索磷布韦维帕他韦片治疗慢性丙肝的临床研究

Clinical study on sofosbuvir and velpatasvir in the treatment of chronic hepatitis C

摘要:

目的：探讨索磷布韦维帕他韦对丙肝患者的病毒学应答情况、抗肝纤维化疗效及其安全性。方法：选取未合并肝硬化的慢性丙肝患者80例进行回顾性分析，其中对照组40例使用利巴韦林联合聚乙二醇干扰素治疗，观察组一40例单独服用索磷布韦维帕他韦片治疗。另外纳入服用索磷布韦维帕他韦片的合并代偿期肝硬化的慢性丙肝患者18例为观察组二进行对比观察。对比治疗前后HCV-RNA、生化学指标、肝脏瞬时弹力成像及不良反应等情况。结果：观察组治疗末病毒学应答率、持续病毒学应答率分别为95%、95%，高于对照组的80%（P=0.043）、72.5%（P=0.006）。对比治疗前的观察组一及对照组谷草转氨酶（aspartate aminotransferase，AST）、谷丙转氨酶（alanine aminotransferase，ALT），治疗后2组AST、ALT均明显下降，且观察组下降幅度明显大于对照组（P＜0.05）。停药12周后，合并肝硬化代偿期的观察组二Ⅲ型前胶原（type Ⅲ procollagen，PCⅢ）（125.616±14.683 vs. 25.783±14.006，t=22.091，P=0.000）、透明质酸（hyaluronic acid，HA）（329.927±66.372 vs. 163.883±55.623，t=8.066，P=0.000）、肝硬度值（19.627±3.594 vs. 15.300±3.645，t=3.456，P=0.003）较前明显下降。观察组一不良反应发生率为25%，对照组不良反应发生率为52.5%（?字2=6.373，P=0.012）。结论：索磷布韦维帕他韦片相较于聚乙二醇干扰素联合利巴韦林，其疗效更佳、不良反应发生率更低、安全性更高，同时有改善肝脏纤维化的作用。

Abstract:

Objective：To explore the virological response，anti-fibrosis efficacy and safety of sofosbuvir and velpatasvir in hepatitis C patients. Methods：Eighty patients with chronic hepatitis C and without cirrhosis were selected as subjects for retrospective analysis. Forty patients in the control group received subcutaneous injection of pegylated interferon α-2b injection and oral ribavirin；forty patients in the observation group one received oral sofosbuvir and velpatasvir；both groups were treated for 12 weeks. Meanwhile，18 patients with compensatory cirrhosis and chronic hepatitis C were selected as the observation group two，which received treatment of sofosbuvir and velpatasvir. HCV-RNA，biochemical indicators，liver transient elastography and adverse reactions before and after medicine treatment were compared. Results：The end of serum virological response rate（95%） and sustained virological response rate（95%） in the observation group were higher than those of 80%（P=0.043） and 72.5%（P=0.006） in the control group. AST and ALT were decreased dramatically after medicine treatment in both groups，especially in the observation group one（P<0.05）. After 12 weeks of treatment，the PCⅢ（125.616±14.683 vs. 25.783±14.006，t=22.091，P=0.000），HA（329.927±66.372 vs. 163.883±55.623，t=8.066，P=0.000） and liver hardness values（19.627±3.594 vs. 15.300±3.645，t=3.456，P=0.003） of patients complicated with compensated cirrhosis in the observation group two were significantly lower. The incidence of adverse reactions in the control group（52.5%） was nearly twice than that in the observation group one（25%）（P<0.05）. Conclusion：Compared with combination of pegylated interferon α-2b combined and ribavirin，combination of sofosbuvir and velpatasvir has better curative effect，lower adverse effect and higher safety and can also delay the progression to liver fibrosis.