Objective: This study, applying Yi Qi Huo Xue Tong Luo therapy on patients with diabetic peripheral neuropathy(DPN), was designed to provide objective evidence on theory, therapy, recipe and drugs for the treatment of diabetic peripheral neuropathy(DPN), by observing the TCM syndrome, the single symptom, the checking of neural function and the determining improvement of neural electrophysiology, thereby we debated the clinical effect of Yi Qi Huo Xue Tong Luo therapy on the treatment of diabetic peripheral neuropathy(DPN).Methods: Eighty patients from our hospital’s inpatient and outpatient suffering diabetic peripheral neuropathy(DPN) caused by qi deficiency and blood stasis were selected and randomly divided into two groups—the treatment group and the control group with the researching method of random, positive drug parallel comparison. Indexes of the two groups’ patients such as blood glucose, blood pressure and blood lipid were controlled in an ideal range through the foundation treatment. Afterwards, the treatment group was treated by Yi Qi Huo Xue Tong Luo prescription decocting in water for the whole day and the control group was given Methycobal tablets(Mecobalamin Tablets), 500μg, three times a day. Course of the treatment: eight weeks. After eight weeks of treatment, the TCM syndrome, the single symptom, the checking of neural function and the determination of neural electrophysiology were compared before and after treatment, then we made the efficacy analysis and the safety evaluation.efficacy analysis.Results:1 Effect of TCM syndrome: The difference between the treatment group and the control group had statistically significant, and the effect of treatment group was better than that of the control group(P < 0.05).2 The total score of TCM symptom: There was statistically significant between two groups compared before and after treatment. The declining extent of the treatment group was greater than that of the control group(P<0.05). The 95% confidence interval for the difference of the scores of the treatment group and the control group were 8.672 to 9.522 and 7.341 to 8.823. The 95% confidence interval for the difference of the score’s difference between the treatment group and the control group was 0.160 to 1.870.3 Neural electrophysiological determination: The indexes’ difference had statistically significant in each group before and after the test. After the treatment the nerve conduction velocity(NCV) was better than before(P <0.05). In the sensory neural velocity, the difference of the nerve conduction velocity(NCV) before and after the treatment in the sural nerve had statistically significant, and the nerve conduction velocity(NCV) increased in treatment group was greater than that in the control group(P<0.05). But the other electrophysiological indexes’ difference had no statistically significant(P > 0.05) before and after treatment.4 Effect of the nerve function: Among the each examination project in the checking of neural function, there was no statistical significance before and after the treatment(P > 0.05).5 Effect of the single symptoms: There was statistical significance in the effect of TCM symptoms such as numbness, cold, spontaneous aches and weakness in the limbs, and the treatment group was better than that of the control group(P < 0.05). But there was no statistical significance in the abnormal sensation and hypaesthesia before and after the treatment(P > 0.05).6 Effect of the blood glucose: Two groups had no statistical significance(P>0.05) in the effect of blood glucose(fasting blood glucose, postprandial 2 hour blood glucose and the glycosylated hemoglobin).7 Effect of tongue and pulse conditions: Comparing the two groups, there was no statistical significance(P > 0.05) in the effect of tongue and pulse conditions,Conclusions:1 The basic pathogenesis of diabetic peripheral neuropathy(DPN) is qi deficiency and blood stasis syndrome.2 Yi Qi Huo Xue Tong Luo therapy as the fundamental method in the treatment of diabetic peripheral neuropathy can significantly improve the patients’ common symptoms, such as numbness, cold, aches and weakness in the limbs, and increase the peripheral nerve conduction velocity in a short time.3 The patients’ compliance and the quality of life can be improved by employing the Yi Qi Huo Xue Tong Luo therapy. |