【摘要】 目的观察慢性丙型肝炎基因1b型患者应用艾尔巴韦/格拉瑞韦治疗的临床效果。方法纳入2018年12月至2019年10月在天津市第三中心医院接受12周艾尔巴韦/格拉瑞韦治疗的99例基因1b型慢性丙型肝炎及代偿期肝硬化患者,均完成治疗及12周随访。收集治疗基线、治疗结束及停药后12周临床数据、血清学指标、病毒学指标及肝硬度值,观察慢性丙型肝炎患者病毒学应答的情况,分析治疗结束时及停药后12周病毒学应答率及肝功能、肝硬度变化,评价艾尔巴韦/格拉瑞韦治疗的安全性。多组间比较应用Friedman检验,进一步两两比较应用Wilcoxon符号秩和检验。结果在99例艾尔巴韦/格拉瑞韦治疗12周的患者中治疗结束时及停药后12周HCV RNA低于检测下限比例分别为100%、99%;治疗结束时ALT、AST较基线明显下降(Z值分别为-5.857、-5.941,P值均<0.05),肝硬度在停药12周明显降低,由基线10.5 k Pa降至8.0 kPa(Z=-4.036,P <0.05);其中24例代偿期肝硬化患者在治疗结束时、停药后12周的病毒学应答率均达到100%,ALT、AST较基线均明显减低(P值均<0.05),肝硬度值基线时21.1 kPa,在治疗结束时下降为17.5 kPa(Z=-1.832,P=0.067),停药后12周为13.6 kPa(Z=-3.182,P=0.001);与无肝硬化组比较,肝硬化组肝硬度下降趋势尤为显著(P <0.05)。治疗期间患者耐受性良好,4例在治疗过程中报告轻度不良事件。结论在真实世界中艾尔巴韦/格拉瑞韦治疗病毒学应答率高,肝功能及肝硬度明显改善,耐受性良好。更多还原

【Abstract】 Objective To investigate the clinical effect of elbasvir/grazoprevir in the treatment of patients with genotype 1 b chronic hepatitis C( CHC). Methods A total of 99 patients with genotype 1 b CHC and compensated cirrhosis who received elbasvir/grazoprevir treatment for 12 weeks and completed treatment and follow-up for 12 weeks after drug withdrawal in Tianjin Third Central Hospital from December2018 to October 2019 were enrolled. Related clinical data,serological markers,virological indices,and liver stiffness measurement were collected at baseline,at the end of treatment,and at week 12 after drug withdrawal,and virologic response was observed. The Friedman test and Wilcoxon signed rank sum test were used to observe virologic response rate and the changes in liver function and liver stiffness measurement at the end of treatment and at week 12 after drug withdrawal,and the safety of elbasvir/grazoprevir was evaluated. Results For the 99 patients treated with elbasvir/grazoprevir for 12 weeks,the proportion of patients with HCV RNA below the lower limit of detection was100% at the end of treatment and 99% at week 12 after drug withdrawal. There were significant reductions in alanine aminotransferase( ALT) and aspartate aminotransferase( AST) from baseline to the end of treatment( Z =-5. 857 and-5. 941,both P < 0. 05). Liver stiffness measurement decreased from 10. 5 kPa at baseline to 8. 0 kPa at week 12 after drug withdrawal( Z =-4. 036,P < 0. 05). Among the 99 patients,24 patients with compensatory cirrhosis reached a virologic response rate of 100% at the end of treatment and at week 12 after drug withdrawal,as well as significant reductions in ALT and AST from baseline( both P < 0. 05),and liver stiffness measurement decreased from 21. 1 kPa at baseline to 17. 5 k Pa at the end of treatment( Z =-1. 832,P = 0. 067) and 13. 6 k Pa at week 12 after drug withdrawal( Z =-3. 182,P = 0. 001). Compared with the non-liver cirrhosis group,the liver cirrhosis group had significantly greater reductions in liver stiffness measurement( P < 0. 05). The patients had good tolerance throughout the treatment,and 4 patients reported mild adverse events during the treatment. Conclusion Patients with genotype 1 b CHC have a high virologic response rate to elbasvir/grazoprevir in the real world,with significant improvements in liver function and liver stiffness measurement and good tolerance.更多还原