Maria Chiara De Angelis, Fedora Ambrosetti, Sabrina Reppuccia, Fabiola Nardelli, Brunella Zizolfi, Antonella Mercurio, Antonio Maiorana, Attilio Di Spiezio Sardo
{"title":"瑞路高利联合治疗症状性子宫肌瘤的安全性和有效性。","authors":"Maria Chiara De Angelis, Fedora Ambrosetti, Sabrina Reppuccia, Fabiola Nardelli, Brunella Zizolfi, Antonella Mercurio, Antonio Maiorana, Attilio Di Spiezio Sardo","doi":"10.52054/FVVO.2025.142","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Relugolix-combination therapy (CT) (oestradiol 1 mg and norethindrone acetate 0.5 mg) is a new gonadotropin-releasing hormone antagonist licensed to treat heavy menstrual bleeding (HMB) associated with uterine fibroids; but little real-world data exists to guide practice.</p><p><strong>Objectives: </strong>To evaluate the efficacy and safety of relugolix-CT in women with fibroid-associated HMB in two large Italian hospitals.</p><p><strong>Methods: </strong>A retrospective multicentre study was conducted on 102 women with symptomatic fibroids and HMB, defined as a Pictorial Blood Assessment Chart (PBAC) score >100, who were treated with relugolix-CT for up to 24 months. Women were divided into three groups: group 1 (n=81) receiving only relugolix-CT treatment; group 2 (n=11) receiving at least two months of relugolix-CT prior to hysteroscopic, laparoscopic or open myomectomy; group 3 (n=10) receiving at least two months of pre- and post-myomectomy relugolix-CT.</p><p><strong>Main outcomes measures: </strong>The primary outcome was resolution of HMB, defined as a PBAC score <100. Secondary outcomes included the side effects of treatment.</p><p><strong>Results: </strong>The population mean age was 43.8 years (±6.06), and the mean baseline PBAC score was 329.9 (± 217 standard deviation). In women treated with relugolix-CT alone, 71 (94.7%) responded after two months. By nine months, only 36 (44.4%) women continued with relugolix-CT. Resolution of HMB was sustained in most women who continued treatment at each follow-up time point. By two months prior to myomectomy, HMB resolved in all women receiving relugolix-CT pre-surgery and nine (90%) women continuing relugolix-CT after myomectomy. No major side effects were reported.</p><p><strong>Conclusions: </strong>This real-world study supports previous controlled trial data showing relugolix-CT to be a safe, efficacious medical treatment for HMB with fibroids.</p><p><strong>What is new?: </strong>Real-life clinical data support the use of relugolix-CT to treat symptomatic fibroids in isolation or combined with myomectomy.</p>","PeriodicalId":46400,"journal":{"name":"Facts Views and Vision in ObGyn","volume":"17 3","pages":"245-252"},"PeriodicalIF":1.4000,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12489269/pdf/","citationCount":"0","resultStr":"{\"title\":\"Safety and efficacy of relugolix combination therapy in symptomatic uterine fibroids.\",\"authors\":\"Maria Chiara De Angelis, Fedora Ambrosetti, Sabrina Reppuccia, Fabiola Nardelli, Brunella Zizolfi, Antonella Mercurio, Antonio Maiorana, Attilio Di Spiezio Sardo\",\"doi\":\"10.52054/FVVO.2025.142\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Relugolix-combination therapy (CT) (oestradiol 1 mg and norethindrone acetate 0.5 mg) is a new gonadotropin-releasing hormone antagonist licensed to treat heavy menstrual bleeding (HMB) associated with uterine fibroids; but little real-world data exists to guide practice.</p><p><strong>Objectives: </strong>To evaluate the efficacy and safety of relugolix-CT in women with fibroid-associated HMB in two large Italian hospitals.</p><p><strong>Methods: </strong>A retrospective multicentre study was conducted on 102 women with symptomatic fibroids and HMB, defined as a Pictorial Blood Assessment Chart (PBAC) score >100, who were treated with relugolix-CT for up to 24 months. Women were divided into three groups: group 1 (n=81) receiving only relugolix-CT treatment; group 2 (n=11) receiving at least two months of relugolix-CT prior to hysteroscopic, laparoscopic or open myomectomy; group 3 (n=10) receiving at least two months of pre- and post-myomectomy relugolix-CT.</p><p><strong>Main outcomes measures: </strong>The primary outcome was resolution of HMB, defined as a PBAC score <100. Secondary outcomes included the side effects of treatment.</p><p><strong>Results: </strong>The population mean age was 43.8 years (±6.06), and the mean baseline PBAC score was 329.9 (± 217 standard deviation). In women treated with relugolix-CT alone, 71 (94.7%) responded after two months. By nine months, only 36 (44.4%) women continued with relugolix-CT. Resolution of HMB was sustained in most women who continued treatment at each follow-up time point. By two months prior to myomectomy, HMB resolved in all women receiving relugolix-CT pre-surgery and nine (90%) women continuing relugolix-CT after myomectomy. No major side effects were reported.</p><p><strong>Conclusions: </strong>This real-world study supports previous controlled trial data showing relugolix-CT to be a safe, efficacious medical treatment for HMB with fibroids.</p><p><strong>What is new?: </strong>Real-life clinical data support the use of relugolix-CT to treat symptomatic fibroids in isolation or combined with myomectomy.</p>\",\"PeriodicalId\":46400,\"journal\":{\"name\":\"Facts Views and Vision in ObGyn\",\"volume\":\"17 3\",\"pages\":\"245-252\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2025-09-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12489269/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Facts Views and Vision in ObGyn\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.52054/FVVO.2025.142\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Facts Views and Vision in ObGyn","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.52054/FVVO.2025.142","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
Safety and efficacy of relugolix combination therapy in symptomatic uterine fibroids.
Background: Relugolix-combination therapy (CT) (oestradiol 1 mg and norethindrone acetate 0.5 mg) is a new gonadotropin-releasing hormone antagonist licensed to treat heavy menstrual bleeding (HMB) associated with uterine fibroids; but little real-world data exists to guide practice.
Objectives: To evaluate the efficacy and safety of relugolix-CT in women with fibroid-associated HMB in two large Italian hospitals.
Methods: A retrospective multicentre study was conducted on 102 women with symptomatic fibroids and HMB, defined as a Pictorial Blood Assessment Chart (PBAC) score >100, who were treated with relugolix-CT for up to 24 months. Women were divided into three groups: group 1 (n=81) receiving only relugolix-CT treatment; group 2 (n=11) receiving at least two months of relugolix-CT prior to hysteroscopic, laparoscopic or open myomectomy; group 3 (n=10) receiving at least two months of pre- and post-myomectomy relugolix-CT.
Main outcomes measures: The primary outcome was resolution of HMB, defined as a PBAC score <100. Secondary outcomes included the side effects of treatment.
Results: The population mean age was 43.8 years (±6.06), and the mean baseline PBAC score was 329.9 (± 217 standard deviation). In women treated with relugolix-CT alone, 71 (94.7%) responded after two months. By nine months, only 36 (44.4%) women continued with relugolix-CT. Resolution of HMB was sustained in most women who continued treatment at each follow-up time point. By two months prior to myomectomy, HMB resolved in all women receiving relugolix-CT pre-surgery and nine (90%) women continuing relugolix-CT after myomectomy. No major side effects were reported.
Conclusions: This real-world study supports previous controlled trial data showing relugolix-CT to be a safe, efficacious medical treatment for HMB with fibroids.
What is new?: Real-life clinical data support the use of relugolix-CT to treat symptomatic fibroids in isolation or combined with myomectomy.
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