Van Thiel D H, Friedlander L, Fagiuoli S, Molloy P, Kania R J, Wright H
Oklahoma Transplantation Institute, Baptist Medical Center of Oklahoma, Oklahoma City 73112, USA.
J Okla State Med Assoc. 1995 Apr;88(4):154-61.
Interferon alpha (IFN) is the only Food and Drug Administration (FDA)-approved therapy available for the treatment of chronic hepatitis C. The ideal dose and frequency of IFN administration that produces the greatest number of patient responders with the least number of relapses following drug withdrawal remains unclear. METHODS. One hundred seventeen patients recruited over a five-year period with chronic hepatitis C were divided into four groups and treated with progressively larger doses. The rate of clinical responses defined as a loss of detectable hepatitis C virus-ribonucleic acid (HCV-RNA) in serum by polymerase chain reaction (PCR) and normalization of the serum ALT (abnormal alanine aminotransferase) for each group was calculated. RESULTS. As the dose of IFN administration increased, the response rate defined by the absence of HCV-RNA in the patient's serum after six months of follow-up increased from 7.7% to 26.6%. If the end point utilized was HCV-RNA negativity after six months of treatment, the response rate varied from 19.2% to 30%. Using the less difficult end point of a normal ALT level, the response rates varied from 32.1% to 63.3% after six months of therapy and from 10.7% to 26.7% after six months of follow-up. CONCLUSIONS. This experience demonstrates that both the response rate at the end of therapy and after six months of follow-up improves with an increase in dose of IFN administered over a six-month period.
干扰素α（IFN）是美国食品药品监督管理局（FDA）批准的唯一可用于治疗慢性丙型肝炎的疗法。能使最多患者产生应答且停药后复发最少的理想干扰素给药剂量和频率仍不明确。方法：在五年期间招募了117例慢性丙型肝炎患者，将其分为四组，给予逐渐增大的剂量进行治疗。计算每组的临床应答率，临床应答定义为通过聚合酶链反应（PCR）检测血清中丙型肝炎病毒核糖核酸（HCV-RNA）消失且血清丙氨酸氨基转移酶（ALT，异常时称谷丙转氨酶）恢复正常。结果：随着干扰素给药剂量增加，随访6个月后患者血清中无HCV-RNA定义的应答率从7.7%增至26.6%。若采用治疗6个月后HCV-RNA阴性作为终点，应答率在19.2%至30%之间。采用ALT水平正常这个难度较小的终点，治疗6个月后的应答率在32.1%至63.3%之间，随访6个月后的应答率在10.7%至26.7%之间。结论：该研究经验表明，在6个月期间增加干扰素给药剂量可提高治疗结束时及随访6个月后的应答率。
