Gynaecology Department, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
Gynaecology Department, Chinese PLA General Hospital, Beijing, China.
Medicine (Baltimore). 2022 Feb 4;101(5):e28766. doi: 10.1097/MD.0000000000028766.
Triptorelin is one of the most commonly used gonadotropin-releasing hormone agonists and has been used in the treatment of deep infiltrating endometriosis (DIE). This study aimed to evaluate the efficacy and safety of up to 24 weeks of triptorelin treatment after conservative surgery for DIE.This prospective, non-interventional study was performed in 18 tertiary hospitals in China. Premenopausal women aged ≥18 years treated with triptorelin 3.75 mg once every 28 days for up to 24 weeks after conservative surgery for DIE were included. Endometriosis symptoms were assessed, using a visual analogue scale (0-10 cm) or numerical range (0-10), at baseline (pre-surgery) and routine visits 3, 6, 9, 12, 18, and 24 months after surgery. Changes in symptom intensity over time were primary outcome measures.A total of 384 women (mean [standard deviation] age, 33.4 [6.2] years) were analyzed. Scores for all symptoms (pelvic pain, dysmenorrhea, ovulation pain, dyspareunia, menorrhagia, metrorrhagia, and gastrointestinal and urinary symptoms) assessed decreased from baseline over 24 months. Cumulative improvement rates in pelvic pain, dysmenorrhoa, ovulation pain, and dyspareunia were 74.4%, 83.6%, 55.1%, and 66.9%, respectively. The 24-month cumulative recurrence rate (≥1 symptom) was 22.2%. The risk of symptom recurrence was higher in patients with ≥2 versus 1 lesion (odds ratio [OR] 2.539; 95% CI: 1.458-4.423; P = .001) and patients with moderate (OR 5.733; 95% CI: 1.623-20.248; P = .007) or severe (OR 8.259; 95% CI: 2.449-27.851; P = .001) pain versus none/mild pain. Triptorelin was well tolerated without serious adverse events.Triptorelin after conservative surgery for DIE improved symptoms over 24 months of follow up. The recurrence rate of symptoms was low and triptorelin was generally well tolerated.Trial registration number: ClinicalTrials.gov, NCT01942369.
曲普瑞林是最常用的促性腺激素释放激素激动剂之一，已用于治疗深部浸润型子宫内膜异位症（DIE）。本研究旨在评估曲普瑞林治疗 DIE 患者接受保守手术后长达 24 周的疗效和安全性。
这项前瞻性、非干预性研究在我国 18 家三级医院进行。纳入年龄≥18 岁的接受曲普瑞林 3.75mg 每 28 天一次治疗的绝经前妇女，在接受 DIE 保守手术后最长 24 周时使用。在基线（手术前）和术后 3、6、9、12、18 和 24 个月时使用视觉模拟量表（0-10cm）或数值范围（0-10）评估子宫内膜异位症症状，以评估症状严重程度。随时间变化的症状强度变化是主要结局指标。
共有 384 名妇女（平均[标准差]年龄，33.4[6.2]岁）进行了分析。24 个月时，所有症状（盆腔疼痛、痛经、排卵痛、性交痛、月经过多、子宫不规则出血、胃肠道和泌尿道症状）评分均从基线下降。盆腔疼痛、痛经、排卵痛和性交痛的累积改善率分别为 74.4%、83.6%、55.1%和 66.9%。24 个月时的累积复发率（≥1 个症状）为 22.2%。与 1 个病变相比，≥2 个病变患者（比值比[OR]2.539；95%置信区间：1.458-4.423；P=0.001）和中重度（OR 5.733；95%置信区间：1.623-20.248；P=0.007）或重度（OR 8.259；95%置信区间：2.449-27.851；P=0.001）疼痛患者的症状复发风险更高。曲普瑞林治疗后，DIE 患者在 24 个月的随访期间症状得到改善。症状的复发率较低，曲普瑞林总体耐受性良好。
ClinicalTrials.gov，NCT01942369。
