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Description for medicine or protocol of treatment in detail：
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Treatment plan
All patients in the group were treated with oral supplementation of Xiaoyong Sanjie Decoction. The basic prescriptions are as follows:
Raw Astragalus 15g, Tuckahoe 15g, Prunella 15g, Hedyotis diffusa 15g
Iwami wear 10g Passepartout 15g
All herbs are provided by the Chinese pharmacy of our hospital. The decoction method is as follows: after the herbs are put into the decoction pot, add water until the water surface does not cover the medicines, boil on high heat, and decoct on low heat for 30 minutes, and decoct the soup to 200ml each time. Each dose of two decoctions should be taken warmly 1 hour after breakfast and dinner.
On this basis, the treatment group applied Wentongxiaoyong Formula for external application of medicinal residues. The prescription of Wentongxiaoyong Formula was as follows:
Hedyotis diffusa 15g, Prunella 15g, Passepartout 15g, safflower 10g
silkworm15g, mugwort 10g, persimmon 15g
External application method: Take Chinese herbal decoction pieces from the Chinese pharmacy of our hospital, take the medicinal residues after decoction, wrap the medicinal residues with a moderate humidity of about 40 degrees Celsius with a single layer of gauze, and apply hot compresses to the affected area.
The edge of the medicine should exceed the scope of the lesion by 1cm, and the thickness should be based on the color of the lesion, 30 minutes each time, 2 times a day.
After the hot compress, cover the ulcerated area with 4 layers of 6.5cm*6.5cm sterile gauze until the next treatment.
This study plans to conduct a randomized controlled trial with an observation time of 4 months.
The experimental group received 4 months of oral administration of "Xiaoyong Sanjie Decoction" combined with the external application of Wentong Xiaoyong Formula, while the control group received 4 months of oral treatment of "Xiaoyong Sanjie Decoction".
Investigation content
① General information about the patient's disease, including the signature of the informed consent, demographics, medical history, tongue and pulse, past medical history, treatment, etc.;
②Observation indicators: the extent of ulceration, the size of the lump, the degree of breast pain, and the color of the skin.
Efficacy evaluation methods
①Break (cut) range (measured by the largest diameter):
According to the traditional Chinese medicine industry standard "Traditional Chinese Medicine Syndrome Diagnosis and Efficacy Standard" issued by the State Administration of Traditional Chinese Medicine in 1995, the evaluation standard of chronic wound efficacy was formulated:
Healing: the wound is completely healed;
Significantly effective: the wound surface is reduced by more than 70%;
Improvement: the wound area is reduced by more than 30% and less than 70%;
Invalid: The wound has been reduced by less than 30%, or not reduced at all, or has a tendency to expand.
②The size of the mass (determined by the clinician's palpation, measured by the largest diameter):
Level 0: 0 points None
Level 1: 1 point <2*2cm2
Level 2: 2 points >2*2cm2, ≤5*5cm2
Level 3: 3 points >5*5cm2
③Skin color:
Level 0: 0 points, local skin is normal
Level 1: 1 point: Local skin is dark red
Grade 2: 2 points Local skin flushing
Level 3: 3 points, localized bright red skin
④ Breast pain: using visual analog scale (VAS)
The patient circles his pain level with a pen according to the number of graded degrees on the "ruler" according to his own pain control.
Grade 0: painless;
Level 1 to 3: slight dull pain and tenderness;
Grade 4 to 6: The pain is severe, distending, dull or channeling pain, which is still tolerable;
Level 7-10: The pain is severe, and the falling pain or stinging pain cannot be close to the clothes.
painless severe pain
0 1 2 3 4 5 6 7 8 9 10
Evaluation Criteria
The wound healing, marked effect, and improvement rates of the two groups were counted respectively, and the rates were compared; the improvement of lump size, skin color, and pain were compared between the two groups. Criteria for recovery from the disease: the ulcer healed and the mass dissipated.
