Camenga D L, Johnson K P, Alter M, Engelhardt C D, Fishman P S, Greenstein J I, Haley A S, Hirsch R L, Kleiner J E, Kofie V Y
Arch Neurol. 1986 Dec;43(12):1239-46. doi: 10.1001/archneur.1986.00520120023011.
This report describes the first use of recombinant-DNA-produced human interferon in patients with multiple sclerosis (MS). Ninety-eight patients who were clinically definite for MS with two or more documented exacerbations during the preceding two years were admitted to this placebo-controlled double-blind randomized trial. Although both groups were similar, placebo patients had later MS onset. Patients injected themselves with 2 X 10(6) IU of alpha-2 interferon or placebo three times each week for up to 52 weeks. This dose of interferon was well tolerated in that side effects were minimal. During the trial, the exacerbation rate was sharply reduced in both groups. In the three-month follow-up period after stopping treatment, more patients who were receiving interferon than placebo became worse neurologically. More patients who were receiving interferon than placebo changed from exacerbating MS to progressive MS during the trial. Thus, no clear therapeutic benefit of alpha-2 interferon for MS was detected.
本报告描述了重组DNA生产的人干扰素在多发性硬化症（MS）患者中的首次应用。98例临床确诊为MS且在过去两年中有两次或更多次明确病情加重记录的患者被纳入了这项安慰剂对照双盲随机试验。尽管两组患者情况相似，但安慰剂组患者的MS发病时间较晚。患者每周自行注射2×10⁶国际单位的α-2干扰素或安慰剂，共注射3次，持续52周。该剂量的干扰素耐受性良好，副作用极小。在试验期间，两组患者的病情加重率均大幅降低。在停止治疗后的三个月随访期内，接受干扰素治疗的患者中神经功能恶化的人数比接受安慰剂治疗的患者更多。在试验期间，从病情加重型MS转变为进行性MS的接受干扰素治疗的患者比接受安慰剂治疗的患者更多。因此，未检测到α-2干扰素对MS有明显的治疗益处。
