Department of Clinical Pharmacy, Faculty of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.
Nephrol Dial Transplant. 2010 May;25(5):1541-7. doi: 10.1093/ndt/gfp628. Epub 2009 Dec 10.
Generalized pruritus is a significant complication in end-stage renal disease patients. The mechanism is unknown and most treatments are ineffective. This study is the first clinical trial designed to evaluate the effect of cromolyn sodium (CS) on renal itch.
Sixty-two haemodialysis (HD) patients with pruritus were enrolled into the study and were randomly assigned to receive CS or placebo (135 mg three times daily) for 8 weeks. Patients were asked to record the severity of their pruritus on each dialysis session on a visual analogue scale (VAS) during the 8 weeks of treatment and 4 weeks following discontinuation of treatment. Serum tryptase levels were determined at baseline, after 8 weeks of treatment and 4 weeks after discontinuation of treatment.
Data were analysed in 21 patients in the CS group and 19 patients in the placebo group that completed the study. A significant difference was seen in the severity of pruritus between the two groups during the period of study. Level of pruritus decreased from 8.48 +/- 2.2 to 0.9 +/- 1.8 after 8 weeks of treatment with CS. Geometric mean of serum tryptase at baseline and 8 weeks after treatment were 21.3 and 19.5 ng/ml for the CS group and 18.03 and 18.2 ng/ml for the placebo group, respectively. Although the geometric mean of tryptase had decreased in the CS group, this decrease was not statistically significant (P = 0.214).
CS can significantly reduce the severity of pruritus in HD patients, but this effect is not due to a decrease in serum tryptase level.
全身性瘙痒是终末期肾病患者的一种严重并发症。其发病机制尚不清楚，且多数治疗方法无效。本研究是首个旨在评估色甘酸钠（CS）对肾性瘙痒影响的临床试验。
62 名接受血液透析（HD）治疗且伴有瘙痒的患者被纳入本研究，并被随机分配至 CS 组（135mg，每日三次）或安慰剂组（接受安慰剂治疗，每日三次），疗程为 8 周。在治疗的 8 周内和停药后的 4 周内，患者在每次透析时均使用视觉模拟量表（VAS）记录瘙痒严重程度。在基线时、治疗 8 周后和停药 4 周后测定血清胰蛋白酶原水平。
21 名 CS 组患者和 19 名安慰剂组患者完成了研究，对其数据进行了分析。研究期间，两组瘙痒严重程度存在显著差异。CS 治疗 8 周后，瘙痒严重程度从 8.48±2.2 降至 0.9±1.8。CS 组治疗前和治疗 8 周后的血清胰蛋白酶原几何均数分别为 21.3ng/ml 和 19.5ng/ml，安慰剂组分别为 18.03ng/ml 和 18.2ng/ml。尽管 CS 组的胰蛋白酶原几何均数有所下降，但无统计学意义（P=0.214）。
CS 可显著减轻 HD 患者的瘙痒严重程度，但这种作用并非由于血清胰蛋白酶原水平降低所致。
