Kabasawa Hideyuki, Hosojima Michihiro, Kanda Eiichiro, Nagai Miho, Murayama Toshiko, Tani Miyuki, Kamoshita Satoru, Kuroda Akiyoshi, Kanno Yoshihiko
Department of Clinical Nutrition Science, Kidney Research Center, Niigata University Graduate School of Medical and Dental Sciences, Niigata City, Niigata, Japan.
Department of Health Data Science, Kawasaki Medical School, Kurashiki, Okayama, Japan.
PLoS One. 2024 Dec 12;19(12):e0311671. doi: 10.1371/journal.pone.0311671. eCollection 2024.
The objective of this study was to investigate the efficacy and safety of intradialytic parenteral nutrition (IDPN) using ENEFLUID® (310 kcal, 550 mL) in mild-moderate malnutrition patients receiving maintenance hemodialysis. A total of 40 adult patients with a Nutritional Risk Index-Japanese Hemodialysis (NRI-JH) score of 5-10 were enrolled in this multicenter, randomized, open-label study. Patients in the intervention group received IDPN using ENEFLUID® via the dialysis circuit 3 times a week for 12 weeks; those in the control group did not. The primary endpoint was change in serum transthyretin (TTR). The secondary endpoints were changes in nutritional laboratory tests, nutritional parameters, food intake, plasma amino acids, and blood glucose. For both groups, mean age (72.1±11.4 years) and BMI (20.3±3.0), and median NRI-JH score [7.0 (interquartile range, 6-8)], did not differ. One patient withdrew before intervention, leaving 20 intervention and 19 control patients. Mean (95% confidence interval) change in serum TTR (mg/dL) at 12 weeks did not differ between groups: Intervention, 1.0 (-1.1-3.2); Control, -0.3 (-2.4-1.9); Intragroup difference, 1.3 (-1.7-4.3); P = 0.41. The values reflecting protein intake at 12 weeks compared to those on the study initiation day increased in the intervention group [the changes of blood urea nitrogen, 9.4 (2.6-16.2) mg/dL; P = 0.007, and normalized protein catabolic rate, 0.10 (0.02-0.18) g/kg/day; P = 0.02]. Mean food protein intake (g/kg/day) at 12 weeks increased in the intervention group and decreased in the control group, and differed between groups: Intervention, 0.12 (-0.03-0.28); Control, -0.18 (-0.43-0.08); Inter-group difference, 0.30 (0.00-0.60); P = 0.050. No adverse events occurred. In patients with mild to moderate malnutrition receiving ENEFLUID® for 12 weeks as IDPN, serum TTR was not improved, decreases in protein intake was mitigated, no adverse events occurred. Trial registration Name of the registry: Japan Registry of Clinical Trials Registration number: jRCTs031220296.
本研究的目的是调查使用ENEFLUID®（310千卡，550毫升）进行透析期间肠外营养（IDPN）对接受维持性血液透析的轻至中度营养不良患者的疗效和安全性。共有40名营养风险指数-日本血液透析（NRI-JH）评分为5-10的成年患者纳入了这项多中心、随机、开放标签研究。干预组患者通过透析回路每周3次接受使用ENEFLUID®的IDPN，共12周；对照组患者则不接受。主要终点是血清转甲状腺素蛋白（TTR）的变化。次要终点是营养实验室检查、营养参数、食物摄入量、血浆氨基酸和血糖的变化。两组患者的平均年龄（72.1±11.4岁）、体重指数（20.3±3.0）以及NRI-JH评分中位数[7.0（四分位间距，6-8）]均无差异。1名患者在干预前退出，最终干预组有20名患者，对照组有19名患者。12周时两组血清TTR（毫克/分升）的平均（95%置信区间）变化无差异：干预组为1.0（-1.1-3.2）；对照组为-0.3（-2.4-1.9）；组内差异为1.3（-1.7-4.3）；P = 0.41。与研究开始日相比，干预组12周时反映蛋白质摄入量的值有所增加[血尿素氮变化为9.4（2.6-16.2）毫克/分升；P = 0.007，标准化蛋白质分解代谢率变化为0.10（0.02-0.18）克/千克/天；P = 0.02]。干预组12周时平均食物蛋白质摄入量（克/千克/天）增加，对照组减少，且两组间存在差异：干预组为0.12（-0.03-（0.28）；对照组为-0.18（-0.43-0.08）；组间差异为0.30（0.00-0.60）；P = 0.050。未发生不良事件。在接受ENEFLUID®作为IDPN治疗12周的轻至中度营养不良患者中，血清TTR未得到改善，蛋白质摄入量的减少得到缓解，且未发生不良事件。试验注册 注册机构名称：日本临床试验注册中心 注册号：jRCTs031220296
