Tsai Hsiao-Wen, Wang Peng-Hui, Huang Ben-Shian, Twu Nae-Fang, Yen Ming-Shyen, Chen Yi-Jen
Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; National Yang-Ming University, School of Medicine, Taipei, Taiwan; Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan.
National Yang-Ming University, School of Medicine, Taipei, Taiwan; Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei, Taiwan.
Taiwan J Obstet Gynecol. 2016 Feb;55(1):55-9. doi: 10.1016/j.tjog.2015.04.004.
Low-dose add-back therapy during postoperative GnRH agonist treatment could lower the risk of add-back-induced endometriosis recurrence and reduce treatment dropout compared with a regular dose. However, the effect of low-dose add-back therapy is still unknown. The aim of this study was to determine whether low-dose add-back therapy can also effectively relieve the hypoestrogenic side effects and simultaneously maintain a therapeutic response of GnRH agonist treatment.
This analysis was a prospective cohort study. During postoperative GnRH agonist treatment, a total of 107 women were prescribed add-back therapy [oral combination tablet; estradiol valerate (1 mg) and medroxyprogesterone acetate (2.5 mg)] (Indivina; Orion, Espoo, Finland) for 20 weeks. Patients in the low dose add-back therapy group were prescribed the tablet once a day, and patients in the regular dose group were given the tablet twice a day. Hypoestrogenic side effects, such as hot flashes and insomnia, were recorded. Patients were also questioned regarding their pelvic symptoms and pain to evaluate the possibility of endometriosis recurrence. Lumbar spine (L2-L4) bone mineral density was measured using dual X-ray absorptiometry. The dropout rates in both groups were also evaluated.
The incidence of hypoestrogenic side effects was lower in the low dose group compared with the regular dose group, including hot flashes (19.2% vs. 21.8%, p = 0.741) and insomnia (15.4% vs. 18.2%, p = 0.699), although there were no significant difference between the groups. In addition, a higher number of patients in the regular dose group dropped out of treatment compared to the low dose group (14.5% and 9.6%, respectively, p = 0.435). The patients in both groups had a significant loss of mean bone mineral density during therapy (p < 0.001 and p = 0.018 for the low dose and regular dose groups, respectively).
Low dose add-back therapy could effectively ameliorate hypoestrogenic side effects and simultaneously maintain the therapeutic response of GnRH agonist treatment. The treatment dropout was lower compared with a regular dose. Therefore, low dose add-back therapy can be considered a treatment choice during postoperative GnRH agonist treatment.
与常规剂量相比,术后GnRH激动剂治疗期间的低剂量补充疗法可降低补充疗法引起的子宫内膜异位症复发风险,并减少治疗中断情况。然而,低剂量补充疗法的效果仍不明确。本研究的目的是确定低剂量补充疗法是否也能有效缓解雌激素缺乏的副作用,同时维持GnRH激动剂治疗的疗效。
本分析为前瞻性队列研究。在术后GnRH激动剂治疗期间,共有107名女性接受了补充疗法[口服复方片剂;戊酸雌二醇(1毫克)和醋酸甲羟孕酮(2.5毫克)](Indivina;芬兰埃斯波的奥立安公司),为期20周。低剂量补充疗法组的患者每天服用一次该片剂,常规剂量组的患者每天服用两次该片剂。记录潮热和失眠等雌激素缺乏的副作用。还询问了患者的盆腔症状和疼痛情况,以评估子宫内膜异位症复发的可能性。使用双能X线吸收法测量腰椎(L2-L4)骨密度。还评估了两组的治疗中断率。
低剂量组雌激素缺乏副作用的发生率低于常规剂量组,包括潮热(19.2%对21.8%,p = 0.741)和失眠(15.4%对18.2%,p = 0.699),尽管两组之间无显著差异。此外,常规剂量组退出治疗的患者数量高于低剂量组(分别为14.5%和9.6%,p = 0.435)。两组患者在治疗期间平均骨密度均有显著下降(低剂量组和常规剂量组分别为p < 0.001和p = 0.018)。
低剂量补充疗法可有效改善雌激素缺乏的副作用,同时维持GnRH激动剂治疗的疗效。与常规剂量相比,治疗中断率更低。因此,低剂量补充疗法可被视为术后GnRH激动剂治疗期间的一种治疗选择。