| Recent years along with the rise of incident rate of Diabetes Mellitus ,the research about complications of DM has been paid more attention. Diabetic peripheral neuropathy (DPN) is one of the common chronic complications of DM. The prevalence rate of DPN has been estimated to be 60%. DPN is the main reason resulting in diabetic foot and amputations. Once DPN happened, the life quality of diabetic patients will be damaged badly. Since the high incident rate, DPN has become the important project in diabetic research. The pathogenesis of DPN is still unknown. Presently, DPN is seen as the result of a complex interplay of several factors, which include the metabolism and circulation problems due to hyperglycemia, the reduction of neuron growth factors, immune damage and gene factors. Till now there is no effective remedy for curing DPN. Through hard work and clinical experience accumulation, according to Chinese traditional medical theory professor GaoYanbin thought that DPN was caused by the deficiency of liver, kidney, Qi and Yin, the blockage of blood in small channel. The herb formula TangLuoNing(TLN) is directed by this theory which showed better result after clinical use.This research consisted two parts: clinical trials and experimental research. We observed the clinic effect of TLN through clinical trial and discussed the effect mechanism of TLN through experimental research.Clinical trial Objective is to assess the clinic effect of TLN for treating DPN. Method: 80 DPN patients conforming to the diagnostic criteria were randomly divided into the herb group (40 patients) and control group(40 patients). Based on the basic treatment for blood pressure,blood glucose and blood lipid, the herb group was given Tangluoning(for nourishing liver and kidney, benefiting qi and nourishing yin and activating blood circulation). The control group was given the Methycobal (mecobalamin). The changes of the symptoms, nerve conductive velocity were observed in the patients. Result: the total effective rate of the TLN group was 92.11% and that of control group was 72.22%. After the Ridit test, the effect of herb group was better than the control group, the difference was significant (P<0.05).The TLN group and the control group had obviously difference in improvement of symptom and the nerve conductive velocity(P<0.05).There were no obvious side effects has been found during the treatment.Conclusion: Tangluoning had significant effect for curing DNP,total effect is better than methycobal.Experimental research Objective To observe the effect mechanism of TLN for curing DPN. Method Among 24 male SD rats,pick up 10 rats randomly as normal control group, the rest were induced by STZ celiac injection (60mg/kg). Ten days after the injection, the rats with fasting blood glucose level above 16.7mmol/L were diabetes model group for observation. After feeding for 8 weeks, the morphology of sciatic nerves was investigated by HE staining under microscope. It showed that the diabetic model rats were suffering from neuropathy. Then, pick up 15 rats randomly as normal control group among 120 male SD rats,the rest for diabetic model group. After induced by STZ, the rats which successfully became diabetic model were divide into diabetic model group, methycobal group, TLN high dose group, TLN middle dose group and TLN low dose group.Methycobal was given by 175ug/kg?d, TLN was given by 5,10,20g/kg?d herb according to low,middle,high dose. After curing for 12 weeks, we measured some items.Experiment 1: Glycosylated hemoglobin: Compared with normal rats group, glycosylated hemoglobin levels in all diabetic groups were significantly higher (P<0.01). Compared with diabetic model group, glycosylated hemoglobin levels in the middle and high dose TLN were lower (P<0.05). But Methycobal group had no this effect; The weight of STZ rat: The weight of all diabetic rats was increased significantly (P<0.01), but the weight increasing during two weeks had no such significant change. Compared with diabetic model group, the rats weight of little, middle, high dose TLN group and Methycobal group had no significant difference(P>0.05); The plasma sugar: Similar to the glycosylated hemoglobin, compared with diabetic model group, the plasma sugar levels in the middle and high dose TLN were lower (P<0.05). The Methycobal group had no significant difference(P>0.05); The thermal response latency: Compared with diabetic model group, methycobal group had significant difference in week 2, week 4, week 8, week 12.