| Recent year 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% to 90%, among them nearly 30% to 40% patients did not show any special symptoms. 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 think that DPN is caused by the deficiency of 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 consists two parts: clinical trials and experimental research. We observed the clinic effect of TLN through clinical trial and discuss the effect mechanism of TLN through experimental research.Clinical trial Objective to assess the clinic effect of TLN for treating DPN. Method 66 DPN patients conforming to the diagnostic criteria were randomly divided into the herb group(33 patients)and control group(33 patients).Based on the basic treatment for blood pressure,blood glucose and blood lipid, the herb group was given Tangluoning(for benefiting qi and nourishing yin and activating blood circulation). The control group was given the methycobal(mecobalamin).The changes in the symptoms, nerve conductive velocity were observed in the patients. Results The total effective rate of the TLN group was 90.3% and that of control group was 65.5%. 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 investigated the concentration of sorbitol and AR in sciatic nerve, the expression of AR and NGF mRNA of sciatic nerve by RT-PCR, the NGF concentration in serum. Results 1 sorbital concentration of sciatic nerve: Compare with normal rats group, sorbital concentration of sciatic nerve in all diabetic groups was significant higher (P<0.01). Compare with diabetic model group, sorbital concentration of sciatic nerve in TLN and Methycobal group was lower (P<0.05 or P<0.01). The middle and high dose TLN group can lower the sorbital concentration of sciatic nerve better than Methycobal group(P<0.05). 2 Aldose reductase (AR) activity of sciatic nerve: Compare with normal rats group, AR activity of sciatic nerve in all diabetic groups was significant higher (P<0.01). Compare with diabetic model group, AR activity of sciatic nerve in middle,high dose of TLN group and Methycobal group was lower (P<0.05 or P<0.01).The high dose TLN group is significant better than Methycobal group(P<0.05).3 Expression of AR mRNA in sciatic nerve: Compare with normal rats group, expression of AR mRNA in sciatic nerve in all diabetic groups was significant higher (P<0.01). Compare with diabetic model group, the expression level of AR mRNA in sciatic nerve is significant lower in Methycobal group and middle,high dose TLN group (P<0.05 or P<0.01). The high dose TLN group is especially lower than Methycobal group (P<0.05). 4 Neuron growth factor (NGF) concentration in serum: Compare with normal rats group, NGF concentration of serum in all diabetic groups was significant lower (P<0.01). Compare with diabetic model group, NGF concentration in serum is higher in Methycobal group and TLN group (P<0.05 or P<0.01). High dose TLN group is significant better than Methycobal group (P<0.01). 5 Expression of NGF mRNA in sciatic nerve: Compare with normal rats group, expression level of NGF mRNA in sciatic nerve in all diabetic groups was significant lower (P<0.01). Compare with diabetic model group, middle dose TLN and Methycobal group can promote the expression level of NGF mRNA in sciatic nerve (P<0.05), high dose TLN group can significantly promote the expression level of NGF mRNA in sciatic nerve (P<0.01).Conclusion Through the rats experiment, it showed that TLN can reduce the AR activity and sorbitol concentration in diabetic rats'sciatic nerve, depress the expression of AR mRNA in diabetic rats'sciatic nerve. Meanwhile, TLN can promote the NGF concentration in serum and the expression level of NGF mRNA in sciatic nerve of diabetic rats induced by STZ. It indicated that the effect mechanism of TLN for treating DPN is achieved by depressing the polyol path and improving the NGF.This research indicated that 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 AR activity and sorbitol concentration in diabetic rats'sciatic nerve, depress the expression of AR mRNA in diabetic rats'sciatic nerve which showed that the depression of polyol path is one of main effect mechanism of TLN. TLN can promote the NGF concentration in serum and the expression level of NGF mRNA in sciatic nerve of diabetic rats induced by STZ which indicated that improvement of NGF is another effective pathway of TLN for treating DPN. So, TLN is effective and safe for curing DPN.
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