Clinical Observation Of Shengji Yuhong Ointment For External Use In Treating Granulomatous Mastitis At The Late Stage Of Collapse

Objective: To explore the efficacy and safety of Shengji Yuhong Ointment for external use in treating granulomatous mastitis at the late stage of collapse.Methods: From December 1st,2020 to November 30 th,2021,60 patients who were hospitalized in the breast thyroid surgery clinic or ward of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine were definitely diagnosed as granulomatous mastitis and were at the late stage of collapse.All the selected cases met the inclusion criteria of this study and signed the informed consent form.They were randomly divided into treatment group and control group,with 30 cases in each group.The control group was treated with conventional treatment(conventional dressing change plus oral Chinese medicine).On the basis of routine treatment,the treatment group was given Shengji Yuhong Ointment.Two groups were treated with four weeks as a course of treatment for two consecutive courses.The wound area,local symptoms(including wound fester,granulation shape and pain),TCM syndrome and lesion scope under ultrasound were evaluated at the time of admission(that is,the 1st day,hereinafter referred to as D1))and after each course of treatment(that is,the 28 th day,hereinafter referred to as D28;On the 56 th day,hereinafter referred to as D56).Serum inflammatory factors level(IL-6,hereinafter referred to as IL-6;Tumor necrosis factor-α,hereinafter referred to as TNF-α)in two groups were measured on the first day and the fifty-sixth day.Count the total effective cases after treatment,and calculate the total effective rate.At the end of the treatment period,the effective cases were followed up for 2 months,the recurrence rate was statistically analyzed,the adverse reactions in the treatment process were recorded truthfully,and the clinical efficacy of Shengji Yuhong Ointment in treating granulomatous mastitis at the late stage of collapse was comprehensively analyzed and evaluated.Result:(1)Two patients in the treatment group lost follow-up,and one patient in the control group was excluded,and 28 patients in the treatment group and 29 patients in the control group completed the established treatment.(2)In terms of wound area,there was no difference between the two groups on 28 th day(P > 0.05).With the prolongation of treatment time,the wound area in the treatment group was smaller than that in the control group on 56 th day(P < 0.05).After two courses of treatment,the wound area in the two groups was smaller than that in the group(P < 0.01).The reduction rate of wound area in the treatment group was higher than that in the control group on 28 th and 56 th day(P <0.01).(3)In terms of improvement of local symptoms,on 28 th and 56 th day,the scores of wound fester in the treatment group were lower than those in the control group(P < 0.05).On the 28 th day,there was no difference in wound granulation shape score and pain score between the two groups(P > 0.05).With the extension of treatment time,the wound granulation shape score and pain score between the two groups on the 56 th day were lower in the treatment group than those in the control group(P < 0.05).After the end of two courses of treatment,the wound fester score,granulation shape score and pain score of the two groups decreased compared with those in the group at the time of admission(P <0.01).(4)In the aspect of TCM syndrome score,the TCM syndrome score of the treatment group was lower than that of the control group on 28 th and 56 th day(P < 0.05).After eight weeks of treatment,the TCM syndrome score of the patients in both groups was lower than that in the group when they entered the group(P < 0.01).(5)In terms of lesion scope under ultrasound,there was no difference between the two groups on 28 th day(P > 0.05),but with the extension of treatment time,the treatment group was smaller than the control group on 56 th day(P < 0.05);On the 56 th day,the ultrasound lesion range of both groups decreased compared with that of the 1st day(P < 0.01).On the 28 th day,there was no difference between the two groups in the reduction rate of lesion scope under ultrasound(P> 0.05),but on the 56 th day,the treatment group was larger than the control group(P <0.05).(6)In terms of serum inflammatory factors,the levels of IL-6 and TNF-α in D56 of both groups were lower than those in D1(P < 0.01),but there was no difference between the two groups(P > 0.05).(7)In terms of total effective rate,the total effective rate of the treatment group was 96.43% and that of the control group was 72.41%,which was higher than that of the control group(P < 0.05).(8)As far as the recurrence rate is concerned,the recurrence rate of the treatment group is 3.70% and that of the control group is 4.76%,and there is no difference between the two groups(P > 0.05).(9)In terms of safety and adverse reactions,there were no abnormalities in both groups.Conclusion:Compared with conventional treatment,external application of Shengji Yuhong Ointment in treating patients with granulomatous mastitis at the late stage of collapse can reduce the wound surface,facilitate wound healing,promote granulation tissue regeneration of the wound surface,relieve patients’ pain,improve related TCM syndromes,and reduce the lesion scope under ultrasound.It is safe,free from toxic and side effects,simple and easy to implement,and has the value of further research and clinical application.