinant interferon variant combined with ribavirin (PegIFN-SA/RBV) treatment.

Total of 45 patients with CHC admitted in Wuhan University Zhongnan Hospital during September 2013 and December 2015 were collected. Patients in test group were treated with PegIFN-SA subcutaneous injection once a week (1.5 μg/kg). Patients in control group were treated with PegIFN α-2a for subcutaneous injection once a week (180 μg). All patients were also treated with oral RBV (1 000-1 200 mg/d) .The patients with HCV genotype 2/3 were treated for 24 weeks, the other patients with no-genotype 2/3 HCV were treated for 48 weeks, all patients were followed up for 24 weeks after treatment. Thyroid function and HCV RNA were measured at baseline, every 3 months during therapy and 6 months after treatment.

Among the 30 patients who completed treatment with PegIFN-SA/RBV and 24 weeks follow-up, 14 cases were males and the median age was (36.5 ± 12.0) years old (19-56 years old), 6 cases were with HCV genotype 2/3, 83.3% (25/30) cases achieved sustained virological response (SVR); 13 (43.3%, 13/30) patients developed TD/TAs during the PegIFN-SA/RBV treatment. The relapse rate of HCV was higher in patients with TD than those without TD (44.4% vs. 4.8%, P = 0.02).

The development of TD/TAs was common in patients with CHC receiving Peg-IFN-SA/RBV treatment. TD is associated with an unfavorable virological response to PegIFN-SA/RBV.