| Objective:Study and summarize the recent Chinese and Western medicine research on diabetic peripheral neuropathy and other related contents.To observe the clinical efficacy and safety of Yiqi Zhuyu Tongluo Decoction in the treatment of qi deficiency to blood stasis syndrome in type 2 diabetic peripheral neuropathy through clinical study,and to provide effective prescription for clinical treatment of this disease.Methods:Sixty patients with qi deficiency and blood stasis syndrome in type 2 diabetic peripheral neuropathy meeting the inclusion criteria were collected.According to the randomized control method,the included patients were randomly divided into the treatment group and the control group with 30 patients in each group.The control group received conventional hypoglycemic agents,during hospitalization,plus lipoic acid injection,0.6g,once a day,intravenously for a week,After discharge,followed by lipoic acid capsules,0.2g,three times a day,orally for 11 weeks;Treatment group was given Yiqi Zhuyu Tongluo Decoction on the basis of the control part.3 period of treatment of two groups were observed before and after the treatment.Observe curative effect and cilinical safety by studying traditional Chinese medicine clinical symptoms,TCM syndrome integral,blood glucose,blood fat,homocysteine index,electromyography nerve conduction velocity,blood rheology,Michigan screening scale(MNSI),cytokines.Results:①Symptoms of traditional Chinese medicine:Statistical analysis of the data of the two groupscomparison after treatment showed that the single symptom of traditional Chinese medicine in the treatment group was significantly improved(P<0.01).In contrast,in the control group,only numbness of hands and feet,tingling pain at the end of limbs(mainly lower limbs),severe pain at night and sweating and anemophobia,and decreased immunity symptoms were significantly improved(P<0.05 or P<0.01).Compared with the control group,the symptoms in the treatment group were significantly improved(P<0.05)except feel ants.②TCM Syndrome Points:Both groups can improve TCM syndromes and relieve clinical symptoms after treatment.The total effective rate of TCM syndromes in the treatment group is 93.33%,and the total effective rate in the control group is 66.67%.The overall effective rate of the treatment group was better than that of the control group(P<0.01).③ Blood glucose related indexes:Compared among groups,three indexes of the treatment group were improved compared with those before treatment,and there was a statistical significance in results(P<0.05).Except the indexes of HbAlc in the control group were improved compared with those before treatment,and there was a statistical significance in results(P<0.05).Comparison among groups showed that the treatment group was better than the control group(P<0.01).④ Blood lipid related indexes:Intra-group comparison after treatment showed that the effect of the treatment group after treatment was better than that before treatment,with statistical significance(P<0.05);After treatment,there was no significant difference in the control group compared with the indexes before treatment,with statistical significance(P>0.05).The two groups were compared,the difference was significant,the treatment group had better performance(P<0.01).⑤ Comparison of homocysteine:Intra-group comparison after treatment showed that the improvement of homocysteine in the treatment group after treatment was better than before treatment,with statistical significance(P<0.05).In the control group after treatment,there was no significant difference compared with the indexes before treatment,with statistical significance(P>0.05).Compare among groups the therapeutic effect of the treatment group was better than that of the control group,and the difference was significant(P<0.05).⑥ Comparison of MCV and SCV:After treatment,scores of both groups MCV and SCV were improved,the difference was significant(P<0.05).Comparison among groups showed that the treatment group was better than the control group(P<0.01).⑦ Comparison of hemarheology indexes:After treatment,scores of both groups were improved,the difference was significant(P<0.05).Comparison among groups showed that the treatment group was better than the control group(P<0.05).⑧ MNSI:Before treatment,the camparison of the Michigan screening scale(MNSI)showed no significant difference(P>0.05).After treatment,the Michigan screening scale(MNSI)was significantly decreased in both groups,and the treatment group was significantly lower than the control group,the difference was significant(P<0.01).⑨ Comparison of cytokines:After treatment,scores of both groups were improved,the difference was significant(P<0.01).Comparison among groups showed that the treatment group was better than the control group(P<0.05).⑩ Comparison of efficacy:The total effective rate in the treatment group was 86.67%,and the total effectine rate in the control group was 46.67%.The control group was significantly lower than the treatment group,which was statistically significant(P<0.05).(11)Safety indicators:There were no abnormalities in safety indicators such as blood,urine,feces,liver and kidney function in the two groups,and no serious adverse reactions occurred.Conclusion:Compared with lipoic acid therapy,Yiqi Zhuyu Tongluo Decoction combined lipoic acid has better effect on the treatment of type 2 diabetes peripheral neuropathy qi deficiency and qi deficiency to blood stasis syndrome,especially in lowering the indexes of blood sugar,homocysteine,TNF alpha,CRP,and MNSI score,regulating blood lipid,improving hemarheology indexess,and MCV and SCV of median nerve and sural total nerve.Without obvious adverse reactions and side effects,Yiqi Zhuyu Tongluo Decoction combined lipoic acid improve the total effective rate of treatment significantly superior to use lipoic acid treatment,safe and effective,which is worth in clinical promoted. |
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