Therapeutic effect of Xihuang capsules in combination with low-power high-intensity focused ultrasound on granulomatous mastitis and its impact on macrophage (CD68) and proliferative (Ki67) markers | [Pakistan Journal of Pharmaceutical Sciences • 2025]

Author(s):

1. Xiaolong Li: Department of Breast Surgery, Shijiazhuang Fourth Hospital,Shijiazhuang,China

2. Hang Li: Department of Breast Surgery, Shijiazhuang Fourth Hospital,Shijiazhuang,China

3. Chunling Mu: Department of Breast Surgery, Shijiazhuang Fourth Hospital,Shijiazhuang,China

4. Haonan Li: Department of Breast Surgery, Shijiazhuang Fourth Hospital,Shijiazhuang,China

5. Qianqian Du: Department of Breast Surgery, Shijiazhuang Fourth Hospital,Shijiazhuang,China

6. Wei Liu: Department of Breast Surgery, Shijiazhuang Fourth Hospital,Shijiazhuang,China

Abstract:

Granulomatous mastitis (GM) is a chronic inflammatory breast disease with a high recurrence rate and low effectiveness of the traditional treatments. This randomized controlled trial compared the effectiveness of the combined use of Xihuang Capsules and low-power High-Intensity Focused Ultrasound (HIFU) and their impact on macrophage infiltration (CD68) and cell proliferation (Ki67). Sixty women with histologically proven GM were randomized to experimental (HIFU + Xihuang) or control (HIFU alone) groups (n=30 each group). Follow-up was for 12 weeks and recurrence at 6 months. Compared with controls, the combination group experienced more lesion reduction (3.50±0.79 cm to 0.92±0.42 cm vs. 3.42±0.88 cm to 1.85±0.60 cm, p<0.001), improved complete resolution (86.7% vs. 60.0%, p = 0.023), earlier resolution (6.2±1.4 vs. 9.1±1.8 weeks, p<0.001) and greater pain reduction (VAS: 7.2±1.1 to 1.3±0.6 vs. 7.0±1.3 to 2.8±0.9, p<0.001). Immunohistochemistry also demonstrated marked reductions in CD68+ macrophages and Ki67 index, both blindly graded. Recurrence at 6 months reduced with combination therapy (6.7% vs. 20.0%, p=0.098). Both treatments were well tolerated. These data indicate that Xihuang Capsules plus low-power HIFU produce faster regression of lesions, disappearance of symptoms and modulation of macrophage infiltration and cell proliferation in GM, with tendency of decreased recurrence.

Page(s): 2453-2461

DOI: 10.36721/PJPS.2025.38.6.REG.15239.1

Published: Journal: Pakistan Journal of Pharmaceutical Sciences, Volume: 38, Issue: 6, Year: 2025

Keywords:

Combination therapy , Xihuang capsules , Lowpower highintensity focused ultrasound , Granulomatous mastitis , Proliferation marker Ki67 , Macrophage marker CD68

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