| Objective:To observe the clinical effect of Jiedu Shengji Ointment,which was developed according to the theory of "clearing away heat and toxic substances,eliminating decay and generating muscle",on promoting the healing of chronic skin ulcers in diabetes.To explore whether Jiedu Shengji Ointment can promote healing by reducing the expression of AGEs and IL-6 in local wound tissue and shortening the continuous inflammatory reaction process of the wound,so as to provide a theoretical basis for the clinical treatment of diabetes chronic skin ulcer with Jiedu Shengji Ointment.Methods:Seventy-two patients with diabetic skin ulcers with toxic decay evidence were selected from the First Hospital of Hunan University of Chinese Medicine and randomly divided into 36 patients in the test group and 36 patients in the control group,and the test group was given Jiedu Shengji ointment and the control group was given silver sulfadiazine cream,which was changed once a day and observed for 14 days.The quantitative scores of TCM symptoms(including trauma exudate,granulation,putrefaction,epithelial volume,trauma and peri-trauma,pain,etc.)were recorded on the 1st,7th and 14th days of treatment,and the changes of treatment scores were compared among the groups;the changes of serum WBC,CRP,IL-6 and other indexes were analyzed before and after 14 days of treatment;the expression levels of trauma AGEs and IL-6 were detected by ELISA,and all data were analyzed by SPSS26.0 statistical analysis software was used to process all data,and P<0.05 indicated that the differences were statistically significant.Results:A total of 72 patients were included in this study,of which 4 cases were shed in the test group and 4 cases were shed in the control group,and 64 cases were finally completed.Before treatment,the general information situation(age and gender)and symptom score of the two groups were compared,and the differences between the groups were not statistically different(P>0.05)and were comparable.In terms of clinical efficacy,after 14 days of treatment,2 cases were cured,22 cases showed efficacy,7 cases were effective,and 1 case was invalid,with an effective rate of 96.87%and a significant rate of 68.7%;in the control group,1 case was cured,13 cases showed efficacy,13 cases were effective,and 5 cases were invalid,with an effective rate of 81.25%and a significant rate of 40.6%(P<0.05),and the difference was statistically significant,and the detoxification and muscle growth cream group was better than the sulfadoxine-pyrimethamine silver cream group.The difference was statistically significant,and the Jiedu Shengji ointment group was better than the silver sulfadiazine cream group.The expression of AGEs and IL-6 in the traumatic tissue was lower than before treatment,and the test group was lower than the control group(P<0.05);the serum WBC,CRP and IL-6 count were lower than before treatment(P<0.05).The symptom scores of traumatic exudate,granulation,putrefaction,epithelial volume,traumatic and peri-traumatic conditions,and pain were dynamically assessed in both groups on days 1,7,and 14 of treatment,and the results showed that the scores of both groups decreased compared with those before treatment,and day 14<day 7<day 1,and the test group was better than the control group in the intergroup comparison(P<0.05).Safety:there was no difference between the two groups,and no serious toxic side effects or adverse reactions were observed in either group.Conclusion:Jiedu Shengji Ointment can improve the symptom scores such as wound exudation,carrion,wound and peritraumatic conditions,granulation,epithelial volume,and pain,reduce the expression of AGEs and IL-6 in wound tissue,reduce the expression of IL6,CRP,and WBC in serum,shorten the inflammatory reaction process of the wound,and promote wound healing.The application of the method of "clearing away heat,detoxifying,removing decay and regenerating muscle" in the treatment of diabetes chronic skin ulcer has a definite clinical effect,which is better than sulfadiazine silver,and is feasible in clinical promotion and safe. |