Nomura H, Tsuchiya Y, Maruyama T, Miki K, Yokota T, Okubo H
Department of Internal Medicine, Shin-Kokura Hospital, Kita-Kyushu, Japan.
J Gastroenterol Hepatol. 1999 Jan;14(1):85-9. doi: 10.1046/j.1440-1746.1999.01801.x.
To shorten the period of interferon (IFN) treatment for chronic hepatitis C, we investigated the clinical efficacy of a regimen using a higher dose and a shorter treatment period. Fifty chronic hepatitis C patients who were hepatitis C virus (HCV)-RNA positive and who were histologically diagnosed as having chronic hepatitis, took part in the study. Virus levels were measured before and 2 weeks after starting the treatment. We administered natural IFNalpha, 10 MU, i.m. daily for 2 consecutive weeks and then three times per week for the subsequent 14 weeks (total dose 560 MU). Patients who were HCV-RNA negative at the completion of the therapy and 6 months later, were evaluated as sustained responders (SR; 32%). Those who were not HCV-RNA negative at the two time points were evaluated as non-responders. Nucleotide and clone differences in the hypervariable region (HVR) and predictive factors for prognosis were also analysed. Low virus level and HCV-RNA genotype 2a/2b were the predictors for good prognosis, whereas the numbers of nucleotide differences and clone differences in HVR were not. Sustained responder patients became HCV-RNA negative 2 weeks after starting the treatment at a significantly higher rate, whereas no non-responder patients were HCV-RNA negative at that time. The SR rate (32%) was equivalent to those reported in previous 24 week treatment studies. This IFN therapy using a higher dose and a shorter period was useful.
为缩短慢性丙型肝炎的干扰素(IFN)治疗周期,我们研究了一种采用更高剂量和更短治疗周期方案的临床疗效。五十名丙型肝炎病毒(HCV)-RNA阳性且经组织学诊断为慢性肝炎的慢性丙型肝炎患者参与了该研究。在开始治疗前及治疗2周后测量病毒水平。我们给予天然α干扰素,10 MU,肌肉注射,连续2周每日一次,随后14周每周三次(总剂量560 MU)。在治疗结束时及6个月后HCV-RNA阴性的患者被评估为持续应答者(SR;32%)。在这两个时间点HCV-RNA未转阴的患者被评估为无应答者。还分析了高变区(HVR)的核苷酸和克隆差异以及预后的预测因素。低病毒水平和HCV-RNA基因2a/2b型是预后良好的预测因素,而HVR中的核苷酸差异数量和克隆差异则不是。持续应答者患者在开始治疗2周后HCV-RNA转阴的比例显著更高,而此时无应答者患者中无一人HCV-RNA阴性。SR率(32%)与先前24周治疗研究中报道的相当。这种采用更高剂量和更短周期的IFN治疗是有效的。