Objective: To evaluate the efficacy and safety of dienogest (DNG) in the treatment of refractory endometriosis-associated pain (REAP). Methods: In this study, REAP was defined according to the following criteria: (1) the pain duration was ≥12 months and visual analogue scale (VAS)≥60 mm; (2) the previous treatments with over two medicines like oral contraceptives and levonorgestrel-releasing intrauterine system failed to achieve satisfactory relief of pain, with VAS reduction less than 50%; with gonadotropin-releasing hormone agonist or mifepristone, the pain could be controlled temporarily, but it recurred after discontinuation of medicines; (3) the pain could not be relieved by surgery or even repeated surgeries. In the present study, 48 patients with REAP were treated with DNG 2 mg/day orally and the clinical outcomes were retrospectively analyzed. The VAS scores, levels of CA125, estradiol, FSH, LH and changes in the size of endometriotic lesions before and after treatment were compared respectively. The side effects were also analyzed. Results: The average duration of DNG treatment was (20.1±12.8) months. After 3 months of medication, the VAS score was significantly reduced from (77.9±15.8) mm to (20.8±10.7) mm (P<0.01), and CA125 level was significantly reduced from (95±139) kU/L to (38±45) kU/L (P<0.05). The effects were maintained with continuation of DNG treatment. Endometriotic lesions tended to shrink, after 12 months of DNG treatment, the size of ovarian endometriomas was reduced significantly from (3.1±1.0) cm to (1.9±1.2) cm (P<0.05). The mean level of estradiol was maintained at 124.82-221.04 pmol/L and levels of FSH and LH did not change significantly during the treatment. The major side effect was irregular bleeding (75%, 36/48). Conclusions: DNG could effectively relieve REAP and is a well-tolerated therapy. It may supply an alternative option for patients with REAP.
目的： 评价地诺孕素（DNG）对于难治性子宫内膜异位症（内异症）疼痛的临床疗效和安全性。 方法： 本研究将难治性内异症疼痛定义为：（1）内异症相关疼痛时间≥12个月，疼痛视觉模拟评分（VAS）≥60 mm；（2）既往经口服避孕药、左炔诺孕酮宫内缓释系统等2种以上药物治疗效果不满意，VAS评分降幅<50%；或应用促性腺激素释放激素激动剂、米非司酮等可控制疼痛，但停药后疼痛再次发生；（3）疼痛经手术或反复手术后，仍不能控制。本研究对2016年11月至2020年2月48例符合标准的难治性内异症疼痛患者口服DNG（2 mg/d）的治疗情况进行回顾性分析，比较用药前后VAS评分、CA125水平、雌二醇、FSH、LH、内异症病灶大小的变化，并记录副作用。 结果： DNG用药时间为（20.1±12.8）个月。用药3个月时VAS评分由基线的（77.9±15.8） mm显著降低至（20.8±10.7） mm（P<0.01），CA125水平由基线的（95±139） kU/L显著降低至（38±45） kU/L （P<0.05）。随着用药时间延长，疼痛缓解的治疗效果继续维持，CA125继续维持在低水平。卵巢子宫内膜异位囊肿经用药12个月后囊肿最大径线由（3.1±1.0） cm显著缩小至（1.9±1.2） cm（P<0.05）。用药期间雌二醇平均水平维持在124.82~221.04 pmol/L，FSH、LH水平无明显变化。主要副作用是不规则出血（75%，36/48）。 结论： DNG能有效缓解内异症疼痛，且耐受性好，可作为复杂的难治性内异症疼痛患者长期治疗的选择之一。.