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Physician-patient alignment on menopause-associated symptom burden: real-world evidence from the USA and Europe. 更年期相关症状负担的医患一致性:来自美国和欧洲的真实世界证据。
IF 2.9 4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-12-01 Epub Date: 2024-10-14 DOI: 10.1080/13697137.2024.2401366
Sheryl Kingsberg, Rossella E Nappi, Megan Scott, Nils Schoof, Carsten Moeller, Lauren Lee, Cecile Janssenswillen, Cecilia Caetano, Victoria Banks

Objective: This study aimed to evaluate physician-patient alignment on menopausal symptom burden and impact for women experiencing natural vasomotor symptoms (nVMS) or VMS induced by endocrine therapy for breast cancer (iVMS).

Methods: For this real-world, cross-sectional survey, physicians from the USA and five European countries provided data for consulting patients experiencing nVMS/iVMS; patients optionally self-reported their experiences. Alignment between physician and patient responses was assessed using weighted Cohen's κ analysis.

Results: Physicians and patients completed 1029 pairs of surveys (846 nVMS; 183 iVMS). In 28.1% of cases for nVMS and 29.6% for iVMS, patients reported more severe vasomotor symptoms (VMS) than physicians; alignment of responses was slight (nVMS, κ = 0.1364, p ≤ 0.0001; iVMS, κ = 0.1014, p = 0.039). For the non-VMS symptoms surveyed, 18.5-34.9% of patients with nVMS and iVMS reported symptoms without a corresponding physician report; sleep disturbances, cognitive difficulties and mood changes were among the symptoms most under-reported by physicians. Alignment regarding the impact of nVMS and iVMS on sleep, mood and overall quality of life was moderate.

Conclusions: Only slight to moderate physician-patient alignment was found across all areas surveyed. These findings suggest that physicians often underestimate the severity of VMS and the presence of other menopausal symptoms, highlighting a need to improve physician-patient communication.

目的:本研究旨在评估医生与患者在更年期症状负担和影响方面的一致性,包括自然血管运动症状(nVMS)或乳腺癌内分泌治疗诱发的血管运动症状(iVMS):在这项真实世界的横断面调查中,来自美国和五个欧洲国家的医生提供了 nVMS/iVMS 患者的咨询数据;患者可选择自我报告其经历。使用加权科恩κ分析评估了医生和患者回答的一致性:医生和患者共完成了 1029 对调查(846 份 nVMS;183 份 iVMS)。在 28.1% 的 nVMS 和 29.6% 的 iVMS 案例中,患者报告的血管运动症状 (VMS) 比医生报告的更严重;回答略有一致(nVMS,κ = 0.1364,p ≤ 0.0001;iVMS,κ = 0.1014,p = 0.039)。在所调查的非 VMS 症状中,18.5%-34.9% 的 nVMS 和 iVMS 患者报告的症状没有相应的医生报告;睡眠障碍、认知困难和情绪变化是医生报告最少的症状。关于nVMS和iVMS对睡眠、情绪和整体生活质量的影响,医生与患者之间的一致程度为中等:在所有调查领域中,医生与患者之间的一致性仅为轻微至中等程度。这些调查结果表明,医生往往低估了更年期综合征的严重程度以及其他更年期症状的存在,这凸显了改善医患沟通的必要性。
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引用次数: 0
Is it possible that menopause is associated with telomere length? Findings of an integrative review. 更年期可能与端粒长度有关吗?综合审查结果。
IF 2.9 4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-12-01 Epub Date: 2024-07-18 DOI: 10.1080/13697137.2024.2376193
M M S Bem, C M S Paraizo-Horvath, P S Freitas, T R P Brito

Objective: Knowing the important repercussions of menopause for women's health and that female longevity can be better understood through studies based on aging biomarkers, studies on the relationship between menopause and telomere shortening may help to better understand this stage of life. This study aimed to analyze what research has been produced regarding the relationship between menopause and telomere length.

