Murphy M, Reaich D, Pai P, Finn P, Carmichael A J
Department of Dermatology, South Cleveland Hospital, Middlesbrough, TS4 3BW, UK.
Br J Dermatol. 2003 Feb;148(2):314-7. doi: 10.1046/j.1365-2133.2003.05172.x.
Renal itch is a relatively common and distressing problem for patients with chronic renal failure. Ondansetron, a serotonin type 3 receptor antagonist was developed for relief of chemotherapy induced nausea. Recently, anecdotal reports describe relief of renal itch with ondansetron.
We performed a double-blind randomized placebo-controlled trial to objectively assess the effectiveness of ondansetron in renal itch.
With approval from the local ethical committee, 24 patients on haemodialysis were enrolled in the trial. On a random basis 14 patients were blindly allocated to the ondansetron-placebo sequence and 10 to the placebo-ondansetron sequence. Baseline values for itch were obtained for 7 days before the treatment period and there was a 7-day washout between the treatment periods. During the treatment patients received either 8 mg of ondansetron three times a day or a placebo tablet three times a day for 2 weeks. Patients were asked to record the severity of their pruritus on a visual analogue scale (VAS) twice a day. At the end of the study patients were asked blindly which treatment they had preferred.
Seventeen patients completed the trial. Pruritus decreased by 16% (95% CI: 0.5-32%) during active treatment and by 25% (95% CI: 9-41%) during treatment with placebo. The change in VAS scores during treatment with ondansetron (P = 0.04) and placebo (P = 0.01) were both significant. Eleven patients expressed a preference, seven for placebo and four for ondansetron.
Our results show that ondansetron is no better than placebo in controlling renal itch.
肾性瘙痒是慢性肾衰竭患者相对常见且令人苦恼的问题。昂丹司琼是一种5-羟色胺3型受体拮抗剂,最初用于缓解化疗引起的恶心。最近,有轶事报道称昂丹司琼可缓解肾性瘙痒。
我们进行了一项双盲随机安慰剂对照试验,以客观评估昂丹司琼治疗肾性瘙痒的有效性。
经当地伦理委员会批准,24例接受血液透析的患者纳入试验。随机将14例患者分配至昂丹司琼-安慰剂组序,10例患者分配至安慰剂-昂丹司琼组序。在治疗期前7天获取瘙痒的基线值,治疗期之间有7天的洗脱期。治疗期间,患者每天三次服用8毫克昂丹司琼或每天三次服用一片安慰剂,持续2周。要求患者每天两次在视觉模拟量表(VAS)上记录瘙痒的严重程度。在研究结束时,盲目询问患者更喜欢哪种治疗。
17例患者完成试验。在积极治疗期间瘙痒减轻了16%(95%CI:0.5-32%),在安慰剂治疗期间减轻了25%(95%CI:9-41%)。昂丹司琼治疗期间(P = 0.04)和安慰剂治疗期间(P = 0.01)VAS评分的变化均具有显著性。11例患者表达了偏好,7例偏好安慰剂,4例偏好昂丹司琼。
我们的结果表明,在控制肾性瘙痒方面,昂丹司琼并不比安慰剂更好。