TREATMENT EVALUATION IN PREMENSTRUAL SYNDROME PATIENTS

经前综合症患者的治疗评估

• 批准号: 2197696
• 负责人: ELLEN W FREEMAN
• 金额: $ 25.57万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-02-01 至 1997-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2197696
• 关键词: GABA receptor; alprazolam; antidepressants; desipramine; dosage; drug adverse effect; female; hormone therapy; human subject; human therapy evaluation; longitudinal human study; menstrual cycle; neuroendocrine system; oral administration; placebos; premenstrual syndrome; progesterone; psychometrics; quality of life; receptor binding; reproductive system disorder chemotherapy; serotonin inhibitor; statistics /biometry; young adult human (21-34)

The proposed project is a 5-year competing renewal of "Treatment Evaluation in Premenstrual Syndrome Patients". The purpose of these studies is to a) determine the efficacy of selected anti-depressant, hormonal and anxiolytic medications in treatment of premenstrual syndrome (PMS) and b) determine the course and stability of premenstrual symptoms and the extent to which they continue to impact the quality of life. These studies relate to our working hypothesis that the mood and behavioral changes of PMS derive from central effects, possibly an altered CNS sensitivity to gonadal-adrenal steroids. The specific aims are as follows: 1) Compare a serotonin-selective antidepressant versus a noradrenergic anti-depressant to determine their effects in PMS treatment; 2) Identify the effects of reduced A ring metabolites of progesterone (allopregnanolone and pregnanolone) in PMS subjects following oral micronized progesterone dose; 3) Complete the current study comparing the efficacy or oral micronized progesterone and the benzodiazepine alprazolam, both of which are postulated to potentiate GABA transmission through binding to the GABA receptor complex, although at different binding sites; 4) Determine the course and stability of PMS symptoms following diagnosis and the impact of these symptoms on the quality of life. The methods to achieve these aims are 1) conduct a definitive randomized, double-blind, placebo-controlled study of Sertraline and Desipramine in PMS patients; 2) measure progesterone metabolites following double- blinded oral progesterone dose and correlate metabolite levels behavioral measures and treatment responses; 3) complete the current oral progesterone/alprazolam/placebo efficacy study in the first continuation year with sufficient sample size for definitive results; and 4) conduct a long-term follow-up study of women diagnosed with PMS. PMS is a complex, poorly understood, menstrually-related disorder reported at severe levels by 5-10% of cycling women. The sheer number of these women in the prime ages of life would indicate that PMS is a significant health problem that merits development of effective treatments. Additionally, the proposed studies will contribute to understanding of neuroendocrine effects in PMS and the identification of subgroups in the PMS population. Information on the course of PMS symptoms is important for understanding its occurrence and chronicity, which reduces the quality of life and affects the use of costly medical resources.

拟议中的项目是一项为期5年的竞争性续期治疗计划。 在经前综合征患者中的评估“。这些目的 研究的目的是a)确定选定的抗抑郁剂的疗效， 激素和抗焦虑药物治疗经前综合征 (经前综合征)和b)决定经前症状的病程和稳定性 以及它们继续影响生活质量的程度。 这些研究与我们的工作假设有关，即情绪和 经前综合征的行为改变源于中枢效应，可能是 改变中枢神经系统对性腺-肾上腺类固醇激素的敏感性。 具体目的如下：1)比较5-羟色胺选择性 抗抑郁剂与去甲肾上腺素能抗抑郁剂的比较 经前综合征治疗中的效果；2)确定减少A环的效果 孕酮(别孕酮和孕酮)在经前综合征中的代谢产物 口服微粒化黄体酮后的受试者；3)完成 最新研究比较口服微粒化黄体酮和黄体酮的疗效 苯二氮卓类阿普唑仑，这两种药物都被认为可以增强 GABA通过与GABA受体复合体结合而传递，尽管 在不同的结合部位；4)决定经前综合征的进程和稳定性 诊断后的症状以及这些症状对 生活质量。 实现这些目的的方法是1)进行确定的随机、 舍曲林和地塞帕明的双盲安慰剂对照研究 经前综合征患者；2)检测孕酮代谢产物 口服黄体酮剂量及相关代谢物水平的行为学研究 措施和治疗反应；3)完成本期口腔治疗 黄体酮/阿普唑仑/安慰剂的首次疗效研究 具有足够样本量以获得最终结果的年份；以及4)进行 一项对诊断为经前综合症的妇女的长期随访研究。 经前综合症是一种复杂的、鲜为人知的月经相关疾病。 5%-10%的骑自行车妇女报告了严重的水平。纯粹的数字 这些处于黄金时代的女性表明经前综合症是一种 值得有效开发的重大健康问题 治疗。此外，拟议的研究将有助于 经前综合征神经内分泌作用的认识及鉴别 经前综合症人群中的亚群。关于经前综合症病程的信息 症状对于了解其发生和慢性很重要， 这降低了生活质量，并影响了昂贵的医疗服务的使用 资源。