Goodkin D E
UCSF/MT Zion Multiple Sclerosis Center, USA.
Mult Scler. 1996 Jul;1(6):321-4. doi: 10.1177/135245859600100605.
Doctors Noseworthy and Summerfield have reviewed the results of placebo-controlled, double-masked, clinical trials of interferon beta-1b (IFNB-1b, Betaseron) and interferons beta-1a (IFNB-1a, Avonex,) in patients with relapsing multiple sclerosis (MS). IFNB-1b, administered subcutaneously every other day to ambulatory patients with relapsing-remitting MS, significantly reduces annual exacerbation rate and percentage change from baseline MRI T2-weighted total lesion area. There is also evidence that IFNB-1b reduces the number of new gadolinium-enhancing lesions in patients with relapsing-remitting MS. IFNB-1a (Avonex), administered intramuscularly every week to patients with relapsing MS, significantly reduces annual exacerbation rate, the number and volume of new focal gadolinium-enhanced T1-weighted lesions, and slows the accumulation of physical disability over time. However, questions remain regarding the efficacy of these treatments, the significance of neutralizing antibody formation, indications for therapy, adverse events, optimal dose, and route of administration. Design limitations of the Phase III trial of IFNB-1b have been reviewed elsewhere, and a critical review of the results of the Phase III trial of IFNB-1a should be undertaken after the publication of the clinical and imaging results of that study.
诺斯沃西医生和萨默菲尔德医生回顾了干扰素β-1b（IFNB-1b，倍泰龙）和干扰素β-1a（IFNB-1a，阿沃尼）在复发型多发性硬化症（MS）患者中进行的安慰剂对照、双盲临床试验结果。对于复发-缓解型MS的非卧床患者，每隔一天皮下注射IFNB-1b，可显著降低年复发率以及与基线MRI T2加权总病灶面积相比的百分比变化。也有证据表明，IFNB-1b可减少复发-缓解型MS患者新出现的钆增强病灶数量。对于复发型MS患者，每周肌肉注射IFNB-1a（阿沃尼），可显著降低年复发率、新出现的局灶性钆增强T1加权病灶的数量和体积，并随着时间推移减缓身体残疾的累积。然而，这些治疗方法的疗效、中和抗体形成的意义、治疗指征、不良事件、最佳剂量和给药途径等问题仍然存在。IFNB-1b的III期试验的设计局限性已在其他地方进行了回顾，在IFNB-1a的III期试验的临床和影像学结果发表后，应对该试验结果进行批判性回顾。