Methods: This integrative literature review included searches in PubMed, CINAHL, LILACS, Web of Science and Scopus databases. Four studies were selected for the final sample.

Results: The findings of these studies indicate that older age for menopause and longer reproductive life (difference between age at menopause and menarche) are associated with longer telomeres, that is, with longevity.

Conclusion: The relationship between menopause and telomere length is uncertain. The small number of studies included in this review, and the fact that the results indicate that the relationship between menopause and telomere length may be dependent on the stage of the menopause and race/ethnicity, suggest that additional research focusing on these variables should be carried out.

研究目的鉴于更年期对女性健康的重要影响,以及通过基于衰老生物标志物的研究可以更好地了解女性的长寿,对更年期与端粒缩短之间关系的研究可能有助于更好地了解这一生命阶段。本研究旨在分析有关更年期与端粒长度之间关系的研究成果:这项综合性文献综述包括在PubMed、CINAHL、LILACS、Web of Science和Scopus数据库中进行检索。结果:这些研究结果表明,老年女性的雌激素水平较高,而雌激素水平较低的女性的雌激素水平较低:这些研究结果表明,绝经年龄越大、生育期越长(绝经年龄与月经初潮年龄之差)与端粒越长,即与长寿有关:结论:绝经与端粒长度之间的关系尚不确定。本综述中包含的研究数量较少,而且研究结果表明更年期与端粒长度之间的关系可能取决于更年期的阶段和种族/民族,这表明应针对这些变量开展更多的研究。
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引用次数: 0
Heartwired for change: advancing women's cardiovascular health. 心动不如行动:促进女性心血管健康。
IF 2.9 4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-12-01 Epub Date: 2024-10-21 DOI: 10.1080/13697137.2024.2413499
Alina Yang
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引用次数: 0
Rapid and random-start endometrial preparation before outpatient hysteroscopic polypectomy in patients of perimenopausal age. 围绝经期患者在门诊宫腔镜息肉切除术前快速和随机启动子宫内膜准备。
IF 2.9 4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-12-01 Epub Date: 2024-09-27 DOI: 10.1080/13697137.2024.2404574
Andrea Etrusco, Antonio D'Amato, Vittorio Agrifoglio, Vito Chiantera, Giuseppe Russo, Tullio Golia D'Augè, Marco Monti, Gaetano Riemma, Antonio Simone Laganà, Andrea Giannini

Objective: This study aimed to assess the efficacy of randomly started oral dienogest/ethinylestradiol (DNG/EE) for swift endometrial preparation prior to outpatient hysteroscopic polypectomy in perimenopausal women.

Method: A multicenter, prospective, randomized controlled trial was conducted in university hospitals. Eighty perimenopausal women scheduled for outpatient hysteroscopic polypectomy between January 2023 and March 2024 were randomly assigned to either intervention (n = 40) or control (n = 40) groups. Exclusion criteria included concomitant endometrial pathologies, recent therapy and adnexal diseases. The intervention group received oral DNG/EE 2 mg/0.03 mg/day started on any day of the menstrual cycle for 14 days. The control group underwent polypectomy between menstrual cycle days 8 and 11 without pharmacological treatment.

Results: Pre-procedure (p < 0.001) and post-procedure (p < 0.001) endometrial thickness were significantly reduced in the intervention group, along with a higher incidence of hypotrophic/atrophic endometrial patterns (p < 0.001). Surgical parameters also differed significantly between groups.

Conclusion: DNG/EE treatment offers rapid, cost-effective endometrial preparation, enhancing surgical outcomes and patient satisfaction during outpatient polypectomy.

Trial registration: ClinicalTrials.gov NCT06316206.

