Gajdos P, Chevret S, Toyka K
Raymond Poincaré Hospital, AP-HP, Intensive Care Unit, 104, boulevard Raymond Poincaré, Garches, Ile de France, France, 92380.
Cochrane Database Syst Rev. 2008 Jan 23(1):CD002277. doi: 10.1002/14651858.CD002277.pub3.
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 (IVIg).
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 GroupTrials Register (April 2007) and MEDLINE (January 1966 to May 2007) 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 review author extracted the data and two others checked these data and the source from which they were derived. For methodological reasons, no formal meta-analysis was performed.
We identified six randomised controlled trials, all of which investigated short-term benefit. A trial of IVIg compared with placebo including 51 patients provided evidence for the effectiveness of IVIg in myasthenia gravis worsening. A study of 87 participants with exacerbation found no statistically significant difference between immunoglobulin and plasma exchange after two weeks. A 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. A study with 15 participants with mild or moderate myasthenia gravis found no statistically significant difference in efficacy of IVIg and placebo after six weeks. A study included 33 participants with moderate exacerbations of myasthenia gravis and showed no statistically significant difference in the efficacy of IVIg and methylprednisolone. The last trial including 173 people with myasthenia gravis exacerbations, showed no superiority of IVIg 1 g/kg on two consecutive days over IVIg 1 g/kg on a single day.
AUTHORS' CONCLUSIONS: In exacerbation of myasthenia gravis, one randomised controlled trial of IVIg versus placebo demonstrated the efficacy of IVIg and another did not show a significant difference between IVIg and plasma exchange. Another showed no significant difference in efficacy between 1 g/kg and 2 g/kg of IVIg. A further, but underpowered, trial showed no significant difference between IVIg and oral methylprednisolone. In chronic myasthenia gravis, there is insufficient evidence from randomised trials to determine whether IVIg is efficacious. More research is needed to determine whether IVIg reduces the need for corticosteroids 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(IVIg)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急性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(2007年4月)和MEDLINE(1966年1月至2007年5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。
一位综述作者提取数据,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。
我们确定了六项随机对照试验,所有试验均研究了短期获益情况。一项将IVIg与安慰剂进行比较的试验纳入了51名患者,为IVIg治疗重症肌无力病情恶化的有效性提供了证据。一项对87名急性加重期患者的研究发现,两周后免疫球蛋白与血浆置换之间无统计学显著差异。一项采用交叉设计试验对12名中度或重度重症肌无力患者进行治疗的研究发现,四周后免疫球蛋白与血浆置换的疗效无统计学显著差异。一项对15名轻度或中度重症肌无力患者的研究发现,六周后IVIg与安慰剂的疗效无统计学显著差异。一项纳入33名重症肌无力中度急性加重期患者的研究表明,IVIg与甲基强的松龙的疗效无统计学显著差异。最后一项试验纳入了173名重症肌无力急性加重期患者,结果显示连续两天给予1g/kg IVIg并不优于单日给予1g/kg IVIg。
在重症肌无力急性加重期,一项IVIg与安慰剂对比的随机对照试验证明了IVIg的疗效,另一项试验未显示IVIg与血浆置换之间存在显著差异。另一项试验表明1g/kg和2g/kg IVIg的疗效无显著差异。还有一项试验样本量不足,未显示IVIg与口服甲基强的松龙之间存在显著差异。在慢性重症肌无力方面,随机试验的证据不足,无法确定IVIg是否有效。如两个病例系列所示,是否IVIg能减少对皮质类固醇的需求,还需要更多研究来确定。