| Objective:This research through clinical randomized controlled trial was conducted to observe and analyze the clinical efficacy of Runjidan oil combined with Modified Si Miao Yong An Decoction in the treatment of diabetic foot ulcer with damp-heat and toxicity accumulation type,and to objectively evaluate its effectiveness and safety,so as to provide evidence-based basis for the clinical application of Runjidan oil.Methods:A total of 60 patients with diabetic foot ulcer who met the criteria were selected and divided into the treatment group and the control group with 30 patients in each group by random number table method.One patient in the control group dropped off due to personal reasons,and a total of 59 patients were included,including 30 patients in the treatment group and 29 patients in the control group.Two groups after the foundation treatment,routine debridement,after being wound to perfect,the treatment group take the external use Runjidan oil gauze strip with Modified Si Miao Yong An Decoction oral therapy,the control group take the external use of Compound comfrey oil yarn article combined oral Modified Si Miao Yong An Decoction treatment,both groups treatment 1times a day,with 2 weeks for a period of treatment,treatment of two period of treatment.The changes of wound local syndrome score,wound area,wound depth,WBC and CRP counts in whole blood,bacteria positive rate and wound central temperature were observed and recorded before treatment,2 weeks and 4 weeks after treatment in the two groups.SPSS 24.0software was used for statistical analysis and evaluation of clinical efficacy.Results:(1)Baseline data: Before treatment,age,gender,Wagner grade,BMI,ABI,course of diabetes,course of diabetic foot ulcer and blood glucose related indicators were compared between the two groups,showing no statistical significance(P > 0.05).(2)Observation indicators: After 4 weeks of treatment,local syndrome score,wound area,wound depth,WBC and CRP counts in whole blood,wound central temperature and bacterial positive rate in both groups were significantly improved compared with before treatment,with statistical significance(P<0.05),and the treatment group was superior to the control group.(3)Total effective rate: after 4 weeks of treatment,the total effective rate of the control group was 75.86%,and the total effective rate of the treatment group was 90.00%,the comparison between the two groups was statistically significant(P < 0.05),and the treatment group was significantly better than the control group.Conclusion:(1)Runjidan Oil combined with Modified Si Miao Yong An Decoction can improve the wound symptoms of diabetic foot ulcer with damp-heat toxicity accumulation type,increase the central temperature of the wound,reduce the WBC and CRP counts in whole blood and the bacterial positive rate in wound secretions,and accelerate wound healing.(2)Patients in the treatment group had definite clinical efficacy,no obvious toxic and side effects and adverse reactions were observed,which confirmed the effectiveness and safety of Runjidan oil and had certain clinical application and research value. |