TY -的T1 -肌内干扰素beta-1a在慢性炎性脱髓鞘多神经根神经病JF -神经学乔-神经病学SP - 651 LP - 657 - 10.1212 / WNL。首页0 b013e3181d1a862六世- 74 - 8 AU -休斯R.A.C.盟k.c. Gorson AU - d横AU - j·格里芬盟- j·波拉德AU - j - m。Vallat AU - s·l·毛雷尔AU - k·里斯特盟- g . Davar AU - k·道森盟a .沙岩A2 - Y1 - 2010/02/23 UR - //www.ez-admanager.com/content/74/8/651.a首页bstract N2 -目的:慢性炎性脱髓鞘多神经根神经病(CIDP)免疫功能与多发性硬化症(MS)。因为我干扰素beta-1a (IM IFNβ-1a)是一种有效和安全的治疗女士,我们进行了一项dose-ranging IFNβ-1a在CIDP患者的疗效研究。方法:成人静脉免疫球蛋白(丙种球蛋白)端依赖CIDP (n = 67)参加这32周的双盲试验,随机IFNβ-1a化生。患者接受30μg一旦每周加安慰剂(n = 12), IM IFNβ-1a 60μg一旦每周加安慰剂(n = 11), IM IFNβ-1a 30μg每周两次(n = 11), IM IFNβ-1a 60μg每周两次(n = 11),每周两次或安慰剂(n = 22)。参与者保持丙种球蛋白在第16周,丙种球蛋白时停止。恶化的患者在丙种球蛋白重启。主要结果是总剂量丙种球蛋白(g / kg)管理从16到32周。结果:总共丙种球蛋白剂量没有区别IFNβ-1a患者在第16周(1.20 g / kg)与安慰剂比较(1.34 g / kg;p = 0.75)。 However, exploratory analyses suggested IFNβ-1a significantly reduced total dose of IVIg compared with placebo for participants who required either high-dose IVIg (>0.95 g/kg per month) or had greater weakness at baseline (Medical Research Council sum score <51). Adverse events included flu-like symptoms, headache, and fatigue in the IFNβ-1a groups. Conclusions: Interferon beta-1a (IFNβ-1a) therapy did not provide significant benefit over IV immunoglobulin (IVIg) therapy alone for patients with chronic inflammatory demyelinating polyradiculoneuropathy. However, IFNβ-1a might be beneficial for patients with more severe disability or those needing high doses of IVIg. Level of evidence: This study was designed to provide Class I evidence for the safety and efficacy of IM IFNβ-1a in the treatment of CIDP but has been subsequently classified as Class II due to a >20% patient dropout rate. Thus, this randomized, controlled clinical trial provides Class II evidence of no effect on primary and secondary endpoints of 4 dosage regimens of IM IFNβ-1a added to IVIg in persons with CIDP. AE=adverse event; ANCOVA=analysis of covariance; CIDP=chronic inflammatory demyelinating polyradiculoneuropathy; CTC=common toxicity criteria; EP=electrophysiology; IM IFNβ-1a=intramuscular interferon beta-1a; IVIg=IV immunoglobulin; ITT=intent-to-treat; MRC=Medical Research Council; MS=multiple sclerosis; ODSS=Overall Disability Sum Score; QOL=quality of life; SAE=serious adverse events; SF-36=Short Form-36. ER -