Objective,2,To evaluate the clinical efficacy of Qingre Jiedu Formula in the treatment of acute granulomatous mastitis.,Methods,2,60 patients with acute granulomatous mastitis who visited the mammary clinic of Beijing Hospital of Traditional Chinese Medicine affiliated to the Capital Medical University from August 2021 to February 2023 were included. These cases were randomly divided into Qingre Jiedu Foumula Liquid group of 30 cases and Cefuroxime axetil control group of 30 cases. Both groups were treated for 7 days and follow-up for 7 days. The effective rate of breast tumor area reduction， the reduction rate of breast tumor area， the reduction rate of redness and swelling area， VAS pain score， local skin color change， total ultrasound tumor range， maximum ultrasound focus range， white blood cells（WBC）， absolute value of neutrophils（NEUT#）， C-reactive protein（CRP）， Erythrocyte sedimentation rate（ESR） were compared.,Results,2,Seven days after the treatment， the effective rate of tumor reduction was 63.3% in the Qingre Jiedu Formula group， and 59.3% in the Cefuroxime axetil group.During the treatment period， the effective rate of breast tumor area reduction， the reduction rate of breast tumor area， the reduction rate of redness and swelling area， VAS pain score， total ultrasound tumor range， maximum ultrasound focus range， WBC， NEUT#（,P,<,0.05） were significantly improved in both the Qingre Jiedu Decoction group and the Cefuroxime axetil group ）. And there was no significant difference compared with the Cefuroxime axetil group（,P,>,0.05）. There was statistical difference in the skin color score and CRP between Qingre Jiedu Formula group and the Cefuroxime axetil group （,P,<,0.05）.,Conclusion,2,Qingre Jiedu Formula can significantly reduce breast mass， alleviated inflammatory reaction and prevent anxiety and depression. So it is a simple and effective program for the treatment of granulomatous mastitis in acute phase.