Boulton A J, Levin S, Comstock J
Department of Medicine, Manchester Royal Infirmary, UK.
Diabetologia. 1990 Jul;33(7):431-7. doi: 10.1007/BF00404095.
The effects of the aldose-reductase inhibitor, tolrestat, on chronic symptomatic diabetic sensorimotor neuropathy were studied during a placebo-controlled, randomised, 52-week multicentre trial. Of the four tolrestat doses investigated, only the highest dose group, 200 mg once daily, showed subjective and objective benefit over baseline and placebo, and further analyses are confined to this group (n = 112) and placebo (n = 107). Painful and paraesthetic symptoms were analysed separately: improvement in paraesthetic symptoms were seen at one year (p = 0.04), though painful symptoms improved on both placebo and active therapies. Significant improvement in both tibial and peroneal motor nerve conduction velocities were seen at 52 weeks. Tolrestat 200 mg once daily was significantly better than placebo in producing concordant improvements in both motor nerve conduction velocities and paraesthetic symptom scores at 24 weeks (p = 0.01), 42 weeks (p = 0.01) and 52 weeks (p = 0.02). Long-term benefit [concordant improvement at 24 weeks maintained until 52 weeks] was seen in 28% of treated patients compared to 5% on placebo (p = 0.001). It is concluded that some sustained improvement in symptomatic diabetic neuropathy may be obtained following aldose-reductase inhibition with tolrestat 200 mg once daily.
在一项为期52周的安慰剂对照、随机、多中心试验中，研究了醛糖还原酶抑制剂托瑞司他对慢性症状性糖尿病感觉运动神经病变的影响。在所研究的四种托瑞司他剂量中，只有最高剂量组（每日一次200毫克）在主观和客观方面比基线和安慰剂组有改善，进一步分析仅限于该组（n = 112）和安慰剂组（n = 107）。对疼痛和感觉异常症状分别进行了分析：感觉异常症状在一年时有所改善（p = 0.04），尽管疼痛症状在安慰剂和活性治疗组中均有改善。在52周时，胫神经和腓总运动神经传导速度均有显著改善。每日一次200毫克的托瑞司他在24周（p = 0.01）、42周（p = 0.01）和52周（p = 0.02）时，在运动神经传导速度和感觉异常症状评分方面产生一致改善方面显著优于安慰剂。28%接受治疗的患者出现长期获益（24周时的一致改善持续至52周），而安慰剂组为5%（p = 0.001）。结论是，每日一次服用200毫克托瑞司他抑制醛糖还原酶后，症状性糖尿病神经病变可能会有一些持续改善。
