Nevols Jacqueline, Watkins Lynn, Lewis Robert
Consultant Nephrologist.
Lead Renal Research Nurse.
Clin Kidney J. 2023 Mar 29;16(8):1307-1315. doi: 10.1093/ckj/sfad066. eCollection 2023 Aug.
Chronic kidney disease-associated pruritus (CKD-aP) is a common, distressing complaint in patients with advanced renal disease that is frequently overlooked. Treatment is often unsatisfactory. Balneum Plus (Almirall, Barcelona, Spain) is a cream containing 3% lauromacrogols and 5% urea, commonly used to treat atopic dermatitis. It has not been studied in CKD-aP to date.
Adult haemodialysis patients were randomised 1:1 to apply Balneum Plus or E45 (Reckitt Beckiser, Slough, UK) to compare the active ingredients of lauromacrogol and urea with a control cream. Itch was defined as three episodes of itching during the last 2 weeks, appearing a few times a day, lasting a few minutes and troubling the patient [1]. Patients with other causes of itch, e.g. eczema and liver disease, were excluded. The primary outcome was a reduction in itch as measured by the visual analogue scale (VAS) score at 4 weeks and analysed using an analysis of covariance approach.
A total of 314 patients were screened and 58 patients were randomised, 29 in each group. Three patients dropped out in each group. The median baseline VAS scores were 6.5 [interquartile range (IQR) 4.4-8.0] in the Balneum Plus group and 6.3 (IQR 5.1-7.3) in the E45 group. After 4 weeks, VAS scores decreased to 2.6 (IQR 0.9-4.5) and 2.0 (IQR 0.5-4.8) in the Balneum Plus and E45 groups respectively ( = 0.64 for the difference). Using a validated questionnaire to assess secondary outcomes, we found that the Balneum Plus group had longer itching episodes, more difficulty staying asleep and itching was more annoying than in the E45 group. There was no significant difference in adverse events between the two groups. One patient reported inflamed spots on the abdominal skin in the Balneum Plus group.
This is the first randomised controlled study of two different emollients for the treatment of CKD-aP and is a negative study. We found no significant difference in itch scores between Balneum Plus and E45.
慢性肾脏病相关性瘙痒（CKD-aP）是晚期肾病患者常见且令人苦恼的症状，常被忽视。治疗效果往往不尽人意。Balneum Plus（西班牙巴塞罗那的Almirall公司生产）是一种含有3%月桂醇聚醚和5%尿素的乳膏，常用于治疗特应性皮炎。迄今为止，尚未对其在CKD-aP中的应用进行研究。
成年血液透析患者按1:1随机分组，分别使用Balneum Plus或E45（英国斯劳的利洁时公司生产），以比较月桂醇聚醚和尿素的活性成分与对照乳膏。瘙痒定义为过去2周内出现三次瘙痒发作，每天发作几次，每次持续几分钟并困扰患者[1]。排除其他瘙痒原因的患者，如湿疹和肝病患者。主要结局是4周时通过视觉模拟量表（VAS）评分测量的瘙痒减轻情况，并采用协方差分析方法进行分析。
共筛选314例患者，58例患者随机分组，每组29例。每组各有3例患者退出。Balneum Plus组的基线VAS评分中位数为6.5[四分位数间距（IQR）4.4 - 8.0]，E45组为6.3（IQR 5.1 - 7.3）。4周后，Balneum Plus组和E45组的VAS评分分别降至2.6（IQR 0.9 - 4.5）和2.0（IQR 0.5 - 4.8）（差异为0.64）。使用经过验证的问卷评估次要结局，我们发现Balneum Plus组的瘙痒发作时间更长，入睡困难更多，且瘙痒比E45组更烦人。两组不良事件无显著差异。Balneum Plus组有1例患者报告腹部皮肤出现炎症斑点。
这是第一项针对两种不同润肤剂治疗CKD-aP的随机对照研究，结果为阴性。我们发现Balneum Plus和E45在瘙痒评分上无显著差异。
