Clinical Efficacy Observation Of Shenqi Fuzheng Injection Combined With Glucocorticoid In Treating Tumor Phase Of Granulomatous Mastitis

Objective: This study compared the improvement of local breast symptoms and conservative treatment rate,effective rate,incidence of adverse reactions and other indicators to observe the clinical efficacy of Shenqi Fuzheng injection combined with glucocorticoid and glucocorticoid alone in treating tumor phase of granulomatous mastitis;To investigate the potential mechanism of Shenqi Fuzheng injection and glucocorticoid in treating tumor phase of granulomatous mastitis and the expression of IL-6,IL-10 and TNF-α cytokines.Methods: Sixty patients with granulomatous mastitis in tumor phase who met the diagnostic,inclusion and exclusion criteria were randomly divided into Shenqi combine hormone group and hormone group,with 30 cases in each group.The hormone group was treated with glucocorticoid,and the Shenqi combine hormone group was treated with Shenqi Fuzheng injection on the basis of glucocorticoid.The change trend of tumor,improvement of symptoms and signs,conservative treatment rate,effective rate,incidence of adverse reactions and expression of cytokines(IL-6,IL-10 and TNF-α)were observed after 14 days of treatment.SPSS 25.0 software was used for data processing and statistical analysis.Results:1.Local symptoms of the breast:(1)The change trend of the tumor:The tumor size of the two groups was significantly reduced in the first four days of treatment.In the hormone group,the tendency of the tumor to continue to shrink was not obvious on the seventh to eighth days after the treatment,and there were even five cases of rebound;Tumors in Shenqi combine hormone group showed a continuous shrinking trend without rebound.(2)The change of tumor size:After treatment,the tumors of the patients in the Shenqi combine hormone group and the hormone group were significantly reduced(P<0.05),and there was no significant difference in the tumor size between the two groups after treatment(P > 0.05);The proportion of tumor reduction in Shenqi combine hormone group was higher than that in hormone group(P<0.05).(3)Breast swelling and pain:From the comparison of breast pain score and skin color score,after treatment,the breast swelling and pain of patients in the Shenqi combine hormone group and the hormone group was significantly relieved(P<0.05);comparison between groups,the combination of Shenqi Fuzheng injection was superior to glucocorticoid alone in alleviating breast swelling and pain(P<0.05).2.TCM syndrome score:After treatment,TCM symptoms of Shenqi combine hormone group and the hormone group were significantly relieved(P<0.05);combined with Shenqi Fuzheng injection,it can better improve the uncomfortable symptoms of the chest fullness,irritability,mental fatigue,insomnia and anxiety(P<0.05).3.Clinical efficacy: After fourteen days of treatment,the effective rate of Shenqi combine hormone group was,which was higher than 85.71% of the hormone group(P<0.05),reflecting the advantages of Shenqi Fuzheng injection in the treatment of this disease.4.Adverse reactions and conservative treatment rate:There were 2 cases of adverse reactions in the Shenqi combine hormone group and 6 cases in the hormone group;the combination of Shenqi Fuzheng injection can reduce the occurrence of adverse reactions in patients to a certain extent,but there is no significant difference compared with the hormone group(P>0.05).The conservative treatment rate of Shenqi combine hormone group is93.10%,which was higher than 71.43% of the hormone group(P<0.05).The combination of Shenqi Fuzheng injection can increase the conservative treatment rate of patients,and avoid trauma caused by surgical treatment and damage to the appearance of the breast.5.Follow-up results:The follow-up after two months of conservative treatment in hospital or outpatient department showed that the cure rate of Shenqi combine hormone group was 51.85%,which was higher than that of hormone group(40.00%).The study proved that the combination of Shenqi Fuzheng injection could increase the cure rate of conservative treatment to a certain extent,and there was no significant difference between the two groups(P>0.05).6.Positive expression of cytokines: Compared with before treatment,the positive expression rate of IL-6 and TNF-α in the inflammation tissue of the Shenqi combine hormone group and the hormone group were significantly reduced(P<0.05),and the positive expression rate of IL-10 was significantly increased(P < 0.05);after treatment,the positive expression rate of IL-6 and TNF-α in the inflammation tissue of the Shenqi combine hormone group was significantly lower than that of the hormone group(P<0.05),and the positive expression rate of IL-10 in inflammatory tissue of Shenqi combine hormone group was higher than that of the hormone group,but there was no significant statistical difference(P>0.05).Conclusion: 1.Shenqi Fuzheng injection combined with glucocorticoid therapy and glucocorticoid therapy alone had a certain clinical effect on granulomatous mastitis in mass stage,and effectively improved clinical symptoms and signs.Compared with hormone therapy alone,the combination of Shenqi Fuzheng Injection can increase the conservative treatment rate,effective rate and incidence of adverse reactions.It shows that Shenqi Fuzheng injection has advantages in treating granulomatous mastitis.2.From the immunological point of view,Shenqi Fuzheng injection and glucocorticoid in treating tumor phase of GM may be related to the decrease of the positive expression rate of IL-6 and TNF-α and the increase of the positive expression rate of IL-10 in inflammatory tissue.It can inhibit the inflammatory response,regulate the balance of Th1/Th2 cytokines and improve the local immune microenvironment.Combined Shenqi Fuzheng injection can better inhibit inflammatory response,reflecting the characteristics of traditional Chinese medicine in treating this Disease.