Kataoka Hiroshi, Mochizuki Toshio, Ohara Mamiko, Tsuruta Yuki, Iwasa Naomi, Yoshida Rie, Tsuchiya Ken, Nitta Kosaku, Kimura Kenjiro, Hosoya Tatsuo
Department of Nephrology, Tokyo Women's Medical University, Tokyo, 162-8666, Japan.
Department of Nephrology, Clinical Research Division for Polycystic Kidney Disease, Tokyo Women's Medical University, Tokyo, 162-8666, Japan.
Sci Rep. 2022 Mar 8;12(1):3784. doi: 10.1038/s41598-022-07737-9.
Attribute-based medicine is essential for patient-centered medicine. To date, the groups of patients with chronic kidney disease (CKD) requiring urate-lowering therapy are clinically unknown. Herein, we evaluated the efficacy of febuxostat using a cross-classification, attribute-based research approach. We performed post hoc analysis of multicenter, randomized, double-blind, placebo-controlled trial data for 395 patients with stage 3 CKD and asymptomatic hyperuricemia. Participants were divided into febuxostat or placebo groups and subcohorts stratified and cross-classified by proteinuria and serum creatinine concentrations. In patients stratified based on proteinuria, the mean eGFR slopes were significantly higher in the febuxostat group than in the placebo group (P = 0.007) in the subcohort without proteinuria. The interaction between febuxostat treatment and presence of proteinuria in terms of eGFR slope was significant (P for interaction = 0.019). When cross-classified by the presence of proteinuria and serum creatinine level, the mean eGFR slopes significantly differed between the febuxostat and placebo groups (P = 0.040) in cross-classified subcohorts without proteinuria and with serum creatinine level ≥ median, but not in the cross-classified subcohorts with proteinuria and serum creatinine level < median. Febuxostat mitigated the decline in kidney function among stage 3 CKD patients with asymptomatic hyperuricemia without proteinuria.
基于属性的医学对于以患者为中心的医学至关重要。迄今为止,需要降尿酸治疗的慢性肾脏病(CKD)患者群体在临床上尚不清楚。在此,我们使用交叉分类、基于属性的研究方法评估了非布司他的疗效。我们对395例3期CKD和无症状高尿酸血症患者的多中心、随机、双盲、安慰剂对照试验数据进行了事后分析。参与者被分为非布司他组或安慰剂组,并根据蛋白尿和血清肌酐浓度进行分层和交叉分类。在根据蛋白尿分层的患者中,在无蛋白尿的亚组中,非布司他组的平均估算肾小球滤过率(eGFR)斜率显著高于安慰剂组(P = 0.007)。非布司他治疗与蛋白尿的存在在eGFR斜率方面的交互作用显著(交互作用P = 0.019)。当根据蛋白尿和血清肌酐水平进行交叉分类时,在无蛋白尿且血清肌酐水平≥中位数的交叉分类亚组中,非布司他组和安慰剂组的平均eGFR斜率有显著差异(P = 0.040),但在有蛋白尿且血清肌酐水平<中位数的交叉分类亚组中没有差异。非布司他减轻了无蛋白尿的3期CKD无症状高尿酸血症患者的肾功能下降。