研究目的本研究旨在评估围绝经期妇女在门诊宫腔镜息肉切除术前随机开始口服双烯雌酚/炔雌醇(DNG/EE)以迅速进行子宫内膜准备的疗效:在大学医院开展了一项多中心、前瞻性、随机对照试验。80名计划在2023年1月至2024年3月期间接受门诊宫腔镜息肉切除术的围绝经期妇女被随机分配到干预组(40人)或对照组(40人)。排除标准包括合并子宫内膜病变、近期接受过治疗和患有附件疾病。干预组在月经周期的任何一天开始口服 DNG/EE 2 毫克/0.03 毫克/天,持续 14 天。对照组在月经周期第 8 天和第 11 天之间接受息肉切除术,不进行药物治疗:手术前(P P P P 结论:DNG/EE治疗提供了快速、经济有效的子宫内膜准备,提高了门诊息肉切除术的手术效果和患者满意度:试验注册:ClinicalTrials.gov NCT06316206。
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引用次数: 0
Effect of hormone therapy on personality traits: preliminary evidence in older men and women. 荷尔蒙疗法对人格特质的影响:老年男性和女性的初步证据。
IF 2.9 4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-12-01 Epub Date: 2024-09-16 DOI: 10.1080/13697137.2024.2393128
Rachel A Schroeder, Kristen L Mordecai, Susan M Resnick, Antonio Terracciano, Adrian Dobs, Samuel C Durso, Paul T Costa, Pauline M Maki

Objective: Findings concerning the effects of hormone therapy (HT) on cognition and dementia are mixed, with some trials suggesting increased harm at older ages. Personality, like cognition, changes with dementia, but no clinical trials to date have examined the effects of HT on personality traits. This study aimed to determine the effects of HT on personality traits in older men and women.

Method: Secondary data analysis was performed from randomized, double-blind, placebo-controlled cross-over studies of menopausal HT in women and testosterone therapy (TT) in men. Participants were community-dwelling cognitively normal adults (mean age = 75.2 years), including 29 men and 22 women. Three months of hormone intervention (for women, 0.625 mg/day conjugated equine estrogen with or without 2.5 mg/day medroxyprogesterone acetate; for men, 200 mg intramuscular testosterone enanthate every 2 weeks) were crossed over with 3 months of identical placebo with a 3-month washout between intervention phases. The main outcome measure was neuroticism and conscientiousness personality domains and facets assessed with the Revised NEO Personality Inventory (NEO-PI-R) after the active and placebo intervention phases.

Results: In linear mixed-effect models, HT in women decreased conscientiousness (p < 0.01) and the conscientiousness facet of achievement striving (p < 0.01), and increased vulnerability, a facet of neuroticism (p < 0.05). Testosterone in men decreased conscientiousness (p < 0.05) and the conscientiousness facet of dutifulness (p < 0.05), and increased vulnerability (p < 0.05).

Conclusion: In a preliminary study of healthy older adults, HT and TT formulations produced adverse changes in vulnerability and conscientiousness facets that parallel personality changes in dementia.

目的:荷尔蒙疗法(HT)对认知能力和痴呆症的影响研究结果不一,一些试验表明,荷尔蒙疗法对老年患者的危害更大。人格与认知一样,会随着痴呆症的发生而改变,但迄今为止还没有临床试验研究过激素疗法对人格特征的影响。本研究旨在确定高温热疗对老年男性和女性人格特征的影响:对女性更年期 HT 和男性睾酮疗法(TT)的随机、双盲、安慰剂对照交叉研究进行了二次数据分析。参与者均为社区认知正常的成年人(平均年龄为 75.2 岁),包括 29 名男性和 22 名女性。三个月的激素干预(对于女性,0.625 毫克/天的结合马雌激素与或不与 2.5 毫克/天的醋酸甲羟孕酮;对于男性,200 毫克肌肉注射庚酸睾酮,每两周一次)与三个月的相同安慰剂交叉进行,干预阶段之间有三个月的冲洗期。主要结果是在积极干预阶段和安慰剂干预阶段之后,用修订版NEO人格问卷(NEO-PI-R)评估神经质和自觉性人格领域和方面:结果:在线性混合效应模型中,女性的 HT 降低了自觉性(p p p p p p p p p p p p p p p p p p p p p p p p p p p在一项针对健康老年人的初步研究中,HT 和 TT 制剂在脆弱性和自觉性方面产生了与痴呆症人格变化相似的不利变化。
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引用次数: 0
Updated premature ovarian insufficiency guideline. 更新卵巢早衰指南。
IF 2.9 4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-12-01 Epub Date: 2024-12-16 DOI: 10.1080/13697137.2024.2408922
Nick Panay, Amanda J Vincent
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引用次数: 0
Vaginal microbiome of women with premature ovarian insufficiency: a descriptive cross-sectional study. 卵巢早衰妇女的阴道微生物组:一项描述性横断面研究。
IF 2.9 4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-12-01 Epub Date: 2024-10-07 DOI: 10.1080/13697137.2024.2393140
Helena Patricia Giraldo, Paulo César Giraldo, Ticiana A Mira, Gabriela Pravatta Rezende, Daniela Angerame Yela, Rose Luce Gomes do Amaral, Cristina Laguna Benetti-Pinto

