 Ductal lavage followed by observation versus oral corticosteroids in idiopathic granulomatous mastitis: A randomized trialXiaolin 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 () and
Kai Chen ()
Nature Communications, 2024, vol. 15, issue 1, 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. Date: 2024 Downloads: (external link) Related works: Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text Persistent link: https://EconPapers.repec.org/RePEc:nat:natcom:v:15:y:2024:i:1:d:10.1038_s41467-024-53143-2 Ordering information: This journal article can be ordered from DOI: 10.1038/s41467-024-53143-2 Access Statistics for this article Nature Communications is currently edited by Nathalie Le Bot, Enda Bergin and Fiona Gillespie More articles in Nature Communications from Nature |
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