静脉注射免疫球蛋白治疗重症肌无力危象的随机双盲临床试验  

Treatment of myasthenia gravis exacerbation with intravenous immunoglobulin: A randomized double-blind clinical trial

作　　者：Gajdos P Tranchant C Clair B. 樊慧婷 

机构地区：[1]Medical Intensive Care Unit, Raymond PoincaréTeaching Hospital, Assistance Publique-hpitaux de Paris, 104 Blvd. Raymond Poincaré, 92380 Garches,France

出　　处：《世界核心医学期刊文摘（神经病学分册）》2006年第3期8-9,共2页Digest of the World Core Medical Journals:Clinical Neurology

摘　　要：Background: The optimal dose of intravenous immunoglobulin (IVIG) in acute exacerbation of myasthenia gravis remains unknown. Increasing the treatment duration might provide added efficacy. Objective: To determine the optimal dose of IVIG for treating myasthenia gravis exacerbation. Design: Randomized double-blind placebo-controlled multicenter trial designed to demonstrate superiority of the 2 g/kg dose over the 1 g/kg dose of IVIG, conducted between November 13, 1996, and October 26, 2002. Participants: One hundred seventy-three patients aged 15 to 85 years with acute exacerbation of myasthenia gravis. Intervention: Participants were randomly assigned to receive 1 g/kg of IVIG on day 1 and placebo on day 2 (group 1)vs 1 g/kg of IVIG on 2 consecutive days (group 2). Main Outcome Measure: Improvement in the myasthenic muscular score after 2 weeks. Results: The mean improvements in the myasthenic muscular scores after 2 weeks were 15.49 points (95%confidence interval, 12.09-18.90 points) in group 1 and 19.33 points (95%confidence interval, 15.82-22.85 points) in group 2. However, the difference between the 2 groups was not significant (effect size, 3.84 [95%confidence interval, -1.03 to 8.71]; P=.12). Conclusion: This trial found no significant superiority of 2 g/kg over 1 g/kg of IVIG in the treatment of myasthenia gravis exacerbation.Background: The optimal dose of intravenous immunoglobulin (IVIG) in acute exacerbation of myasthenia gravis remains unknown. Increasing the treatment duration might provide added efficacy. Objective: To determine the optimal dose of IVIG for treating myasthenia gravis exacerbation. Design: Randomized double-blind placebo-controlled multicenter trial designed to demonstrate superiority of the 2 g/kg dose over the 1 g/kg dose of IVIG, conducted between November 13, 1996, and October 26, 2002. Participants: One hundred seventy-three patients aged 15 to 85 years with acute exacerbation of myasthenia gravis. Intervention: Participants were randomly assigned to receive 1 g/kg of IVIG on day 1 and placebo on day 2 (group 1)vs 1 g/kg of IVIG on 2 consecutive days (group 2). Main Outcome Measure: Improvement in the myasthenic muscular score after 2 weeks. Results: The mean improvements in the myasthenic muscular scores after 2 weeks were 15.49 points (95%confidence interval, 12.09-18.90 points) in group 1 and 19.33 points (95%confidence interval, 15.82-22.85 points) in group 2. However, the difference between the 2 groups was not significant (effect size, 3.84 [95%confidence interval, -1.03 to 8.71]; P=.12). Conclusion: This trial found no significant superiority of 2 g/kg over 1 g/kg of IVIG in the treatment of myasthenia gravis exacerbation.

关 键 词：重症肌无力危象 随机双盲 肌无力 安慰剂对照 多中心试验 适宜剂量 日至 

分 类 号：R746.1[医药卫生—神经病学与精神病学]