Objective: This study aimed to describe the vaginal microbiome of women with premature ovarian insufficiency (POI) receiving systemic hormone therapy (HT).

Methods: Forty women with POI receiving systemic HT for at least 6 months, who were sexually active, were included in the descriptive cross-sectional study. Vaginal secretion was collected for DNA extraction followed by pyrosequencing of the 16S rRNA. The samples were pooled into phylogenetic groups (Ravel groups I-V).

Results: Women had mean age of 37.13 (± 7.27) years and POI diagnosis at age 27.90 (± 8.68) years, and a mean HT duration of 8.20 (± 8.73) years. It was observed that 33.4% of the women presented group I flora, with a predominance of Lactobacillus crispatus; 9% group II flora, with a predominance of Lactobacillus gasseri; 33.4% group III flora, with a predominance of Lactobacillus iners; 15.2% group IV flora, with a predominance of anaerobic bacteria; and 9% group V flora, with a predominance of Lactobacillus jensenii.

Conclusion: Women with POI receiving HT presented a vaginal microbiome with a predominance of lactobacilli in the composition of the vaginal flora, specifically L. crispatus and L. iners when evaluated by molecular biology through pyrosequencing of 16S rRNA.

研究目的本研究旨在描述接受系统性激素治疗(HT)的卵巢早衰(POI)妇女的阴道微生物组:方法:40 名接受系统性激素治疗至少 6 个月且性生活活跃的卵巢早衰女性被纳入描述性横断面研究。采集阴道分泌物进行 DNA 提取,然后对 16S rRNA 进行热测序。结果显示,妇女的平均年龄为 37.13 岁:妇女的平均年龄为 37.13 (± 7.27)岁,POI 诊断年龄为 27.90 (± 8.68)岁,平均 HT 持续时间为 8.20 (± 8.73)年。观察发现,33.4%的妇女体内存在 I 组菌群,主要是脆片乳杆菌;9%的妇女体内存在 II 组菌群,主要是加塞乳杆菌;33.4%的妇女体内存在 III 组菌群,主要是内斯乳杆菌;15.2%的妇女体内存在 IV 组菌群,主要是厌氧菌;9%的妇女体内存在 V 组菌群,主要是简森乳杆菌:结论:通过 16S rRNA 热测序进行分子生物学评估,患有 POI 并接受 HT 治疗的妇女的阴道微生物群在阴道菌群组成中以乳酸杆菌为主,特别是 L. crispatus 和 L. iners。
{"title":"Vaginal microbiome of women with premature ovarian insufficiency: a descriptive cross-sectional study.","authors":"Helena Patricia Giraldo, Paulo César Giraldo, Ticiana A Mira, Gabriela Pravatta Rezende, Daniela Angerame Yela, Rose Luce Gomes do Amaral, Cristina Laguna Benetti-Pinto","doi":"10.1080/13697137.2024.2393140","DOIUrl":"10.1080/13697137.2024.2393140","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to describe the vaginal microbiome of women with premature ovarian insufficiency (POI) receiving systemic hormone therapy (HT).</p><p><strong>Methods: </strong>Forty women with POI receiving systemic HT for at least 6 months, who were sexually active, were included in the descriptive cross-sectional study. Vaginal secretion was collected for DNA extraction followed by pyrosequencing of the 16S rRNA. The samples were pooled into phylogenetic groups (Ravel groups I-V).