在慢性丙型肝炎无反应者中进行的随机对照试验，比较α干扰素联合利巴韦林加与不加硫酸金刚烷胺的疗效。

Randomized, controlled trial with IFN-alpha combined with ribavirin with and without amantadine sulphate in non-responders with chronic hepatitis C.

作者信息

Teuber Gerlinde, Pascu M, Berg T, Lafrenz M, Pausch J, Kullmann F, Ramadori G, Arnold R, Weidenbach H, Musch E, Junge U, Wiedmann K H, Herrmann E, Zankel M, Zeuzem S

机构信息

Medizinische Klinik II, Klinikum der Johann Wolfgang Goethe-Universität, Theodor-Stern Kai 7, D-60590 Frankfurt/M, Germany.

出版信息

J Hepatol. 2003 Oct;39(4):606-13. doi: 10.1016/s0168-8278(03)00298-8.

DOI:10.1016/s0168-8278(03)00298-8

PMID:12971972

Abstract

BACKGROUND/AIMS: Efficacy and safety of interferon-alpha (IFN-alpha)/ribavirin retreatment with or without amantadine sulphate were evaluated in non-responders with chronic hepatitis C.

METHODS

Two hundred twenty five consecutive non-responders to previous antiviral treatment(s) with IFN-alpha alone or in combination with ribavirin or amantadine were treated with IFN-alpha 2b 5 MU daily for 4 weeks, 5 MU tiw for 20 weeks, followed by 3 MU tiw for additional 24 weeks combined with ribavirin 1000-1200 mg/d. One hundred fifteen of 225 patients were randomized to receive amantadine sulphate 100 mg bid for 48 weeks. Treatment was discontinued in patients with detectable serum hepatitis C virus (HCV)-RNA at treatment week 24.

RESULTS

An overall sustained virologic response with undectable serum HCV-RNA levels was observed in 49/225 patients (22%). Patients infected with HCV-genotype non-1 (P<0.001), low viremia (P=0.011) and only one previous antiviral treatment (P=0.032) were more likely to respond to antiviral retreatment. There was a trend towards higher sustained virologic response rates in patients receiving triple retreatment compared with those treated with IFN-alpha/ribavirin alone (25 versus 18%, P=0.172).

CONCLUSIONS

The addition of amantadine was well tolerated and led to an improvement of sustained virologic responses compared with retreatment with IFN-alpha/ribavirin alone, in particular in patients with low baseline viremia.

摘要

背景/目的：评估在慢性丙型肝炎无应答者中，使用或不使用硫酸金刚烷胺的情况下，α-干扰素（IFN-α）/利巴韦林再治疗的疗效和安全性。

方法

对225例先前单独使用IFN-α或联合利巴韦林或金刚烷胺进行抗病毒治疗无应答的患者，先给予IFN-α 2b每日5 MU，共4周，然后每周3次，每次5 MU，共20周，随后每周3次，每次3 MU，再持续24周，并联合利巴韦林1000 - 1200 mg/d。225例患者中的115例被随机分配接受硫酸金刚烷胺100 mg，每日2次，共48周。在治疗第24周时血清丙型肝炎病毒（HCV）-RNA仍可检测到的患者停止治疗。

结果

225例患者中有49例（22%）观察到血清HCV-RNA水平不可检测的总体持续病毒学应答。感染非1型HCV基因型（P<0.001）、低病毒血症（P=0.011）且仅接受过一次先前抗病毒治疗（P=0.032）的患者更有可能对抗病毒再治疗产生应答。与单独使用IFN-α/利巴韦林治疗的患者相比，接受三联再治疗的患者持续病毒学应答率有升高趋势（分别为25%和18%，P=0.172）。