Female benign intraductal papilloma of the breast duct
Conditions
Interventions
treatment group:Yanghe Decoction combined with hot compresses
control group:active surveillance
Sponsors
Chongqing Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Young and middle-aged women of childbearing age (aged 18 to 55); 2. Diagnosed with intraductal breast lesions by breast color Doppler ultrasound, and classified by BI-RADS as strictly category 3 or 4a (category 4a requires confirmation by MDT); the patient clearly expressed a refusal of surgical treatment (this intention must be clearly recorded in the medical record and reconfirmed during the informed consent process); only patients who have been unanimously assessed by MDT as being acceptable for short-term observation or non-surgical treatment can be included. 3. Complete clinical data; 4. Meet the diagnostic criteria of the TCM syndrome of Yang deficiency and cold coagulation; 5. Voluntarily participate in the trial, have signed the informed consent approved by the ethics committee, and cooperate with this research project; 6. Have good compliance, take the prescribed medications as per the research regulations and undergo follow-up examinations.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors; 2. Exclude those who are planning to conceive, have a conception plan within the past three months, are pregnant, or are in the lactation period with breast diseases; 3. Exclude those who have undergone breast surgery due to breast diseases in the past; 4. Exclude those with severe systemic diseases, who cannot express their own will, those with mental disorders, or those with hysteria; 5. Exclude those with allergic constitution, who are allergic to external medications or external dressings; 6. Exclude those who have taken drugs that may affect the observation indicators of this study within the recent period (about one month before enrollment) and cannot stop using them.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of lesion progression;Surgical delay rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Simplified McGill Pain Questionnaire (SF-MPQ);Amount of nipple discharge;Breast Mass Score;Traditional Chinese Medicine Syndrome Score; | — |
Countries
China
Contacts
Public ContactGang Lyu
Chongqing Traditional Chinese Medicine Hospital
Outcome results
None listed