</p><p><strong>Results: </strong>Women had mean age of 37.13 (± 7.27) years and POI diagnosis at age 27.90 (± 8.68) years, and a mean HT duration of 8.20 (± 8.73) years. It was observed that 33.4% of the women presented group I flora, with a predominance of <i>Lactobacillus crispatus</i>; 9% group II flora, with a predominance of <i>Lactobacillus gasseri</i>; 33.4% group III flora, with a predominance of <i>Lactobacillus iners</i>; 15.2% group IV flora, with a predominance of anaerobic bacteria; and 9% group V flora, with a predominance of <i>Lactobacillus jensenii</i>.</p><p><strong>Conclusion: </strong>Women with POI receiving HT presented a vaginal microbiome with a predominance of lactobacilli in the composition of the vaginal flora, specifically <i>L. crispatus</i> and <i>L. iners</i> when evaluated by molecular biology through pyrosequencing of 16S rRNA.</p>","PeriodicalId":10213,"journal":{"name":"Climacteric","volume":" ","pages":"542-547"},"PeriodicalIF":2.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142380160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Maintaining the menopause momentum. 保持更年期的势头
IF 2.9 4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-10-01 Epub Date: 2024-09-25 DOI: 10.1080/13697137.2024.2395137
Tim Hillard
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引用次数: 0
Menopausal age does not affect ventricular structure and function: a Mendelian randomization study. 绝经年龄不会影响心室结构和功能:孟德尔随机研究。
IF 2.9 4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-10-01 Epub Date: 2024-07-25 DOI: 10.1080/13697137.2024.2380009
Youjie Zeng, Si Cao, Yuan Yuan

Objectives: Observational studies have suggested an association between age at natural menopause (ANM) and ventricular structure and function. Nevertheless, the causal relationship remains unclear. This study aimed to evaluate the causal effects of ANM on ventricular structure and function by Mendelian randomization (MR) analysis.

Methods: Genome-wide association summary statistics for ANM and 16 ventricular structures and functions were obtained. The inverse variance weighted (IVW) method was the primary MR approach for assessing causal associations. In addition, three additional MR methods (MR-Egger, weighted median and weighted mode) were performed to complement the IVW method. Furthermore, various sensitivity tests were conducted to evaluate the reliability of the MR results.

Results: The IVW method identified no causal association between ANM and all 16 ventricular structures or functions (p > 0.05). Three additional MR methods yielded parallel results to the IVW approach (p > 0.05). Various sensitivity tests revealed stability of the MR results, indicating no heterogeneity or horizontal pleiotropy.

Conclusion: The present MR study indicated that ANM would not causally affect ventricular structure or function. Therefore, the correlation between ANM and ventricular characteristics in previous observational studies might be attributed to shared upstream cardiovascular risk factors or unidentified genetic mutations that simultaneously affect both ANM and ventricular structure and function.

