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鼻腔冲洗 200μg/ml 两性霉素 B 在后鼻内镜鼻窦手术中的疗效:一项随机、安慰剂对照、双盲研究。

Efficacy of nasal irrigation with 200 μg/mL amphotericin B after functional endoscopic sinus surgery: a randomized, placebo-controlled, double-blind study.

机构信息

Department of Otolaryngology, Taichung Veterans General Hospital, Taichung, Taiwan.

School of Medicine, Chung Shan Medical University, Taichung, Taiwan.

出版信息

Int Forum Allergy Rhinol. 2018 Jan;8(1):41-48. doi: 10.1002/alr.22033. Epub 2017 Oct 30.

Abstract

BACKGROUND

Previous studies have shown controversial results of topical amphotericin B (AMB) nasal irrigation for chronic rhinosinusitis (CRS). The purpose of this study was to evaluate the efficacy of 200 μg/mL AMB nasal irrigation as an adjuvant therapy after functional endoscopic sinus surgery (FESS).

METHODS

Patients with CRS who had received FESS for treatment were recruited and assigned to 1 of 2 groups at random at 1 month postsurgery. In the AMB group patients received nasal irrigation with 200 μg/mL of AMB for 2 months on a daily basis. In the control group normal saline irrigation was given instead. Before FESS and before and after nasal irrigation, patients' sinonasal symptoms were assessed through a questionnaire that was a Taiwanese version of the 22-item Sino-Nasal Outcome Test (TWSNOT-22). In addition, patients received endoscopic examination, acoustic rhinometry, smell test, saccharine transit test, and bacterial cultures obtained from their middle meati.

RESULTS

A total of 73 patients completed the study between December 2014 and January 2017. Among them, 37 received nasal irrigation with AMB solution, and 36 with saline. In the AMB group, scores of TWSNOT-22 dropped significantly after irrigation compared with before (p = 0.005). In the control group, TWSNOT-22 scores did not changed after irrigation (p = 0.451). However, there were no significant differences in TWSNOT-22, endoscopic score, smell test, saccharine transit test, and bacterial culture rate after irrigation between 2 groups.

CONCLUSION

Our study showed that in post-FESS care, nasal irrigation with 200 μg/mL of AMB did not provide additional benefit compared with saline irrigation.

摘要

背景

先前的研究显示,局部使用两性霉素 B(AMB)鼻腔冲洗治疗慢性鼻-鼻窦炎(CRS)的结果存在争议。本研究的目的是评估 200μg/ml AMB 鼻腔冲洗作为功能性内镜鼻窦手术(FESS)后的辅助治疗的疗效。

方法

招募接受 FESS 治疗的 CRS 患者,并在术后 1 个月随机分为 2 组。在 AMB 组,患者接受 200μg/ml AMB 鼻腔冲洗,每天 1 次,持续 2 个月。在对照组,给予生理盐水冲洗。在 FESS 之前以及鼻腔冲洗之前和之后,通过台湾版 22 项鼻-鼻窦结局测试(TWSNOT-22)问卷评估患者的鼻-鼻窦症状。此外,患者还接受了内镜检查、声反射鼻腔测量、嗅觉测试、糖精传递试验和从中鼻道获得的细菌培养。

结果

共有 73 例患者于 2014 年 12 月至 2017 年 1 月完成了这项研究。其中,37 例接受 AMB 溶液鼻腔冲洗,36 例接受生理盐水冲洗。在 AMB 组,冲洗后 TWSNOT-22 评分明显低于冲洗前(p=0.005)。在对照组,冲洗后 TWSNOT-22 评分没有变化(p=0.451)。然而,冲洗后两组之间 TWSNOT-22、内镜评分、嗅觉测试、糖精传递试验和细菌培养率均无显著差异。

结论

我们的研究表明,在 FESS 后护理中,与生理盐水冲洗相比,200μg/ml AMB 鼻腔冲洗并未提供额外的益处。

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