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

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.

International consensus statement on allergy and rhinology: rhinosinusitis 2021

“…Liang et al definitively excluded CRSwNP cases 1164 and 1 study did not provide details about whether participants had NPs 1163 . Five studies cited NPs as an inclusion criterion; 1165–1169 the remaining 4 studies reported polyps in 20%, 1170 35.6%, 1171 43.8% 1162 , and 81.9% 1172 of participants. Four studies excluded patients with AFRS 1165–1167,1172 and 1 study reported on double density signs and positive fungal cultures being present in 29% and 30% of cases, respectively, but did not definitively diagnose AFRS 1168 .…”

“…From the 11 studies that investigated the use of topical antifungal agents, amphotericin B was used in 10 studies and fluconazole in only 1 study. The Cochrane review of 2018 summarized the evidence for topical antifungals 618 and there were 3 additional RCTs published after the review that have been included here 1168,1170,1171 . The delivery methods varied among the studies with nasal irrigations being most popular, 1164,1168,1170–1172 followed by syringe delivery; 1163,1165,1166 Weschta et al and Gerlinger et al used a spray delivery method 1167,1169 and Hashemian et al formulated the fluconazole as nasal drops 1162…”

Influence of Intranasal Drugs on Human Nasal Mucociliary Clearance and Ciliary Beat Frequency

“…However, a study on the safety of a novel formulation of nanodisc (ND) containing super aggregated AMB (ND-AMB) for sinonasal delivery has recently demonstrated apically administered 75 μg/mL ND-AMB or AMB solution for 15 minutes to insignificantly alter the CBF of human nasal epithelial cells grown as air-liquid interface cultures 44. More recently, Jiang and colleagues45 evaluated the efficacy of AMB nasal irrigation as adjuvant therapy after functional endoscopic sinus surgery (ESS) on chronic rhinosinusitis patients, and demonstrated that nasal irrigation with 200 μg/mL AMB for 2 months did not significantly alter saccharine transit time, compared to pre-irrigation. The influence of different antimicrobials and antivirals on human nasal mucociliary clearance and CBF is summarized in Table 4.…”

Antibacterial Effect of Hypochlorous Acid Solution on Nasal Discharge from Patients with Chronic Rhinosinusitis

“…Saline irrigation is mostly acceptable. Antimicrobial agents as antibiotics or antifungal agents had been added to the irrigation fluid [ 14 – 16 ]. Some researchers had also used additives as manuka honey, xylitol, or surfactant for improvement of the effect of nasal irrigation [ 17 ].…”