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单次直肠给予西沙必利对胃排空延迟的影响。

The effect of a single rectal dose of cisapride on delayed gastric emptying.

作者信息

Brummer R J, Schoenmakers E A, Kemerink G J, Heidendal G A, Sanders D G, Stockbrügger R W

机构信息

Department of Gastroenterology, University Hospital Maastricht, The Netherlands.

出版信息

Aliment Pharmacol Ther. 1997 Aug;11(4):781-5. doi: 10.1046/j.1365-2036.1997.t01-1-00204.x.

Abstract

BACKGROUND

Cisapride has an established prokinetic effect in patients with delayed gastric emptying. However, rectal administration of the drug might be preferred in patients with either dysphagia or nausea due to gastroparesis.

AIM

To determine the effect of a single rectal dose of cisapride 60 mg on gastric emptying in patients with delayed gastric emptying.

METHODS

Thirty-two patients (16 males, 16 females) with demonstrated delayed gastric emptying received a single dose of two suppositories containing either cisapride (2 x 30 mg) or placebo, according to a double-blind randomized crossover design. Three hours after administration of the suppositories, the patients received a radio-labelled test meal and radio-opaque markers for measurement of gastric emptying.

RESULTS

The mean t1/2 after cisapride administration (76 min, 95% CI: 68-95) was significantly shorter (P = 0.005: n = 28, per-protocol analysis) than after placebo administration (104 min, 81-126). Four hours after ingestion of the meal significantly fewer radio-opaque markers remained in the stomach after cisapride than after placebo administration (P < 0.05). Mild to moderate adverse events, mainly involving the gastrointestinal tract, were reported in 10 patients (31%) after cisapride treatment and in four patients (13%) after placebo (N.S.: n = 32).

CONCLUSION

A single suppository dose of cisapride 60 mg significantly accelerates gastric emptying of the solid phase of a meal and of radio-opaque markers in patients with previously demonstrated delayed gastric emptying.

摘要

背景

西沙必利对胃排空延迟的患者具有确切的促动力作用。然而,对于吞咽困难或因胃轻瘫导致恶心的患者,直肠给药可能更为可取。

目的

确定单次直肠给予60毫克西沙必利对胃排空延迟患者胃排空的影响。

方法

32例(16例男性,16例女性)已证实胃排空延迟的患者,根据双盲随机交叉设计,接受一剂含有西沙必利(2×30毫克)或安慰剂的两粒栓剂。在给予栓剂3小时后,患者接受放射性标记的试验餐和不透X线标志物,以测量胃排空情况。

结果

西沙必利给药后的平均t1/2(76分钟,95%可信区间:68 - 95)显著短于安慰剂给药后(104分钟,81 - 126)(P = 0.005;n = 28,符合方案分析)。进食后4小时,西沙必利给药后胃内残留的不透X线标志物明显少于安慰剂给药后(P < 0.05)。西沙必利治疗后10例患者(31%)报告有轻度至中度不良事件,主要累及胃肠道,安慰剂治疗后4例患者(13%)报告有此类不良事件(无显著性差异:n = 32)。

结论

单次栓剂剂量的60毫克西沙必利可显著加速先前已证实胃排空延迟患者餐食固相和不透X线标志物的胃排空。

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