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[NEJM读者来信]:ADRENAL试验的长期预后
2018年05月12日 时讯速递, 进展交流 暂无评论

CORRESPONDENCE

Long-Term Outcomes of the ADRENAL Trial

Balasubramanian Venkatesh, Simon Finfer, John Myburgh, et al

N Engl J Med April 25, 2018

DOI: 10.1056/NEJMc1803563

TO THE EDITOR:

We recently reported the primary results of the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial, which tested the hypothesis that hydrocortisone would result in lower mortality than placebo among patients with septic shock.1 Further analysis of the trial data has been conducted according to a previously published statistical analysis plan, which designated death 6 months after randomization as a secondary end point.2 These data are now available and are reported here.

我们近期报告了ADRENAL研究的结果,这一研究旨在验证如下假设,即与安慰剂相比,氢化可的松能够降低感染性休克患者的病死率。我们根据已经发表的统计分析计划对试验数据进行了进一步分析,将随机分组后6个月的死亡作为次要预后终点。目前数据分析已经结束,在此进行报告。

Among patients for whom trial data were available, data on death at 90 days after randomization were obtained for 1832 of 1853 patients (98.9%) assigned to hydrocortisone and 1826 of 1860 (98.2%) assigned to placebo. At 6 months, we obtained data on vital status (alive or dead) for 1812 patients (97.8%) and 1803 patients (96.9%), respectively.

在试验数据完整的患者中,氢化可的松组1852名患者中1832名(98.9%)以及安慰剂组1860名患者中1826名(98.2%)可以得到随机分组90天的死亡数据。6个月时,我们分别对两组患者中的 1812名(97.8%)及1803名(96.9%)得到了生存数据(存活或死亡)。

Figure 1. Subgroup Analysis of Death at 180 Days.

At 6 months, among the patients for whom data on vital status were available, 571 of 1812 (31.5%) assigned to hydrocortisone and 574 of 1803 (31.8%) assigned to placebo had died (odds ratio, 0.99; 95% confidence interval, 0.86 to 1.13; P=0.83). The results were not altered by adjustment for stratification variables or additional covariates, as described in our original article1 (Table S1 in the Supplementary Appendix, available with the full text of this letter at NEJM.org). There was no significant heterogeneity in the effect of the trial regimen on the risk of death at 6 months in the six prespecified subgroups (Figure 1), nor were there geographic differences (Fig. S1 in the Supplementary Appendix). We conclude that in adult patients with septic shock, hydrocortisone did not affect mortality at 6 months after randomization; these findings are in concert with the 90-day mortality results published earlier in the Journal.

在6个月时,在生存状况数据齐全的患者中,氢化可的松组1812名患者中571名(31.5%)以及安慰剂组1803名患者中574名(31.8%)死亡(比数比0.99; 95% 可信限, 0.86 to 1.13; P=0.83)。根据最初发表文章描述的方法,对分层数据或其他协变量进行校正也不改变上述结果。在6个预先确定的亚组中,治疗方案的疗效没有明显的异质性,也没有地域差异性。我们由此得出结论,对于成年感染性休克患者而言,氢化可的松不能影响随机分组后6个月病死率;这一发现与杂志先前报告的90天病死率结果相一致。

 

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