| Objective:To investigate the role of oxidative stress in the mechanism of diabetic peripheral neuropathy (DPN) and to analyze the risk factors for the development of DPN; To evaluate efficacy of Qi Gui Lei Fang in treating DPN patients of qi-yin deficiency and inter-obstruction between phlegm and stasis internally and externally, and discuss its mechanism of action.Methods:Select139cases of T2DM patients with30-75years old of Endocrinology department in Affiliated Hospital of Jining Medical College from September2012to April2013, including Mechanism discussion group (77cases) and clinical research group (62cases).(1) According to the clinical symptoms and the nerve electrophysiological examination, the mechanism discussion group(77cases) was divided into DPN group (50cases) and non-DPN group (NDPN group,27cases), record and analyze the clinical data including systolic pressure (SBP), diastolic pressure (DBP), body mass index (BMI), triglyceride (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), Hemoglobin AlC (HbAlc), fasting plasma glucose (FPG),2-hour postprandial plasma glucose (2hPG), fasting C peptide (FC-P),2-hour C peptide (2hC-P).; the levels of Total antioxidant capacity (T-AOC), Malondialdehyde (MDA) and superoxide dismutase (SOD) were examined to evaluate the level of oxidative stress. The risk factors in statistical significance were subjected to multiple Logistic regression analysis to screen for the risk factors for DPN.(2)62DPN patients of qi-yin deficiency and inter-obstruction between phlegm and stasis syndrome were randomly divided into the treatment group (31cases) and the control group (31cases),①the treatment group was given Qi Gui Mixture(200ml/time,2times/d) and Mecobalamine(500ug/time,3times/d) orally and plus lavipeditum of Qi Gui Huoxue Lotion while the control group was given Mecobalamine orally only(500ug/time,3times/d). The therapeutic course for all was3months.②The changes of scoring for Chinese medicine (CM) symptoms assessment, Toronto clinical scoring system (TCSS) score and nerve conduction velocity were observed. The serum total antioxidant capacity (T-AOC), malondialdehyde (MDA), superoxide dismutase (SOD) were detected.Results:(1) Compared with NDPN group:Age, duration of DM, FPG, TG, MDA increased and2hC-P, SOD decreased significantly in DPN group (P<0.05); while there was no significant difference in sex, BMI, SBP, DBP,2hPQ FC-P, TC, HDL-C, LDL-C, HbAlc, T-AOC between2groups of patients (P>0.05).(2)Through the multi-factor Logistic regression analysis, age, TG,2hC-P, MDA came into the regression equation.(3)The levels of MDA and SOD are correlated with the TCSS score, R value is0.287,0.261respectively (P<0.05),but the level of TAOC is not associated with the TCSS score(P>0.05).(4)The total effective rates of the CM symptoms and TCSS score efficacy in treatment group were82.8%,82.8%respectively, significantly higher than the control group (P<0.05).Compared with treatment before, the motor nerve conduction velocities of right median nerve, bilateral tibial nerve, bilateral common peroneal nerve and the sensory nerve conduction velocities of left median nerve, bilateral ulnar nerve, left tibial nerve in two groups were significantly increased (P<0.05), the treatment group was better than the control group (P<0.05).The levels of T-AOC and SOD increased significantly and the levels of MDA decreased significantly in the treatment group (P<0.05), but only the level of SOD increased significantly in the control group(P<0.05), comparison of elevated levels of T-AOC and SOD and decline levels of MDA between two groups were statistically significant (P<0.05). No severe adverse events occurred during the therapeutic course. Conclusion:(1) The decrease of SOD and increase of MDA are interrelated with DPN, oxidative stress plays an important role in the pathogenesis of DPN.(2) Age, TG,2hC-P, MDA levels are the independent risk factors for DPN.(3) The levels of MDA and SOD were correlated with the TCSS score, suggests that both levels may be associated with the damage degree of peripheral nerve.(4)Qi Gui Lei Fang treated internally and externally combining with Mecobalamine can improve the clinical symptoms and nerve conduction velocities of DPN patients of qi-yin deficiency and inter-obstruction between phlegm and stasis,the efficacy is more significant than Mecobalamine, and it’s safe, its mechanism may be associated with resistance to oxidative stress,may also is increasing the antioxidant capacity of Mecobalamine by complementary synergy. |
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