TREATMENT EVALUATION IN PREMENSTRUAL SYNDROME PATIENTS

经前综合症患者的治疗评估

• 批准号: 3315736
• 负责人: ELLEN W FREEMAN
• 金额: $ 22.95万
• 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 1993-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3315736
• 关键词: GABA receptor; alprazolam; behavior test; behavioral medicine; dosage; drug adverse effect; female reproductive system disorder diagnosis; human subject; human therapy evaluation; menstrual cycle; neuroendocrine system; placebos; premenstrual syndrome; progesterone; psychometrics; psychopharmacologic agent; sign /symptom; statistics /biometry

The proposed project is a 5-year competing renewal of "Treatment Evaluation in Premenstrual Syndrome Patients". The specific aims of the project are to (1) complete the study of progesterone vaginal suppository treatment; (2) conduct a dose- response study of oral administration of micronized progesterone to determine an optimal dose and to determine if oral P elicits neuroendocrine and psychometric effects known to be associated with activation of the GABA-beta zeta -barbiturate receptor complex: (3) conduct a major treatment effectiveness study of 3 treatments -- oral progesterone, alprazolam and placebo; (4) test whether the treatment response is modified by high or low clinical contact during the treatment sequences; (5) evaluate treatments for 6 menstrual cycles to determine whether the presently observed trends in progesterone treatment are maintained or further increased. Aims 1-2 will be completed in Year 1; the treatment effectiveness study will be conducted in Years 2-5. The treatment study design is 3 parallel treatment sequences, each divided into high and low clinical contact under double-blind conditions. Random assignment to these treatments and contact groups will be made from the unimproved patients following evaluation and 2 placebo cycles. Two hundred forth women will complete the treatment sequences. Measures are at 10 times points using daily symptom reports, objective self-assessment instruments, physician and counselor evaluations. Descriptive and multivariate statistical methods are employed. There continues to be demand from both physicians and women who suffer from PMS (which may severely affect about 10% of reproductive-age females) for effective diagnosis and treatment of this disorder. This study will provide the following (1) definitive information on whether these treatments reduce PMS symptoms; (2) optimal dosage information for oral P; (3) further understanding of neuroendocrine and psychometric effects of oral P; (4) information on whether treatment response is modified by high or low clinical contact; (5) further diagnostic information on the symptom subgroups within the broad range of premenstrual symptoms.

拟议的项目是一项为期5年的竞争性续订 《经前综合征患者的治疗评价》。这个 该项目的具体目标是：(1)完成对 黄体酮阴道栓治疗；(2)进行剂量- 微粒化孕酮口服给药的疗效研究 确定最佳剂量并确定口服P是否会引起 神经内分泌和心理测量效应已知相关 激活GABA-β-Zeta-巴比妥酸受体 复合体：(3)进行3项主要治疗效果研究 治疗--口服黄体酮、阿普唑仑和安慰剂；(4)试验 治疗反应是否受临床疗效高低的影响 治疗顺序中的接触；(5)评估治疗 6个月经周期，以确定目前是否 观察到的孕酮治疗的趋势是维持或 进一步增加。 AIMS 1-2将在1年级完成；治疗 成效研究将在第二至第五年进行。治疗方法 研究设计为3个平行治疗序列，每个序列分为 双盲条件下的高、低临床接触。 对这些治疗和接触小组的随机分配将是 由未改善的患者经评估和2 安慰剂周期。第二百名女性将完成 治疗顺序。每天使用10倍的度量值 症状报告、客观自我评估工具、医生 和辅导员评估。描述性和多变量 研究中采用了统计方法。 医生和女性的需求依然存在。 患有经前综合症(可能会严重影响约10%的 育龄女性)进行有效的诊断和治疗 这种紊乱。这项研究将提供以下(1)最终结论 关于这些治疗是否减轻经前综合症症状的信息； (2)口服P的最佳剂量信息；(3)进一步认识 口服P的神经内分泌和心理测量效应；(4) 关于治疗反应是否由HIGH或HIGH修改的信息 临床接触少；(5)有关 大范围经前症状亚群 症状。