使用艾拉戈利治疗的女性在出血和非出血期与子宫内膜异位症相关的疼痛减轻情况。
Endometriosis-Related Pain Reduction During Bleeding and Nonbleeding Days in Women Treated with Elagolix.
作者信息
Agarwal Sanjay K, Singh Sukhbir S, Archer David F, Mai Yabing, Chwalisz Kristof, Gordon Keith, Surrey Eric
机构信息
Department of Obstetrics and Gynecology and Reproductive Sciences, Center for Endometriosis Research and Treatment, UC San Diego, La Jolla, CA, USA.
Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
出版信息
J Pain Res. 2021 Feb 2;14:263-271. doi: 10.2147/JPR.S284703. eCollection 2021.
OBJECTIVE
In this post hoc analysis, we evaluated the impact of elagolix on dysmenorrhea and nonmenstrual pelvic pain across menstrual period (bleeding days) and nonmenstrual (nonbleeding) days.
METHODS
Data from two randomized, 6-month, placebo-controlled trials (Elaris Endometriosis (EM)-I and EM-II) of elagolix (150 mg once daily (QD) and 200 mg twice daily (BID)) in premenopausal women with moderate to severe endometriosis-associated pain (N = 1686) were pooled. Women recorded the presence of menstrual period and severity of dysmenorrhea or nonmenstrual pelvic pain in a daily electronic diary.
RESULTS
At baseline, women in the placebo group and both elagolix treatment groups reported moderate or severe dysmenorrhea, on average, 81% of their menstrual period days and moderate/severe nonmenstrual pelvic pain, on average, 56% of their nonmenstrual (nonbleeding) days. Compared with placebo at month 6, elagolix-treated women had a significantly lower mean (standard deviation (SD)) percentage of menstrual period days with moderate or severe dysmenorrhea (elagolix 150 mg QD = 52.4 (38.9), p = 0.002; elagolix 200 mg BID = 38.5 (43.6), p < 0.001, placebo = 61.3 (33.7)) and a significantly lower mean (SD) percentage of nonmenstrual (nonbleeding) days with moderate or severe nonmenstrual pelvic pain (elagolix 150 mg QD = 31.1 (35.8), p < 0.001; elagolix 200 mg BID = 19.7 (29.9), p < 0.001; placebo = 35.6 (33.9)).
CONCLUSION
Following 6 months of elagolix treatment, women who still menstruated had a lower proportion of menstrual period days with moderate or severe dysmenorrhea compared with placebo, demonstrating pain reduction despite continued menses. Additionally, pain did not shift from dysmenorrhea to nonmenstrual pelvic pain, as the percentage of days with moderate or severe nonmenstrual pelvic pain was also reduced for elagolix-treated women compared with placebo.
TRIAL REGISTRATION
The Elaris EM-I study is registered with the US National Library of Medicine, www.ClinicalTrials.gov, NCT01620528. The Elaris EM-II study is registered with the US National Library of Medicine, www.ClinicalTrials.gov, NCT01931670. Both studies are registered with the EU Clinical Trial Register, www.clinicaltrialsregister.ed, 2011-004295-11.
目的
在本次事后分析中，我们评估了艾拉戈利克对整个月经期（出血日）和非月经期（非出血日）痛经及非月经性盆腔疼痛的影响。
方法
汇总了两项针对中度至重度子宫内膜异位症相关疼痛的绝经前女性（N = 1686）进行的为期6个月的随机、安慰剂对照试验（Elaris子宫内膜异位症（EM）-I和EM-II）的数据，试验中使用了艾拉戈利克（每日一次150 mg（QD）和每日两次200 mg（BID））。女性通过每日电子日记记录月经情况以及痛经或非月经性盆腔疼痛的严重程度。
结果
在基线时，安慰剂组以及两个艾拉戈利克治疗组的女性报告，平均而言，其月经期的81%有中度或重度痛经，非月经期（非出血日）的56%有中度/重度非月经性盆腔疼痛。与第6个月时的安慰剂相比，接受艾拉戈利克治疗的女性中度或重度痛经的月经期平均（标准差（SD））百分比显著更低（艾拉戈利克150 mg QD = 52.4（38.9），p = 0.002；艾拉戈利克200 mg BID = 38.5（43.6），p < 0.001，安慰剂 = 61.3（33.7）），中度或重度非月经性盆腔疼痛的非月经期（非出血日）平均（SD）百分比也显著更低（艾拉戈利克150 mg QD = 31.1（35.8），p < 0.001；艾拉戈利克200 mg BID = 19.7（29.9），p < 0.001；安慰剂 = 35.6（33.9））。
结论
经过6个月的艾拉戈利克治疗，仍有月经的女性与安慰剂相比，中度或重度痛经的月经期比例更低，表明尽管仍有月经，但疼痛减轻。此外，疼痛并未从痛经转移至非月经性盆腔疼痛，因为与安慰剂相比，接受艾拉戈利克治疗的女性中度或重度非月经性盆腔疼痛的天数百分比也有所降低。
试验注册
Elaris EM-I研究已在美国国立医学图书馆（www.ClinicalTrials.gov）注册，编号为NCT01620528。Elaris EM-II研究已在美国国立医学图书馆（www.ClinicalTrials.gov）注册，编号为NCT01931670。两项研究均已在欧盟临床试验注册库（www.clinicaltrialsregister.ed）注册，编号为2011-004295-11。
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