评价长效孕激素与复方口服避孕药预防子宫内膜异位症相关疼痛复发的临床效果。
预防子宫内膜异位症复发的实用、平行组、开放标签、随机对照试验。
34家英国医院
405名因子宫内膜异位症接受保守性手术的育龄妇女。
参与者以1:1的比例随机分配到长效孕激素（长效醋酸甲羟孕酮或左炔诺孕酮宫内缓释系统）或复方口服避孕药。
主要结果是随机分组三年后使用子宫内膜异位症健康概况30（EHP-30）问卷的疼痛领域测量的疼痛。次要结果（在6个月、1年、2年和3年时评估）包括EHP-30的4个核心和6个模块领域，以及治疗失败（进一步的治疗性手术或二线药物治疗）。
405名妇女随机接受长效孕激素（n=205）或复方口服避孕药（n=200）。三年后，两组的疼痛评分没有差异（调整后的平均差异为-0.8，95%置信区间为-5.7至4.2，P=0.76），与术前相比，两组的疼痛评分均提高了约40%（长效孕激素和复方口服避孕药组分别平均提高了24和23分）。与术前评分相比，EHP-30的大多数其他领域在所有时间点也显示出改善，但没有证据表明两组之间存在任何差异。与随机分配到复方口服避孕药组的妇女相比，随机分配到长效孕激素组的妇女接受的外科手术或二线治疗较少（73比97；危害比0.67，95%置信区间0.44至1.00）。
三年后，长效孕激素或复方口服避孕药的术后处方对子宫内膜异位症相关疼痛的改善程度相似，与术前水平相比，两组均显示约40%的改善。虽然妇女可以放心，这两种选择都是有效的，但子宫内膜异位症和子宫切除术重复手术的风险降低，可能使长效可逆性孕激素对一些人来说更可取。
ISRCTN注册ISRCTN97865475。
英文原文如下：
OBJECTIVES To evaluate the clinical effectiveness of long acting progestogens compared with the combined oral contraceptive pill in preventing recurrence of endometriosis related pain.
DESIGN The PRE-EMPT (preventing recurrence of endometriosis) pragmatic, parallel group, open label, randomised controlled trial.
SETTING 34 UK hospitals.
PARTICIPANTS 405 women of reproductive age undergoing conservative surgery for endometriosis.
INTERVENTIONS Participants were randomised in a 1:1 ratio using a secure internet facility to a long acting progestogen (depot medroxyprogesterone acetate or levonorgestrel releasing intrauterine system) or the combined oral contraceptive pill.
MAIN OUTCOME MEASURES The primary outcome was pain measured three years after randomisation using the pain domain of the Endometriosis Health Profile 30 (EHP-30) questionnaire. Secondary outcomes (evaluated at six months, one, two, and three years) included the four core and six modular domains of the EHP-30, and treatment failure (further therapeutic surgery or second line medical treatment).
RESULTS 405 women were randomised to receive a long acting progestogen (n=205) or combined oral contraceptive pill (n=200). At three years, there was no difference in pain scores between the groups (adjusted mean difference -0.8, 95% confidence interval -5.7 to 4.2, P=0.76), which had improved by around 40% in both groups compared with preoperative values (an average of 24 and 23 points for long acting progestogen and combined oral contraceptive pill groups, respectively). Most of the other domains of the EHP-30 also showed improvement at all time points compared with preoperative scores, without evidence of any differences between groups. Women randomised to a long acting progestogen underwent fewer surgical procedures or second line treatments compared with those randomised to the combined oral contraceptive pill group (73 v 97; hazard ratio 0.67, 95% confidence interval 0.44 to 1.00).
CONCLUSIONS Postoperative prescription of a long acting progestogen or the combined oral contraceptive pill results in similar levels of improvement in endometriosis related pain at three years, with both groups showing around a 40% improvement compared with preoperative levels. While women can be reassured that both options are effective, the reduced risk of repeat surgery for endometriosis and hysterectomy might make long acting reversible progestogens preferable for some.
TRIAL REGISTRATION ISRCTN registry ISRCTN97865475.
