Dubois B D, Keenan E, Porter B E, Kapoor R, Rudge P, Thompson A J, Miller D H, Giovannoni G
Institute of Neurology and National Hospital for Neurology and Neurosurgery, London, UK.
J Neurol Neurosurg Psychiatry. 2003 Jul;74(7):946-9. doi: 10.1136/jnnp.74.7.946.
The efficacy of interferon beta (IFN beta) is well established in relapsing-remitting multiple sclerosis (MS). However, the use of this drug in clinical practice is complex, especially because it is only partially effective, its long term efficacy and side effects are unknown, its efficacy may be abrogated by the development of neutralising antibodies, compliance is variable, and its cost effectiveness is controversial.
Analysis of a prospectively followed up series of 101 MS patients treated with IFN beta was undertaken to: (1) monitor the outcome of IFN beta treatment in clinical practice; (2) compare the immunogenicity of the three commercial IFN beta preparations available; (3) assess the proportion of patients fulfilling the current guidelines of the Association of British Neurologists for stopping IFN beta therapy.
During a median treatment period of 26 months (range 2-85), the relapse rate decreased by 41%. Although the reduction in the relapse rate was similar for all three commercial products, none of the Avonex treated patients were relapse free, compared with 19% of the Betaferon treated and 27% of the Rebif treated patients (p=0.02). Neutralising antibodies were not detected in Avonex treated patients (0 of 18), compared with 12 of 32 (38%) Betaferon treated and 10 of 23 (44%) Rebif treated patients (p=0.02). Forty of 101 (40%) patients satisfied the current (2001) Association of British Neurologists criteria for stopping IFN beta treatment at some stage during their treatment.
IFN beta is effective in reducing the relapse rate in patients with relapsing-remitting MS in routine clinical practice. However, after a median treatment duration of 26 months, 40% of initially relapsing-remitting MS patients seem to have ongoing disease activity, presenting as disabling relapses or insidious progression.
干扰素β(IFNβ)在复发缓解型多发性硬化症(MS)中的疗效已得到充分证实。然而,该药物在临床实践中的应用较为复杂,特别是因为它仅部分有效,其长期疗效和副作用尚不清楚,其疗效可能会因中和抗体的产生而失效,依从性各不相同,且其成本效益存在争议。
对101例接受IFNβ治疗的MS患者进行前瞻性随访分析,以:(1)监测IFNβ治疗在临床实践中的结果;(2)比较三种市售IFNβ制剂的免疫原性;(3)评估符合英国神经学家协会当前停止IFNβ治疗指南的患者比例。
在中位治疗期26个月(范围2 - 85个月)内,复发率下降了41%。尽管三种市售产品的复发率降低情况相似,但接受Avonex治疗的患者中无一人无复发,而接受Betaferon治疗的患者中有19%无复发,接受Rebif治疗的患者中有27%无复发(p = 0.02)。接受Avonex治疗的患者中未检测到中和抗体(18例中的0例),而接受Betaferon治疗的32例中有12例(38%),接受Rebif治疗的23例中有10例(44%)检测到中和抗体(p = 0.02)。101例患者中有40例(40%)在治疗的某个阶段符合英国神经学家协会当前(2001年)停止IFNβ治疗的标准。
在常规临床实践中,IFNβ可有效降低复发缓解型MS患者的复发率。然而,在中位治疗持续时间26个月后,40%最初为复发缓解型的MS患者似乎仍有疾病活动,表现为致残性复发或隐匿性进展。