Rosenberg Harriet, Allard Danielle
Health and Society Program, Division of Social Science, York University, Toronto, Ontario, Canada.
Scand Cardiovasc J. 2008 Aug;42(4):268-73. doi: 10.1080/14017430801993180.
This paper is based on a longer report on the benefits, safety and modalities of information representation with regard to women and statin use, situated within the historical context of Women's Health Movement which has advocated for unbiased, appropriate medical research and prescribing for women based on the goals of full-disclosure, informed consent, evidence-based medicine and gender-based analysis. The evidence base for prescribing statins for women, especially for primary prevention is weak, yet Canadian data suggest that half of all prescriptions are for women. Safety meta-analyses do not disaggregate for women; do not consider female vulnerability to statin induced muscle problems, and women-centred concerns such as breast-cancer, miscarriage or birth defects are under-researched. Many trials have not published their non-cardiac serious adverse event data. These factors suggest that the standards of full-disclosure, informed consent, evidence-based prescribing and gender-based analysis are not being met and women should proceed with caution.
本文基于一份更长的报告，该报告涉及女性使用他汀类药物的益处、安全性及信息呈现方式，其背景是妇女健康运动的历史背景，该运动倡导基于充分披露、知情同意、循证医学和基于性别的分析目标，进行公正、适当的医学研究和为女性开处方。为女性开具他汀类药物的证据基础，尤其是用于一级预防的证据基础薄弱，但加拿大的数据表明，所有处方中有一半是开给女性的。安全性荟萃分析未按女性进行分类；未考虑女性对他汀类药物引起的肌肉问题的易感性，且对乳腺癌、流产或出生缺陷等以女性为中心的问题研究不足。许多试验尚未公布其非心脏严重不良事件数据。这些因素表明，充分披露、知情同意、循证开处方和基于性别的分析标准未得到满足，女性应谨慎行事。
