TREATMENT EVALUATION IN PREMENSTRUAL SYNDROME PATIENTS
TREATMENT EVALUATION IN PREMENSTRUAL SYNDROME PATIENTS
批准号:
2197696
负责人:
ELLEN W FREEMAN
金额:
$25.57万
依托单位国家:
美国
项目类别:
财政年份:
1985
资助国家:
美国
项目状态:
已结题
起止时间:
1985-02-01 至 1997-03-31
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)
中文摘要
拟议的项目是一个为期5年的竞争性更新“治疗
经前综合征患者的评估”。 施行本
研究的目的是a)确定所选择的抗肿瘤药物的功效,
激素和抗焦虑药物治疗经前期综合征
(PMS)和B)确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,
经前综合征的行为变化来自中枢效应,可能是一种
中枢神经系统对性腺-肾上腺类固醇的敏感性改变。
具体目的如下:1)比较一种选择性的甜菜碱,
抗抑郁药与去甲肾上腺素能抗抑郁药比较,以确定其
PMS治疗的影响; 2)确定减少A环的影响
PMS中孕酮的代谢物(别孕烯醇酮和孕烯醇酮)
受试者口服微粒化孕酮剂量后; 3)完成
目前的研究比较了口服微粒化孕酮和
苯二氮卓类药物阿普唑仑,这两种药物都被认为可以增强
GABA通过与GABA受体复合物结合进行传递,尽管
在不同的结合位点; 4)确定PMS的过程和稳定性
诊断后的症状以及这些症状对
生活质量
实现这些目标的方法是:1)进行明确的随机化,
舍曲林和地昔帕明治疗抑郁症的双盲、安慰剂对照研究
经前综合征患者; 2)测量孕激素代谢物后,双-
盲法口服孕酮剂量和相关代谢物水平行为
措施和治疗反应; 3)完成当前的口头
孕酮/阿普唑仑/安慰剂有效性研究,第一个连续研究
一年,有足够的样本量获得确定的结果;以及4)进行
对经前综合症妇女的长期随访研究。
经前综合症是一种复杂的、人们知之甚少的、与生殖系统有关的疾病
据报道,5-10%的骑自行车的妇女处于严重水平。 数量之多
这些妇女在生命的黄金年龄将表明,经前综合症是一个
重大健康问题,值得制定有效的
治疗。 此外,拟议的研究将有助于
了解经前综合征的神经内分泌效应,
PMS人群中的亚组。 关于PMS过程的信息
症状对于理解其发生和慢性化是重要的,
这降低了生活质量,影响了昂贵的医疗服务的使用。
资源
英文摘要
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.
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