目的:观察性研究表明,自然绝经年龄(ANM)与心室结构和功能之间存在关联。然而,其中的因果关系仍不清楚。本研究旨在通过孟德尔随机化(MR)分析评估自然绝经年龄对心室结构和功能的因果影响:方法:获得 ANM 与 16 种心室结构和功能的全基因组关联汇总统计。反方差加权(IVW)法是评估因果关联的主要 MR 方法。此外,还采用了另外三种 MR 方法(MR-Egger、加权中位数和加权模式)来补充 IVW 方法。此外,还进行了各种敏感性测试,以评估 MR 结果的可靠性:结果:IVW方法未发现ANM与所有16个心室结构或功能之间存在因果关系(P>0.05)。另外三种磁共振方法得出的结果与 IVW 方法相同(P > 0.05)。各种敏感性测试显示 MR 结果稳定,表明没有异质性或水平多向性:本磁共振研究表明,ANM 不会对心室结构或功能产生因果影响。因此,以往观察性研究中 ANM 与心室特征之间的相关性可能归因于共同的上游心血管风险因素或同时影响 ANM 和心室结构与功能的未识别基因突变。
{"title":"Menopausal age does not affect ventricular structure and function: a Mendelian randomization study.","authors":"Youjie Zeng, Si Cao, Yuan Yuan","doi":"10.1080/13697137.2024.2380009","DOIUrl":"10.1080/13697137.2024.2380009","url":null,"abstract":"<p><strong>Objectives: </strong>Observational studies have suggested an association between age at natural menopause (ANM) and ventricular structure and function. Nevertheless, the causal relationship remains unclear. This study aimed to evaluate the causal effects of ANM on ventricular structure and function by Mendelian randomization (MR) analysis.</p><p><strong>Methods: </strong>Genome-wide association summary statistics for ANM and 16 ventricular structures and functions were obtained. The inverse variance weighted (IVW) method was the primary MR approach for assessing causal associations. In addition, three additional MR methods (MR-Egger, weighted median and weighted mode) were performed to complement the IVW method. Furthermore, various sensitivity tests were conducted to evaluate the reliability of the MR results.</p><p><strong>Results: </strong>The IVW method identified no causal association between ANM and all 16 ventricular structures or functions (<i>p</i> > 0.05). Three additional MR methods yielded parallel results to the IVW approach (<i>p</i> > 0.05). Various sensitivity tests revealed stability of the MR results, indicating no heterogeneity or horizontal pleiotropy.</p><p><strong>Conclusion: </strong>The present MR study indicated that ANM would not causally affect ventricular structure or function. Therefore, the correlation between ANM and ventricular characteristics in previous observational studies might be attributed to shared upstream cardiovascular risk factors or unidentified genetic mutations that simultaneously affect both ANM and ventricular structure and function.</p>","PeriodicalId":10213,"journal":{"name":"Climacteric","volume":" ","pages":"501-506"},"PeriodicalIF":2.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141757464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Ultra-low-dose estradiol and dydrogesterone for treatment of vasomotor symptoms in Europe and China. 欧洲和中国用于治疗血管运动症状的超低剂量雌二醇和地屈孕酮。
IF 2.9 4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-10-01 Epub Date: 2024-07-30 DOI: 10.1080/13697137.2024.2380364
Qi Yu, John C Stevenson, Tetiana Tatarchuk, Rossella E Nappi, Marcelo Graziano Custodio, Elke Kahler, Tommaso Simoncini, Junyi Yang, Mulan Ren

Objective: Among postmenopausal women, oral, ultra-low-dose continuous combined estradiol (E0.5 mg) plus dydrogesterone (D2.5 mg) reduces vasomotor symptoms (VMS).

Methods: This study was a post hoc analysis of data from two phase 3, double-blind studies. Postmenopausal women were randomized 2:1:2 to receive E0.5 mg/D2.5 mg, E1 mg/D5 mg (not included in this analysis) or placebo for 13 weeks (European study), or randomized 1:1 to receive E0.5 mg/D2.5 mg or placebo for 12 weeks (Chinese study). Endpoints assessed in ethnicity subgroups (European and Chinese) included changes from baseline in number of hot flushes, number of moderate-to-severe hot flushes and Menopause Rating Scale (MRS) score.

Results: Overall, 579 women were included in the analysis (E0.5 mg/D2.5 mg, n = 288; placebo, n = 291). European and Chinese women receiving E0.5 mg/D2.5 mg experienced greater reductions from baseline in mean daily number of hot flushes and mean daily number of moderate-to-severe hot flushes at week 4, week 8 and end of treatment versus those receiving placebo. Significant improvements in the 'hot flushes, sweating' MRS item score were reported in both European and Chinese women.

