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亚洲女性生活质量类别(领域)的差异患病率以及三种剂量结合雌激素/醋酸甲羟孕酮治疗后的变化:泛亚洲更年期(PAM)研究。

Differential prevalence of quality-of-life categories (domains) in Asian women and changes after therapy with three doses of conjugated estrogens/medroxyprogesterone acetate: the Pan-Asia Menopause (PAM) study.

作者信息

Limpaphayom K K, Darmasetiawan M S, Hussain R I, Burriss S W, Holinka C F, Ausmanas M K

机构信息

Chulalongkorn University, Bangkok, Thailand.

出版信息

Climacteric. 2006 Jun;9(3):204-14. doi: 10.1080/13697130600722520.

Abstract

OBJECTIVES

To assess the prevalence of four categories (domains) of menopausal symptoms as markers for quality of life in nine ethnic groups of Asian women. To evaluate changes in quality of life (MENQOL scores) in Asian women following hormone therapy.

METHODS

A prospective, randomized, double-blind, multinational clinical trial in 1028 healthy postmenopausal women of nine ethnic groups from 11 Asian countries/regions. Following 2 weeks of baseline observation, the women received one of three conjugated estrogens (CE)/medroxyprogesterone acetate (MPA) doses (in mg) daily for 24 weeks: 0.625/2.5, 0.45/1.5, or 0.3/1.5. At baseline and at the end of weeks 4, 12 and 24 following the start of therapy, the study participants were asked to record, on a menopause-specific quality of life (MENQOL) questionnaire, 29 menopausal symptoms, as experienced during the preceding month. The symptoms were categorized into four domains: vasomotor, psychosocial, physical and sexual.

RESULTS

The baseline (pretreatment) symptom scores in each of the four domains varied substantially among the different ethnic groups, ranging from 2.21 to 5.71 in the vasomotor, 2.37-5.96 in the psychosocial, 2.66-5.39 in the physical, and 2.11-6.55 in the sexual domain. Overall, Vietnamese and Pakistani women had the highest baseline scores, i.e. were most afflicted by each set of symptoms in a given domain, and Indonesian, Malay, Taiwanese and Thai women were least afflicted. In the overall population, intervention resulted in statistically significant decreases in the scores of all four domains within 4 weeks of intervention. The beneficial effects were similar in the three dose groups.

CONCLUSIONS

The prevalence of four domains of menopausal symptoms, representative of quality of life as recorded on a MENQOL questionnaire, varies considerably among ethnic groups of Asian women. The MENQOL scores in the overall population were significantly lowered in the course of the study, indicating an improvement in quality of life. In the absence of a placebo group, the relative contribution of hormones and placebo in our intervention is unknown.

摘要

目的

评估亚洲女性九个种族中四类(领域)更年期症状作为生活质量指标的流行情况。评估激素治疗后亚洲女性生活质量(MENQOL评分)的变化。

方法

一项针对来自11个亚洲国家/地区的九个种族的1028名健康绝经后女性的前瞻性、随机、双盲、多国临床试验。在进行2周的基线观察后,这些女性每天接受三种结合雌激素(CE)/醋酸甲羟孕酮(MPA)剂量(以毫克计)中的一种,持续24周:0.625/2.5、0.45/1.5或0.3/1.5。在基线以及治疗开始后的第4、12和24周结束时,研究参与者被要求在一份针对更年期的生活质量(MENQOL)问卷上记录前一个月所经历的29种更年期症状。这些症状被分为四个领域:血管舒缩、心理社会、身体和性方面。

结果

四个领域中每个领域的基线(治疗前)症状评分在不同种族之间差异很大,血管舒缩领域为2.21至5.71,心理社会领域为2.37 - 5.96,身体领域为2.66 - 5.39,性方面领域为2.11至6.55。总体而言,越南和巴基斯坦女性的基线评分最高,即在给定领域中受每组症状的影响最大,而印度尼西亚、马来、台湾和泰国女性受影响最小。在总体人群中,干预导致干预后4周内所有四个领域的评分在统计学上显著降低。三个剂量组的有益效果相似。

结论

代表MENQOL问卷所记录生活质量的四类更年期症状的流行情况在亚洲女性的不同种族之间差异很大。在研究过程中,总体人群的MENQOL评分显著降低,表明生活质量有所改善。由于没有安慰剂组,我们干预中激素和安慰剂的相对作用尚不清楚。

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