| Objective In this study,we observed the clinical efficacy of Yiqi Tongluo decoction combined with Liraglutide in the treatment of type 2 diabetic patients with lower extremity vascular disease（Qi Yin deficiency and blood stasis syndrome）,providing meaningful data support for clinical treatment in the future.Methods（1）Fifty-four eligible patients in the outpatient and inpatient department of Endocrinology Department of Hubei Hospital of traditional Chinese medicine from October 2020 to September 2021 were randomly divided into control group and treatment group.（2）Before treatment,the general indexes（age,gender,course of disease,BMI）and curative effect indexes（FPG,2h PG,Hb A1 c,TC,TG,HDL-C,LDL-C,ankle brachial index,color Doppler of both lower limbs and symptom score）of the two groups were compared and analyzed.The differences were not statistically significant（P > 0.05）.Two groups of patients were given diabetes diet guidance and exercise intervention.The control group was treated with Liraglutide on the basis of treatment regimen.The initial dose of 0.6mg was given first weeks,subcutaneous injection ones a day.If there was no clinical adverse reaction,1.2mg was given in the second week,and ones a day.Based on the treatment of the control group,the treatment group took Yiqi Tongluo Decoction orally in the second week（200ml each time,once a day after breakfast and dinner）.（4）After 12 weeks of treatment,the curative effect indexes of the two groups were observed and statistically analyzed to evaluate the therapeutic effect.（5）The safety indexes such as vital signs,adverse reactions,three routines and liver and kidney function were observed and evaluated.Results（1）Actual enrollment: during the experiment,a total of 54 patients who met the inclusion criteria were selected in this clinical study.One patient in the control group withdrew due to severe gastrointestinal reaction during the test,and one patient in the treatment group withdrew due to poor compliance and unable to cooperate with the treatment.Finally,52 patients were actually enrolled,26 in the control group and 26 in the treatment group.（2）There was no significant difference in age,sex,course of disease and BMI between the two groups,which was comparable（P > 0.05）.There was no significant difference in efficacy indexes between the two groups,which was comparable（P > 0.05）.（3）Comparison of blood glucose indexes: FBG,2hpbg and Hb A1 c in the two groups decreased significantly compared with those before treatment（P < 0.05）.In improving blood glucose,the treatment group was better than the control group（P <0.05）.（4）After treatment,the blood lipid indexes were compared:TC,TG,LDL-C in the two groups decreased significantly compared with that before treatment,and the level of HDL-C increased significantly compared with that before treatment（P< 0.05）;In improving the blood lipid level of patients,the treatment group was better than the control group（P < 0.05）.（5）Comparison of curative effects of vascular diseases: The ankle brachial index of the two groups increased significantly compared with that before treatment（P < 0.05）,and the color Doppler ultrasound score of both lower limbs decreased significantly compared with that before treatment（P < 0.05）.In terms of the improvement of vascular wall diseases,the treatment group was better than the control group（P < 0.05）.（6）Comparison of TCM syndrome efficacy: After 12 weeks of treatment,the TCM syndrome score of the two groups was significantly lower than that before treatment（P < 0.05）.In terms of improving clinical symptoms such as lower limb pain,intermittent claudication,the treatment group was lower than the control group（P < 0.05）.The total effective rate of the treatment group was 86.31%,which was significantly better than that of the control group（P < 0.05）.（7）Safety comparison: the three routine and liver and kidney function indexes of the two groups were not significantly abnormal,and the vital signs monitored every week were stable.During the safety observation,a few patients had gastrointes tinal reactions,and the symptoms were relieved after taking measures.The incidence of adverse drug reactions between the two groups was statistically significant（P <0.05）.Conclusion Yiqi Tongluo decoction combined with Liraglutide in treatment of type 2 diabetic patients with lower extremity vascular disease with Qi Yin deficiency and blood stasis syndrome is satisfactory.1.Improve the clinical symptoms of lower limb pain,numbness,intermittent claudication,plantar paresthesia and so on;2.It can improve the disorder of glucose and lipid metabolism and increase the blood supply of affected limbs to a certain extent,so as to improve ABI index and reduce the color Doppler ultrasound score of both lower limbs;3.This comprehensive treatment is superior to the single use of liraglutide,with good safety and can be popularized in clinic. |
