Gajdos P, Chevret S, Clair B, Tranchant C, Chastang C
Service de Réanimation, Hôpital Raymond Poincaré, Garches, France.
Ann Neurol. 1997 Jun;41(6):789-96. doi: 10.1002/ana.410410615.
We have conducted a trial to randomly assess the efficacy and tolerance of intravenous immunoglobulin (i.v.Ig) or plasma exchange (PE) in myasthenia gravis (MG) exacerbation and to compare two doses of i.v.Ig. Eighty-seven patients with MG exacerbation were randomized to receive either three PE (n = 41), or i.v.Ig (n = 46) 0.4 gm/kg daily further allocated to 3 (n = 23) or 5 days (n = 23). The main end point was the variation of a myasthenic muscular score (MSS) between randomization and day 15. The MSS variation was similar in both groups (median value, +18 in the PE group and +15.5 in the i.v.Ig group, p = 0.65). Similar efficacy, although slightly reduced in the 5-day group was observed with both i.v.Ig schedules. The tolerance of i.v.Ig was better than that of PE with a total of 14 side effects observed in 9 patients, 8 in the PE group and 1 in the i.v.Ig group (p = 0.01). Although our trial failed to show a pronounced difference in the efficacy of both treatments, it exhibited a very limited risk for i.v.Ig. i.v.Ig is an alternative for the treatment of myasthenic crisis. The small sample sizes in our trial, however, could explain why a difference in efficacy was not observed. Further studies are needed to compare PE with i.v.Ig and to determine the optimal dosage of i.v.Ig.
我们开展了一项试验，旨在随机评估静脉注射免疫球蛋白（i.v.Ig）或血浆置换（PE）对重症肌无力（MG）加重期的疗效及耐受性，并比较两种剂量的i.v.Ig。87例MG加重期患者被随机分组，分别接受3次PE治疗（n = 41）或i.v.Ig治疗（n = 46），i.v.Ig剂量为每日0.4 g/kg，进一步分为3天疗程组（n = 23）或5天疗程组（n = 23）。主要终点是随机分组至第15天期间重症肌无力肌肉评分（MSS）的变化。两组的MSS变化相似（中位数，PE组为+18，i.v.Ig组为+15.5，p = 0.65）。两种i.v.Ig疗程方案均观察到相似的疗效，尽管5天疗程组的疗效略有降低。i.v.Ig的耐受性优于PE，共观察到9例患者出现14次副作用，PE组8次，i.v.Ig组1次（p = 0.01）。尽管我们的试验未能显示两种治疗方法在疗效上有显著差异，但i.v.Ig显示出极低的风险。i.v.Ig是治疗重症肌无力危象的一种替代方法。然而，我们试验中的样本量较小，这可能解释了为何未观察到疗效差异。需要进一步研究来比较PE和i.v.Ig，并确定i.v.Ig的最佳剂量。
