| Objective:To observe the clinical efficacy of Bushen Huazhuo Jiedu Decoction,resolving turbidity and detoxifying soup intervention in diabetic foot（DF）,and to explore its efficacy mechanism from the perspective of microcirculation.Methods:Seventy-eight DF patients who met the inclusion criteria were selected and divided into a test group and a control group of 39 cases each according to a random number table.The general data（gender,age,limb of onset,Course of disease,Wagner Classification）were collected from the two groups,symptoms and signs were recorded,and the overall efficacy and efficacy of TCM symptoms were judged based on the TCM evidence scale score,and the area of the wound,the depth of the wound,the amount of exudate,the amount of purulent tissue,the amount of granulation tissue and the circumference of the wound were evaluated according to the evidence points,and ultrasensitive C-reactive protein（hs-CRP）,tumor necrosis factor-α（TNF-α）,interleukin 6（IL-6）,lipoprotein phospholipase A2（Lp-PLA2）,total cholesterol（TC）,triglycerides（TG）,lipoprotein（α）[Lp（α）],fibrinogen（FIB）,vascular endothelial growth factor（VEGF）,transcutaneous partial pressure of oxygen（Tc PO2）,blood perfusion,ankle brachial index（ABI）were measured.The control group was given the basic treatment plan,and the experimental group was given Bushen Huazhuo Jiedu Decoction,resolving turbidity and detoxifying soup on top of the basic treatment plan.On the 14th and 28th days of treatment,the patient’s traditional Chinese medicine syndrome efficacy scores were recorded,and the ulcer condition was evaluated.Transcutaneous oxygen partial pressure（Tc PO2）and blood flow perfusion were measured.The total efficacy of the two groups was recorded on the 28th day of treatment,and the above blood indicators and safety indicators were tested.The differences between the two groups before and after treatment and between the two groups were compared.Results:Two cases were shed in the test group and three cases in the control group,and the study was finally completed with 37 cases in the test group and 36 cases in the control group.（1）The overall efficiency and apparent healing rate of patients in the trial group were higher than those in the control group（P<0.05）.（2）Patients in both groups had significantly lower levels of TCM evidence points on day 14 and day 28 of treatment than before（P<0.01）,and the levels of TCM evidence points on day 28 were significantly lower than those on day 14（P<0.01）.Patients in the test group had lower levels of TCM syndrome points on both day 14 and day 28 of treatment compared with the control group（P<0.05,P<0.01）.（3）Compared with before treatment,the wound depth,exudate volume,purulent tissue volume,granulation tissue volume,and wound circumference of the two groups of patients were significantly improved on the 14th and 28th days of treatment（P<0.05,P<0.01）.The wound area score of the experimental group patients was significantly reduced on the 14th and 28th days of treatment（P<0.01）,while the wound area score of the control group patients was significantly reduced on the 28th day of treatment（P<0.05）.Compared with the 14th day of treatment,on the 28th day of treatment,the experimental group showed an improvement in wound area,wound depth,exudate volume,pyogenic tissue volume,granulation tissue volume,and wound circumference（P<0.05,P<0.01）,while the control group showed a significant improvement in wound depth,exudate volume,pyogenic tissue volume,granulation tissue volume,and wound circumference（P<0.05,P<0.01）.Compared with the control group,the granulation tissue volume and wound circumference of the experimental group were significantly improved on the 14th and 28th days of treatment（P<0.05,P<0.01）.On the 28th day,the wound area,depth,and quantity of septic tissue in the experimental group were significantly improved（P<0.05）.（4）Compared with the pre-treatment period,hs-CRP,TNF-α,IL-6,Lp-PLA2,TC,TG,Lp（α）and FIB levels were significantly lower（P<0.01）and ABI and VEGF levels were higher（P<0.01）in both groups at day 28 of treatment;at day 28 of treatment,patients in the test group had significantly lower hs-CRP,TNF-α,IL-6,TC and FIB levels were lower（P<0.05,P<0.01）and VEGF levels were higher（P<0.01）in the test group compared with the control group.（5）Tc PO2,baseline hemoperfusion,heated hemoperfusion and hemoperfusion change rate were significantly higher in both groups on day 14 and day 28of treatment compared with before（P<0.01）;Tc PO2,baseline hemoperfusion,heated hemoperfusion and hemoperfusion change rate were higher in both groups on day 28 of treatment compared with on day 14（P<0.01）.Compared with the control group,patients in the test group had significantly higher Tc PO2 levels on day 28 of treatment（P<0.05）,and higher levels of baseline perfusion,heated perfusion and rate of change of perfusion on day 14 and28 in the test group（P<0.05,P<0.01）.（6）No allergic reactions occurred in either group during treatment,and no other adverse events such as significant liver or kidney function impairment occurred.Conclusion:Bushen Huazhuo Jiedu Decoction is a safe and effective treatment for DF,which can effectively alleviate local symptoms on the wound surface,improve TCM syndrome scores,increase ulcer healing rate,and improve foot microcirculation disorders in DF patients.Its mechanism of action may be related to reducing inflammatory reactions,controlling blood lipid levels,improving blood hypercoagulability,and promoting the expression of vascular growth factors. |
