非哺乳期乳腺炎患者的乳管灌洗：单臂、概念验证试验。

Ductal Lavage for Patients With Nonlactational Mastitis: A Single-Arm, Proof-of-Concept Trial.

机构信息

Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China; Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, PR China.

出版信息

J Surg Res. 2019 Mar;235:440-446. doi: 10.1016/j.jss.2018.10.023. Epub 2018 Nov 19.

DOI:10.1016/j.jss.2018.10.023

PMID:30691827

Abstract

BACKGROUND

Surgery, steroids, and/or observations alone have been proposed for patients with nonlactational mastitis (NLM), but most of these studies were retrospective. The optimal treatment for these patients remains unclear. This prospective, single-arm, proof-of-concept trial aimed to evaluate the feasibility and safety of ductal lavage as a novel treatment for patients with NLM.

METHODS

Eligible patients with NLM received an intraductal infusion of corticosteroids and antimicrobial agents and returned the next day for a breast massage. This cycle was repeated for 2 wk, and we followed up these patients for 1 y. Patients did not receive surgery or steroids after ductal lavage. The primary endpoint was the time to complete response (CR).

RESULTS

This trial included 32 patients with a median (range) age of 32 (20-53). Skin erythema and tenderness were the major symptoms. The median (range) visual analog score was 5 (0-9). There were 21 (65.6%), 4 (12.5%), and 7 (21.9%) patients diagnosed as idiopathic granulomatous mastitis, periductal mastitis, and unspecific NLM, respectively. During the ductal lavage, the median (range) number of cannulated ducts at first attempt was 5 (3-8). Ductal lavage significantly reduced the visual analog score and mastitis score (M-score) (P < 0.01). Within a median follow-up of 15.6 mo, 93.8% (30/32) of patients achieved CR. The median (range) time to CR was 6 (0.5-21) mo. Three patients (10.0%) relapsed. No adverse events associated with ductal lavage were observed.

CONCLUSIONS

Ductal lavage for patients with NLM is feasible and safe, and a definitive randomized controlled trial for further investigation is warranted.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT02794688.

摘要

背景

对于非哺乳期乳腺炎（NLM）患者，单独手术、类固醇或观察治疗已被提出，但这些研究大多是回顾性的。这些患者的最佳治疗方法仍不清楚。本前瞻性、单臂、概念验证试验旨在评估乳管灌洗作为 NLM 患者新疗法的可行性和安全性。

方法

符合条件的 NLM 患者接受乳管内皮质类固醇和抗生素输注，并于次日返回进行乳房按摩。该周期重复 2 周，我们对这些患者进行了 1 年的随访。乳管灌洗后，患者不接受手术或类固醇治疗。主要终点是完全缓解（CR）的时间。

结果

该试验纳入了 32 名年龄中位数（范围）为 32 岁（20-53 岁）的患者。皮肤红斑和触痛是主要症状。中位数（范围）视觉模拟评分（VAS）为 5（0-9）。分别有 21 例（65.6%）、4 例（12.5%）和 7 例（21.9%）患者被诊断为特发性肉芽肿性乳腺炎、导管周围乳腺炎和非特异性 NLM。在乳管灌洗时，第一次尝试的中位数（范围）导管数量为 5（3-8）。乳管灌洗显著降低了 VAS 评分和乳腺炎评分（M 评分）（P<0.01）。在中位数随访 15.6 个月内，93.8%（30/32）的患者达到 CR。CR 的中位数（范围）时间为 6（0.5-21）个月。3 例（10.0%）患者复发。未观察到与乳管灌洗相关的不良事件。