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口香糖治疗女性患者术后恶心呕吐:一项多中心随机试验

Chewing Gum to Treat Postoperative Nausea and Vomiting in Female Patients: A Multicenter Randomized Trial.

作者信息

Darvall Jai N, De Silva Anurika P, von Ungern-Sternberg Britta, Story David A, Davidson Andrew J, Allen Megan L, Tran-Duy An, Schultz-Ferguson Cindy, Ha Vi, Braat Sabine, Leslie Kate

机构信息

Department of Critical Care, Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia; Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Victoria, Australia.

Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia; Methods and Implementation Support for Clinical and Health Research Hub, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.

出版信息

Anesthesiology. 2025 Mar 1;142(3):454-464. doi: 10.1097/ALN.0000000000005283. Epub 2024 Oct 30.

Abstract

BACKGROUND

Postoperative nausea and vomiting is common after general anesthesia, with consequences for patient outcomes, satisfaction with care, and healthcare costs. The aim was to compare a new treatment, chewing gum, with a widely used intravenous agent, ondansetron, to treat postoperative nausea and vomiting in female patients in the postanesthesia care unit.

METHODS

This study was a multicenter, randomized, controlled noninferiority trial in 17 hospitals in Australia and New Zealand. Female patients aged 12 yr or older undergoing volatile anesthetic-based general anesthesia for laparoscopic or breast surgery were enrolled. Protocolized antiemetic prophylaxis was administered. Patients who developed postoperative nausea and vomiting in the postanesthesia care unit were randomized to either 15 min of chewing gum or 4 mg intravenous ondansetron. The primary outcome was cessation of nausea, retching, or vomiting with no recurrence nor rescue medication for 2 h after administration of the randomized intervention ( i.e. , complete response).

RESULTS

Of 865 enrolled patients, 218 were randomized. In a per-protocol analysis, 50 of 105 (47.6%) ondansetron-treated patients compared with 31 of 103 (30.1%) chewing gum-treated patients achieved the primary outcome (absolute risk difference [95% CI], -17.3 [-30.4 to -4.3]%), not reaching the prespecified noninferiority limit. The time to complete response was longer for patients randomized to chewing gum (hazard ratio [95% CI], 0.53 [0.34 to 0.83]), and they were more likely to receive antiemetics in the 24 h after surgery (absolute risk difference [95% CI], 14.1 [1.6 to 26.5]%).

CONCLUSIONS

Chewing gum cannot be recommended as an alternative to ondansetron for treatment of postoperative nausea and vomiting in female patients administered antiemetic prophylaxis.

摘要

背景

全身麻醉后,术后恶心呕吐很常见,会对患者的治疗结果、护理满意度和医疗费用产生影响。本研究旨在比较一种新的治疗方法——口香糖,与一种广泛使用的静脉用药——昂丹司琼,在麻醉后护理单元中治疗女性患者术后恶心呕吐的效果。

方法

本研究是一项在澳大利亚和新西兰17家医院进行的多中心、随机、对照非劣效性试验。纳入年龄在12岁及以上、接受基于挥发性麻醉剂的全身麻醉进行腹腔镜手术或乳腺手术的女性患者。给予标准化的止吐预防措施。在麻醉后护理单元出现术后恶心呕吐的患者被随机分为咀嚼口香糖15分钟或静脉注射4毫克昂丹司琼。主要结局是在给予随机干预后2小时内恶心、干呕或呕吐停止,且无复发,也未使用急救药物(即完全缓解)。

结果

在865名纳入的患者中,218名被随机分组。在符合方案分析中,105名接受昂丹司琼治疗的患者中有50名(47.6%)达到主要结局,而103名咀嚼口香糖治疗的患者中有31名(30.1%)达到主要结局(绝对风险差异[95%CI],-17.3[-30.4至-4.3]%),未达到预先设定的非劣效性界限。随机分组至咀嚼口香糖组的患者达到完全缓解的时间更长(风险比[95%CI],0.53[0.34至0.83]),并且他们在术后24小时内更有可能接受止吐药治疗(绝对风险差异[95%CI],14.1[1.6至26.5]%)。

结论

对于接受止吐预防的女性患者,不建议将口香糖作为昂丹司琼治疗术后恶心呕吐的替代方法。

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