| ObjectiveEvaluate the clinical efficacy of the Chinese herbal compound Tangbikang on treatment of diabetic peripheral neuropathy (DPN)and to explore its mechanism.MethodsA match-up,paired comparison method was adopted in clinical trial.38 DPN patients conforming to the diagnostic criteria and traditional Chinese meidicine syndrome(Deficiency of both qi and Yin, Blood stasis of choroid) with similar conditions in terms of sex, age (±5 years), body mass index (±5Kg/m2), treatment time (±1 month), duration of diabetes (± 1 year), traditional Chinese meidicine syndrome score (±5), Michigan diabetic neuropathy score (MDNS)(±5), diabetic neuropathy grade, were matched into 19 pairs,then each pair were randomly divided into treatment group (Tangbi Kang group) and control group (Methycobal group).The period of treatment lasted for eight weeks.The primary outcome measures was traditional Chinese meidicine syndrome score and Michigan diabetic neuropathy score, while EMG andserum NSE level was choosen for secondary outcome measures,in order to Evaluate the clinical efficacy of the Chinese Herbal Compound Tangbikang on treatment of DPN.In experimental research,60 pure SPF SD male rats,10 rats with normal forage was randomly selected for control group, after 8 weeks, others with high fat forage and small dose of streptozotocin intraperitoneal injection(35mg/kg) induced animal models of type 2 diabetic rats,72h after the injection, the rats with fasting blood glucose level above 16.7mmol/L were diabetes model group for observation. These rats wer randomly divided into model group, alpha lipoic acid group, Tangbikang low, medium and high dose groups according to body weight. There wer 10 rats in each group, were treated by different doses of Tangbikang and alpha lipoic acid intragastric dose:Tangbikang low dose group (4.175g/kg/d), medium dose group (8.35g/kg/d), high dose group (16.7g/kg/d), alpha lipoic acid group:(20mg/kg/d).The observation lasted for 16 weeks.The rats sciatic nerve motor nerve conduction velocity (MNCV), serum NSE level (by chemiluminescence), expression of Drpl, Bax and Bcl-2 gene in sciatic nerve tissue(by real-time fluorescence quantitative PCR method)were detected to analyse the molecular mechanism of Tangbikang’s effect.ResultsThe clinical trial:There were significant differences between the treatment group and the control group in traditional Chinese meidicine syndrome score, Michigan diabetic neuropathy score (MDNS), bilateral tibial nerve motor nerve conduction velocity (MNCV)/sensory nerve conduction velocity (SNCV)and serum NSE levels (P<0.01), the treatment group was superior to the control group.In different levels of neuropathy patiens, there was no significant difference of efficacy (P>0.05) in two groups of treatment of grade 1 neuropathy (mild neuropathy), while in grade 2and3 neuropathy (moderate and severe neuropathy) the effect was significant different (P<0.01), the effect of treatment group was better than that of the control group. The total effective rate in treatment group was 89.48%, and in control group was 57.89%,the efficacy of the treatment group was superior to the control group by Ridit test. No obvious side effects was found in the treatment group throughthe experiment process.The experimental research:In experiment 1, After 16 weeks, the body weight of rats in the model group decreased significantly (P<0.01), compared with model group, the body weight in Tangbikang low dose,medium dose group and α-lipoic acid group was significant increased(P<0.01); Compared with normal group, the blood glucose of model group rats increased significantly(P<0.01), Compared with model group, the blood glucose of other group rats had been improved, α-lipoic acid group (P<0.05) and Tangbikang low dose group (P＜0.01) were significantly different after 16 weeks, the blood glucose of Tangbikang medium dose group and high dose group had decreased significantly (P<0.01 and P<0.05) at 4,8,12,16 weeks; The sciatic nerve conduction velocity of rats was slowed down significantly in model group compared with normal group; compared with model group, Tangbikang high dose group and α-lipoic acid group can improve diabetic rat sciatic nerve conduction velocity (P<0.05), between the two groups, the effect of Tangbikang high dose group was better than α-lipoic acid group (P<0.05), the highdose group was significantly better in different doses of Tangbikang group(P<0.05); In experiment 2, the serum NSE level increased significantly in rats of diabetes mellitus compared with normal group (P<0.01), while in high dose Tangbikang group and α-lipoic acid group decreased significantly (P<0.05)compared with the model group, but there was no significant difference between the two groups; In experiment 3, compared with the normal group,the expression level of Drp1 increased significantly in the treatment group and the model group(P<0.05),the expression of Bax also increased significantly (P<0.05), the expression of Bcl-2 was significantly decreased (P<0.05); the expression level of Drp1,Bax of Tangbikang high dose group was lower than α-lipoic acid group (P＜0.05)), while the expression of Bcl-2 was significantly higher (P＜0.05).ConclusionThe Chinese herbal compound Tangbikang can improve the symptoms and signs, the tibial nerve conduction velocity of DPN patients, decrease the serum NSE level in them, the clinical trial suggest that the curative effect is superior to the methycobal in moderate and severe neuropathy patiens.The Chinese herbal compound Tangbikang can improve blood glucose and body weight, decrease the serum NSE level, improve the motor nerve conduction velocity of sciatic nerve in diabetic peripheral neuropathy rats; Tangbikang may inhibit nerve cell apoptosis by reducing the expression levels of pro apoptotic gene Drp-1 and Bax, increasing the expression of anti apoptosis gene Bcl-2 in diabetic peripheral neuropathy rats, relieve the progress of DPN; Results suggest that the anti Drp-1 signal pathway of apoptosis effect may be one of the mechanism of neuroprotective effect of Tangbikang in diabetic peripheral neuropathy.
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