Sima Anders A F, Calvani Menotti, Mehra Munish, Amato Antonino
Department of Pathology, Wayne State University School of Medicine, Detroit, Michigan 48201, USA.
Diabetes Care. 2005 Jan;28(1):89-94. doi: 10.2337/diacare.28.1.89.
We evaluated frozen databases from two 52-week randomized placebo-controlled clinical diabetic neuropathy trials testing two doses of acetyl-L-carnitine (ALC): 500 and 1,000 mg/day t.i.d.
Intention-to-treat patients amounted to 1,257 or 93% of enrolled patients. Efficacy end points were sural nerve morphometry, nerve conduction velocities, vibration perception thresholds, clinical symptom scores, and a visual analogue scale for most bothersome symptom, most notably pain. The two studies were evaluated separately and combined.
Data showed significant improvements in sural nerve fiber numbers and regenerating nerve fiber clusters. Nerve conduction velocities and amplitudes did not improve, whereas vibration perception improved in both studies. Pain as the most bothersome symptom showed significant improvement in one study and in the combined cohort taking 1,000 mg ALC.
These studies demonstrate that ALC treatment is efficacious in alleviating symptoms, particularly pain, and improves nerve fiber regeneration and vibration perception in patients with established diabetic neuropathy.
我们评估了两项为期52周的随机安慰剂对照临床糖尿病神经病变试验的冷冻数据库，这两项试验测试了两种剂量的乙酰左旋肉碱（ALC）：每日三次，每次500毫克和1000毫克。
意向性治疗患者共计1257例，占入组患者的93%。疗效终点包括腓肠神经形态测量、神经传导速度、振动觉阈值、临床症状评分以及最困扰症状（最显著的是疼痛）的视觉模拟量表。两项研究分别进行评估并合并分析。
数据显示腓肠神经纤维数量和再生神经纤维簇有显著改善。神经传导速度和波幅没有改善，而两项研究中的振动觉均有改善。在一项研究以及服用1000毫克ALC的合并队列中，作为最困扰症状的疼痛有显著改善。
这些研究表明，ALC治疗在缓解症状，尤其是疼痛方面有效，并且能改善已确诊糖尿病神经病变患者的神经纤维再生和振动觉。
