Yoshikawa Hiroaki
Kanazawa University Health Service Center.
Brain Nerve. 2017 Jan;69(1):51-59. doi: 10.11477/mf.1416200636.
In August 2016, the results of the international randomized, controlled, trial that studied the safety and efficacy of extended trans-sternal thymectomy (ETTX) for patients with non-thymomatous myasthenia gravis (MG) was published. The inclusion criteria for this study were: 1) male and female subjects aged>18.0 and <60.0 years with non-thymomatous MG; 2) MG Foundation of America (MGFA) Clinical Classification Class II-IV at entry; 3) anti-acetylcholine receptor antibody (AChRAb) positive; and 4) receiving optimal oral anticholinesterase treatment with or without oral prednisone. Subjects were randomized to one of two protocols: prednisone alone or extended transsternal thymectomy (ETTX) plus prednisone. A total of 126 patients were randomized. The ETTX plus prednisone protocol improved the quantitative MG scores, decreased the total amount of prednisone, and decreased symptoms and side effects, resulting in a better quality of life compared with the prednisolone alone protocol. These results have required us to change our standard therapeutic protocol for MG. In addition, the safety and efficacy of ETTX with thymectomy via robotic methods needs to be considered. The MGTX study did not address the efficacy and safety of ETTX for younger or older patients, for MGFA Clinical Classification Class I or V patients, or for AChRAb-negative patients.
2016年8月,一项针对非胸腺瘤性重症肌无力(MG)患者开展的国际随机对照试验公布了其关于扩大经胸骨胸腺切除术(ETTX)安全性和有效性的研究结果。该研究的纳入标准为:1)年龄大于18.0岁且小于60.0岁的非胸腺瘤性MG男女受试者;2)入组时美国重症肌无力基金会(MGFA)临床分级为II-IV级;3)抗乙酰胆碱受体抗体(AChRAb)呈阳性;4)正在接受最佳口服抗胆碱酯酶治疗,且正在使用或未使用口服泼尼松。受试者被随机分为两种方案之一:单独使用泼尼松或扩大经胸骨胸腺切除术(ETTX)加泼尼松。共有126例患者被随机分组。与单独使用泼尼松龙方案相比,ETTX加泼尼松方案改善了MG定量评分,减少了泼尼松的总量,减轻了症状和副作用,从而带来了更好的生活质量。这些结果促使我们改变了MG的标准治疗方案。此外,还需要考虑通过机器人方法进行胸腺切除术的ETTX的安全性和有效性。MGTX研究未涉及ETTX对年轻或老年患者、MGFA临床分级为I级或V级患者或AChRAb阴性患者的疗效和安全性。