Howard F M, Duane D D, Lambert E H, Daube J R
Ann N Y Acad Sci. 1976;274:596-607. doi: 10.1111/j.1749-6632.1976.tb47718.x.
Thirteen patients with moderately severe myasthenia gravis participated in a double-blind study using either 100 mg of prednisone or an equivalen numbder of placebo tablets on alternate days. Anticholinesterase therapy was continued on a demand basis. At the end of 6 months the code was broken. Seven patients were on placebo and three of these had improved to such a degree that steroid therapy was not indicated. Four of these patients ultimately were started on prednisone and improved. Of the six patients on prednisone, three showed no improvement and three were improved. At the end of 2 years, the seven patients still taking prednisone were on maintenance dosage of this drug. Three of this group had experienced relapses when the dosage was cut to 15 to 25 mg on alternate days, and they again improved when the prednisone dosage was increased. No statistical evaluation is possible because of the small number of patients. It can be stated that seven patients improved with steroid therapy. Conversely, not all patients treated with alternate-day prednisone improved. Finally, any evaluation of treatment of myasthenia gravis must take into consideration the potential for spontaneous improvement, as demonstrated by three of the patients treated with placebo.
13名中度重症肌无力患者参与了一项双盲研究,他们隔日服用100毫克泼尼松或同等数量的安慰剂片。抗胆碱酯酶疗法根据需要持续使用。6个月末,盲底被揭开。7名患者服用安慰剂,其中3名患者改善程度显著,无需进行类固醇治疗。这4名患者最终开始服用泼尼松并有所改善。在服用泼尼松的6名患者中,3名无改善,3名有所改善。2年末,仍在服用泼尼松的7名患者接受该药物的维持剂量治疗。该组中有3名患者在隔日剂量减至15至25毫克时出现复发,当泼尼松剂量增加时他们再次改善。由于患者数量较少,无法进行统计学评估。可以说,7名患者接受类固醇治疗后有所改善。相反,并非所有接受隔日泼尼松治疗的患者都有改善。最后,对重症肌无力治疗的任何评估都必须考虑到自发改善的可能性,服用安慰剂治疗的3名患者就证明了这一点。