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Objective To observe the efficacy and safety of Tangmoning Granule(TMG)in treating diabetic peripheral neuropathy with Qi-deficiency and collateral stagnation syndrome.Methods A randomized,positive drug parallel controled,multi-center clinical trial was adopted.The tested group was treated with TMG orally and the control group received Mikebao tablet orally.Treatment course of each group was 8 weeks.Results The marked effective rate and total effective rate on electromyogram was 60.06 %and 68.47 %respectively in the tested group,and those on TCM Syndrome were 23.12 %and 90.99 %respectively.Non-inferiority test with the criterion of 15 %was conducted on the efficacy of electromyogram and TCM Syndrome,and the result showed statistical significant.Conclusion TMG has good efficacy and safety in treating diabetic peripheral neuropathy with Qi-deficiency and collateral stagnation syndrom.
RESUMO
AIM: To investigate the effects of Tangmoning (TMN) Granule on nerve conduction velocity, red blood cell sorbitol (RBC S) level in diabetic rats and probe the mechanism of prevention and treatment of diabetic peripheral neuropathy. METHODS: The model of diabetic rat was induced by strepotozotocin. The animals were randomly divided into six groups:TMN minimal dose group, TMN mild moderate dose group, TMN maximal dose group, methycobal group, model group and normal control group. All TMN groups were treated with TMN Granule through tube feeding (2.95 g/kg、5.90g/kg、11.80g/kg). Methycobal group was treated with methycobal tablets through tube feeding (0.14mg/kg). The duration of treatment was 3 weeks. The caudal nerve conduction velocity, RBC S content were investigated before and after treatment. RESULTS: It showed that TMN Granule could increase the caudal nerve conduction velocity significantly in the maximal dose group and the mild moderate dose gorup ( P