Gotch Frank
Renal Research Institute, New York, N.Y., USA.
Contrib Nephrol. 2008;161:168-177. doi: 10.1159/000130674.
The relationships of clinical outcome to Kt/V and treatment time (t) in the two large randomized controlled trials of dialysis (National Cooperative Dialysis Study, NCDS, and the Hemodialysis Study, HEMO) were reviewed and compared to several major observational studies (OS). The HEMO study was originally conceived to determine whether outcome was improved by increasing Kt/V to 1.40, 40% higher than spKt/V >1.00 which was concluded to be adequate in the NCDS. However, OS suggested improvement in outcome up to and higher than Kt/V 1.40, so the HEMO dose targets were changed to 1.40 and 1.70. HEMO showed there was no change in outcome over this dose range but when the data were analyzed as a dose targeting OS, there was spurious improvement in outcome over the total range studied. Thus it cannot be concluded that Kt/V >1.0 results in improvement in clinical outcome since the range 1.00-1.40 has not been studied and both levels found adequate in randomized controlled trials. The borderline inverse correlation of outcome to treatment time in NCDS was shown to be meaningless because Kt/V was not successfully separated from t.
回顾了两项大型透析随机对照试验(国家合作透析研究,NCDS;以及血液透析研究,HEMO)中临床结局与Kt/V和治疗时间(t)之间的关系,并与几项主要的观察性研究(OS)进行了比较。HEMO研究最初旨在确定将Kt/V提高到1.40是否能改善结局,这一比NCDS中认为足够的标准Kt/V >1.00高出40%。然而,观察性研究表明,在Kt/V达到1.40及以上时结局有所改善,因此HEMO的剂量目标改为1.40和1.70。HEMO表明,在这个剂量范围内结局没有变化,但当将数据作为针对观察性研究的剂量进行分析时,在整个研究范围内结局出现了虚假的改善。因此,由于1.00 - 1.40这个范围未被研究,且在随机对照试验中发现这两个水平都是足够的,所以不能得出Kt/V >1.0会导致临床结局改善的结论。NCDS中结局与治疗时间的临界负相关被证明是没有意义的,因为Kt/V未能成功地与t区分开来。