药物许可证文件在研究更年期后荷尔蒙治疗对心血管疾病的影响中的价值
1National Research and Development Centre for Welfare and Health, Health Services Research Unit, Helsinki, Finland. elina.hemminiki@stakes.fi
Lancet (London, England)
|February 22, 2000
概括
绝经后的激素治疗 (PHT) 没有证据表明有心血管方面的益处. 芬兰未发表的试验数据没有改变以前的发现,表明PHT与心血管疾病风险的降低无关.
科学领域:
- 心血管科学 心血管科学
- 内分泌学 在内分泌学.
- 临床试验 临床试验
背景情况:
- 之前对已发表的试验的综合分析发现没有证据支持绝经后激素治疗 (PHT) 减少心血管疾病.
- 对于心血管结果的PHT的疗效和安全性仍然是研究和临床关注的关键领域.
研究的目的:
- 评估获取和利用芬兰药物许可申请中的临床试验报告用于PHT研究的可行性.
- 确定这些未发表的试验报告是否证实或反驳PHT和心血管事件的现有发现.
主要方法:
- 获得芬兰社会事务和卫生部的特别许可,在药物许可申请中访问机密的临床试验数据.
- 分析了提交给芬兰药物管理局的PHT药物申请的临床部分,重点是将PHT与安慰剂或对照组进行比较的试验.
- 从新试验中识别和汇总的数据报告心血管,血栓栓塞事件或表面炎与先前发表的试验数据.
主要成果:
- 审查了17个PHT药物的许可申请,揭示了试验报告质量的显著变化.
- 确定了六项符合纳入标准的新试验,但它们的数据对整体分析的贡献很小.
- 与PHT相比没有PHT的心血管和血栓栓塞事件的合并几率比率为1.97 (95% CI 0.84-4.63),类似于前一项研究的1.65 (0.65-4.21).
结论:
- 由于数据类型和报告质量,芬兰药物许可申请中的未公布的临床试验数据提供了有限的额外信息.
- 包括这些新数据并没有改变既定的结论:临床试验不支持PHT对心血管疾病的有益作用.
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