聚乙二醇干扰素α-2a与聚乙二醇干扰素α-2b对慢性丙型病毒性肝炎患者早期病毒学应答（EVR）疗效的比较研究。

Comparative study concerning the efficacy of Peg-IFN alpha-2a versus Peg-IFN alpha-2b on the early virological response (EVR) in patients with chronic viral C hepatitis.

作者信息

Sporea Ioan, Danila Mircea, Sirli Roxana, Popescu Alina, Laza Ariana, Baditoiu Luminita

机构信息

Department of Gastroenterology, University of Medicine and Pharmacy, Str. Ion Bulbuca no.156, Timisoara, Romania.

出版信息

J Gastrointestin Liver Dis. 2006 Jun;15(2):125-30.

PMID:16802006

Abstract

BACKGROUND

Pegylated interferons (Peg-IFNs) represent, in association with Ribavirin, the first line of treatment in chronic C viral hepatitis. The AIM of our paper was to compare the efficacy of Peg-IFN alpha 2a (Pegasys) and Peg-IFN alpha 2b (PegIntron) in a group of patients from the Department of Gastroenterology in Timisoara.

MATERIAL AND METHOD

116 patients with chronic C viral hepatitis were treated. The patients were randomized in chronological order (1:1), so that 58 patients were treated with Peg-IFN alpha 2a 180 microg/kg/week + Ribavirin (group 1) and 58 were treated with Peg-IFN alpha 2b 1.5 microg/kg/week + Ribavirin (group 2). Ribavirin was administered in the recommended doses, according to weight. The mean age was: group 1 -- 49.3 years, group 2 -- 50.9 years (p=0.37). Group 1 consisted of 37 women and 21 men and group 2 of 44 women 14 men (p=0.22). In group 1, 48 patients were naïve (N1), 7 were relapsers after previous treatment (RL1) and 3 non-responders to previous treatment (NR1). In group 2, 33 patients were naive (N2), 18 relapsers (RL2) and 7 non-responders (NR2). After 12 weeks of treatment we evaluated the early virological response (EVR), defined as a drop in the viral load with 2 logs compared to the baseline viremia.

RESULTS

The following EVR rates were found: in group 1 (Pegasys) - 82.2% (48/58); in group 2 (PegIntron) -- 67.2% (39/58) (p=0.08). There were also no significant statistical differences between the response rates in the subgroups: naïve patients [89.6% vs. 75.2%, p = 0.61], relapsers [57.1% vs. 66.6%, p = 0.67] and non responders [33.3% vs. 28.6%, p = 1].

CONCLUSION

Our head to head comparative study showed that there are no statistically significant differences in the EVR between the patients treated with Peg-IFN alpha 2a and Peg-IFN alpha 2b.

摘要

背景

聚乙二醇化干扰素（Peg-IFNs）与利巴韦林联合使用，是慢性丙型病毒性肝炎的一线治疗方案。我们这篇论文的目的是比较聚乙二醇化干扰素α-2a（派罗欣）和聚乙二醇化干扰素α-2b（佩乐能）在蒂米什瓦拉胃肠病科一组患者中的疗效。

材料与方法

对116例慢性丙型病毒性肝炎患者进行治疗。患者按时间顺序随机分组（1:1），58例患者接受聚乙二醇化干扰素α-2a 180μg/kg/周 + 利巴韦林治疗（第1组），58例患者接受聚乙二醇化干扰素α-2b 1.5μg/kg/周 + 利巴韦林治疗（第2组）。根据体重按推荐剂量给予利巴韦林。平均年龄为：第1组——49.3岁，第2组——50.9岁（p = 0.37）。第1组由37名女性和21名男性组成，第2组由44名女性和14名男性组成（p = 0.22）。在第1组中，48例患者为初治患者（N1），7例为既往治疗后复发患者（RL1），3例为既往治疗无应答者（NR1）。在第2组中，33例患者为初治患者（N2），18例复发患者（RL2），7例无应答者（NR2）。治疗12周后，我们评估了早期病毒学应答（EVR），定义为病毒载量较基线病毒血症下降2个对数。

结果

发现以下EVR率：第1组（派罗欣）——82.2%（48/58）；第2组（佩乐能）——67.2%（39/58）（p = 0.08）。各亚组的应答率之间也无显著统计学差异：初治患者[89.6%对75.2%，p = 0.61]、复发患者[57.1%对66.6%，p = 0.67]和无应答者[33.3%对28.6%，p = 1]。