国际乳腺癌干预研究 (IBIS-I) 的第一个结果:一种随机预防试验
Lancet (London, England)
|September 24, 2002
概括
在高危女性中,他莫西芬可将乳腺癌的风险降低32%. 然而,它增加了子宫内膜癌,血栓和全因死亡率的风险,使其整体益处不清楚.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 预防医学 预防医学
背景情况:
- 以往对乳腺癌预防的坦莫西芬试验的混合结果.
- 有证据表明,他莫西芬可以降低乳腺癌的风险,但风险效益平衡尚不确定.
- 需要进一步调查塔莫西芬在预防乳腺癌方面的疗效和安全性.
研究的目的:
- 评估塔莫西芬在预防乳腺癌方面的疗效和安全性.
- 评估他莫西芬对高风险女性乳腺癌发病率的影响.
- 为了确定预防性使用他莫西芬的风险益益比.
主要方法:
- 双盲,安慰剂对照随机试验.双盲,安慰剂对照随机试验.
- 7152名年龄在35-70岁,患乳腺癌风险较高的妇女接受了坦莫西芬 (20毫克/天) 或安慰剂5年.
- 主要结局:乳腺癌的发生频率;治疗意图分析.
主要成果:
- 在中位数50个月的随访后,他莫西芬使乳腺癌风险降低了32% (p=0.013).
- 子宫内膜癌的非显著增加 (11对5).
- 血栓塞栓事件显著增加与他莫西芬 (OR 2.5,p=0.001);所有原因的死亡率也显著增加 (25对11,p=0.028).
结论:
- 预防性他莫西芬显著降低了乳腺癌的风险.
- 血栓塞栓事件和子宫内膜癌的风险增加需要仔细考虑.
- 在乳腺癌预防中,他莫西芬的整体风险益处比率尚不清楚,需要持续跟踪.
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