中-高剂量重组α -2b干扰素延长慢性丙型肝炎治疗:一项评估疗效和长期复发的开放研究

G P Benetti, G Ramella, A Corbellini, M Lazza, U Rossi, R Macchi, G Vitaliani, R Merlini
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摘要

本文对36例丙型肝炎病毒rna阳性慢性肝炎患者进行了研究,以评估重组α -2b干扰素在中高剂量(6-9 μ 3次/周)长期(12-18个月)治疗中,是否比历史试验更有效地降低或正常化丙氨酸转氨酶值,并降低复发率。治疗第12、18个月末,丙氨酸转氨酶平均值显著降低;12个月末完全缓解率为36.1%,18个月末(治疗意向)完全缓解率为19.4%。这些结果并不比文献中类似的发现更好。在第一次随访结束时(12个月),完全缓解率降至15.5%,复发率为14.3%。在第二次随访结束时(第24个月),完全缓解的百分比进一步下降到11.1%(所有4例持续24个月的患者均显示没有病毒血症),复发率为42.9%;即使这些百分比也被认为是不令人满意的。总之,延长干扰素治疗和/或使用更高剂量没有显著的优势。然而,从成本效益分析的角度来看,所有长期应答者可能的病毒清除似乎证明了进一步研究的合理性。
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Prolonged treatment of chronic C hepatitis by means of medium-high doses of recombinant alpha-2b interferon: an open study to evaluate response and long-term relapse.

Thirty-six patients with hepatitis C virus-RNA positive chronic hepatitis were studied to evaluate whether recombinant alpha-2b interferon, in medium-high doses, (6-9 MU 3 times/week) over a long period (12-18 months), was more effective in reducing or normalizing alanine aminotransferase values, and in reducing the relapsing percentage than the historical trials. At the end of the 12th and 18th month of treatment, mean alanine aminotransferase values were significantly reduced; the level of complete responses was 36.1%, at the end of the 12th month, and 19.4% at the end of the 18th month (intention to treat). These results were no better than comparable findings in the literature. At the end of the first follow-up (12th month), percent complete responses fell to 15.5%, with a relapse rate of 14.3%. At the end of the second follow-up (24th month), percent complete responses fell further to 11.1% (all 4 patients with a 24 months sustained response showed absence of viraemia), with a relapse rate of 42.9%; even these percentages were judged unsatisfactory. In conclusion, no significant advantage was obtained by prolonging interferon treatment and/or using higher dosages. However, the possible virus clearance in all the long-term responders seems to justify further investigation in terms of cost-benefit analysis.

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