Objective: To observe clinical efficacy and safety of the Qidi muteng tongbi decoction on diabetic peripheral neuropathy(Qi and yin deficiency and blood stasis).Methods: 90 patients were randomly divided into two groups based on the order numbers of admission. The 45 patients in treatment group were given basic treatment and Mecobalamin tablets and Qidi muteng tongbi decoction, while the 45 cases in control group were given basic treatment and Mecobalamin tablets. Treatment observation period for 12 weeks. The TCM syndrome score, TCSS score, nerve conduction velocity, Hcy, Cyc-C, hs-CRP, FPG, 2hPG, HbAlc, TC, TG, HDL-C, LDL-C and hemorheology indexes in two groups were observed pre and post treatment. The data were analyzed by SPSS statistics software.Results:1. The comparison of comprehensive efficacy: Total effective rate in the treatment group and the control group was 85.71% and 64.28%, respectively. The treatment group was better than the control group(P<0.05).2. The comparison of efficacy of TCM: Total effective rate in the treatment group and the control group was 88.09% and 69.04%, respectively. The treatment group was better than the control group(P<0.05).3.The comparison of Hcy, Cyc-C, hs-CRP,TCSS score: Compared with before treatment Hcy, Cyc-C, hs-CRP,TCSS scores were reduced in two groups(P<0.05),the treatment group is lower than control group, the comparison between the two groups has statistical meaning(P<0.05).4.The comparison of nerve conduction velocity : compared with before treatment, motor nerve conduction velocity(MCV) of tibial nerve and common peroneal nerve were increased in two groups(P<0.05),the treatment group is higher than control group, the comparison between the two groups has statistical meaning(P<0.05).5.The comparison of blood glucose and hemorheology indexes: after treatment, the blood glucose and hemorheology indexes in treatment group were lower than before; while the control group had no statistical significance, the comparison between the two groups has statistical meaning(P<0.05).6.The comparison of blood lipid: after treatment, TC, TG, LDL-C were reduced in two groups(P<0.05); the comparison between the two groups has statistical meaning(P<0.05). there was no statistical significance in the HDL-C.7. Safety evaluation of two groups: after treatment,there were no significant adverse reactions in the two groups.Conclusions:1. Qidi muteng tongbi decoction could improve the clinical symptoms of DPN patients, and improve the quality of patients life.2. Qidi muteng tongbi decoction could regulate DPN patients blood glucose, blood lipid, blood rheology, improve the DPN patients nerve conduction velocity.3.No adverse reactions were found in the clinical application of Qidi muteng tongbi decoction,it is safe. |