Lack of applicable safety data has effected an ease in federal restriction on the inclusion of women in clinical trials, particularly because: (1) they consume more prescription and over-the-counter medications than do men; (2) most require some type of drug therapy during pregnancy; and (3) many drugs that have been withdrawn from the market had higher health risks for women. The desire for more women-specific data prompted the Women's Health Initiative (WHI) studies, which reported an unfavorable risk-benefit relationship for hormone replacement therapy (HRT), as well as no significant reduction in disease or fracture risk with calcium and vitamin D supplementation but possible kidney stone development. Although the health risks were minimal, physicians feared any possible litigation involved with the use of HRT and were concerned with any possible adverse effects from calcium supplementation, and therefore altered their prescribing practices. Women, fearing any long-term health risks, also began seeking alternative treatments. However, the safety of these alternative therapies may be questionable, because they often are not subjected to extensive scrutiny and do not require federal approval. Alternative prescription drug treatments may have long-term adverse consequences that will only become evident with years of use. It is important to recognize that over-generalization and extrapolation of data may deny appropriate treatment to certain subgroups of women who may benefit.

译文

缺乏适用的安全性数据已使联邦政府对将女性纳入临床试验的限制变得容易,特别是因为 :( 1) 她们比男性服用更多的处方药和非处方药; (2) 大多数人在怀孕期间需要某种类型的药物治疗; (3) 许多已退出市场的药物对女性的健康风险更高。对更多针对女性的数据的渴望促使了妇女健康倡议 (WHI) 的研究,该研究报告了激素替代疗法 (HRT) 的不利风险-收益关系,并且钙和维生素d补充剂没有显着降低疾病或骨折风险,但可能会发展肾结石。尽管健康风险很小,但医生担心与使用HRT有关的任何可能的诉讼,并担心钙补充剂可能产生的不利影响,因此改变了他们的处方做法。担心任何长期健康风险的女性也开始寻求替代疗法。但是,这些替代疗法的安全性可能值得怀疑,因为它们通常不受广泛审查,也不需要联邦批准。替代处方药治疗可能会产生长期的不良后果,只有在使用多年后才会变得明显。重要的是要认识到,数据的过度概括和推断可能会拒绝对可能受益的某些妇女亚组进行适当的治疗。

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