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经蝶窦内镜手术治疗垂体瘤术后口服抗生素与鼻腔鼻窦结局研究:一项多中心、前瞻性、随机、双盲、安慰剂对照研究。

Postoperative Oral Antibiotics and Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Tumors Study: A Multicenter, Prospective, Randomized, Double-Blinded, Placebo-Controlled Study.

机构信息

Department of Neurosurgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.

Department of Neurosurgery and Brain Tumor and Neuro-Oncology Center, Cleveland Clinic, Cleveland, Ohio, USA.

出版信息

Neurosurgery. 2021 Oct 13;89(5):769-776. doi: 10.1093/neuros/nyab301.

Abstract

BACKGROUND

Postoperative prophylactic antibiotics are commonly used in pituitary surgery, but evidence supporting their use is lacking, which has implications for antibiotic stewardship.

OBJECTIVE

To evaluate whether receipt of postoperative oral antibiotics results in superior sinonasal quality of life (QOL) compared with placebo among patients who undergo endoscopic endonasal transsphenoidal pituitary surgery.

METHODS

Patients were randomized to receive either oral placebo or cefdinir (trimethoprim-sulfamethoxazole in patients intolerant to cefdinir) for 7 d after surgery. They were monitored for 12 wk. The primary outcome measure was sinonasal QOL at 2 wk on the Anterior Skull Base Nasal Inventory-12. Supplementary end points included sinonasal QOL reported on the Sinonasal Outcome Test-22 and objective endoscopy scores to assess nasal healing according to the Lund-Kennedy method.

RESULTS

A total of 461 patients were screened, 131 were randomized, and 113 (placebo arm: 55; antibiotic arm: 58) were analyzed. There was no clinically meaningful or statistically significant difference in sinonasal QOL at any measured time point (P ≥ .24) using either instrument. Nasal cavity endoscopy scores were not significantly different at 1 to 2 wk after surgery (P = .25) or at 3 to 4 wk after surgery (P = .08).

CONCLUSION

Postoperative prophylactic oral antibiotics did not result in superior sinonasal QOL compared with placebo among patients who underwent standard endoscopic transsphenoidal surgery.

摘要

背景

术后预防性使用抗生素在垂体手术中较为常见,但缺乏支持其使用的证据,这对抗生素管理具有重要意义。

目的

评估与安慰剂相比,接受内镜经鼻蝶窦垂体手术后的患者使用术后口服抗生素是否可改善鼻窦鼻腔生活质量(QOL)。

方法

患者随机接受口服安慰剂或头孢地尼(头孢地尼不耐受的患者使用复方磺胺甲噁唑)治疗 7 d。术后 12 周进行监测。主要结局指标为术前 2 周的前颅底鼻腔 Inventory-12 量表的鼻窦鼻腔 QOL 评分。补充终点指标包括使用鼻内镜鼻窦结局测试-22 量表报告的鼻窦鼻腔 QOL 评分以及根据 Lund-Kennedy 方法评估鼻腔愈合的客观内镜评分。

结果

共筛选了 461 例患者,其中 131 例患者被随机分配,113 例(安慰剂组:55 例;抗生素组:58 例)患者纳入分析。在任何测量时间点(P≥.24),使用任何仪器测量,鼻窦鼻腔 QOL 均无明显的临床差异或统计学差异。术后 1 至 2 周(P=.25)和术后 3 至 4 周(P=.08)的鼻腔内镜评分无显著差异。

结论

与安慰剂相比,标准内镜经蝶窦垂体手术后患者术后预防性使用口服抗生素并未改善鼻窦鼻腔 QOL。

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