格拉司琼单独使用与联合地塞米松用于腹腔镜胆囊切除术后呕吐症状的随机双盲对照研究。

A randomized, double-blind comparison of granisetron alone and combined with dexamethasone for post-laparoscopic cholecystectomy emetic symptoms.

作者信息

Fujii Yoshitaka, Tanaka Hiroyoshi, Kawasaki Tsuneo

机构信息

Department of Anesthesiology, University of Tsukuba Institute of Clinical Medicine, Tsukuba, Ibaraki, Japan, and Departments of.

Anesthesiology and.

出版信息

Curr Ther Res Clin Exp. 2003 Sep;64(8):514-21. doi: 10.1016/j.curtheres.2003.08.009.

DOI:10.1016/j.curtheres.2003.08.009

PMID:24944401

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4053038/

Abstract

BACKGROUND

Granisetron hydrochloride, a selective serotonin receptor antagonist, has been used to treat established postoperative nausea and vomiting (PONV). Dexamethasone has been shown to reduce the incidence of chemotherapy-induced emesis when added to an antiemetic regimen.

OBJECTIVE

The aim of this study was to examine the differences in efficacy and tolerability between the combination of granisetron plus dexamethasone and granisetron alone for the treatment of PONV.

METHODS

This study was a randomized, double-blind trial conducted at Toride Kyodo General Hospital (Toride, Ibaraki, Japan). Men and women aged 25 to 65 years and experiencing emetic symptoms after laparoscopic cholecystectomy were eligible for the study. Patients received IV therapy with either granisetron 40 μg/kg alone or with dexamethasone 8 mg. Patients were observed for 24 hours. Emetic episodes and the need for a rescue antiemetic were recorded by nursing staff, who were blinded to treatment assignment.

RESULTS

One hundred patients (63 women, 37 men; mean [SD] age, 47 [10] years; range, 25-65 years) were enrolled; 50 patients were randomized to each treatment group. No significant differences in baseline demographic or clinical characteristics were observed between the groups. Complete control of established PONV, defined as no emetic symptoms and no need for another rescue antiemetic medication, occurred in significantly more patients who received the combination (49/50 [98%]) than in those who received granisetron alone (41/50 [82%]) (P = 0.008). No clinically important adverse effects due to the study drugs were observed in either group.

CONCLUSION

In this study population of patients experiencing post-cholecystectomy emesis, the combination of granisetron plus dexamethasone was more efficacious than granisetron alone for the treatment of PONV. Tolerability between the 2 treatments was similar.

摘要

背景

盐酸格拉司琼是一种选择性5-羟色胺受体拮抗剂，已被用于治疗已出现的术后恶心和呕吐（PONV）。地塞米松在添加到止吐方案中时，已显示可降低化疗引起的呕吐发生率。

目的

本研究的目的是检查格拉司琼加地塞米松联合用药与单独使用格拉司琼治疗PONV在疗效和耐受性方面的差异。

方法

本研究是在鸟取协同综合医院（日本茨城县鸟取市）进行的一项随机双盲试验。年龄在25至65岁之间且在腹腔镜胆囊切除术后出现呕吐症状的男性和女性符合研究条件。患者接受静脉注射治疗，要么单独使用40μg/kg的格拉司琼，要么使用8mg的地塞米松。对患者进行24小时观察。护理人员记录呕吐发作情况以及使用急救止吐药的需求，护理人员对治疗分配情况不知情。

结果

共招募了100名患者（63名女性，37名男性；平均[标准差]年龄，47[10]岁；范围，25 - 65岁）；每个治疗组随机分配50名患者。两组之间在基线人口统计学或临床特征方面未观察到显著差异。完全控制已出现的PONV（定义为无呕吐症状且无需使用其他急救止吐药物）的患者中，接受联合用药的患者（49/50[98%]）明显多于单独接受格拉司琼治疗的患者（41/50[82%]）（P = 0.008）。两组均未观察到因研究药物引起的具有临床意义的不良反应。