A Clinical Controlled Study Of Traditional Chinese Medicine Combined With Surgery In The Treatment Of Granulomatous Lobular Mastitis

Objective:A comparative analysis of the efficacy of TCM Xiaoyong Decoction combined with surgery in the treatment of granulomatous lobular mastitis(GLM),comparing the difference in efficacy between the TCM oral combined simple surgery,summarizing the outstanding advantages of TCM in the treatment process to provide a more reliable evidence-based medical basis for the evaluation of clinical treatment methods.Methods:Female patients with granulomatous lobular mastitis who were included in the outpatient clinic of the Oriental Hospital from May 2018 to February 2019 were enrolled.It is expected that 52 patients will be enrolled,of which 6 will be shedding,and 46 will be included.For example,25 patients in the Chinese medicine combined operation group and 21 patients in the simple operation group.TCM combined operation group:The whole course was treated with oral Chinese medicine Xiaoyong Decoction,and according to the changes of local breast lesions,abscess sharp debridement and GLM radical surgery were performed at the appropriate time.The corresponding antibiotics were given before and after surgery.In the surgery group alone,except for the treatment of oral Chinese medicine,the remaining treatment measures were the same as those in the TCM group.According to the "clinical Chinese medicine clinical path"table,self-made"granuloma lobular mastitis efficacy evaluation quantitative score table"score measurement,collect patient-related clinical data for collation and summary,use the spass21.0 software to analyze the data in detail.Furthermore,the clinical efficacy of the oral administration of Xiaoyong Decoction was evaluated,and the advantages of the two different methods in the treatment process were compared.The evaluation indicators mainly include changes in clinical syndrome scores,local wound changes,course of treatment,clinical cure rate,breast shape,recurrence rate,side effects and adverse reactions.The study endpoint was the end of follow-up.Results:1.Among the 46 patients,GLM can occur in all ages,mainly in the 26-40 years old(91.3%),and more than 40%patients with BMI in the overweight range(≥25.0).Most of the patients were diagnosed(66.64%)within 3 to 6 years after delivery,and the initial symptoms were sudden masses of 35(76.09%).20 cases(43.48%)with nipple retraction or malformation,19 cases(41.3%)had a history of abortion,8 cases of acute mastitis(21.05%),and 9 cases(23.91%)had a history of trauma.There were 3 people(6.52%)who had oral emergency contraception.2.The disease can occur in all seasons.The course of the disease is concentrated within 6 months before treatment.39 cases(90.48%)were treated in the external hospital.The concomitant rate of systemic symptoms was about 8.6%,and the average diameter of the mass was 9.95 cm.There were 4 patients(8.7%)with bilateral breast disease;29 patients(63.04%)with ruptured breasts were the most common in the upper and upper quadrants,and more than 50%of the patients occupied more than 2 quadrants.And the white blood cell count,neutrophil count increased with a low rate,only 3 people increased the level of prolactin to more than 2 times the normal value.3.Twenty-one patients were cured by traditional Chinese medicine combined with 12 cases,and 10 cases were markedly effective.In the alone operation group,10 cases were cured and 3 cases were markedly effective.The cure rate was 100%in both groups.The curative effect was statistically significant(P=0.008).The average treatment of traditional Chinese medicine combined operation group.The duration of treatment was 89.48±31.51d.The average duration of treatment in the simple operation group was 77.67±37.15d.There was no significant difference in the length of treatment time between the two groups(P=0.298)The combination of Chinese medicine and traditional surgery group promoted the growth of wounds and the reduction of secretions.Compared with the alone operation group(P<0.05),there was no significant difference in the syndrome scores between the two groups in the enrollment,2 weeks,sharp debridement and GLM radical surgery,but the TCM group is better than the single surgery group in the relief of TCM syndromes.In the evaluation of breast shape,the TCM combined surgery group,it was better than the simple operation group(P=0.047<0.05).There were 2 cases of recurrence in the operation group alone,but there was no significant difference compared with the TCM combined operation group.The local incision and drainage were healed after 2 weeks of dressing change.4.There were no serious side effects or adverse events in the two groups.The blood routine and liver function were normal in the group,and the prolactin was elevated in both groups after operation.Considering that the increase of the value did not exceed 2 times of the normal value,it has little significance for clinical diagnosis.Conclusions:Compared with surgery alone,the total effective rate of TCM combined with surgery is 100%.The two methods are effective for the treatment of this disease,but the Chinese medicine combined surgery group relieves the TCM syndrome,shortens the dressing time,and keeps the better breast shape.The effect of excellentness is more prominent,with no toxic side effects,and it is worthy of clinical use.Because of the short follow-up time,there was no significant difference in recurrence within 3 months(P>0.05).The clinical classifications that are suitable for each of the two methods require more stringent constraints,and further large sample sizes of research data are needed to support the validation.