Nelson Heidi D
Oregon Evidence-based Practice Center, Department of Medical Informatics and Clinical Epidemiology, Oregon Health and Science University, Portland 97239, USA.
JAMA. 2004 Apr 7;291(13):1610-20. doi: 10.1001/jama.291.13.1610.
Recommendations for postmenopausal hormone therapy have changed since the Women's Health Initiative indicated that estrogen was harmful for use in disease prevention; however, treatment of menopausal symptoms with low-dose estrogen remains an approved indication for use.
To compare the short-term efficacy and adverse effects of 2 commonly used estrogens, conjugated equine estrogen (CEE) and 17beta-estradiol, for reducing menopausal hot flashes by systematically reviewing randomized controlled trials.
MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews, and Cochrane Controlled Trials Registry were searched from the database start dates to July 2003 using database-specific key words. Reference lists of published articles, experts, and pharmaceutical manufacturers were also consulted.
English-language abstracts of double-blind, randomized, placebo-controlled trials and systematic evidence reviews of oral CEE and oral and transdermal 17beta-estradiol, and treatment of menopausal hot flashes and their adverse effects.
Study design, population characteristics, eligibility criteria, interventions, withdrawals, adverse effects, and results for each outcome. Study quality was assessed using predefined criteria based on parameters developed with the US Preventive Services Task Force and the UK National Health Services Centre.
A total of 32 trials including 4 head-to-head comparisons met inclusion criteria; 14 trials met criteria for meta-analysis. All estrogen agents significantly reduced the weekly number of hot flashes compared with placebo (CEE, 1 trial: mean change, -19.1; 95% confidence interval [CI], -33.0 to -5.1; oral 17beta-estradiol, 5 trials: pooled weighted mean difference, -16.8; 95% CI, -23.4 to -10.2; transdermal 17beta-estradiol, 6 trials: pooled weighted mean difference, -22.4; 95% CI, -35.9 to -10.4); differences between agents were not significant. Breast tenderness and atypical vaginal bleeding were the most frequently reported adverse effects among estrogen users. The influence of progestin or progesterone use, cyclic and continuous regimens, and differences in adverse effects could not be determined.
Conjugated equine estrogen and 17beta-estradiol have consistent and comparable effects on treatment of menopausal hot flashes and may have similar short-term adverse effects.
自妇女健康倡议表明雌激素对疾病预防有害以来,绝经后激素治疗的建议发生了变化;然而,使用低剂量雌激素治疗更年期症状仍然是一个批准的适应症。
通过系统回顾随机对照试验,比较两种常用雌激素——结合马雌激素(CEE)和17β-雌二醇——在减轻更年期潮热方面的短期疗效和不良反应。
使用特定数据库关键词,从数据库起始日期至2003年7月对MEDLINE、EMBASE、Cochrane系统评价数据库和Cochrane对照试验注册库进行检索。还查阅了已发表文章的参考文献列表、专家和制药商的资料。
双盲、随机、安慰剂对照试验的英文摘要,以及关于口服CEE、口服和经皮17β-雌二醇治疗更年期潮热及其不良反应的系统证据综述。
每项研究的设计、人群特征、纳入标准、干预措施、退出情况、不良反应和结果。根据美国预防服务工作组和英国国家医疗服务中心制定的参数,使用预定义标准评估研究质量。
共有32项试验(包括4项直接比较试验)符合纳入标准;14项试验符合荟萃分析标准。与安慰剂相比,所有雌激素制剂均显著减少每周潮热次数(CEE,1项试验:平均变化,-19.1;95%置信区间[CI],-33.0至-5.1;口服17β-雌二醇,5项试验:合并加权平均差,-16.8;95%CI,-23.4至-10.2;经皮17β-雌二醇,6项试验:合并加权平均差,-22.4;95%CI,-35.9至-10.4);各制剂之间的差异不显著。乳房压痛和非典型阴道出血是雌激素使用者中最常报告的不良反应。无法确定孕激素或孕酮的使用、周期性和连续性方案以及不良反应差异的影响。
结合马雌激素和17β-雌二醇在治疗更年期潮热方面具有一致且可比的效果,并且可能具有相似的短期不良反应。