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本文报道了在欧美用Tolrestat(Tr)对1300例糖尿病并发神经病病人进行了14次双盲和开放试验.作者结合对Tr组和安慰剂组病人的可比次数的随访,根据早期生物利用度、药物代谢动力学和临床药理试验资料,证明糖尿病病人使用Tr是安全的.
This article reports 14 double-blind, open-label trials of 1,300 diabetic patients with neuropathy using Tolrestat (Tr) in Europe and the United States. The authors, in combination with a comparable number of patients in the Tr and placebo groups, followed up with early bioavailability, Metabolism and clinical pharmacology test data to prove that the use of Tr in diabetic patients is safe.