国产聚乙二醇化重组集成干扰素变异体联合利巴韦林治疗慢性丙型病毒性肝炎患者甲状腺功能异常及其对疗效的影响

目的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。 方法前瞻性观察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。 结果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）。 结论国产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。

Incidence of thyroid dysfunction during pegylated recombinant interferon variant and ribavirin combined treatment in patients with chronic hepatitis C and the impact on anti-HCV treatment

ObjectiveTo 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. MethodsTotal 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. ResultsAmong 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). ConclusionsThe 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.