Department of Maternal Infantile and Urological Sciences, Sapienza University of Rome, Viale del Policlinico, 155-00161, Rome, Italy.
Division of Informatics, Imaging and Data Sciences, University of Manchester, Greater Manchester, Manchester, UK.
Reprod Sci. 2023 Nov;30(11):3135-3143. doi: 10.1007/s43032-023-01266-0. Epub 2023 May 22.
The objective of this study is to determine whether dienogest therapy after endometriosis surgery reduces the risk of recurrence compared with placebo or alternative treatments (GnRH agonist, other progestins, and estro-progestins). The design used in this study is systematic review with meta-analysis. The data source includes PubMed and EMBASE searched up to March 2022. A systematic review and meta-analysis were performed in accordance with guidelines from the Cochrane Collaboration. Keywords such as "dienogest," "endometriosis surgery," "endometriosis treatment," and "endometriosis medical therapy" were used to identify relevant studies. The primary outcome was recurrence of endometriosis after surgery. The secondary outcome was pain recurrence. An additional analysis focused on comparing side effects between groups. Nine studies were eligible, including a total of 1668 patients. At primary analysis, dienogest significantly reduced the rate of cyst recurrence compared with placebo (p < 0.0001). In 191 patients, the rate of cyst recurrence comparing dienogest vs GnRHa was evaluated, but no statistically significant difference was reported. In the secondary analysis, a trend toward reduction of pain at 6 months was reported in patients treated with dienogest over placebo, with each study reporting a significantly higher reduction of pain after dienogest treatment. In terms of side effects, dienogest treatment compared with GnRHa significantly increased the rate of spotting (p = 0.0007) and weight gain (p = 0.03), but it was associated with a lower rate of hot flashes (p = 0.0006) and a trend to lower incidence of vaginal dryness. Dienogest is superior to placebo and similar to GnRHa in decreasing rate of recurrence after endometriosis surgery. A significantly higher reduction of pain after dienogest compared with placebo was reported in two separate studies, whereas a trend toward reduction of pain at 6 months was evident at meta-analysis. Dienogest treatment compared with GnRHa was associated with a lower rate of hot flashes and a trend to lower incidence of vaginal dryness.
本研究旨在确定与安慰剂或其他治疗方法（促性腺激素释放激素激动剂、其他孕激素和雌孕激素）相比，地诺孕素治疗是否能降低内异症手术后的复发风险。本研究采用的设计是系统评价和荟萃分析。数据来源包括截至 2022 年 3 月的 PubMed 和 EMBASE。按照 Cochrane 协作组的指南进行了系统评价和荟萃分析。使用了“地诺孕素”、“内异症手术”、“内异症治疗”和“内异症药物治疗”等关键词来识别相关研究。主要结局是手术后内异症的复发。次要结局是疼痛复发。另外的分析侧重于比较组间的副作用。符合条件的研究有 9 项，共纳入 1668 例患者。在主要分析中，与安慰剂相比，地诺孕素显著降低了囊肿复发率（p < 0.0001）。在 191 例比较地诺孕素与 GnRHa 的患者中，报告囊肿复发率无统计学差异。在次要分析中，报告地诺孕素治疗组在 6 个月时疼痛减轻呈下降趋势，每个研究报告地诺孕素治疗后疼痛减轻明显更高。关于副作用，与 GnRHa 相比，地诺孕素治疗显著增加了点滴出血的发生率（p = 0.0007）和体重增加（p = 0.03），但与潮热发生率降低（p = 0.0006）和阴道干燥发生率降低的趋势相关。地诺孕素在降低内异症手术后的复发率方面优于安慰剂，与 GnRHa 相似。两项独立研究报告地诺孕素与安慰剂相比疼痛明显减轻，而荟萃分析显示 6 个月时疼痛减轻呈下降趋势。与 GnRHa 相比，地诺孕素治疗与潮热发生率降低和阴道干燥发生率降低的趋势相关。
