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Efficacy of ' Zhixiangpi and Baizhi Medicated Thread ' drainage in the treatment of granulomatous mastitis in abscess stage

Phase 4
Recruiting
Conditions
Granulomatous lobular mastitis
Registration Number
ITMCTR2200005819
Lead Sponsor
o.1 Affiliated Hospital of Henan University of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

( 1 ) The clinical symptoms were inflammation, color ultrasound examination and breast masses were punctured by color ultrasound-guided core biopsy needle, and pathological examination confirmed GLM ;
( 2 ) The clinical symptom stage is abscess stage ;
( 3 ) Breast skin without damage ;
( 4 ) Non-lactation onset, female ;
( 5 ) The affected breast is single pus cavity, or multiple pus cavity with pus cavity number = 2 ;
( 6 ) Mass with obvious fluctuation, without breast incision and drainage before admission ;
( 7 ) The informed consent of the patient and the voluntary signing of the informed agreement by the patient meet the basic requirements of the Ethics Committee.

Exclusion Criteria

( 1 ) Women in pregnancy or lactation ;
( 2 ) The local skin of the breast becomes thinner, which is estimated by our group of clinicians to be broken within 10 days ;
( 3 ) Patients with previous primary diseases such as heart and lung, liver and kidney, tuberculosis ;
( 4 ) Patients with breast surgery or hormone therapy in recent 3 months ;
( 5 ) Patients with breast cancer ;
( 6 ) Poor compliance or a history of mental illness, unable to cooperate with treatment and follow-up ;
( 7 ) Patients with severe primary diseases such as heart and lung, liver and kidney, tuberculosis ;
( 8 ) Those who received other drugs within 3 months or had evidence of drug abuse or dependence recently.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Tumor Size;
Secondary Outcome Measures
NameTimeMethod
CD4/CD8;Degree of breast pain;CD3(+)CD8(+);complement C4;CD3(+);Local skin color of breast;complement C3;IgA;Lymphocyte Count;CD3(+)CD8(+);C-reactive protein;IgG;IgG;
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