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格拉司琼在预防术后恶心呕吐方面并不优于胃复安:一项随机临床试验。

No Superiority of Granisetron Over Metoclopramide in Prevention of Post-operative Nausea and Vomiting: A Randomized Clinical Trial.

作者信息

Aleyasin Ashraf, Hayatshahi Alireza, Saffarieh Elham, Torkamandi Hassan, Aghahosseini Marzieh, Hanafi Somayeh, Sadeghi Fariborz, Javadi Mohammadreza

机构信息

Obstetrics and Gynecology Department, Dr.Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.

Clinical Pharmacy Department, College of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

J Obstet Gynaecol India. 2014 Feb;64(1):59-62. doi: 10.1007/s13224-013-0471-6. Epub 2013 Oct 8.

Abstract

PURPOSE

Post-operative nausea and vomiting (PONV) is considered as one of the most disturbing sequels of surgeries under general anesthesia, which if not controlled appropriately increases post-operative morbidity, nursing burden, and general healthcare costs. In this study, we compared granisetron with its brand Kytril(®) and also with metoclopramide regarding PONV management.

METHODS

A total of 180 obstetrics and gynecology patients who underwent surgeries under general anesthesia participated in this prospective study at the Dr. Shariati Teaching Hospital, Tehran, Iran. The patients were randomly assigned to single-dose generic granisetron (40 mcg/kg), Kytril(®) (40 mcg/kg), or metoclopramide (0.2 mg/kg) at the end of the surgery. Two episodes of emetic symptoms (nausea and vomiting) were recorded by a gynecologist who had no knowledge of which treatment each patient had received. This gynecologist observed the patients at three different intervals: 0-6, 6-12, and 12-18 h post-surgery.

RESULTS

One hundred and thirty-seven patients (76.1 %) underwent hysterectomy and 40 patients (22.2 %) underwent myomectomy. Each group consisted of 60 patients (33 %). The incidence of vomiting in the first 6, 12, and 18 h post-surgery was 22, 15.2, and 13.3 % for granisetron; 18.6, 10, and 8.3 % for Kytril; and 22, 11.9, and 5 % for generic metoclopramide, respectively. There was no significant difference in the incidence of PONV with any of these agents.

CONCLUSIONS

All three anti-nausea and vomiting agents, granisetron, its brand (Kytril), and generic metoclopramide, have a similar effect to manage PONV in obstetrics and gynecological surgeries. Trial registration This trial is registered with www.irct.ir, number IRCT201010134927N1.

摘要

目的

术后恶心呕吐(PONV)被认为是全身麻醉下手术最令人困扰的后遗症之一,若控制不当会增加术后发病率、护理负担及总体医疗费用。在本研究中,我们比较了格拉司琼及其品牌凯他敏(Kytril®)以及胃复安在PONV管理方面的效果。

方法

总共180例在伊朗德黑兰沙里亚蒂教学医院接受全身麻醉手术的妇产科患者参与了这项前瞻性研究。患者在手术结束时被随机分配接受单剂量的普通格拉司琼(40微克/千克)、凯他敏(40微克/千克)或胃复安(0.2毫克/千克)。由一位不知道每位患者接受何种治疗的妇科医生记录两起呕吐症状发作(恶心和呕吐)情况。这位妇科医生在术后三个不同时间段观察患者:术后0 - 6小时、6 - 12小时和12 - 18小时。

结果

137例患者(76.1%)接受了子宫切除术,40例患者(22.2%)接受了子宫肌瘤切除术。每组由60例患者(33%)组成。术后前6小时、12小时和18小时,格拉司琼组的呕吐发生率分别为22%、15.2%和13.3%;凯他敏组分别为18.6%、10%和8.3%;普通胃复安组分别为22%、11.9%和5%。这些药物中任何一种的PONV发生率均无显著差异。

结论

三种抗恶心呕吐药物,格拉司琼、其品牌(凯他敏)和普通胃复安,在妇产科手术中管理PONV方面具有相似效果。试验注册 本试验在www.irct.ir上注册,编号为IRCT201010134927N1。

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