Caruso Salvatore, Cagnacci Angelo, Caruso Giuseppe, Cianci Stefano, Palumbo Marco
Research Center for the PreDiCT Study -Department of Biomedical and Biotechnological Sciences, School of Medicine University of Catania, Italy.
Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Infant Health, University of Genoa, Italy.
Eur J Obstet Gynecol Reprod Biol X. 2025 Aug 5;27:100421. doi: 10.1016/j.eurox.2025.100421. eCollection 2025 Sep.
To study the effects on the quality of life (QoL), sexual function and metabolic aspects in women using a subcutaneous implant containing Etonogestrel (ENG-implant) over 10 years of observation period.
This study was performed from January 2011 to September 2023. A database was set up to collect data from women. Counseling on the ENG-implant to be inserted at the termination of pregnancy, and on insert a new device every 3 years was adopted. The Short Form-36 (SF-36), the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale (FSDS) questionnaires were used to investigate the QoL, sexual function and sexual distress, respectively, of women at baseline and at 6, 12, 24, 36, 72 and 108-month follow-ups. Blood samples were collected from women to measure metabolic parameters.
32 of 52 (61.5 %) enrolled women completed the study. In summary, after removing the first (at 36th month of use) and the second implant (at 72nd month of use), 44 (84.6 %) and 32 (61.5 %) women asked for the insertion of a new device, respectively. Somatic (p < 0.001) and mental (p = 0.04) categories of SF-36 improved from the 12-month follow-up to the 108-month follow-up (p < 0.001). FSFI scores also increased from 12-month follow-up to the 108-month follow-up (p < 0.001). The improvement of the total scores depended on the gradual increase in each FSFI item (p < 0.001).FSDS score became statistically significant starting from the 12-month follow-up to the 108-month follow-up (p < 0.001). Although lipid metabolism, fasting glucose, liver function and hemostatic parameters were slightly reduced, they remained within the range of the normal values.
The long observation period of 10 years allowed us to state that the ENG-implant could have neutral effects on metabolic parameters, promote a better quality of life, and improve sexuality in the users. The main limitation of our study was the small number of women enrolled, mainly due to the cost of the implant. These results should be confirmed on a larger sample.
研究在长达10年的观察期内，使用含依托孕烯皮下植入剂（ENG植入剂）对女性生活质量（QoL）、性功能和代谢方面的影响。
本研究于2011年1月至2023年9月进行。建立了一个数据库来收集女性的数据。采用在妊娠终止时植入ENG植入剂以及每3年更换一次新装置的咨询建议。使用简短健康调查问卷36项版本（SF - 36）、女性性功能指数（FSFI）和女性性困扰量表（FSDS）问卷，分别在基线以及随访6、12、24、36、72和108个月时调查女性的生活质量、性功能和性困扰情况。采集女性血液样本以测量代谢参数。
52名入选女性中有32名（61.5%）完成了研究。总体而言，在取出第一枚植入剂（使用36个月时）和第二枚植入剂（使用72个月时）后，分别有44名（84.6%）和32名（61.5%）女性要求植入新装置。SF - 36的躯体（p < 0.001）和精神（p = 0.04）类别从12个月随访至108个月随访有所改善（p < 0.001）。FSFI评分从12个月随访至108个月随访也有所增加（p < 0.001）。总分的改善取决于每个FSFI项目的逐渐增加（p < 0.001）。FSDS评分从12个月随访至108个月随访开始具有统计学意义（p < 0.001）。尽管脂质代谢、空腹血糖、肝功能和止血参数略有降低，但仍保持在正常范围内。
10年的长期观察期使我们能够表明，ENG植入剂可能对代谢参数具有中性影响，促进使用者有更好的生活质量，并改善性功能。我们研究的主要局限性是入选女性数量较少，主要原因是植入剂的成本。这些结果应在更大样本上得到证实。
