| Objective: To observe and objectively evaluate the clinical efficacy of Fufang guishao tongluo decoction in the treatment of type 2 diabetic peripheral neuropathy(DPN).Meanwhile,the effect of Fufang guishao tongluo decoction on serum ferritin(SF)and oxidative stress indicators: effects of superoxide dismutase(SOD),malondialdehyde(MDA),and glutathione peroxidase(GSH-Px)are also analyzed.Finally,the possible mechanism of its role in the treatment of DPN is explored.Methods: Sixty patients with DPN were enrolled and randomized divided into two groups,namely the treatment group(30 cases)and the control group(30 cases).The control group was received conventional hypoglycemic,conventional diabetes diet and exercise intervention.Moreover,300 mg of lipoic acid injection was dissolved in 0.9% sodium chloride injection 100 ml intravenously,once a day(inpatients)/ lipoic acid tablets 0.6g before breakfast once a day,two tablets were taken orally(outpatients or inpatients continue to take the drug after discharge);the treatment group was given compound Fufang guishao tongluo decoction(200ml,One dose a day)on the basis of the control group,observe three courses of treatment.The efficacy index,SF index,oxidative stress index(SOD,MDA,GSH-Px),blood glucose index,nerve conduction velocity,etc.were compared before and after treatment,and safety indicators were detected.Results:(1)Clinical efficacy indicate that the total effective rate of the treatment group and the control group are 93.33% and 70%,respectively,and the two groups showed significant statistical difference(P<0.05);(2)TCM symptom score comparison: the TCM syndrome scores of treatment group and control group are all showed a downward trend(P<0.01)after treatment,and the treatment group showed a significant decrease compared with the control group(P<0.05);(3)Comparison of Toronto scores: the Toronto scores of treatment group and control group are all decreased(P<0.01)after treatment,and the Toronto score of the treatment group is significantly lower than that of the control group(P<0.05);(4)Comparison of serum SF and oxidative stress related indicators: the SF and MDA levels decreased after treatment in the treatment group and the control group(P<0.01).Conversely,SOD and GSH-Px levels increased(P<0.01).The decrease of SF and MDA in the treatment group was more significant than that of the control group(P<0.05).The levels of SOD and GSH-Px increased more significantly(P<0.05);(5)Comparison of nerve conduction velocity: MNCV and SNCV were significantly improved in the treatment group and the control group after treatment(P<0.01),and the improvement of MNCV and SNCV in the control group was significantly lower than that of the treatment group(P<0.05);(6)Comparison of blood glucose levels: after treatment,the fasting plasma glucose(FPG),2h-Postprandial plasma glucose(2hPG),and glycosylated hemoglobin(HbA1c)of the treatment group and the control group were all lower than those before treatment(P<0.01),and the decrease of FPG and 2hPG in the treatment group was more significant than that of the control group(P<0.05);(7)Safety analysis: no obvious adverse reactions were found in each group during the clinical treatment.Conclusion: The results of this study indicate that the compound Fufang guishao tongluo decoction has a significant improvement on the clinical symptoms and signs of patients with DPN.The clinical efficacy is better than the application of western medicine lipoic acid alone.Compound Fufang guishao tongluo decoction can improve the levels of serum SF,SOD,MDA and GSH-Px.Through observed the safety indicators,we have confirmed the safety and effectiveness of the decoction.It is worthy of popularization and application.Its mechanism of action may be through the iron metabolism pathway to resist oxidative stress,thus achieving the purpose of treating DPN. |
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