Efficacy and Safety of Sanyong Jiedu Granules in Treating Lumps-Type Non-Lactational Mastiti

Overall Response Rate

(Complete Response + Partial Response)/Total number of cases × 100%

Lump Size

The maximum diameter (longitudinal diameter) of the target lesion is measured by the investigator through imaging examinations (with breast ultrasound as the preferred method). If multiple lesions are present, one largest lesion is selected as the target lesion for tracking.Evaluate the percentage change in the maximum diameter of the target lesion relative to baseline at 4 weeks and 8 weeks post-treatment.

NRS Score

A 0-10 point numerical rating scale (NRS) was used, where 0 points indicated "no pain" and 10 points indicated "the most severe imaginable pain." Investigators guided patients to rate their pain intensity based on the average pain level over the past 24 hours during the visit.The relative changes in NRS scores from baseline were evaluated at 2, 4, and 8 weeks post-treatment and at 1 and 3 months after discontinuation of medication.

Course of the disease

Imaging complete response: Imaging evaluation demonstrates complete resolution of all target lesions; Clinical response: The mass persists without clinical symptoms such as redness, swelling, heat, or pain. Imaging assessment: Breast ultrasound examinations were performed at baseline, 4 weeks after medication initiation (D28±5 days), and at treatment completion (D56/withdrawal ±7 days). Investigators assessed the size of target lesions based on ultrasound findings during follow-up visits. Clinical examination: Record the maximum diameter of the mass (unit: cm), tenderness level (using the NRS scoring system), and severity of clinical symptoms (cutaneous erythema, tissue swelling, and localized heat sensation) at baseline, 2 weeks after medication initiation (D14±3 days), 4 weeks after medication initiation (D28±5 days), and at treatment completion (D56/withdrawal ±7 days).

Recurrence Rate

The assessment is conducted by the investigator during the visit based on the results of imaging examinations and clinical examinations.

Safety evaluation indicators

Refer to the NCI-CTCAE 5.0 classification criteria for adverse drug events.

Exploratory indicators

Breast lesion tissues (matched pathological tissue samples from pre-enrollment puncture biopsy and post-treatment lesion resection), blood samples collected 56 days after administration of San Yong Jie Du Granules or until complete symptom relief/stabilization, compared with baseline levels: detection of serum T-cell subsets (CD4+, CD8+), serum antibodies (IgG, IgA), and measurement of inflammatory cytokine expression including IL-6, IL-1β, NF-κB, and TNF-α.