安慰剂对照研究
双盲
锌
双盲研究
不利影响
临床试验
麻醉
作者
Mohammad Ali Mapar,Nader Pazyar,Amir Siahpoosh,Seyed Mahmoud Latifi,S S Beladi Mousavi,Ahmad Khazanee
出处
期刊:Giornale italiano di dermatologia e venereologia : organo ufficiale, Società italiana di dermatologia e sifilografia
日期:2015-08-01
卷期号:150 (4): 351-355
被引量:6
摘要
Aim Improvement of uremic pruritus has been reported under short-term administration of oral zinc sulfate. Objective of the study was to confirm efficacy and safety of oral zinc sulfate in pruritus of hemodialytic patients Methods A pilot randomized, triple-blind study was conducted to evaluate the pruritus of hemodialytic patients. Forty eligible patients were screened and assigned to receive either zinc sulfate (220 mg/d) or matched placebo for a 4-week trial. Pruritus scale was evaluated at the initiation of the study and 1, 2, 3, and 4 weeks after the treatment. We used a modified score proposed by Duo assessing pruritus severity, distribution of pruritus, and frequency of pruritus-related sleep disturbance. Results Thirty-six patients completed the study. The mean pruritus score decreased in both groups during the first and the second weeks of trial; however, it was more prominent in zinc group than placebo one. In the zinc group, 4 (20%) patients showed pruritus discontinuation during treatment period whereas, in the placebo group, the number was only 1 (5%) patient. Nonetheless, T-test revealed no statistically significant difference between the zinc and placebo groups (P=0.88 and P=0.56, respectively). Conclusion Our findings demonstrated that oral zinc sulfate (220 mg/d) during four weeks treatment might be safe and effective in discontinuation of uremic pruritus, but it was not significant. This could be because of the small number of patients; therefore, we suggest conducting more studies with larger sample size.
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