| ObjectiveType 2 diabetes is a common endocrine metabolic disease. Results of an epidemiology investigation show that the clinical diabetic neuropathy often occurs during 10 years after the diagnosis of diabetes.60 percent to 90 percent of the diabetic patients had different degree neuropathy by the examination of neural function.30 percent to 40 percent of the diabetic neuropathy patients had no clinical symptoms. It is a universal phenomenon that the diabetic patients have chronic complication in China. The neural complication incidence is over 50 percent. The illness frequency rate of TD1M is 44.9 percent and TD2M is 61.8 percent. To the diabetic peripheral neuropathy(DPN) patients, inchoate diagnosis and appropriate tampering methods can reduce the incidence of ulcer by 60 percent and the incidence of amputation by 85 percent, which will raise their survival rate and make better their quality of life. Although There are many disputation about its intricate mechanism, the common consensus is that oxidative stress which is caused by hyperglycemia and microcirculation obstruction are two important factors. Simultaneously there are no remarkable and effective medicine to cure DPN. In the field of TCM syndrome differentiation, the blood stasis of DPN appear the most frequently and the syndrome is the most prominent.The object of this research is to observe the clinical healing efficacy about Xuesaitong with Lipoic Acid to the blood stasis DPN patient, to probe the useful effect and the possible mechanism of improving lost nerve, to provide clinical reference for the useful effect which is about curing DPN by combining traditional Chinese medicine with western medicine. Method Accord to the western diagnosis standard from《The prevention and treatment guidance of Chinese diabetes 2007》and the traditional Chinese Medicine dialectical standard from《The clinical research guiding principle of new traditional Chinese medicine》(The front page of 2002),80 blood stasis DPN patients were chosen from in-and-out patients coming from endocrinology department in the Chinese medical hospital of GuangDong Province from March of 2008 to January of 2009. These selected patients were randomly divided into 2 groups(Group A, B), Group A(40patients) was given Mecobalamin lmg to inject into vein on thebasis of basic treatment, Group B(40patients) was given xuesaitong with Lipoic Acid to inject into vein on the basis of basic treatment, the frequency of both two groups was once a day, one course of treatment was three weeks, the next course of treatment was arranged after one week, the course of treatment of two groups were both three. Sex,age,course of disease index of patients in each group were measured statistically, and there were no significant difference(P>0.5), which meant the comparison between groups. Observation indexes include clinical syndromes, fasting plasma glucose(FPG),2h plasma glucose(2hPG), blood coagulation, nerve conduction velocity, meanwhile, the change of general safe items such as three routine tests(Blood Routine Test, Urine Routine Test, Stool Routine Test), Hepatic and Renal Function, Electrical Cardiogram were observed before and after treatment. ResultsAfter three courses of treatment, the clinical symptom, blood coagulation and nerve conduction velocity improve parentally comparing with pre- treatment (P<0.01 or P<0.05). Variation of observation indexes in group B after treatment has significant difference comparing with group A.The safety indexes demonstrated no evident differences before and after the treatment, and no adverse side effects were reported. ConclusionIn the study, Xuesaitong with Lipoic Acid not only improve clinical symptom and blood coagulation of DPN patient significantly, but also reinstate the nerve conduction velocity effectively. And the study point out that it is a safe and effective method that treating DPN through traditional chinese medicine differential diagnosis by stages. When the method was used clinically, no adverse effect was reported.Therefore, the clinical use of treatment combining Xuesaitong with Lipoic Acid is safe.
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