PDF(Pubmed)
Abstract：
OBJECTIVE: Diabetic polyneuropathy is one of the most frequent diabetic complications, and impairs patients\' quality of life. We evaluated the efficacy and safety of ranirestat (40 mg/day) in patients with diabetic polyneuropathy.
METHODS: This was a multicenter, placebo-controlled, randomized double-blind, parallel-group, phase III study in which 557 patients were randomly assigned to either the ranirestat or placebo group and assessed for 52 weeks. The co-primary end-points were the changes in tibial motor nerve conduction velocity and total modified Toronto Clinical Neuropathy Score as a measure of clinical symptoms.
RESULTS: There was a significant increase in tibial motor nerve conduction velocity in the ranirestat group compared with the placebo group. The difference between groups in the change at last observation was 0.52 m/s (P = 0.021). Increases in nerve conduction velocity in the ranirestat group were found not only in the tibial motor nerves, but also in the median motor nerves, proximal median sensory nerves and distal median sensory nerves. No significant differences in modified Toronto Clinical Neuropathy Score or safety parameters were found between the two groups.
CONCLUSIONS: Ranirestat (40 mg/day) was well tolerated and improved nerve conduction velocity. Regarding symptoms and signs, no detectable benefits over the placebo were observed in the ranirestat group during the 52 weeks of treatment.
METHODS: This was a multicenter, placebo-controlled, randomized double-blind, parallel-group, phase III study in which 557 patients were randomly assigned to either the ranirestat or placebo group and assessed for 52 weeks. The co-primary end-points were the changes in tibial motor nerve conduction velocity and total modified Toronto Clinical Neuropathy Score as a measure of clinical symptoms.
RESULTS: There was a significant increase in tibial motor nerve conduction velocity in the ranirestat group compared with the placebo group. The difference between groups in the change at last observation was 0.52 m/s (P = 0.021). Increases in nerve conduction velocity in the ranirestat group were found not only in the tibial motor nerves, but also in the median motor nerves, proximal median sensory nerves and distal median sensory nerves. No significant differences in modified Toronto Clinical Neuropathy Score or safety parameters were found between the two groups.
CONCLUSIONS: Ranirestat (40 mg/day) was well tolerated and improved nerve conduction velocity. Regarding symptoms and signs, no detectable benefits over the placebo were observed in the ranirestat group during the 52 weeks of treatment.
摘要：
目的：糖尿病多发性神经病是糖尿病最常见的并发症之一，并损害患者的生活质量。我们评估了雷尼司他（40mg/天）在糖尿病性多发性神经病患者中的疗效和安全性。
方法：这是一个多中心，安慰剂对照,随机双盲，平行组，III期研究,其中557例患者被随机分配到拉尼司他或安慰剂组,并进行52周评估.共同的主要终点是胫骨运动神经传导速度的变化和总的改良多伦多临床神经病变评分作为临床症状的量度。
结果：与安慰剂组相比，拉尼司他组的胫骨运动神经传导速度显着提高。末次观察组间变化差异为0.52m/s(P=0.021)。拉尼司他组的神经传导速度增加不仅在胫骨运动神经中发现，而且在正中运动神经中，近端正中感觉神经和远端正中感觉神经。两组之间在改良的多伦多临床神经病变评分或安全性参数方面没有发现显着差异。
结论：雷尼司他（40mg/天）耐受性良好，神经传导速度改善。关于症状和体征，在治疗52周期间,没有观察到雷尼司他组相对于安慰剂的显著获益.
方法：这是一个多中心，安慰剂对照,随机双盲，平行组，III期研究,其中557例患者被随机分配到拉尼司他或安慰剂组,并进行52周评估.共同的主要终点是胫骨运动神经传导速度的变化和总的改良多伦多临床神经病变评分作为临床症状的量度。
结果：与安慰剂组相比，拉尼司他组的胫骨运动神经传导速度显着提高。末次观察组间变化差异为0.52m/s(P=0.021)。拉尼司他组的神经传导速度增加不仅在胫骨运动神经中发现，而且在正中运动神经中，近端正中感觉神经和远端正中感觉神经。两组之间在改良的多伦多临床神经病变评分或安全性参数方面没有发现显着差异。
结论：雷尼司他（40mg/天）耐受性良好，神经传导速度改善。关于症状和体征，在治疗52周期间,没有观察到雷尼司他组相对于安慰剂的显著获益.
