Zinman Lorne, Ng Eduardo, Bril Vera
Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
Neurology. 2007 Mar 13;68(11):837-41. doi: 10.1212/01.wnl.0000256698.69121.45.
We aimed to determine the effectiveness of IV immunoglobulin (IVIG) in the treatment of patients with myasthenia gravis (MG) and worsening weakness in a randomized, placebo-controlled, masked study.
Fifty-one patients with worsening weakness due to MG were randomized to infusion with 2 g/kg of IVIG or an equivalent volume of IV dextrose 5% in water. The Quantitative Myasthenia Gravis (QMG) Score for Disease Severity, a validated clinical composite scale, was calculated by a masked observer at baseline and days 14 and 28.
In IVIG-treated patients, a clinically meaningful improvement in QMG Score for Disease Severity was observed at day 14 and persisted at day 28. The greatest improvement occurred in patients with more severe disease as defined by a QMG Score for Disease Severity greater than 10.5.
This study provides level 1 evidence for the effectiveness of IV immunoglobulin in patients with worsening weakness due to myasthenia gravis.
在一项随机、安慰剂对照、双盲研究中，我们旨在确定静脉注射免疫球蛋白（IVIG）治疗重症肌无力（MG）患者及改善肌无力症状的有效性。
51例因MG导致肌无力症状加重的患者被随机分为两组，一组输注2 g/kg的IVIG，另一组输注等量的5%葡萄糖溶液。由一名双盲观察者在基线、第14天和第28天计算重症肌无力定量（QMG）疾病严重程度评分，这是一种经过验证的临床综合量表。
在接受IVIG治疗的患者中，第14天观察到QMG疾病严重程度评分有临床意义的改善，并持续至第28天。疾病严重程度QMG评分大于10.5定义为病情更严重的患者改善最为明显。
本研究为静脉注射免疫球蛋白治疗重症肌无力导致肌无力症状加重患者的有效性提供了一级证据。
