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重组α干扰素治疗慢性丙型肝炎。一项多中心随机对照试验。肝炎介入治疗组。

Treatment of chronic hepatitis C with recombinant alpha-interferon. A multicentre randomized, controlled trial. The Hepatitis Interventional Therapy Group.

作者信息

Davis G L, Balart L A, Schiff E R, Lindsay K, Bodenheimer H C, Perrillo R P, Carey W, Jacobson I M, Payne J, Dienstag J L

机构信息

Division of Gastroenterology, Hepatology and Nutrition, University of Florida, Gainesville 32610.

出版信息

J Hepatol. 1990;11 Suppl 1:S31-5. doi: 10.1016/0168-8278(90)90160-s.

DOI:10.1016/0168-8278(90)90160-s
PMID:2127785
Abstract

To assess the efficacy of therapy with the antiviral agent interferon in chronic hepatitis C (non-A, non-B hepatitis), we randomly assigned 166 chronic hepatitis C patients to treatment with either 3 million or 1 million units of recombinant interferon alfa-2b three times weekly for 24 weeks, or to no treatment. The probability of normalization or near normalization of the serum alanine aminotransferase levels after 6 months of interferon therapy was 46% in patients treated with 3 million units of interferon (p less than 0.001) and 28% in those treated with 1 million units (p less than 0.02), but only 8% in untreated patients. Serum alanine aminotransferase levels became completely normal in 22 of the 26 patients (85%) who responded to treatment with 3 million units of interferon and 9 of the 16 patients (56%) who responded to treatment with 1 million units. The patients who received 3 million units of interferon had histological improvement because of the regression of lobular and periportal inflammation. Relapse within 6 months after the completion of treatment occurred in 51% of the patients treated with 3 million units of interferon and 44% of those treated with 1 million units. We conclude that a 24-week course of interferon therapy is effective in controlling disease activity in many patients with hepatitis C, although relapse after the cessation of treatment is common.

摘要

为评估抗病毒药物干扰素治疗慢性丙型肝炎(非甲非乙型肝炎)的疗效,我们将166例慢性丙型肝炎患者随机分为三组,分别接受每周三次、每次300万或100万单位重组干扰素α-2b治疗,疗程24周,或不接受治疗。接受300万单位干扰素治疗的患者在干扰素治疗6个月后血清丙氨酸氨基转移酶水平恢复正常或接近正常的概率为46%(p<0.001),接受100万单位治疗的患者为28%(p<0.02),而未接受治疗的患者仅为8%。在接受300万单位干扰素治疗有反应的26例患者中,22例(85%)血清丙氨酸氨基转移酶水平完全恢复正常;在接受100万单位干扰素治疗有反应的16例患者中,9例(56%)完全恢复正常。接受300万单位干扰素治疗的患者因小叶和汇管区炎症消退而有组织学改善。治疗结束后6个月内,接受300万单位干扰素治疗的患者复发率为51%,接受100万单位治疗的患者为44%。我们得出结论,尽管治疗停止后复发很常见,但24周疗程的干扰素治疗对控制许多丙型肝炎患者的疾病活动有效。

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Treatment of chronic hepatitis C with recombinant alpha-interferon. A multicentre randomized, controlled trial. The Hepatitis Interventional Therapy Group.重组α干扰素治疗慢性丙型肝炎。一项多中心随机对照试验。肝炎介入治疗组。
J Hepatol. 1990;11 Suppl 1:S31-5. doi: 10.1016/0168-8278(90)90160-s.
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引用本文的文献

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Clinical toxicity of the interferons.
Drug Saf. 1994 Feb;10(2):115-50. doi: 10.2165/00002018-199410020-00003.
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Clinical pharmacology and therapeutics.临床药理学与治疗学。
Postgrad Med J. 1991 Dec;67(794):1042-54. doi: 10.1136/pgmj.67.794.1042.