(P<0.01,or P<0.05) The middle, high dose TLN group had significant difference only in week 8, week12 , compared with diabetic model group(P<0.01,or P<0.05). But the middle dose TLN group had significant difference in week 8 compared with methycobal group (P<0.05). The cold response latency: Compared with diabetic model group, methycobal group only had significant difference in week 8.(P<0.05) The middle, high dose TLN group had significant difference in week 8, week12 , compared with diabetic model group(P<0.01,or P<0.05). Compared with methycobal group the middle, high dose TLN group also had significant difference in week 8, week12.(P<0.05)Experiment 2: Sciatic nerve conduction velocity: Compared with normal group, the MNCV of model group decreased significantly in week 2, week 4, week 8, week 12.(P<0.01). Compared with diabetic model group, methycobal group had significant increace difference in week 4, week 8, week 12(P<0.01,or P<0.05). Compared with diabetic model group, The low, middle and high dose TLN group had significant amelioration in week4, week 8, week12 (P<0.01,or P<0.05). Only the high dose TLN group had significant difference in week 12 compared with methycobal group (P<0.05).Experiment 3: There was significant injury in aciatic nerve morhpometrics of diabetic rats, which could be alleviated by TNL in different extent. The frequency of structurally abnormal fibril was significantly increased and the axon diameter of nerve fibril was reduced remarkably in 12 weeks diabetic rats. There were significant decrease in the frequency of sturctrually abnormal fibril and increase in the axon diameter of nerve fibril in TLN treated group compared with that in Methycobal group.Experiment 4: Adhesion molecule CD54: Compare with normal rats group, CD54 activities in all diabetic groups were significant higher (P<0.01). CD54 activities in middle dose TLN group and Methycobal group were lower. But only the activity of middle dose TLN group were significantly lower than the diatetic model group(P<0.01).The activity of middle dose TLN group was also significantly lower than the Methycobal group(P<0.05). Adhesion molecule CD62P: Compare with normal rats group, CD62P activities in all diabetic groups were significant higher (P<0.01). CD62P activity in middle dose TLN group and Methycobal group were lower. But only the activity of middle dose TLN group was significantly lower than the diatetic model group(P<0.01).The activity of middle dose TLN group was also significantly lower than the Methycobal group(P<0.05).Experiment 5:Insulin-like growth factor (IGF-â… ) concentration in serum: Compare with normal rats group, IGF-â… concentration of serum in all diabetic groups was significant lower (P<0.01). Compare with diabetic model group, IGF-â… concentration in serum is higher in Methycobal group and TLN group (P<0.05 or P<0.01). Middle dose TLN group is significant better than Methycobal group (P<0.01). Expression of IGF-â… mRNA in hepatic tissue: Compare with normal rats group, expression level of IGF-â… mRNA in hepatic tissue in all diabetic groups was significant lower (P<0.01). Compare with diabetic model group, Methycobal group can promote the expression level of IGF-â… mRNA in hepatic tissue (P<0.05), middle dose TLN group can significantly promote the expression level of IGF-â… mRNA in hepatic tissue (P<0.01).Conclusion:Through the rats experiment, it showed that TLN can reduce the plasma sugar and Glycosylated hemoglobin. It can also ameliorate the disesthesia and hyperaesthesia symptoms of STZ DM-rats. TLN can reduce the activities of adhesion molecule CD54 and CD62P. Meanwhile, TLN can promote the IGF-â… concentration in serum and the expression level of IGF-â… mRNA in hepatic tissue of diabetic rats induced by STZ. It indicated that the effect mechanism of TLN for treating DPN is achieved by depressing the vessel factor and improving the nerve nurtritional fator. TLN (as a herb formula) can significantly improve symptoms and nerve conductive velocity in patients with DPN, and showed better effect than Methycobal and has no side effect. Meanwhile, through rats experiment TLN can reduce the adhesion molecule CD54 and CD62P activity in diabetic rats'sciatic serum which showed that the depression of vessel inflammation is one of main effect mechanism of TLN. TLN can promote the IGF-â… concentration in serum and the expression level of IGF-â… mRNA in hepatic tissue of diabetic rats induced by STZ which indicated that improvement of nerve nurtritional factor is another effective pathway of TLN for treating DPN. So, TLN is effective and safe for curing DPN.
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