Long-Term Effects of Gonadotropin-Releasing Hormone Agonists and Add-Back in Adolescent Endometriosis
Long-Term Effects of Gonadotropin-Releasing Hormone Agonists and Add-Back in Adolescent Endometriosis
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DOI：
10.1016/j.jpag.2018.03.004
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发表时间：
2018-08-01
影响因子：
1.8
通讯作者：
DiVasta, Amy D.
中科院分区：
文献类型：
--
作者：
Gallagher, Jenny Sadler;Missmer, Stacey A.;DiVasta, Amy D.
研究目的：探讨青春期子宫内膜异位症患者使用促性腺激素释放激素激动剂（GnRHa）加2种不同加回方案的潜在长期副作用及耐受性。设计：2016年对2008 - 2012年参与药物试验的患者进行随访问卷调查。地点：马萨诸塞州波士顿的三级医疗中心。参与者：手术确认子宫内膜异位症的女性青少年（n = 51），她们在青少年时期参加了GnRHa + add-back试验。干预措施：Leuprolide depot肌肉注射11.25 mg，每3个月，加口服醋酸去诺丁酮5 mg /天或口服醋酸去诺丁酮5 mg /天，口服共轭马雌激素0.625 mg /天。主要观察指标：治疗期间和治疗后的副作用、不可逆的副作用、疼痛的变化、总体满意度。结果：应答率为61%（25 / 41,10名受试者无法定位）。几乎所有（25人中有24人）报告了治疗期间的副作用；80%（16 / 21）报告的副作用在停止治疗后持续超过6个月。近一半（20人中的9人）报告了他们认为不可逆转的副作用，包括记忆力减退、失眠和潮热。尽管有副作用，参与者认为GnRHa加add-back是治疗子宫内膜异位症疼痛最有效的激素药物；三分之二（25人中有16人）会推荐给其他人。相比于标准的单药补充方案，接受改良的2药补充方案的更多参与者会推荐GnRHa，并认为它是最有效的激素药物。结论：受试者认为GnRHa与add-back联合使用是有效的，并会推荐给其他人，尽管有明显的副作用。接受两种药物补充治疗的患者比接受标准药物补充治疗的患者更成功。一部分患者报告了他们认为不可逆的副作用。
Study Objective: To explore the potential occurrence of long-term side effects and tolerability of gonadotropin-releasing hormone agonist (GnRHa) plus 2 different add-back regimens in adolescent patients with endometriosis.Design: Follow-up questionnaire sent in 2016 to patients who participated in a drug trial between 2008 and 2012.Setting: Tertiary care center in Boston, Massachusetts.Participants: Female adolescents with surgically confirmed endometriosis (n = 51) who enrolled in a GnRHa plus add-back trial as adolescents.Interventions: Leuprolide depot 11.25 mg intramuscular injection every 3 months, plus oral norethindrone acetate 5 mg daily or oral norethindrone acetate 5 mg daily and oral conjugated equine estrogens 0.625 mg daily.Main Outcome Measures: Side effects during and after treatment, irreversible side effects, changes in pain, overall satisfaction.Results: The response rate was 61% (25 of 41; 10 subjects could not be located). Almost all (24 of 25) reported side effects during treatment; 80% (16 of 21) reported side effects lasting longer than 6 months after stopping treatment. Almost half (9 of 20) reported side effects they considered irreversible, including memory loss, insomnia, and hot flashes. Despite side effects, participants rated GnRHa plus add-back as the most effective hormonal medication for treating endometriosis pain; two-thirds (16 of 25) would recommend it to others. More participants who received a modified 2-drug add-back regimen vs standard 1-drug add-back would recommend GnRHa and believed it was the most effective hormonal medication.Conclusion: Subjects believed that GnRHa used with add-back was effective and would recommend it to others, despite significant side effects. Those who received 2-drug add-back reported more success than those who received standard add-back. A subset of patients reported side effects they consider to be irreversible.