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临床试验对激素替代疗法使用的影响。一项基于人群的研究。

The impact of clinical trials on the use of hormone replacement therapy. A population-based study.

作者信息

Kim Nancy, Gross Cary, Curtis Jeptha, Stettin Glen, Wogen Stephen, Choe Nami, Krumholz Harlan M

机构信息

Section of General Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.

出版信息

J Gen Intern Med. 2005 Nov;20(11):1026-31. doi: 10.1111/j.1525-1497.2005.0221.x.

DOI:10.1111/j.1525-1497.2005.0221.x
PMID:16307628
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1490267/
Abstract

BACKGROUND

The last 5 years of trial data demonstrate the ineffectiveness of hormone replacement therapy (HRT). The impact of these trials on age-specific HRT use, HRT discontinuation, and regional HRT variation has not been evaluated extensively.

OBJECTIVE

To characterize the relation between HRT trial dissemination and age-specific HRT use, HRT discontinuation, and regional HRT variation before and after the trials' publication.

DESIGN

Using the Medco Health database, we analyzed HRT prescription filling, discontinuation, and regional variation among women > or =55 years from May 1998 to May 2003.

MEASUREMENTS AND MAIN RESULTS

Approximately 340,000 women were eligible for Medco benefits each month. Within 3 months of the Women's Health Initiative (WHI), HRT prescriptions declined from 12.5% to 9.4%, P< or =.0001. When stratified by age, a statistically significant decline in HRT post-WHI occurred in all age groups, with the biggest decline among women > or =55 to 64 (18% to 11%, P< or =.0001). Among HRT users, we found statistically significant increases in discontinuation in 2002 (67%) compared with 2001 (53%, P<.0001). Prior to the WHI there was substantial regional variation in HRT use, with the West South Central and mid-Atlantic having the highest and lowest proportions, respectively (19% vs 6%, P< or =.0001). Despite a relative decline in HRT use of 25% to 42% across all regions, substantial geographic variation remained.

CONCLUSIONS

Hormone replacement therapy use decreased significantly immediately post-WHI, suggesting that trial results can have a rapid effect on practice. Marked regional variation in HRT use persisted after the WHI, suggesting that local practice patterns exert a strong effect on clinical behavior even after new evidence is available.

摘要

背景

过去5年的试验数据表明激素替代疗法(HRT)无效。这些试验对特定年龄的HRT使用、HRT停药以及区域HRT差异的影响尚未得到广泛评估。

目的

描述HRT试验传播与试验发表前后特定年龄的HRT使用、HRT停药以及区域HRT差异之间的关系。

设计

利用美可保健数据库,我们分析了1998年5月至2003年5月期间55岁及以上女性的HRT处方配药、停药情况及区域差异。

测量指标及主要结果

每月约有340,000名女性符合美可保健福利条件。在妇女健康倡议(WHI)发布后的3个月内,HRT处方从12.5%降至9.4%,P≤0.0001。按年龄分层时,WHI后所有年龄组的HRT使用均出现统计学上的显著下降,其中55岁及以上至64岁女性的下降幅度最大(从18%降至11%,P≤0.0001)。在HRT使用者中,我们发现2002年的停药率(67%)与2001年(53%,P<0.0001)相比有统计学上的显著增加。在WHI之前,HRT使用存在显著的区域差异,美国西南中部和大西洋中部地区的比例分别最高和最低(19%对6%,P≤0.0001)。尽管所有地区的HRT使用相对下降了25%至42%,但仍存在显著的地理差异。

结论

WHI发布后,激素替代疗法的使用立即显著下降,表明试验结果可对临床实践产生迅速影响。WHI后,HRT使用的显著区域差异仍然存在,表明即使有了新证据,当地的临床实践模式对临床行为仍有很大影响。

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