Department of Obstetrics and Gynecology, Tottori University Faculty of Medicine, Tottori 683-8503, Japan.
Department of Gynecology, Kurashiki Heisei Hospital, Okayama 710-0826, Japan.
Contraception. 2022 Dec;116:22-28. doi: 10.1016/j.contraception.2022.08.006. Epub 2022 Aug 31.
We collected real-world data on the safety and clinical outcomes of the levonorgestrel-releasing intrauterine system (LNG-IUS) for heavy menstrual bleeding and dysmenorrhea.
This was a prospective, multicenter, single-cohort, open-label, post-authorization 12-month follow-up study of Japanese patients initiating the LNG-IUS for heavy menstrual bleeding and/or dysmenorrhea. The primary endpoint was the safety profile based on adverse events and adverse drug reactions (ADRs), including expulsions and abnormal bleeding, within 12 months of LNG-IUS insertion. Secondary endpoints included changes from baseline in menstrual blood loss based on bleeding days and dysmenorrhea graded on a visual analog scale (VAS).
Of the 595 patients included, many had underlying conditions such as adenomyosis (39.5%), uterine leiomyoma (30.8%), or endometriosis (12.9%). The incidences of ADRs and serious ADRs were 59.7% and 0.3%, respectively. Frequently reported ADRs were metrorrhagia (48.9%), procedural pain (14.1%), and ovarian cyst (6.2%). The cumulative incidence of expulsions at 12 months was 8.7%. Risk factors for expulsion were obesity (body mass index ≥25 kg/m), adenomyosis, and uterine cavity length ≥8 cm. The median [interquartile range] VAS score for dysmenorrhea improved from 46.5 [13.0-68.0] at insertion to 1.0 [0.0-13.0] at 12 months, and improvements were also observed in chronic pelvic pain and painful defecation.
The LNG-IUS safely and effectively reduced dysmenorrhea, chronic pelvic pain, and painful defecation. Risk factors for expulsion suggest that patients with underlying organic disease should be monitored carefully when using the LNG-IUS.
The LNG-IUS is an effective treatment for secondary dysmenorrhea with organic disease, and for the reduction of chronic pelvic pain; however, physicians should be aware of the increased risk of expulsion in patients with organic conditions.
我们收集了左炔诺孕酮宫内节育系统（LNG-IUS）用于治疗月经过多和痛经的安全性和临床结局的真实世界数据。
这是一项针对日本患者的前瞻性、多中心、单队列、开放标签、上市后 12 个月随访研究，旨在评估 LNG-IUS 治疗月经过多和/或痛经的安全性。主要终点是 LNG-IUS 置入后 12 个月内基于不良事件和药物不良反应（ADR）的安全性概况，包括脱落和异常出血。次要终点包括基于出血天数和视觉模拟量表（VAS）评分的痛经变化。
在纳入的 595 例患者中，许多患者存在子宫内膜异位症（39.5%）、子宫肌瘤（30.8%）或子宫腺肌病（12.9%）等基础疾病。ADR 和严重 ADR 的发生率分别为 59.7%和 0.3%。常报告的 ADR 是月经过多（48.9%）、操作疼痛（14.1%）和卵巢囊肿（6.2%）。12 个月时脱落的累积发生率为 8.7%。脱落的危险因素包括肥胖（体重指数≥25kg/m²）、子宫内膜异位症和宫腔长度≥8cm。痛经的 VAS 评分中位数[四分位间距]从置入时的 46.5[13.0-68.0]降至 12 个月时的 1.0[0.0-13.0]，慢性盆腔痛和排便痛也有改善。
LNG-IUS 安全有效地减轻了痛经、慢性盆腔痛和排便痛。脱落的危险因素表明，对于患有基础器质性疾病的患者，在使用 LNG-IUS 时应密切监测。
LNG-IUS 是治疗有器质性疾病的继发性痛经和慢性盆腔痛的有效方法，也可减轻痛经；然而，医生应注意到患有器质性疾病的患者脱落风险增加。
