单用干扰素β-1a或与利巴韦林联合使用：一项比较慢性丙型肝炎疗效和安全性的随机试验。
Interferon beta-1a alone or in combination with ribavirin: a randomized trial to compare efficacy and safety in chronic hepatitis C.
作者信息
Pellicano Rinaldo, Craxi Antonio, Almasio Piero-Luigi, Valenza Mario, Venezia Giovanna, Alberti Alfredo, Boccato Silvia, Demelia Luigi, Sorbello Orazio, Picciotto Antonino, Torre Francesco, Ideo Gaetano, Cattaneo Carlo, Berrutti Mara, Rizzetto Mario
机构信息
U.O.A.D.U. Gastro-Epatologia, Ospedale S. Giovanni Battista (Molinette), Corso Bramante 88-10126 Torino, Italy.
出版信息
World J Gastroenterol. 2005 Aug 7;11(29):4484-9. doi: 10.3748/wjg.v11.i29.4484.
AIM
To compare the efficacy and safety of recombinant human IFN beta-1a alone or in combination with ribavirin in treatment-naive subjects with chronic hepatitis C.
METHODS
Open, randomized trial was performed in 6 Italian tertiary centers: 102 of the 108 patients screened were randomized to receive 6 MIU of recombinant human IFN beta-1a subcutaneously daily for 24 wk, alone (Group 1, n = 51) or in combination with ribavirin 1,000 to 1,200 mg/d (Group 2, n = 51).
RESULTS
The end-of-treatment virologic response rate was 29.4% in Group 1 and 41.2% in Group 2 (non-significant). Twenty-four weeks after stopping therapy, sustained virologic response rate was 21.6% in Group 1 and 27.4% in Group 2 (non-significant). All subjects in Group 1 completed treatment, while two subjects in Group 2 stopped therapy due to treatment-related adverse events.
CONCLUSION
Recombinant human IFN beta-1a, alone or in combination with ribavirin, has an excellent safety profile and, may represent an alternative for chronic hepatitis C patients who are unable to tolerate pegylated alpha-interferon.
目的
比较重组人干扰素β-1a单药治疗与联合利巴韦林治疗初治慢性丙型肝炎患者的疗效和安全性。
方法
在意大利6个三级医疗中心进行了一项开放性随机试验：108例筛查患者中的102例被随机分组，分别接受以下治疗：第1组（n = 51），皮下注射重组人干扰素β-1a 6 MIU，每日1次，共24周；第2组（n = 51），皮下注射重组人干扰素β-1a 6 MIU，每日1次，共24周，同时联合利巴韦林1000至1200 mg/d。
结果
治疗结束时，第1组病毒学应答率为29.4%，第2组为41.2%（差异无统计学意义）。停药24周后，第1组持续病毒学应答率为21.6%，第2组为27.4%（差异无统计学意义）。第1组所有受试者均完成治疗，第2组有2名受试者因治疗相关不良事件停止治疗。
结论
重组人干扰素β-1a单药治疗或联合利巴韦林治疗具有良好的安全性，对于无法耐受聚乙二醇化α干扰素的慢性丙型肝炎患者可能是一种替代治疗方案。
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