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托烷司琼与甲氧氯普胺治疗急诊科恶心呕吐的随机、双盲、临床试验。

Tropisetron versus metoclopramide for the treatment of nausea and vomiting in the emergency department: A randomized, double-blinded, clinical trial.

机构信息

Department of Medicine, University of Melbourne Department of Medicine, Austin Hospital, Melbourne, Victoria, Australia.

出版信息

Emerg Med Australas. 2011 Oct;23(5):554-61. doi: 10.1111/j.1742-6723.2011.01444.x. Epub 2011 Jun 20.

Abstract

AIM

We aimed to compare the relative efficacy of tropisetron and metoclopramide in treating nausea/vomiting in undifferentiated ED patients.

METHODS

We undertook a randomized, double-blinded, clinical trial. Adult patients requiring treatment for nausea/vomiting were randomly assigned to either tropisetron (5 mg) or metoclopramide (10 mg), by i.v. bolus. The primary end-point was incidence of vomiting. Secondary end-points were decrease in nausea score from baseline (0-100 VAS), the requirement of 'rescue' anti-emetics, ongoing nausea over 48 h and side-effects.

RESULTS

Fifty patients were enrolled in each group. The demographic variables, presenting complaints and nausea scores at baseline did not differ (P > 0.05). By 180 min, two (4.0%) and nine (18.0%) patients had vomited in the tropisetron and metoclopramide groups respectively (difference 14.0%, 95% CI 0.1-28.0, P= 0.05). Also, there were two and 20 episodes of vomiting respectively. Vomiting rates were 0.02 and 0.16 episodes/person-hour (difference 0.14 episodes/person-hour, 95% CI 0.07-0.21, P < 0.001) respectively. By 60 min and thereafter, the decrease in nausea score from baseline was greater (although not significantly so) in the tropisetron group. At 180 min, the decreases were 47.9 mm and 37.0 mm respectively (difference 10.9 mm, 95% CI -0.7-22.6). Five (10.0%) and 13 (26.0%) patients required a rescue anti-emetic respectively (difference 16.0%, 95% CI -0.7-32.7, P= 0.07). Of patients followed up, 13/47 (27.7%) and 20/49 (40.8%) had ongoing nausea respectively (difference 13.2%, 95% CI -7.7-34.0, P= 0.25). The tropisetron group had less akathisia.

CONCLUSIONS

Tropisetron was associated with a significantly lower vomiting rate and shows promise as an alternative anti-emetic in the ED.

摘要

目的

比较托烷司琼和甲氧氯普胺治疗急诊未分化恶心/呕吐的相对疗效。

方法

我们进行了一项随机、双盲、临床试验。需要治疗恶心/呕吐的成年患者被随机分配至托烷司琼(5mg)或甲氧氯普胺(10mg)组,通过静脉推注给药。主要终点是呕吐的发生率。次要终点为从基线开始的恶心评分下降(0-100VAS)、需要“解救”止吐药、48 小时持续恶心和副作用。

结果

每组纳入 50 例患者。人口统计学变量、主诉和基线时的恶心评分无差异(P>0.05)。180 分钟时,托烷司琼组和甲氧氯普胺组分别有 2 例(4.0%)和 9 例(18.0%)患者呕吐(差异 14.0%,95%CI0.1-28.0,P=0.05)。此外,分别有 2 次和 20 次呕吐。呕吐发生率分别为 0.02 和 0.16 次/人/小时(差异 0.14 次/人/小时,95%CI0.07-0.21,P<0.001)。60 分钟后,托烷司琼组的恶心评分从基线开始的下降幅度更大(尽管无统计学意义)。180 分钟时,下降幅度分别为 47.9mm 和 37.0mm(差异 10.9mm,95%CI-0.7-22.6)。分别有 5 例(10.0%)和 13 例(26.0%)患者需要使用解救性止吐药(差异 16.0%,95%CI-0.7-32.7,P=0.07)。在接受随访的患者中,分别有 13/47(27.7%)和 20/49(40.8%)例患者持续恶心(差异 13.2%,95%CI-7.7-34.0,P=0.25)。托烷司琼组的静坐不能发生率较低。

结论

托烷司琼呕吐发生率明显较低,有望成为急诊科的一种替代止吐药。

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