Benetti G P, Ramella G, Corbellini A, Lazza M, Rossi U, Macchi R, Vitaliani G, Merlini R
Unità di Epatologia, Ospedale Predabissi, Melegnano, Italy.
Ital J Gastroenterol. 1996 Apr;28(3):127-35.
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.
对36例丙型肝炎病毒RNA阳性的慢性肝炎患者进行了研究，以评估中高剂量（6 - 9 MU，每周3次）的重组α-2b干扰素在较长时间（12 - 18个月）内，在降低丙氨酸转氨酶值或使其恢复正常以及降低复发率方面是否比既往试验更有效。在治疗的第12个月和第18个月末，丙氨酸转氨酶的平均水平显著降低；按意向性分析，第12个月末完全缓解率为36.1%，第18个月末为19.4%。这些结果并不优于文献中的类似研究结果。在首次随访（第12个月）结束时，完全缓解率降至15.5%，复发率为14.3%。在第二次随访（第24个月）结束时，完全缓解率进一步降至11.1%（所有4例持续缓解24个月的患者均显示无病毒血症），复发率为42.9%；即便这些百分比也被认为不尽人意。总之，延长干扰素治疗时间和/或使用更高剂量并未获得显著优势。然而，所有长期缓解者中可能出现的病毒清除似乎在成本效益分析方面值得进一步研究。
