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高剂量帕洛诺司琼与低剂量帕洛诺司琼联合氟哌利多预防眼球摘除及眼眶羟基磷灰石植入术后恶心呕吐的随机双盲试验

Higher dose of palonosetron versus lower dose of palonosetron plus droperidol to prevent postoperative nausea and vomiting after eye enucleation and orbital hydroxyapatite implant surgery: a randomized, double-blind trial.

作者信息

Hu Xiao, Tan Fang, Gong Lan

机构信息

Department of Anesthesiology, The Eye, Ear, Nose and Throat Hospital of Fudan University, Shanghai Medical College of Fudan University, Shanghai, China.

出版信息

Drug Des Devel Ther. 2017 May 15;11:1465-1472. doi: 10.2147/DDDT.S129022. eCollection 2017.

Abstract

OBJECTIVE

Postoperative nausea and vomiting (PONV) is commonly observed after eye enucleation and orbital hydroxyapatite implant surgery. This prospective, randomized, double-blind trial was conducted to investigate the hypothesis that compared with monotherapy using a higher dose of palonosetron, using a lower dose of palonosetron in combination with droperidol could reduce the incidence of PONV and achieve similar prophylaxis against PONV after the aforementioned surgery.

PATIENTS AND METHODS

A total of 129 patients who were in the American Society of Anesthesiologists Classes I and II, aged between 18 and 70 years, and scheduled for eye enucleation and orbital hydroxyapatite implant surgery, were enrolled in this study. They were randomized into three groups: Group P2.5 (2.5 μg/kg palonosetron), Group P7.5 (7.5 μg/kg palonosetron), and Group P+D (2.5 μg/kg palonosetron and 15 μg/kg droperidol). Patients received the different antiemetic regimens intravenously 5 min before surgery. The severity of nausea and vomiting and the complete response (CR) rate during a 72-h postoperative period were assessed.

RESULTS

All patients completed the trial. The nausea score of Group P2.5 was significantly higher than those of the other two groups at 0-4 h and 24-48 h (<0.05). Vomiting scores among all groups were similar during all intervals (>0.05). Compared with Group P2.5, the CR rate was significantly improved at all intervals in Group P+D, except at 4-72 h, and was also elevated at 24-72 h in Group P7.5 (<0.05). Fewer patients in Group P2.5 did not experience any nausea or vomiting throughout the study (49%) compared with those in Group P7.5 (67%) and Group P+D (81%; <0.01).

CONCLUSION

Combining low-dose palonosetron with droperidol potentiated prophylaxis for PONV and achieved a similar prophylactic effect as that with a higher dose of palonosetron.

摘要

目的

眼球摘除术和眼眶羟基磷灰石植入术后常出现术后恶心呕吐(PONV)。本前瞻性、随机、双盲试验旨在研究以下假设:与使用高剂量帕洛诺司琼的单一疗法相比,低剂量帕洛诺司琼联合氟哌利多可降低PONV的发生率,并在上述手术后实现相似的PONV预防效果。

患者与方法

本研究共纳入129例美国麻醉医师协会分级为I级和II级、年龄在18至70岁之间、计划行眼球摘除术和眼眶羟基磷灰石植入术的患者。他们被随机分为三组:P2.5组(2.5μg/kg帕洛诺司琼)、P7.5组(7.5μg/kg帕洛诺司琼)和P+D组(2.5μg/kg帕洛诺司琼和15μg/kg氟哌利多)。患者在手术前5分钟静脉接受不同的止吐方案。评估术后72小时内恶心呕吐的严重程度和完全缓解(CR)率。

结果

所有患者均完成试验。P2.5组在0至4小时和24至48小时的恶心评分显著高于其他两组(<0.05)。所有组在所有时间段的呕吐评分相似(>0.05)。与P2.5组相比,P+D组在所有时间段(4至72小时除外)的CR率均显著提高,P7.5组在24至72小时的CR率也有所提高(<0.05)。与P7.5组(67%)和P+D组(81%;<0.01)相比,P2.5组在整个研究过程中未出现任何恶心或呕吐的患者较少(49%)。

结论

低剂量帕洛诺司琼与氟哌利多联合使用可增强对PONV的预防作用,并取得与高剂量帕洛诺司琼相似的预防效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4b4/5440036/4a66ea432f56/dddt-11-1465Fig1.jpg

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