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临床试验/NCT06565845
NCT06565845招募中不适用

Analysis of the Clinical Characteristics and Three Treatment Methods of Granulomatous Lobular Mastitis

First Affiliated Hospital of Harbin Medical University1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2024年8月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
350
试验地点
1
主要终点
Differences in the cure rate of the three treatment modalities

研究概览

简要总结

Granulomatous lobular mastitis (GLM) is a rare benign breast disease that is difficult to distinguish from breast cancer based on clinical and imaging findings, and there is currently no standard treatment. This study aims to analyze the clinical characteristics and demographic data of GLM patients and to compare the overall effectiveness of three treatment methods: surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy, with the goal of providing new insights for clinical treatment.

详细描述

In recent years, the incidence of this disease has been increasing annually. The incidence of GLM is region-specific, being higher in Mediterranean regions and Asian countries. The etiology is currently unclear, but many studies suggest that GLM is associated with autoimmune disorders, hormonal imbalances, and microbial infections . GLM has a long course, is difficult to treat, and prone to recurrence, causing significant trauma to the patient's breast appearance and overall well-being. Currently, the main treatment methods for GLM include surgical treatment, drug therapy, combined surgery with drug therapy, and close observation. Surgical treatment options mainly include abscess incision and drainage, segmental resection, subcutaneous mastectomy, mastectomy, and breast reconstruction. Although surgical treatment can rapidly improve the condition, the recurrence rate reported in the literature ranges from 5% to 50% . Although GLM is a benign disease, it can severely impact the patient's normal life, causing physical and psychological trauma. However, few studies have included patients' subjective treatment experiences in the evaluation of treatment outcomes.

To date, there have been no studies comparing the efficacy of three treatment methods (surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy) in the same population of GLM patients. This study aims to compare the efficacy and patient satisfaction of these three treatment methods, with the hope of providing new insights for clinical treatment options.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 65 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • non-lactating and aged 15-65 years
  • histopathological confirmation of GLM
  • normal liver and kidney function

排除标准

  • lactating and pregnant women
  • allergies to rifampin, isoniazid, or ethambutol
  • concurrent malignant breast tumors
  • severe underlying diseases
  • other conditions deemed unsuitable by the investigator and
  • refusal to participate in the study

研究组 & 干预措施

surgery group

The patients underwent surgery

干预措施: Surgery (Procedure)

triple anti-tuberculosis drug therapy group

The patients were treated with triple anti-tuberculosis drugs

干预措施: triple anti-tuberculosis drug (Drug)

combination therapy group

The patients were treated with surgery first, and then took triple anti-tuberculosis drugs after surgery

干预措施: Surgery (Procedure)

combination therapy group

The patients were treated with surgery first, and then took triple anti-tuberculosis drugs after surgery

干预措施: triple anti-tuberculosis drug (Drug)

结局指标

主要结局

Differences in the cure rate of the three treatment modalities

时间窗: Baseline

According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The cure rate was compared among the three groups.

Differences in the recurrence rate of the three treatment modalities

时间窗: Baseline

According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The recurrence rate was compared among the three groups.

Differences in the incidence of adverse reactions of the three treatment modalities

时间窗: Baseline

According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The incidence of adverse reactions was compared among the three groups.

次要结局

  • Differences in the treatment duration (months) of the three treatment modalities(Baseline)
  • Differences in the patient satisfaction score (points) of the three treatment modalities(Baseline)

研究者

发起方
First Affiliated Hospital of Harbin Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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