| PurposeAccording to the research norms of clinical diagnosis and treatment technology of traditional Chinese medicine,this project evaluates the effectiveness and safety of "taking Chinese medicine orally + local skin needle and percussion + back cupping" in the treatment of type 2 diabetes mellitus distal symmetrical multiple neuropathy(DSPN),studies the technical suitability and economic suitability,studies the technical operation norms,and finally forms the conclusive evidence,safe and effective,standardized operation,and easy to promote Comprehensive treatment plan of traditional Chinese medicine.Method 1.According to the principle of randomized controlled clinical trial,patients with distal symmetric polyneuropathy(DSPN)in type 2 diabetes mellitus were divided into treatment group and control group,with 102 cases in each group.The treatment group was treated with "oral administration of Chinese medicine + local skin needle tapping + back cupping",while the control group was treated with conventional western medicine regimen for a total of 6 weeks.The nerve conduction velocity of patients with DSPN was detected by electromyography(EMG);the clinical symptoms and signs were evaluated by the Michigan diabetic peripheral neuropathy scale;the TCM symptom score scale was used to evaluate the TCM symptoms and signs of the patients;the SF-36 quality of life scale was used to evaluate the patients’ TCM symptoms Quality of life level;2.Using the method of questionnaire,the suitability of the scheme was studied,the evaluation of the suitability of the scheme by medical staff and the satisfaction evaluation of the scheme by patients were investigated;the economic suitability of the scheme was studied by using cost-effectiveness analysis method,and the health economic value of the scheme was evaluated.3.According to the evaluation results of clinical efficacy and safety,further clarify the indications and contraindications of the comprehensive scheme of traditional Chinese medicine,standardize the technical operation steps and procedures,key technical links,possible accidents and treatment,and finally form the standard technical operation text of traditional Chinese medicine.Result: 1.Clinical efficacy and safety evaluation results 1.1 baseline data results(1)General information Before treatment,gender,age,course of disease,blood glucose level,BMI,blood pressure,blood lipid and other general data of the two groups were consistent after statistical analysis,with no statistical difference.DSPN symptoms occurred most in the lower extremities,and the first symptom was numbness of the distal extremities.(2)Baseline comparison of effect indicators The baseline of m DNS score and nerve conduction velocity score of the two groups were consistent,and there was a contrast between the two groups.There was no significant difference in TCM symptom score and SF-36 between the two groups.1.2 clinical efficacy of two regimens in the treatment of DSPN The effective rate of TCM Comprehensive Scheme and Western medicine comprehensive scheme was shown by ITT analysis set and PPS analysis set,there was no statistical significance between the two groups.(1)MDNS evaluation resultsAfter 3 weeks of treatment,there was no significant difference in the total score of m DNS between groups;after 6 weeks of treatment,there was statistical difference between groups.After 6 weeks of treatment,there were significant differences in the scores of the treatment group;the scores of sensory disturbance and reflex examination in the control group were decreased,and the comparison within the group was statistically significant.After 6 weeks of treatment,the TCM comprehensive scheme has a significant effect on the recovery of sensory disturbance,muscle strength and tendon reflex in patients with DSPN,and it is superior to conventional western medicine in reducing the scores of sensory disturbance and muscle strength test.(2)Evaluation results of nerve conduction velocityAfter 6 weeks of treatment,there was no significant improvement of nerve conduction velocity in the upper limbs of the two groups.In the treatment group,the curative effect of common peroneal nerve and superficial peroneal nerve in the treatment group was better than that before treatment;there were significant differences in MNCV(median nerve,common peroneal nerve)and SNCV(superficial peroneal nerve)in patients with disease location before and after treatment.In the control group,after 6 weeks of treatment,SNCV of lower limbs(common peroneal nerve)group had significant difference;SNCV of limbs(median nerve,superficial peroneal nerve)had statistical difference,and the remaining nerves had no obvious improvement after treatment.(3)Evaluation results of TCM symptom scoreIn the treatment group,before treatment,3 weeks and 6 weeks after treatment,limb numbness,hypoesthesia and other symptoms were improved,and there were differences within the group;in the control group,only sensory decline improved significantly before treatment,3 weeks and 6 weeks after treatment.After 6 weeks of treatment,in terms of limb numbness,limb pain,hypoesthesia,limb chills,limb weakness and TCM symptom total score,TCM comprehensive program was better than western medicine routine program;both of them had no significant improvement on muscle atrophy symptoms.(4)SF-36 evaluation resultsThe SF-36 score of the treatment group was improved at all time points;the improvement of the control group was not obvious after 6 weeks and 3 weeks of treatment.After 6 weeks of treatment,the comprehensive treatment of traditional Chinese medicine was significantly better than that of conventional western medicine.(5)Follow up study resultsAfter 6 weeks of treatment,the patients with DSPN were followed up for 10 weeks.There was no difference between the two groups.1.3 safety evaluation resultsThere was no significant difference in adverse events between the two groups by chi square test.2.Suitability evaluation results 2.1 results of technical suitability(1)Patient satisfaction survey results82 DSPN patients were satisfied with the evaluation of TCM comprehensive program.Most of the patients said that the treatment time was reasonable,and they could accept the treatment of traditional Chinese medicine,skin acupuncture and cupping;76.82% of the patients said that the treatment plan was effective.(2)The results of doctors’ Evaluation on the suitability of this technique30 doctors evaluated the suitability of the scheme,most doctors thought that the operation requirements and equipment requirements of the technology were "extremely low";the scheme had certain clinical promotion value.2.2 economic suitability evaluation resultsThe results of indirect cost evaluation showed that 53.69 unit costs were needed for each additional unit effect in the treatment group,and 62.54 unit costs were needed for each additional unit in the control group;the incremental cost-effectiveness analysis showed that 71.06 unit costs were required to be paid when the patients with conventional western medicine treatment achieved one unit more effect than those treated with Comprehensive TCM scheme Ben.3.Research results of the operation standard of appropriate technology of traditional Chinese medicine In this study,we discussed the impact of Conclusion1.DSPN occurs not only in the late stage of diabetes,but also in the early stage;the clinical symptoms of DSPN may occur in the limbs,but more easily in the lower limbs;the clinical manifestations of DSPN patients are numbness,pain,abnormal sensation,hair cooling,etc.,but the first symptoms are mainly numbness.2.On the basis of controlling blood glucose,blood pressure and blood lipid,based on the understanding of the basic etiology and pathogenesis of DSPN,"Qi deficiency and blood stasis" and modern medicine,under the guidance of the overall concept of traditional Chinese medicine and the thought of syndrome differentiation and treatment,the comprehensive scheme of traditional Chinese medicine combined with "traditional Chinese medicine internal administration + skin needle local percussion + back cupping" can improve the clinical symptoms of numbness,hypoesthesia,hair cooling and fatigue of DSPN patients Physical signs,improve the nerve conduction speed of patients,improve the quality of life of patients.3.The treatment of type 2 diabetes mellitus distal symmetrical multiple neuropathy(DSPN)with "traditional Chinese medicine oral administration + skin needle local percussion + back cupping" is effective,safe,appropriate,economical and normative,which is a comprehensive treatment plan of traditional Chinese medicine for clinical application. |
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