A Randomized Controlled Clinical Trial Of Shaoyao Gualou Gancao Decoction Combined With Xiaozhongzhitong Plaster In The Treatment Of Acute Mastitis

Objective:The purpose of this study was to observe the clinical effects of Shaoyao gualou gancao decoction combined with Xiaozhong zhitong patches on the initial stage of breast-feeding acute mastitis.Methods:120 patients were included in the study were randomly divided into experimental group and control group.In the experimental group,60 patients were treated with Shaoyao gualou gancao decoction combined with Xiaozhong zhitong patches.60 patients in the control group were given oral antibiotic.The period of treatment is 3 days.By observing the patients’ temperature,blood routine(white blood cell count and neutrophils ratio),pain,the range of breast mass and red skin swelling,TCM symptom scores to analysis the efficacy of two groups.Results:(1)Body temperature:After 3 days of treatment,both the experimental group and the control group can restore the body temperature to the normal’ level.There was no significant difference between the two groups(P>0.05).However,within 24 hours,the body temperature returned to normal in the experimental group was 88.2%,compared with 70%in the control group,There was a statistical significance(P<0.05),which was indicating that the restore time of experimental group was faster than the control group.(2)Blood routine:comparing the white blood cell count and the percentage of neutrophils on the 0th day and the 3rd day,the ratio of the leukocytes to the normal level was 95%and 90%.There wasn’t a statistical difference between the two groups.The rate of neutrophils restore to the normal levels was 95%,compared with 87%in the control group.Statistical analysis showed no significant difference between the groups(P>0.05).We can conclude that the drug in the test group has anti-infective effect when treating this disease.(3)The area of breast mass and skin swelling:After treatment,the difference between the two groups was P<0.05,indicating that the efficacy of the experimental group was better than the control group.(4)Breast pain:The visual analogue scale was used to evaluate the patient’s breast pain sensation.The difference between the two groups was P<0.05 which was statistically significant,as aspects of pain relieving,the experimental group was better than the control group.(5)Symptoms of TCM:TCM symptoms include chest tightness,good fortune,dizziness,headache,body pain,mental depression,irritability,pain,constipation.At the end of the treatment period,there was a statistical difference between the two groups(P<0.001),indicating that the efficacy of the experimental group was better than the control group.(6)There were 3 patients in the experimental group with redness skin on the breasts,but no obvious skin lesions.We speculated that the symptom was skin allergic.There wasn’t other adverse events.Conclusions:The results of the clinical trials showed that the efficacy of Shaoyao gualou gancao decoction combined with Xiaozhong zhitong patches on the initial stage of breast-feeding acute mastitis was significant effective.Shaoyao gualou gancao decoction combined with Xiaozhong zhitong patches can not only restore the patient’s temperature and blood routine to the normal level,but also can reduce the area of breast mass and redness of the patient,relieve the pain of the breast.As aspects of TCM symptoms,It has a good effect on mental depression.There is no obvious adverse effect on the safety inspection expect skin allergic.We can conclude that Shaoyao gualou gancao decoction combined with Xiaozhong zhitong patches can safely and effectively treat the initial stages of breast-feeding acute mastitis.