Gajdos P, Chevret S, Toyka K
Raymond Poincaré Hospital, AP-HP, c/o Intensive Care Unit, 104, boulevard Raymond Poincaré, Garches, Ile de France, France, 92380.
Cochrane Database Syst Rev. 2006 Apr 19(2):CD002277. doi: 10.1002/14651858.CD002277.pub2.
Myasthenia gravis is an autoimmune disease in which autoantibodies interfere with neuromuscular transmission. As with other autoimmune diseases, people with myasthenia gravis would be expected to benefit from intravenous immunoglobulin.
The objective of this review was to examine the efficacy of intravenous immunoglobulin for treating exacerbations of myasthenia gravis or for chronic myasthenia gravis.
We searched the Cochrane Neuromuscular Disease Group trials register (March 2005) and MEDLINE (January 1966 to March 2005) using 'myasthenia gravis' and 'intravenous immunoglobulin' as the search terms.
We included all randomised or quasi-randomised trials in which intravenous immunoglobulin was compared with no treatment, placebo or plasma exchange, in people with myasthenia gravis.
One author extracted the data and the two others checked these data and the source from which they were derived. For methodological reasons, no formal meta-analysis was performed.
We identified five randomised controlled trials, all of which investigated short-term benefit. The first study of 87 participants with exacerbation found no statistically significant difference between immunoglobulin and plasma exchange after two weeks. The second study of 12 participants with moderate or severe myasthenia gravis treated in a crossover design trial found no statistically significant difference in the efficacy of immunoglobulin and plasma exchange after four weeks. The third study with 15 participants with mild or moderate myasthenia gravis found no statistically significant difference in efficacy of intravenous immunoglobulin and placebo after six weeks. The fourth study terminated early. It included 33 participants with moderate exacerbations of myasthenia gravis and showed no statistically significant difference in the efficacy of intravenous immunoglobulin and methylprednisolone. The fifth trial including 173 people with myasthenia gravis exacerbations, showed no superiority of intravenous immunoglobulin 1 g/kg on two consecutive days over intravenous immunoglobulin 1 g/kg on a single day.
AUTHORS' CONCLUSIONS: In severe exacerbations of myasthenia gravis, one randomised controlled trial did not show a significant difference between intravenous immunoglobulin and plasma exchange. Another showed no significant difference in efficacy between 1 g/kg and 2 g/kg of intravenous immunoglobulin. A further trial showed no significant difference between intravenous immunoglobulin and oral methylprednisolone. In chronic myasthenia gravis, there is insufficient evidence from randomised trials to determine whether intravenous immunoglobulin is efficacious. More research is needed to determine whether intravenous immunoglobulin reduces the need for steroids as suggested by two case series.
重症肌无力是一种自身免疫性疾病,自身抗体干扰神经肌肉传递。与其他自身免疫性疾病一样,重症肌无力患者有望从静脉注射免疫球蛋白中获益。
本综述的目的是研究静脉注射免疫球蛋白治疗重症肌无力加重期或慢性重症肌无力的疗效。
我们使用“重症肌无力”和“静脉注射免疫球蛋白”作为检索词,检索了Cochrane神经肌肉疾病组试验注册库(2005年3月)和MEDLINE(1966年1月至2005年3月)。
我们纳入了所有将静脉注射免疫球蛋白与未治疗、安慰剂或血浆置换进行比较的随机或半随机试验,试验对象为重症肌无力患者。
由一位作者提取数据,另外两位作者检查这些数据及其来源。出于方法学原因,未进行正式的荟萃分析。
我们确定了五项随机对照试验,所有试验均研究了短期疗效。第一项针对87名病情加重患者的研究发现,两周后免疫球蛋白与血浆置换之间无统计学显著差异。第二项针对12名中度或重度重症肌无力患者的交叉设计试验研究发现,四周后免疫球蛋白与血浆置换的疗效无统计学显著差异。第三项针对15名轻度或中度重症肌无力患者的研究发现,六周后静脉注射免疫球蛋白与安慰剂的疗效无统计学显著差异。第四项研究提前终止。该研究纳入了33名重症肌无力中度加重患者,结果显示静脉注射免疫球蛋白与甲基强的松龙的疗效无统计学显著差异。第五项试验纳入了173名重症肌无力加重患者,结果显示连续两天静脉注射1 g/kg免疫球蛋白并不优于单日静脉注射1 g/kg免疫球蛋白。
在重症肌无力的严重加重期,一项随机对照试验未显示静脉注射免疫球蛋白与血浆置换之间存在显著差异。另一项试验显示1 g/kg和2 g/kg静脉注射免疫球蛋白的疗效无显著差异。另一项试验显示静脉注射免疫球蛋白与口服甲基强的松龙之间无显著差异。在慢性重症肌无力方面,随机试验的证据不足,无法确定静脉注射免疫球蛋白是否有效。如两个病例系列所示,需要更多研究来确定静脉注射免疫球蛋白是否能减少对类固醇的需求。