Gamez Josep, Salvadó María, Carmona Francesc, de Nadal Miriam, Romero Laura, Ruiz Daniel, Jáuregui Alberto, Martínez Olga, Pérez Javier, Suñé Pilar, Deu María
Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute (VHRI), European Reference Network on Rare Neuromuscular Diseases (ERN EURO-NMD), Department of Medicine, Universitat Autònoma de Barcelona. Passeig de la Vall d'Hebron 119-129, Barcelona E-08035, Spain.
Department of Neurology, Vall d'Hebron University Hospital, Barcelona, Spain.
Ther Adv Neurol Disord. 2019 Jul 17;12:1756286419864497. doi: 10.1177/1756286419864497. eCollection 2019.
Myasthenic crisis (MC) is a potentially life-threatening complication of myasthenia gravis. Its precipitating factors include surgical procedures, particularly thymectomy. The role of preoperative intravenous immunoglobulin (IVIg) in preventing MC in patients scheduled for thymectomy and other surgery with general anaesthesia is unknown. Our objective was to test the hypothesis that preoperative IVIg is effective in preventing myasthenic crisis in patients with myasthenia gravis scheduled for surgery under general anaesthesia, including thymectomy.
A prospective, randomized, double-blind, single-centre study was conducted over a 4-year period. The treatment group received IVIg, 0.4 g/kg/day preoperatively for 5 consecutive days, and the placebo group received saline solution under the same conditions. The two groups were age-matched, with similar functional status, and Myasthenia Gravis Foundation of America class. All patients had well-controlled myasthenia gravis with minimal manifestations before surgery. The primary outcome measured was MC. Intubation times, time in the recovery room, number of postoperative complications, and days of hospitalization were the secondary outcomes measured.
A total of 47 patients were randomized, 25 to the IVIg group and 22 to placebo. There were 19 men and 28 women, with a mean age of 58.6 years, mean body mass index of 27.8 kg/m, and mean acetylcholine receptor antibodies of 12.9 nmol/l. The mean forced vital capacity was 84.4%. The mean quantitative myasthenia gravis sum score was 6.3. Ten patients (five in each arm) had a history of MC. Thymectomy was performed in 16 patients. Only one patient in the placebo group presented with MC requiring non-invasive ventilation (but no reintubation) for 6 days. Neither differences between groups in the univariate analysis nor risk factors for MC in the multivariate analysis were found.
Preoperative IVIg to prevent MC does not appear to be justified in well-controlled myasthenia gravis patients. This study provides class I evidence that preparation with IVIg to prevent MC is not necessary in well-controlled myasthenia gravis patients scheduled for surgery with general anaesthesia.
重症肌无力危象(MC)是重症肌无力的一种潜在危及生命的并发症。其诱发因素包括外科手术,尤其是胸腺切除术。术前静脉注射免疫球蛋白(IVIg)在预防计划接受胸腺切除术及其他全身麻醉手术的患者发生MC中的作用尚不清楚。我们的目的是检验以下假设:术前IVIg对预防计划接受全身麻醉手术(包括胸腺切除术)的重症肌无力患者发生重症肌无力危象有效。
在4年期间进行了一项前瞻性、随机、双盲、单中心研究。治疗组术前连续5天每天接受0.4 g/kg的IVIg,安慰剂组在相同条件下接受生理盐水。两组年龄匹配,功能状态相似,美国重症肌无力基金会分级相同。所有患者在手术前重症肌无力病情控制良好,表现轻微。测量的主要结局是MC。插管时间、在恢复室的时间、术后并发症数量和住院天数是测量的次要结局。
共有47例患者被随机分组,25例进入IVIg组,22例进入安慰剂组。有19名男性和28名女性,平均年龄58.6岁,平均体重指数27.8 kg/m,平均乙酰胆碱受体抗体12.9 nmol/l。平均用力肺活量为84.4%。平均重症肌无力定量总分6.3分。10例患者(每组5例)有MC病史。16例患者接受了胸腺切除术。安慰剂组只有1例患者出现MC,需要无创通气6天(但未再次插管)。单因素分析中两组之间未发现差异,多因素分析中也未发现MC的危险因素。
对于病情控制良好的重症肌无力患者,术前使用IVIg预防MC似乎没有必要。本研究提供了I级证据,表明对于计划接受全身麻醉手术的病情控制良好的重症肌无力患者,使用IVIg预防MC没有必要。