Nature Communications (Oct 2024)
Ductal lavage followed by observation versus oral corticosteroids in idiopathic granulomatous mastitis: A randomized trial
- Xiaolin Chen,
- Heng Huang,
- Hui Huang,
- Juanjuan Yong,
- Liling Zhu,
- Qianru Chen,
- Luyuan Tan,
- Yinduo Zeng,
- Yaping Yang,
- Jianli Zhao,
- Nanyan Rao,
- Linxiaoxiao Ding,
- Wenjing Wu,
- Yudong Li,
- Xiujuan Gui,
- Liming Ye,
- Yanlian Xu,
- Yumei Jiang,
- Linhong Su,
- Qiaozhen Xiao,
- Xueying Cai,
- Tingting Hu,
- Cui Tan,
- Qiongmei Liu,
- Shuyi Liu,
- Jinghua Zhao,
- Ying Wang,
- Fengyan Yu,
- Jian Zhang,
- Shunrong Li,
- Kai Chen
Affiliations
- Xiaolin Chen
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Heng Huang
- Department of Breast Surgery, Lianjiang People’s Hospital
- Hui Huang
- Department of Breast Surgery, Jiang Men Maternity and Child Health Care Hospital
- Juanjuan Yong
- Department of Pathology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Liling Zhu
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Qianru Chen
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Luyuan Tan
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Yinduo Zeng
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Yaping Yang
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Jianli Zhao
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Nanyan Rao
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Linxiaoxiao Ding
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Wenjing Wu
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Yudong Li
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Xiujuan Gui
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Liming Ye
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Yanlian Xu
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Yumei Jiang
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Linhong Su
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Qiaozhen Xiao
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Xueying Cai
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Tingting Hu
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Cui Tan
- Department of Pathology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Qiongmei Liu
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Shuyi Liu
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Jinghua Zhao
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Ying Wang
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Fengyan Yu
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Jian Zhang
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, SunYat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases
- Shunrong Li
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Kai Chen
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- DOI
- https://doi.org/10.1038/s41467-024-53143-2
- Journal volume & issue
-
Vol. 15,
no. 1
pp. 1 – 10
Abstract
Abstract Oral corticosteroids represents the most prevalent treatment for idiopathic granulomatous mastitis. Ductal lavage with triamcinolone acetonide and antibiotics followed by observation (DL-OBS) has emerged as a novel strategy, but a comparison of them remains lacking. Here in this multicenter, open-label, non-inferiority, randomized trial (ClinicalTrials.gov identifier: NCT03724903), we assigned 140 patients to oral corticosteroids (N = 71) and DL-OBS (N = 69), stratified by baseline M-score. The primary outcome is complete Clinical Response rate at 1 year. The non-inferiority margin is −15%. The primary outcome is 85.5% in DL-OBS and 87.3% in oral corticosteroids (difference: −1.8%; 95%CI, 13.2 to 9.5; Pnon-inferiority = .01) in intention-to-treat population, and 92.6% vs 98.2% (difference −5.6%; 95%CI −13.4 to 2.2; Pnon-inferiority = .01) in per-protocol population, respectively. The most common (>15%) adverse events were Cushingoid, epigastric pain and arthralgia in oral corticosteroids, and irregular menstruation in DL-OBS, respectively. Here, we report that DL-OBS shows similar efficacy to oral corticosteroids but with better safety profile.