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垂体神经内分泌肿瘤患者经蝶窦手术前,葡萄糖酸氯己定与聚维酮碘用于鼻腔细菌去定植的前瞻性、随机、双盲、非劣效性试验

Chlorhexidine gluconate versus povidone-iodine for nasal bacteria decolonization before transsphenoidal surgery in patients with pituitary neuroendocrine tumors: a prospective, randomized, double-blind, noninferiority trial.

作者信息

Qian Jinyu, Lin Jie, Liu Jin, Gong Yali, Zheng Shufang, Mei Lu, Tang Xin, Xie Lina, Li Hong, Zhang Chao, Wang Feilong, Yang Xue, Hu Rong, Feng Hua, Xian Jishu, Tan Binbin, Chen Yujie

机构信息

Department of Neurosurgery, Southwest Hospital, Third Military Medical University (Army Medical University).

Chongqing Clinical Research Center for Neurosurgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing.

出版信息

Int J Surg. 2025 Jan 1;111(1):697-705. doi: 10.1097/JS9.0000000000002052.

DOI:10.1097/JS9.0000000000002052
PMID:39172724
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11745714/
Abstract

BACKGROUND

This study aimed to compare the nasal decolonization efficacy and comfort between chlorhexidine gluconate (CHG) and povidone-iodine (PVP) to provide an evidence basis for clinical guidance.

METHODS

A prospective, randomized, single-blinded, noninferior clinical trial was conducted in 174 patients with pituitary neuroendocrine tumors (PitNETs) who were scheduled to undergo transsphenoidal surgery. The noninferiority margin was δ=-0.1. The primary outcome was the effective rate of disinfection. The secondary outcomes included postoperative inflammatory indicators, the intracranial infection rate, and the proportion of intracranial infection.

RESULTS

The effective clearance rate of postoperative nasal bacteria was nonsignificantly different between the CHG and PVP groups (88.64% vs. 82.56%; between-group difference 6.10%; 95% CI [-5.30 to 17.50]). There was no significant difference in the incidence of postoperative central nervous system infections or serum inflammation-related indications between the two groups, but sterilization tended to occur quicker and last longer in the CHG group. CHG seemed to have advantages in terms of comfort, including less nasal irritation, less pungency, and better intranasal coloration.

CONCLUSION

CHG and PVP have equal efficacy in nasal decolonization before transsphenoidal surgery, but CHG seems to have comfort-related advantages in terms of less nasal irritation, less pungency, and better intranasal coloration.

摘要

背景

本研究旨在比较葡萄糖酸氯己定(CHG)和聚维酮碘(PVP)的鼻腔去定植效果及舒适度,为临床指导提供证据依据。

方法

对174例计划接受经蝶窦手术的垂体神经内分泌肿瘤(PitNETs)患者进行了一项前瞻性、随机、单盲、非劣效性临床试验。非劣效界值为δ=-0.1。主要结局为消毒有效率。次要结局包括术后炎症指标、颅内感染率及颅内感染比例。

结果

CHG组和PVP组术后鼻腔细菌有效清除率无显著差异(88.64%对82.56%;组间差异6.10%;95%CI[-5.30至17.50])。两组术后中枢神经系统感染发生率或血清炎症相关指标无显著差异,但CHG组杀菌起效更快且持续时间更长。CHG在舒适度方面似乎具有优势,包括鼻腔刺激更少、刺激性更小以及鼻内染色更好。

结论

CHG和PVP在经蝶窦手术前鼻腔去定植方面疗效相当,但CHG在鼻腔刺激更少、刺激性更小以及鼻内染色更好等与舒适度相关的方面似乎具有优势。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5145/11745714/7323ffcb7bff/js9-111-0697-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5145/11745714/72493a5378b1/js9-111-0697-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5145/11745714/533e5f18cf40/js9-111-0697-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5145/11745714/1c279b5e4f6b/js9-111-0697-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5145/11745714/7323ffcb7bff/js9-111-0697-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5145/11745714/72493a5378b1/js9-111-0697-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5145/11745714/533e5f18cf40/js9-111-0697-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5145/11745714/1c279b5e4f6b/js9-111-0697-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5145/11745714/7323ffcb7bff/js9-111-0697-g004.jpg

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