Crepaldi G, Fedele D, Tiengo A, Battistin L, Negrin P, Pozza G, Canal N, Comi G C, Lenti G, Pagano G
Acta Diabetol Lat. 1983 Jul-Sep;20(3):265-76. doi: 10.1007/BF02581271.
Ganglioside treatment was evaluated with a multicenter, randomized, double-blind, controlled, cross-over vs placebo trial in 140 insulin-treated diabetic subjects with peripheral neuropathy. The patients entered the study when they showed an impairment in at least two of the electroneurographic parameters, and were assigned to two protocols according to the presence and severity of their neurological symptoms. Ninety-seven diabetic subjects with no or mild symptoms were assigned to protocol I, whereas 43 symptomatic patients were assigned to protocol II. the treatment periods lasted 6 weeks with an intermediate washout period of 4 weeks. The treatment consisted in the daily i.m. administration of 20 mg gangliosides or of placebo. Electroneurographic parameters were recorded at the beginning and at the end of each treatment period, whereas clinical and metabolic data (mean daily plasma glucose, glycosuria and glycosylated hemoglobin) were evaluated every three weeks in protocol I and every two weeks in protocol II. No change in the metabolic parameters was observed throughout the trial period. However, the treatment induced a statistically significant improvement of paresthesias (protocol II) and of some electrophysiological parameters; in particular, ganglioside treatment improved MCV of peroneal nerve (p less than 0.03) in patients of protocol I, MCV o ulnar nerve (p less than 0.002) and SCV of median nerve (p less than 0.06) in patients of protocol II. Furthermore, 22 subjects of protocol II showed a 'drug preference' while 10 preferred placebo and 9 had no preference. In conclusion, ganglioside treatment seems to have a positive effect on diabetic peripheral neuropathy, improving both some symptoms and some electrophysiological parameters.
在一项多中心、随机、双盲、对照、交叉对比安慰剂的试验中，对140名接受胰岛素治疗的糖尿病性周围神经病患者进行了神经节苷脂治疗评估。当患者至少两项神经电生理参数出现损害时进入研究，并根据其神经症状的有无及严重程度分为两个方案组。97名无症状或症状轻微的糖尿病患者被分配到方案I，而43名有症状的患者被分配到方案II。治疗期持续6周，中间有4周的洗脱期。治疗方法为每日肌肉注射20mg神经节苷脂或安慰剂。在每个治疗期开始和结束时记录神经电生理参数，而临床和代谢数据（平均每日血浆葡萄糖、糖尿和糖化血红蛋白）在方案I中每三周评估一次，在方案II中每两周评估一次。在整个试验期未观察到代谢参数有变化。然而，治疗使感觉异常（方案II）和一些电生理参数有统计学意义的改善；特别是，神经节苷脂治疗使方案I患者腓总神经的运动神经传导速度（MCV）提高（p<0.03），使方案II患者尺神经的MCV（p<0.002）和正中神经的感觉神经传导速度（SCV）（p<0.06）提高。此外，方案II中有22名受试者表现出“药物偏好”，10名偏好安慰剂，9名无偏好。总之，神经节苷脂治疗似乎对糖尿病性周围神经病有积极作用，可改善一些症状和一些电生理参数。
