Ethics statement

This study was approved by He Bei General Hospital ethics committee, and patients or their families gave informed consent and signed informed consent.

Subjects

A total of 140 patients with adenomyosis admitted to He Bei General Hospital from January 2020 to December 2021 were randomized into group A (laparoscopic surgery), group B (laparoscopic surgery combined with gonadotropin-releasing hormone analogs [GnRH-a]), group C (ultrasound-guided percutaneous radiofrequency ablation), and group D (ultrasound-guided percutaneous radiofrequency ablation combined with GnRH-a), with 25 cases in each group.

Inclusion criteria: (1) Patients were diagnosed with adenomyosis after an ultrasound or magnetic resonance imaging examination, which was consistent with the relevant diagnostic criteria in Obstetrics and Gynecology: ① Clinical manifestations were dysmenorrhea and hypermenorrhea, which had been aggravated; ② Gynecological examination indicated uterine enlargement; ③ Vaginal color ultrasonography indicated that the uterus was enlarged, there were abundant blood flow signals in the uterine wall, manifested as diffuse congestion, and color signals existed in the liquid anechoic area; (2) Patients had fertility requirements and did not use any contraceptive and sex hormone drugs within 3 months before surgery; (3) Patients met the criteria for laparoscopic focal resection.

Exclusion criteria: (1) Patients with cervical and endometrial lesions; (2) Patients with mental illness; (3) Patients with metabolic, immune, and endocrine-related diseases; (4) Patients with significantly decreased ovarian function; (5) Patients with hypoestrogen and hypocalcemia; (6) Patients with allergies; (7) Patients with ovarian cysts and uterine fibroids.

Treatment methods

Patients in Group A underwent laparoscopic surgery, which was performed by 2 professional physicians. Laparoscopy was implanted after Trocar routine puncture, and preoperative ultrasound and MRI imaging data were combined with intraoperative exploration. The spindle incision of the diseased tissue was excised as thoroughly as possible in a location where the lesion was evident, and the lesion was removed without penetrating the uterine wall. Muscle layer and seromuscular layer were sutured to stop bleeding and repair the uterus. No dead space was found during surgery.

Based on group A, patients in group B were given subcutaneous injection of Leuprorelin Acetate (Shanghai Livzon Pharmaceutical Co., Ltd., H20093852) at 3.75 mg each time, once every 4 weeks, for 3 months after pathological diagnosis on the 3rd day after surgery.

Patients in Group C underwent ultrasound-guided percutaneous RFA. Lesion size, location, boundary, and blood supply were evaluated by contrast-enhanced ultrasound in patients posed in a supine position. In the treatment area, the skin was prepared, an indwelling catheter was placed, and venous access was opened. In the case of the lagedes uterus, it could be adjusted and fixed by a transvaginal probe. Routine disinfection was performed, and the intestines and bladder were avoided under ultrasound guidance (appropriate pressure of the probe could squeeze the intestine out). The microwave needle was inserted into the target lesion and ablation began. If the treatment area occurred vaporization, the needle was withdrawn to the surface of the lesion and then moved to enter the lesion again by wigging the needle handle, and a multi-angle puncture was performed until the lesion was completely covered by the treatment area. If the maximum diameter of the lesion was ≥ 5 cm, double-needle ablation could be used. When the treatment area was close to the bowel, artificial ascites could be established to isolate the surrounding bowel and bladder to avoid thermal damage to the surrounding tissue. An intraoperative electrocardiogram was performed to monitor the patient’s vital signs.

On the basis of group C, patients in group D were given subcutaneous injections of Leuprorelin Acetate (Shanghai Livzon Pharmaceutical Co., Ltd., H20093852) at 3.75 mg each time, once every 4 weeks, for 3 months after pathological diagnosis on the 3rd day after surgery.

Observation indices 1.

Dysmenorrhea was evaluated by the Visual Analog Scale (VAS). 0 indicates no pain and 10 indicates the most intense pain.

2.

Uterine volume was measured by vaginal ultrasound before and 3 months after treatment (uterine volume = 0.52 × long diameter × anteroposterior diameter × transverse diameter).

3.

Menstrual volume was assessed by Policy-Based Access Control (PBAC).

4.

Clinical effect was determined. Obviously effective: uterine volume reduced, the focal echo was significantly enhanced, and the clinical symptoms such as dysmenorrhea, menstrual disorders, and painful sexual intercourse were significantly improved; Effective: uterine volume decreased, the echo of the lesion area was moderately enhanced, and the clinical symptoms were partially improved. Ineffective: Uterine volume did not shrink or increase after treatment, and clinical symptoms did not improve significantly. Total effective rate = (cases of obviously effective + effective)/total cases × 100%.

5.

Hormone levels: Before surgery and 3 months after surgery, peripheral venous blood was collected from patients on the 3rd day of menstruation to determine luteinizing hormone (LH), follicle-stimulating hormone (FSH), and estrogen (E2).

6.

Fasting venous blood (5 mL) was collected before surgery and 3 months after surgery, respectively, and serum CA125 was determined by radioimmunoassay.

Recurrence: At 12 months after drug withdrawal, the recurrence of dysmenorrhea, hypermenorrhea, excessive CA125, and uterine enlargement were compared.

7.

Pregnancy status and pregnancy outcomes (miscarriage, premature birth, and full-term birth) were recorded.

Statistical analysis

Data were processed by SPSS 20.0 statistical software. Measurement data were expressed as mean ± standard deviation and compared by t-test or one-way analysis of variance. Enumeration data were expressed as n or n (%) and compared by χ2 test. P < 0.05 was considered statistically significant.