Conclusion: Oral, ultra-low-dose continuous combined 0.5 mg 17β-estradiol and 2.5 mg dydrogesterone improved VMS compared with placebo in European and Chinese postmenopausal women, with a positive impact on health-related quality of life.

目的:在绝经后妇女中,口服超低剂量连续联合雌二醇(E0.5 毫克)加地屈孕酮(D2.5 毫克)可减轻血管运动症状(VMS):本研究是对两项第三阶段双盲研究数据的事后分析。绝经后妇女按 2:1:2 随机分配接受 E0.5 毫克/D2.5 毫克、E1 毫克/D5 毫克(不包括在本分析中)或安慰剂治疗 13 周(欧洲研究),或按 1:1 随机分配接受 E0.5 毫克/D2.5 毫克或安慰剂治疗 12 周(中国研究)。种族亚组(欧洲和中国)的终点评估包括潮热次数、中度至重度潮热次数和更年期评分量表(MRS)得分与基线相比的变化:共有 579 名妇女参与了分析(E0.5 毫克/D2.5 毫克,288 人;安慰剂,291 人)。与服用安慰剂的妇女相比,服用 E0.5 mg/D2.5 mg 的欧洲和中国妇女在第 4 周、第 8 周和治疗结束时的平均每日潮热次数和平均每日中度至重度潮热次数比基线值有更大的减少。欧洲女性和中国女性的 "潮热、出汗 "MRS项目得分均有显著改善:结论:与安慰剂相比,0.5 毫克 17β-estradiol 和 2.5 毫克地屈孕酮的超低剂量连续口服联合治疗可改善欧洲和中国绝经后妇女的 VMS,并对健康相关的生活质量产生积极影响。
{"title":"Ultra-low-dose estradiol and dydrogesterone for treatment of vasomotor symptoms in Europe and China.","authors":"Qi Yu, John C Stevenson, Tetiana Tatarchuk, Rossella E Nappi, Marcelo Graziano Custodio, Elke Kahler, Tommaso Simoncini, Junyi Yang, Mulan Ren","doi":"10.1080/13697137.2024.2380364","DOIUrl":"10.1080/13697137.2024.2380364","url":null,"abstract":"<p><strong>Objective: </strong>Among postmenopausal women, oral, ultra-low-dose continuous combined estradiol (E0.5 mg) plus dydrogesterone (D2.5 mg) reduces vasomotor symptoms (VMS).</p><p><strong>Methods: </strong>This study was a <i>post hoc</i> analysis of data from two phase 3, double-blind studies. Postmenopausal women were randomized 2:1:2 to receive E0.5 mg/D2.5 mg, E1 mg/D5 mg (not included in this analysis) or placebo for 13 weeks (European study), or randomized 1:1 to receive E0.5 mg/D2.5 mg or placebo for 12 weeks (Chinese study). Endpoints assessed in ethnicity subgroups (European and Chinese) included changes from baseline in number of hot flushes, number of moderate-to-severe hot flushes and Menopause Rating Scale (MRS) score.</p><p><strong>Results: </strong>Overall, 579 women were included in the analysis (E0.5 mg/D2.5 mg, <i>n</i> = 288; placebo, <i>n</i> = 291). European and Chinese women receiving E0.5 mg/D2.5 mg experienced greater reductions from baseline in mean daily number of hot flushes and mean daily number of moderate-to-severe hot flushes at week 4, week 8 and end of treatment versus those receiving placebo. Significant improvements in the 'hot flushes, sweating' MRS item score were reported in both European and Chinese women.</p><p><strong>Conclusion: </strong>Oral, ultra-low-dose continuous combined 0.5 mg 17β-estradiol and 2.5 mg dydrogesterone improved VMS compared with placebo in European and Chinese postmenopausal women, with a positive impact on health-related quality of life.</p>","PeriodicalId":10213,"journal":{"name":"Climacteric","volume":" ","pages":"494-500"},"PeriodicalIF":2.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141792000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Climacteric
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