人神经生长因子治疗糖尿病性多发性神经病的疗效和安全性

目的:考察人神经生长因子(hNGF)对糖尿病性多发性神经病(DPN)的疗效和安全性.方法:采用随机双盲对照研究,60例DPN患者分hNGF治疗组30例,给予hNGF 4mL·d-1(1 000U)肌内注射,对照组30例给予安慰剂4mL肌内注射,2组疗程均为12周.主要观察指标为神经体征(密西根糖尿病神经评分,MDNS),辅助观察指标为神经症状(自觉感觉异常)和神经传导速度(NCV).结果:治疗84d后2组中度和重度患者的MDNS评分显效率比较差异均有显著性(P<0.05),治疗后84d和168d,治疗组NCV异常率均显著低于对照组(44.00% vs 72.67%,P<0.01;39.23% vs 62.86%,P<0.01).治疗组疗效确切,未发现严重不良反应.结论:hNGF治疗DPN安全有效,其疗效和NCV的改善与hNGF治疗开始时间、疗程长短、DPN病变的程度密切相关.

Efficacy and safety of human nerve growth factor in the treatment of diabetic polyneuropathy

Objective:To assess the efficacy and safety of human nerve growth factor (hNGF) used in the treatment of diabetic polyneuropathy (DPN). Methods:60 patients with DPN were randomized 1:1 to receive hNGF or placebo treatment. Each group was intramuscularly administrated over 12-week treatment period: (1) 4mL (1 000U) of hNGF daily; (2) 4mL of placebo daily. The primary efficacy endpoints included improvement of Michigan Diabetic Neuropathy Score (MDNS), and the secondary efficacy endpoints were the changes in neuropathy and nerve conduction velocity (NCV). Results: At the d84 of treatment period,the improvement of moderate and severe DPN in hNGF group was significantly greater than the one in placebo group (P<0.05). At the d84 and d!68 of treatment period, the abnormal rate in NCV of hNFG group were significantly lower than the one of placebo group (P < 0.01). The hNGF was well tolerated by patients with DPN. Conclusion: hNGF is effective and safe in the treatment of DPN. The efficacy of hNGF and the improvement of NCV are closely associated with the treatment onset, period and the severity of DPN.