从统计学视角解读SECURE-PCI 研究:负荷剂量阿托伐他汀获益仍是假设

2018-08-07 xujing 中国循环杂志

SECURE-PCI 研究将来自巴西53 个研究中心计划进行经皮冠状动脉介入治疗(PCI)的4 191 例ACS患者随机、双盲分入阿托伐他汀负荷剂量治疗组(2 087 例)和安慰剂对照组(2 104 例)。


SECURE-PCI 研究将来自巴西53 个研究中心计划进行经皮冠状动脉介入治疗(PCI)的4 191 例ACS患者随机、双盲分入阿托伐他汀负荷剂量治疗组(2 087 例)和安慰剂对照组(2 104 例)。

该研究的主要目的是验证PCI 围术期两次给予阿托伐他汀80 mg 负荷剂量治疗是否可以降低30 天患者发生主要不良血管事件发生率。

值得注意的是,该研究在对64.7%行PCI 术的亚组人群进行分析时发现,出现至少一次MACE 的比例分别为:负荷剂量治疗组6.0%(81/1351),对照组8.2%(112/1359),组间差异有统计学意义(HR = 0.72,95%CI: 0.54~0.96,P=0.02)。

阜外医院李卫教授指出,对此亚组结果的解释必须十分慎重。不能简单解释为:PCI 患者围术期使用负荷剂量阿托伐他汀80 mg 治疗可显著降低30 天MACE发生率,而应该认为该亚组分析结果仅仅是产生了一个今后继续研究的假设。

原因如下:

(1)尽管SECURE-PCI 在对主要研究终点进行试验设计时,对PCI 亚组也进行了事先定义,而且还对该亚组进行了统计学设计(80% 的把握度,可以检测25% 的MACE 相对风险的减少)。

但是,由于试验设计时并未调整I 型误差,因此,只有当主要研究终点与亚组分析结果均要在0.05水平上同时显著时方可避免统计学的I 型误差膨胀问题,否则,就可能因为多重比较而导致I 型误差的膨胀,从而有可能出现假阳性结论。

显而易见,由于该研究的主要研究终点为阴性结果,因此,在0.05 显著性水平上,无法避免PCI 亚组分析出现假阳性结果。

(2)由于SECURE-PCI 仅仅对所有预期进行PCI 术的总人群进行随机双盲分组,以保证负荷剂量治疗组与安慰剂对照组间人口统计学等其他基线特征的组间均衡性。

由于事先无法预知哪些患者符合行PCI 术的入选标准,因此,该研究并没有对所有符合行PCI 术指征的患者进行随机分组,也就无法保证行PCI 术人群基线特征的组间均衡性,因此,对于行PCI 术人群的统计分析有可能由于组间基线的不均衡而导致有偏性的结果。

(3)文章中没有给出行PCI 术患者的组间基线分布,因此,也无从对组间的不均衡进行调整,以获得无偏的估计。否则,应该进行灵敏度分析,以判断结果的稳健性。

李卫教授认为,SECURE-PCI 研究中对PCI 亚组人群的分析结果仅仅产生了一个PCI 患者围术期使用负荷剂量阿托伐他汀80 mg治疗有可能降低30天MACE 发生率的假设,而该假设的验证将有待于今后进行仅仅针对PCI 患者的、以围术期使用负荷剂量阿托伐他汀80 mg治疗可以降低30天MACE发生率为主要研究终点的符合统计学原则的前瞻性、多中心、随机、双盲、安慰剂对照临床试验。

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    2019-03-22 徐岩
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    2018-08-09 siiner
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    2018-08-08 liumin1987

    嗯嗯,学习了。

    0

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    2018-08-07 183****7028

    学习

    0

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