A combined,bioidentical, oral, 17β-estradiol and progesterone capsule for the treatment of moderate to severe vasomotor symptoms due to menopause

ABSTRACT

Introduction: Many women seek treatment to alleviate menopausal vasomotor symptoms (VMS). Numerous women use combination compounded hormone therapy (CHT) to achieve the benefits of estrogen/progesterone for endometrial protection. TX-001HR is a combination of bioidentical 17β-estradiol (E2) and progesterone (P4) in a single capsule designed for continuous daily use to treat moderate to severe VMS.

Areas covered: This drug profile describes the efficacy and safety of 4 doses of this E2/P4 (mg/mg: 1/100, 0.5/100, 0.5/50, 0.25/50) for treating moderate to severe VMS in menopausal woman with a uterus.

Expert opinion: In REPLENISH (NCT01942668), the two highest doses of TX-001HR significantly reduced VMS frequency and severity at 4 and 12 weeks versus placebo (co-primary endpoints); all doses met the primary endpoint of endometrial safety. Rates of amenorrhea were high and improved over time; the Menopause Quality of Life and Medical Outcomes Study-Sleep instruments improved with E2/P4. TX-001HR was well tolerated and had no clinically significant impact on vital signs, metabolic or coagulation parameters, or breast safety. The combination bioidentical E2/P4 capsule (1 mg/100 mg dose was FDA-approved as Bijuva in October 2018) may provide a safe, effective, rigorously studied alternative for women with a uterus who prefer CHT for relief of VMS.     

透明质酸钠对预防人工流产术后闭经的作用研究

目的：探讨透明质酸钠在人工流产手术后对预防闭经的实际疗效及价值。方法对400例人工流产术后使用透明质酸钠者进行跟踪调查，观察术后6个月内月经是否正常，有无白带增多、腹痛等症状，统计闭经出现的概率，并调查其年龄、孕次数与闭经之间的关系。随机选择400例进行人工流产术且未使用透明质酸钠等防粘连产品者，作为对照组，同样观察以上指标。结果人工流产术后使用透明质酸钠者仅1例出现闭经，闭经概率为0.26%，未使用防粘连产品者有19例闭经，闭经概率为5.35%，差异有统计学意义。结论透明质酸钠在人工流产术中对预防闭经有显著效果。     

神经性厌食患者内分泌功能的改变

目的　了解神经性厌食患者内分泌功能的改变及其临床特点。方法　分析 3 0例神经性厌食患者内分泌激素水平的变化及临床资料。结果　 (1)本组神经性厌食者均为女性 ,平均年龄 (18.4± 2 .1)岁 ,病程 1～ 6年。临床表现为厌食、严重营养不良和继发性闭经 ;(2 )大多数患者LH、FSH和E2 明显降低 ;8例患者行GnRH刺激时 ,LH、FSH呈延迟反应 ;(3 ) 15例患者甲状腺激素和TSH均正常 ,9例患者表现为单纯性T3 和FT3 减低 ,6例患者甲状腺激素均降低 ;(4 )血、尿皮质醇水平均正常 2 4例 ,增高 6例 ,出现节律紊乱 6例 ;(5 )GH升高 15例 (15 / 16) ,PRL均正常 2 0例(2 0 / 2 0 )。结论　严重营养不良和继发性闭经为神经性厌食患者的主要临床表现 ,伴有多种内分泌功能紊乱 ,继发性闭经是显著体重下降和下丘脑 垂体 性腺轴功能紊乱共同作用的结果。     

Menstrual Cycle and its Disorders in Women with Congenital Heart Disease

Objectives. To investigate the age at menarche, the prevalence of menstrual cycle (interval) disorders, and determinants in women with congenital heart disease (CHD). Design. Using two CHD registries, 1802 (82%) of the 2196 women with CHD contacted (aged 18–58 years) provided written informed consent. After exclusion of patients with genetic disorders known to be associated with menstrual cycle disorders, 1593 eligible patients remained. Interviews by telephone and reviews of medical records were conducted. Results. Overall, the age at menarche was slightly increased in women with CHD (13.3 vs. 13.1 years in the general population), mainly attributable to an increased prevalence of primary amenorrhea (n = 147; 9.2%). Other menstrual cycle disorders were documented: secondary amenorrhea (n = 181, 11.4%), polymenorrhea (n = 103, 6.5%), oligomenorrhea (n = 90, 5.6%), and menorrhagia (n = 117, 6.5%). The occurrence of these disorders also depended on the presence of cyanotic heart disease, surgical status, the number of surgical interventions, and the severity of CHD. Discussion. Menstrual cycle disturbances, in particular primary amenorrhea, were frequently observed in this population. Patients with complex (cyanotic) heart disease needing repeated surgical interventions prior to menarche are especially at risk.     

绝经前乳腺癌患者新辅助化疗相关闭经的影响因素及临床意义探讨

目的分析绝经前乳腺癌患者接受新辅助化疗后闭经的相关影响因素,了解新辅助化疗相关的闭经（NCRA）与新辅助化疗后肿瘤降期的关系。方法回顾性随访观察我院2006年3月至2011年3月期间224例绝经前乳腺癌患者接受新辅助化疗后月经状态的改变及新辅助化疗后彩超下乳房肿瘤的变化情况,分析新辅助化疗时患者年龄、化疗方案、肿瘤病理组织学特征（ER/PR和Her-2）、术后服用他莫昔芬（tamoxifen,TAM）与NCRA及其随后月经恢复的关系,以及新辅助化疗后肿瘤的变化与NCRA的关系。结果 224例患者中有166例（74.11%）患者出现NCRA,其中有15例停经但雌激素水平增高而行卵巢切除或接受戈舍瑞林治疗,余151例NCRA患者中有40例（26.49%）出现月经恢复。单因素及多因素分析结果显示,NCRA的发生及随后的月经恢复均与患者的年龄有关（P〈0.001,P=0.001）;不同化疗方案对NCRA的发生无明显影响（P〉0.05）,但是对NCRA后月经恢复有重要影响（P〈0.001）;肿瘤的ER/PR和Her-2表达和是否服用TAM对NCRA发生及其随后的月经恢复均无明显影响（P〉0.05）。发生NCRA时的化疗周期数随患者年龄的增长而减少,与NCRA后月经的恢复无关（P〉0.05）。NCRA的发生与新辅助化疗后肿瘤的降期无关（P〉0.05）。结论大多数绝经前乳腺癌患者接受新辅助化疗后会出现闭经,年龄越大的患者越容易发生NCRA,而且发生NCRA时接受化疗的周期数更少;年龄和化疗方案都会影响NCRA后月经的恢复;NCRA的发生未影响新辅助化疗的近期疗效。     

LHRH兴奋试验在闭经处理上的应用

本文对18例正常妇女及50例血清促性腺激素正常或低下的闭经患者行LHRH兴奋试验(单次静脉注射法)。建立了早卵泡期妇女正常反应范围。78％闭经患者反应正常或高亢。本试验反应类型与预后及LHRH脉冲治疗效果之间有一定的相关关系。本文对LHRH兴奋试验的临床价值及适应症进行了讨论。