Observation methods
Patients fill in the subject symptom log (including ulcer healing) every 2 weeks to record the changes in the patient's condition during treatment.
①Before treatment, 1 month, 2 months, and 4 months after treatment, the extent of ulceration, the size of the lump, the color of the skin, and the degree of breast pain were recorded respectively. If the patient recovered during the observation period, the drug was discontinued, and the follow-up was followed until the end of the observation period; if the patient did not recover after the observation period, the safety indicators were rechecked, and the relevant treatment was continued, and the follow-up was followed until the recovery.
②Check blood routine (WBC, RBC, HGB, PLT, NE, ), liver and kidney function (ALT, AST, TBIL, DBIL, IBIL, BUN, CREA), and electrocardiogram before treatment, the first month and the fourth month of treatment ;
③Truthfully record the adverse reactions, treatment methods and outcomes of the patients during treatment;
④Compare the wound healing rate, tumor size, skin color, and pain improvement between the two groups;
⑤Follow-up should be carried out for the patients who fall off, and the reasons for falling off and the lesions should be recorded truthfully.
Statistics and analysis methods
The wound healing within 1 month, 2 months, and 4 months of treatment was counted, and the curative effects of the treatment group and the control group in terms of wound healing rate, mass size, skin color, and pain improvement were compared, and the recovery rates of the two groups were compared. Continuous variables were analyzed by variance analysis, count data were analyzed by X2 test, and rank data were analyzed by rank sum test. Compare and analyze the curative effects of the two treatments.
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Inclusion criteria
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1.TCM diagnostic criteria
Referring to the 2012 "Guidelines for Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine Surgery", the diagnostic criteria for acne mastitis:
1.1 Clinical manifestations:
Mostly in women who are not lactating or non-pregnant, unilateral breast disease is more common, and most of them are accompanied by congenital nipples that are all or partially sunken, and have white and smelly powder-like secretions. The clinical manifestations are complex and diverse, and are often divided into discharge stage, mass stage, suppurative stage, and fistula stage. The initial mass was located in the areola, red, swollen, painful, and purulent. After the rupture, the pus is mixed with powder and slag-like substances, and the mouth does not close for a long time;If the attack is repeated, scarring is formed, and there is residual stiffness, the nipple depression will be more obvious. Symptoms such as mild aversion to cold and fever are generally associated with redness, swelling and purulence.
1.2 Auxiliary inspection:
Laboratory tests: Serum prolactin levels were significantly increased in some cases. Imaging examination: B-ultrasound: Irregular sheet-like hypoechoic and enhanced light spots are seen in the lesion. If there are multiple hypoechoic spots, it means that the fistulas can be connected to each other.Mammographic mammography: There are unevenly increased density shadows around the areola and other parts, the boundary is unclear, there are cord-like dense shadows, and the skin around the areola is thickened. CT enhancement: see heterogeneous enhancement, low density shadow in the lesion. Pathological examination: fine needle aspiration cytology examination of breast mass: a variety of cells can be seen mixed, mainly inflammatory cells, and other inflammatory cells.
2 Western medicine diagnostic criteria
Based on pathological examination, the mammary ducts were highly dilated under MDE/PDM, and the cysts were filled with pink granular thick substances; lymphocytes, plasma cells and neutrophils were infiltrated around the dilated ducts.
The most prominent feature of GLM is noncaseating granulomas centered on the lobular unit of the mammary gland, which are multifocal in distribution and vary in size, with or without microabscesses.
3 Inclusion criteria
① Patients who meet three or more of the above-mentioned diagnostic criteria for acne mammary carbuncle (must meet the first item) at the same time in Xiyuan Hospital;
②The pathological diagnosis of non-lactation mastitis such as plasma cell mastitis or granulomatous lobular mastitis;
③ Female patients, aged 18-49;
④ The lesion is in the stage of rupture (including the rupture has not healed, or the incision has not healed after surgery, drainage, etc.);
⑤ Agree to participate in this clinical trial and be willing to cooperate with the completion of this research.
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