Department of Neurology, Spaarne Hospital, Hoofddorp, The Netherlands.
J Peripher Nerv Syst. 2010 Sep;15(3):208-15. doi: 10.1111/j.1529-8027.2010.00274.x.
A randomized trial (ICE trial) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) demonstrated significantly more improvement with intravenous immunoglobulin (Gamunex(®), Talecris Biotherapeutics, Inc., Research Triangle Park, NC) than placebo. To understand the relationship between CIDP impairments, activity and participation restrictions, and quality of life (QoL) in this trial, we investigated the association between scales representing these outcome levels. Gamunex or placebo was given every 3 weeks for up to 24 weeks to 117 patients in an initial treatment period after which treatment failures were crossed over (alternative treatment). We assessed impairments, activity and participation, and SF-36 component mental (MCS) and physical summaries (PCS). Regression analyses of baseline data were performed (all subjects) and change from baseline to endpoint (Gamunex-treated group only) to determine correlations between outcomes. Grip strength, medical research council (MRC) sum score, and inflammatory neuropathy cause and treatment (INCAT) sensory sum score were the strongest explanatory variables of disability (at baseline: r(2) = 0.46; change from baseline: r(2) = 0.66). Only up to half of the variance in QoL scores (PCS at baseline: r(2) = 0.30; change from baseline: r(2) = 0.41; MCS: at baseline: r(2) = 0.10; change from baseline: r(2) = 0.24) was explained by impairment and activity and participation measures. Future studies are required to elucidate the impact of CIDP on disability and QoL changes, because the obtained correlations provide only partial explanation.
一项针对慢性炎症性脱髓鞘性多发性神经病（CIDP）的随机试验（ICE 试验）表明，与安慰剂相比，静脉注射免疫球蛋白（Gamunex（®），Talecris Biotherapeutics，Inc.，Research Triangle Park，NC）的改善更为显著。为了了解该试验中 CIDP 损伤、活动和参与受限以及生活质量（QoL）之间的关系，我们研究了代表这些结果水平的量表之间的关联。在初始治疗期内，117 例患者每 3 周接受 Gamunex 或安慰剂治疗，最多 24 周，然后治疗失败的患者交叉（替代治疗）。我们评估了损伤、活动和参与以及 SF-36 组件心理（MCS）和身体综合（PCS）。对基线数据进行了回归分析（所有患者）和从基线到终点的变化（仅 Gamunex 治疗组），以确定结果之间的相关性。握力、医学研究委员会（MRC）总分和炎症性神经病病因和治疗（INCAT）感觉总分是残疾的最强解释变量（基线：r(2) = 0.46；从基线变化：r(2) = 0.66）。只有一半左右的生活质量评分（基线时的 PCS：r(2) = 0.30；从基线变化：r(2) = 0.41；MCS：基线时：r(2) = 0.10；从基线变化：r(2) = 0.24）可以用损伤和活动及参与措施来解释。需要进一步的研究来阐明 CIDP 对残疾和生活质量变化的影响，因为所获得的相关性仅提供了部分解释。
