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一项关于昂丹司琼治疗肾性瘙痒的随机、安慰剂对照、双盲试验。

A randomized, placebo-controlled, double-blind trial of ondansetron in renal itch.

作者信息

Murphy M, Reaich D, Pai P, Finn P, Carmichael A J

机构信息

Department of Dermatology, South Cleveland Hospital, Middlesbrough, TS4 3BW, UK.

出版信息

Br J Dermatol. 2003 Feb;148(2):314-7. doi: 10.1046/j.1365-2133.2003.05172.x.

DOI:10.1046/j.1365-2133.2003.05172.x
PMID:12588385
Abstract

BACKGROUND

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.

OBJECTIVES

We performed a double-blind randomized placebo-controlled trial to objectively assess the effectiveness of ondansetron in renal itch.

PATIENTS AND METHODS

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.

RESULTS

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.

CONCLUSIONS

Our results show that ondansetron is no better than placebo in controlling renal itch.

摘要

背景

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。

目的

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。

患者与方法

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。

结果

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。

结论

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。

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