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格隆溴铵作为辅助治疗预防腹部、甲状腺及乳腺手术后恶心呕吐的效果:一项多中心随机对照试验

Effects of Glycopyrronium Bromide as an Adjuvant Treatment in the Prevention of Nausea and Vomiting After Abdominal, Thyroid, and Breast Surgery: A Multicenter Randomized Controlled Trial.

作者信息

Chen Jie, Piao Guangxi, Luan Guohui, Yu Yunming, Zheng Wei, Li Yue, Zhang Chao, Duan Yunzhen, Zhao Min, Zhang Yong, Xiang Wei, Cheng Lu, Ji Chengcheng, Duan Guangyou, Huang He

机构信息

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, People's Republic of China.

Department of Anesthesiology, Qijiang District People's Hospital, Chongqing, People's Republic of China.

出版信息

Drug Des Devel Ther. 2025 Aug 19;19:7123-7134. doi: 10.2147/DDDT.S515670. eCollection 2025.

DOI:10.2147/DDDT.S515670
PMID:40859968
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12374710/
Abstract

BACKGROUND

Effective methods for the prevention of postoperative nausea and vomiting remain to be found. Building upon previous evidence, we examined whether glycopyrrolate bromide had a preventive effect on nausea and vomiting when used as an adjuvant treatment.

METHODS

In 11 participating hospitals, patients who were scheduled to receive gynecological (n=123), gastrointestinal (n=201), thyroid (n=93), and breast surgery (n=51) under general anesthesia and received postoperative opioids were randomly allocated to receive 4 mg dexamethasone and 4 mg tropisetron (Group C) or 4 mg dexamethasone and 4 mg tropisetron combined with 0.2 mg glycopyrrolate bromide (Group G). The primary outcome of postoperative nausea and vomiting was assessed. The secondary outcomes included the incidences of significant nausea and vomiting (defined based on a rating scale of intensity ≥ 4), vomiting, and extra intervention.

RESULTS

In total, 471 patients (234 in Group G and 237 in Group C) were included in the final analysis. The incidence of postoperative nausea and vomiting in Group G was lower than that in Group C (27.8% vs 43.0%, odds rate=0.65, 95% confidence interval =0.50-0.83, =0.001). Furthermore, the incidences of significant nausea and vomiting (14.1% vs 27.8%, odds rate=0.50, 95% confidence interval=0.35-0.74, <0.001), vomiting (7.3% vs 15.6%, OR=0.46, 95% confidence interval=0.27-0.80, =0.004) and extra intervention (9.4% vs 17.7%, odds rate=0.53, 95% confidence interval=0.33-0.86, =0.008) in Group G were all significantly lower than those in Group C. The two groups showed no significant difference in adverse events.

CONCLUSION

The intravenous administration of 0.2 mg glycopyrronium bromide at the end of surgery can be an effective adjuvant treatment strategy for prevention of nausea and vomiting in patients undergoing surgery under general anesthesia and receiving postoperative opioids.

TRIAL REGISTRATION

The Hospital Ethics Committee of the Second Affiliated Hospital, Chongqing Medical University (Approval ID: 2022-14-1) approved this study. This trial was registered with Identifier NCT05331651 on ClinicalTrials.gov.

摘要

背景

预防术后恶心呕吐的有效方法仍有待发现。基于先前的证据,我们研究了溴化格隆溴铵作为辅助治疗时对恶心呕吐是否有预防作用。

方法

在11家参与研究的医院中,计划接受全身麻醉并术后使用阿片类药物的妇科手术患者(n = 123)、胃肠手术患者(n = 201)、甲状腺手术患者(n = 93)和乳腺手术患者(n = 51)被随机分配接受4 mg地塞米松和4 mg托烷司琼(C组)或4 mg地塞米松、4 mg托烷司琼联合0.2 mg溴化格隆溴铵(G组)。评估术后恶心呕吐的主要结局。次要结局包括严重恶心呕吐(根据强度评分≥4定义)、呕吐及额外干预的发生率。

结果

最终分析共纳入471例患者(G组234例,C组237例)。G组术后恶心呕吐的发生率低于C组(27.8%对43.0%,优势比=0.65,95%置信区间=0.50 - 0.83,P = 0.001)。此外,G组严重恶心呕吐的发生率(14.1%对27.8%,优势比=0.50,95%置信区间=0.35 - 0.74,P < 0.001)、呕吐的发生率(7.3%对15.6%,OR = 0.46,95%置信区间=0.27 - 0.80,P = 0.004)和额外干预的发生率(9.4%对17.7%,优势比=0.53,95%置信区间=0.33 - 0.86,P = 0.008)均显著低于C组。两组不良事件无显著差异。

结论

手术结束时静脉注射0.2 mg格隆溴铵可作为预防全身麻醉下接受术后阿片类药物治疗患者恶心呕吐的有效辅助治疗策略。

试验注册

重庆医科大学附属第二医院医院伦理委员会(批准文号:2022 - 14 - 1)批准了本研究。本试验在ClinicalTrials.gov上注册,标识符为NCT05331651。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ed4/12374710/4beff6bae2b6/DDDT-19-7123-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ed4/12374710/265a3be25be6/DDDT-19-7123-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ed4/12374710/8cca8d1ea33d/DDDT-19-7123-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ed4/12374710/4beff6bae2b6/DDDT-19-7123-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ed4/12374710/265a3be25be6/DDDT-19-7123-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ed4/12374710/8cca8d1ea33d/DDDT-19-7123-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ed4/12374710/4beff6bae2b6/DDDT-19-7123-g0003.jpg

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