Morotti Matteo, Venturini Pier Luigi, Biscaldi Ennio, Racca Annalisa, Calanni Luana, Vellone Valerio Gaetano, Stabilini Cesare, Ferrero Simone
Academic Unit of Obstetrics and Gynaecology, IRCCS AOU San Martino - IST, Largo R. Benzi 10, 16132, Genoa, Italy; Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genoa, Italy.
Department of Radiology, Galliera Hospital, via Mura delle Cappuccine 14, 16128, Genoa, Italy.
Eur J Obstet Gynecol Reprod Biol. 2017 Jun;213:4-10. doi: 10.1016/j.ejogrb.2017.03.033. Epub 2017 Mar 27.
To study the efficacy of long-term treatment with norethindrone acetate (NETA) in patients with rectovaginal endometriosis.
This retrospective cohort study included 103 women with pain symptoms caused by rectovaginal endometriosis. Patients received NETA alone (2.5mg/day up to 5mg/day) for 5 years. Primary outcome was the degree of satisfaction with treatment after 5 years of progestin therapy. Secondary outcomes were the assessment of any variation in pain symptoms and the volumetric assessment of the disease by magnetic resonance imaging (MRI).
Sixty-one women completed the 5-year follow-up (61/103, 59.2%) with 16 women withdrawing because of adverse effects (38.1%). Overall, 68.8% (42/61) of the women who completed the study were satisfied or very satisfied of this long term NETA treatment. This represents a 40.8% (42/103) of the patients enrolled. Intensity of chronic pelvic pain and deep dyspareunia significantly decreased during treatment (p<0.001 versus baseline at 1 and 5year). Dyschezia improved after 1-year respect to baseline (p=0.008) but remained stable between first and second year (p=0.409). At the end of 5 years treatment, a radiological partial response was observed in 33 patients (55.9%, n 33/59); a stable disease in 19 patients (32.2%, n 19/59). Seven women (7/59, 11.9%) displayed a volumetric increase of rectovaginal endometriosis under NETA treatment.
Five-year therapy with NETA is safe and well tolerated by women with rectovaginal endometriosis. Due to its low cost and good pharmacological profile, it represents a good candidate for long-term treatment in this setting.
研究醋酸炔诺酮(NETA)长期治疗直肠阴道子宫内膜异位症患者的疗效。
这项回顾性队列研究纳入了103例因直肠阴道子宫内膜异位症出现疼痛症状的女性。患者单独接受NETA(2.5mg/天,最高5mg/天)治疗5年。主要结局是孕激素治疗5年后的治疗满意度。次要结局是疼痛症状的任何变化评估以及通过磁共振成像(MRI)对疾病进行体积评估。
61名女性完成了5年随访(61/103,59.2%),16名女性因不良反应退出(38.1%)。总体而言,完成研究的女性中有68.8%(42/61)对这种NETA长期治疗感到满意或非常满意。这占入组患者的40.8%(42/103)。治疗期间慢性盆腔疼痛和深部性交困难的强度显著降低(与第1年和第5年的基线相比,p<0.001)。与基线相比,排便困难在1年后有所改善(p=0.008),但在第1年和第2年之间保持稳定(p=0.409)。在5年治疗结束时,33例患者(55.9%,n=33/59)出现放射学部分缓解;19例患者(32.2%,n=19/59)病情稳定。7名女性(7/59,11.9%)在NETA治疗下直肠阴道子宫内膜异位症体积增大。
NETA五年治疗对直肠阴道子宫内膜异位症女性安全且耐受性良好。由于其成本低且药理学特性良好,它是这种情况下长期治疗的良好选择。