| Objective:To initially discuss the efficacy and safety of internal and external comprehensive therapy of traditional Chinese Medicine for type 2 diabetic peripheral neuropathy(DPN),and provide medical evidence for the clinical treatment of DPN.Method:Seventy patients of type 2 diabetic peripheral neuropathy were randomly divided into two groups according to the random number table.The treatment group(35 cases)received basic western medicine treatment plus internal and external comprehensive therapy of traditional Chinese medicine(Tangbi External Washing Prescription for foot bath+ Prescription for invigorating Qi and nourishing Yin and activating blood circulation).The control group(35 cases)received basic western medicine treatment which included hypoglycemia,hypotension,lipid lowering,diet control,exercise and nutrition of nerve as well as antioxidant therapy.Follow up for 2 weeks,the changes of Toronto clinical score,TCM syndrome score,nerve conduction velocity and Pittsburgh sleep quality index were compared between the two groups after treatment.Result:A total of 70 patients participated in the study,including 0 cases of falling off and 70 cases of completion.No serious adverse event occurred.The indicators were compared as follows:1.Comparison of baseline data: there was no significant difference in general data(age,course of disease,gender composition)and observation indexes before treatment between the two groups(P>0.05),and the baselinedata were balanced and comparable.2.Blood glucose index: after treatment,fasting blood glucose and 2h postprandial blood glucose in both groups were lower than before treatment,with statistically significant differences(P<0.05).After treatment,there was no significant difference in fasting blood glucose or 2h postprandial blood glucose between the two groups(P>0.05).There was no significant difference in the fasting blood glucose and 2h postprandial blood glucose before and after treatment between the two groups(P>0.05).3.Effect on Toronto score: after treatment,Toronto symptom score,sensory score,reflex score and total score of the two groups were decreased compared with those before treatment,and the difference was statistically significant(P<0.05).After treatment,there were statistically significant differences in Toronto symptom score,sensory score and total score between the two groups(P<0.05),and the treatment group was better than the control group.There was no significant difference in Toronto reflex score between the two groups after treatment(P>0.05).The results showed that TCM internal and external comprehensive treatment can effectively decrease Toronto score,and had more advantages in lowering symptom score and sensory score than reflex score.4.Influence on clinical symptoms: the numbness,pain and abnormal sensation in the treatment group were relieved than those in the control group.The difference was statistically significant(P<0.05),indicating that effect of the TCM internal and external treatment in relieving the symptoms of numbness,pain and abnormal sensation was definite.In addition,the relief of numbness was obvious than abnormal sensation,and relief of sensation abnormality was obvious than pain.5.Effect on sleep quality: after treatment,PSQI score of the two groups decreased compared with that before treatment,the difference was statistically significant(P<0.05).After treatment,the PSQI difference between the two groups was statistically significant(P<0.05),and the treatment group was better than the control group.The results showed that TCM internal and external comprehensive treatment can effectively improve the sleep quality of patients.6.Effect on nerve conduction velocity: after treatment,the sensory nerve conduction velocity(SNCV)of median nerve(MN),sural nerve(SN)of treatment group and left MN and right SN of control group increased compared with thatbefore treatment,and the difference was statistically significant(P<0.05).However,the SNCV of right MN and left SN in control group had no significant change after treatment(P>0.05).After treatment,the difference of SNCV of MN and SN was statistically significant(P<0.05),and the treatment group was better than the control group.After treatment,there was no significant difference in motor nerve conduction velocity(MNCV)between the two groups(P>0.05).There was no significant difference in MNCV of MN and TN between groups after treatment(P>0.05).It was suggested that the improvement of SNCV was more obvious,MNCV was more difficult to improve,and the treatment time may be longer.7.Effect on TCM symptoms score: After treatment,the TCM symptom score of the two groups decreased compared with that before treatment,and the difference was statistically significant(P<0.05).After treatment,the difference of TCM symptom score between the two groups was statistically significant(P<0.05),and the treatment group was better than the control group.It showed that the TCM treatment of internal and external can effectively decrease the TCM scores of symptoms.It had an effect in alleviating symptoms of blood stasis such as limb numbness and pain as well as the symptoms of deficiency of both Qi and Yin,such as fatigue,dry throat and mouth,abnormal stomach intake and stool disorder.8.Influence on TCM symptoms: The TCM symptoms of DPN in the treatment group were as follows: limb numbness,sleep disorder,limb pain,abnormal sensation,fatigue,dry throat and mouth,stool disorder and abnormal stomach intake.The comprehensive therapy of TCM and external medicine can effectively alleviate the above symptoms,especially for dry throat and mouth,fatigue,abnormal stomach intake and stool disorder.In the control group,TCM symptoms were ranked as follows: limb numbness,fatigue,dry throat and mouth,sleep disorder,limb pain,abnormal sensation,stool disorder,abnormal stomach intake;after treatment,the symptoms of dry throat and mouth,fatigue were relieved to some extent,while the remission rate of other symptoms was low.9.Efficacy observation: the effective rates of Western Medicine(Toronto clinical score)in the treatment group and the control group were 82.86% and45.71%.The difference between the two groups was statistically significant(P<0.05).The effective rates of TCM in the treatment group and the control group were 94.28% and 68.57%.The difference between the two groups wasstatistically significant(P<0.05),and the treatment group was better than the control group.10.Safety observation: no serious adverse events occurred in both groups,and the safety was good.Conclusion:After 2 weeks of treatment,on the basis of basic western medicine treatment,the combination of internal and external comprehensive therapy of traditional Chinese medicine(Tangbi External Washing Prescription for foot bath+ Prescription for invigorating Qi and nourishing Yin and activating blood circulation)could effectively and safely relieve the clinical symptoms of type 2 diabetic peripheral neuropathy patients,improve the quality of life,and decrease the Toronto clinical score and TCM symptom score,Pittsburgh Sleep Quality Index as well as increase nerve conduction velocity.It is an effective treatment for DPN patients,which deserves further study and promotion. |
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