昂丹司琼对比甲氧氯普胺治疗妊娠剧吐：一项随机对照试验。
Ondansetron compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial.
机构信息
Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Lembah Pantai, Kuala Lumpur, Malaysia.
出版信息
Obstet Gynecol. 2014 Jun;123(6):1272-1279. doi: 10.1097/AOG.0000000000000242.
OBJECTIVE
To compare ondansetron with metoclopramide in the treatment of hyperemesis gravidarum.
METHODS
We enrolled 160 women with hyperemesis gravidarum in a double-blind randomized trial. Participants were randomized to intravenous 4 mg ondansetron or 10 mg metoclopramide every 8 hours for 24 hours. Participants kept an emesis diary for 24 hours; at 24 hours, they expressed their well-being using a 10-point visual numeric rating scale and answered an adverse effects questionnaire. Nausea intensity was evaluated using a 10-point visual numeric rating scale at enrollment and at 8, 16, and 24 hours. Primary analysis was on an intention-to-treat basis.
RESULTS
Eighty women each were randomized to ondansetron or metoclopramide. Median well-being visual numeric rating scale scores were 9 (range, 5-10) compared with 9 (range, 4-10) (P=.33) and vomiting episodes in the first 24 hours were 1 (range, 0-9) compared with 2 (range, 0-23) (P=.38) for ondansetron compared with metoclopramide, respectively. Repeat-measures analysis of variance of nausea visual numeric rating scale showed no difference between study drugs (P=.22). Reported rates of drowsiness (12.5% compared with 30%; P=.01; number needed to treat to benefit, 6), xerostomia (10.0% compared with 23.8%; P<.01; number needed to treat to benefit, 8), and persistent ketonuria at 24 hours (12.5% compared with 30%; P=.01; number needed to treat to benefit, 6) were less frequent with ondansetron. Length of hospital stay was similar.
CONCLUSION
Ondansetron and metoclopramide demonstrated similar antiemetic and antinauseant effects in hyperemesis gravidarum. However, the overall profile, particularly regarding adverse effects, was better with ondansetron. In our setting, metoclopramide was significantly less expensive than ondansetron and remained a reasonable antiemetic choice.
CLINICAL TRIAL REGISTRATION
ISRCN Register, www.isrctn.org, ISRCTN00592566.
LEVEL OF EVIDENCE
I.
目的
比较昂丹司琼与甲氧氯普胺治疗妊娠剧吐的疗效。
方法
我们进行了一项双盲随机试验，共纳入 160 例妊娠剧吐患者。参与者被随机分为静脉内注射昂丹司琼 4mg 或甲氧氯普胺 10mg，每 8 小时 1 次，共 24 小时。参与者在 24 小时内保持呕吐日记；24 小时时，他们使用 10 分制视觉模拟评分量表表达自己的舒适度，并回答不良反应问卷。在入组时和 8、16 和 24 小时时，使用 10 分制视觉模拟评分量表评估恶心强度。主要分析基于意向治疗原则。
结果
昂丹司琼组和甲氧氯普胺组各有 80 例患者被随机分配。中位舒适度视觉模拟评分量表评分分别为 9 分（范围，5-10）和 9 分（范围，4-10）（P=0.33），24 小时内的呕吐发作次数分别为 1 次（范围，0-9）和 2 次（范围，0-23）（P=0.38）。重复测量方差分析显示研究药物之间的恶心视觉模拟评分无差异（P=0.22）。报告的困倦发生率（12.5%比 30%；P=0.01；需要治疗的患者数获益，6）、口干（10.0%比 23.8%；P<.01；需要治疗的患者数获益，8）和 24 小时时持续酮尿（12.5%比 30%；P=0.01；需要治疗的患者数获益，6）发生率较低的是昂丹司琼。住院时间相似。
结论
昂丹司琼和甲氧氯普胺在妊娠剧吐中均表现出相似的止吐和止呕作用。然而，昂丹司琼的整体情况，特别是不良反应方面，要好一些。在我们的环境中，甲氧氯普胺明显比昂丹司琼便宜，仍然是一种合理的止吐选择。
临床试验注册
ISRCN 注册，www.isrctn.org，ISRCTN00592566。
证据水平
I 级。
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