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重组干扰素α-2a治疗慢性丙型肝炎后的长期随访

[Long-term follow-up of chronic hepatitis C after treatment with recombinant interferon alpha-2a].

作者信息

Hopf U, Küther S, König V, Heuft H, Berg T, Bauditz J, Soltani K, Lobeck H, Huhn D

机构信息

Medizinische Klinik und Poliklinik, Universitätsklinikum Rudolf Virchow, Freie Universität Berlin.

出版信息

Z Gastroenterol. 1994 Aug;32(8):425-30.

PMID:7975783
Abstract

As part of a multicenter randomized study 40 patients with chronic hepatitis C (HCV)-infection, 28 kryptogenic and 12 posttransfusional, were treated with recombinant interferon alfa (IFN alpha-2a) for 1 year in a dosage of 3 x 3 Mio. units per week versus dosis escalation after 8 and 16 weeks in serological non-responders. 36 of the 40 patients were followed over 3 years. The rate of patients with normalization of aminotransferases was 42% after two months of therapy, 28% at the end of treatment, 28% after 1 year and 23% after 3 years of follow-up. The polymerase chain reaction (PCR) for detection of HCV-RNA became negative after two months of treatment in 73%, at the end of therapy in 63%, after 1 year follow-up in 63% and after 3 years in 35%. All patients with persisting remission maintained HCV-RNA negative. Dosis escalation was realized in 8 patients without increase of responder rate. Antibodies against IFN alpha-2a developed in 4 (10%) patients without remarkable influence on the IFN-effect. Histological improvement at the end of treatment was observed in 61% including all patients with serological remission. The data support the prognostic relevance of the course of aminotransferases. If aminotransferases are not normalized during the first two months the treatment can be terminated. Persisting normalization of aminotransferases during 1 year after therapy and negative HCV-PCR result indicate maintaining remission.

摘要

作为一项多中心随机研究的一部分,40例慢性丙型肝炎(HCV)感染患者(28例隐源性和12例输血后感染)接受重组干扰素α(IFNα-2a)治疗1年,剂量为每周3×300万单位,血清学无反应者在8周和16周后增加剂量。40例患者中有36例随访了3年。治疗2个月后转氨酶正常化的患者比例为42%,治疗结束时为28%,1年后为28%,随访3年后为23%。检测HCV-RNA的聚合酶链反应(PCR)在治疗2个月后73%呈阴性,治疗结束时63%呈阴性,1年随访后63%呈阴性,3年后35%呈阴性。所有持续缓解的患者HCV-RNA均为阴性。8例患者增加了剂量,但反应率未提高。4例(10%)患者产生了抗IFNα-2a抗体,但对IFN疗效无显著影响。治疗结束时61%的患者出现组织学改善,包括所有血清学缓解的患者。这些数据支持转氨酶变化过程的预后相关性。如果在前两个月转氨酶未恢复正常,可终止治疗。治疗后1年内转氨酶持续正常且HCV-PCR结果为阴性表明维持缓解。

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