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目的:观察人神经生长因子(hNGF)治疗糖尿病性多发性神经病(DPN)的有效性及安全性。方法:采用双盲随机对照研究,48例DPN病人随机分为2组:hNGF组24例,每日给予hNGF 4 mL(1000 u),肌注:对照组 24例,每日给予安慰剂 4 mL,肌注,疗程均为12周。结果:hNGF组治疗12周后,患者MDNS和自觉感觉障碍有效率分别为73.83％和83.33％,明显高于安慰剂组。治疗结束后4及12周,其有效率仍显著高于对照组。治疗期间未发现严重不良反应。结论:hNGF治疗DPN有效且安全。
Objective: To observe the efficacy and safety of human nerve growth factor (hNGF) in the treatment of diabetic polyneuropathy (DPN). Methods: In a double-blind randomized controlled study, 48 patients with DPN were randomly divided into two groups: 24 patients in hNGF group, 4 mL hNGF (1000 u) daily, and 24 patients in control group received intramuscular injection of placebo , Intramuscular injection, treatment are 12 weeks. Results: After 12 weeks of treatment, the effective rates of MDNS and subjective sensory disturbances in patients with hNGF were 73.83% and 83.33%, respectively, significantly higher than those in placebo group. At 4 and 12 weeks after the end of treatment, the effective rate was still significantly higher than the control group. No serious adverse reactions were found during treatment. Conclusion: hNGF is effective and safe in the treatment of DPN.