xRead - Nasal Obstruction (September 2024) Full Articles

20426984, 2021, 3, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/alr.22741 by Stanford University, Wiley Online Library on [01/07/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License

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Orlandi et al.

[University of Pennsylvania Smell Identification Test] and PEA [Phenyl Ethyl Alcohol]) measures. There were no statistically significant differences between the normal saline arm vs normal saline plus budesonide at any of the post-operative visits. All of these studies demonstrate a large clinical benefit from the overall intervention, as it includes ESS, with the patient baseline recorded pre-surgery then again at as early as 30 days post the intervention. The influence of ongoing corticosteroid irrigation in the management of patients with CRSwNP is likely to be demonstrated in long term maintenance phase for these patients and a follow-up longer than 3 to 6 months post ESS. Exhalation delivery systems. Two techniques of exhalation delivery mechanisms have been described. 1591,1592 The breath actuated device delivers fluticasone to the nasal cavity via nasal device and the other is exhaled fine particle beclomethasone dipropionate (HFA-BDP) metered-dose inhaler (MDI). The same RCT on corticosteroid via exha lation delivery system was reported multiple times in the literature, Navigate I/II with differing authors, but likely same patient population and has been treated as 1 study in the aggregate. 1591,1593,1594 All studies show that the use of corticosteroid was better than placebo, but this was the summary finding of the Cochrane review on the use of standard INCS. 1545 While corticosteroid via exhalation delivery system was superior to placebo, the study that is required is against a standard intervention such as cor ticosteroid spray or irrigation, similar to that performed between corticosteroid irrigations and INCS. 1077 Nebulizer/Atomization/Injection. This group of studies is particularly heterogenous. However, 3 RCTs demonstrated that atomization/nebulization yielded better clinical out comes over INCS alone. 1595–1597 One study demonstrated that atomization was similar to corticosteroid drops 1597 and another to corticosteroid irrigations. 1086 New evidence for the use of direct injected corticosteroid to polypoid tissue demonstrated an effect similar to a 2 week course of oral corticosteroid but the patients required 5 separate injec tions over a 4 week period. Although the risk of intravascu lar injection from particulate material is unlikely in polyp tissue, it was not specifically addressed. Safety and Systemic Absorption. Concerns about safety and the impact of systemic corticosteroid absorption have continued. Studies on betamethasone 1598,1599 and budesonide 1600–1602 irrigations either had no effect or showed clinically negligible changes. However, with direct atomization of budesonide, a first generation corticos teroid that does not undergo first-pass liver metabolism, HPA axis suppression and IOP increases can be seen. 1087

Patients using 0.5 mg/240 mL of budesonide irrigation either once or twice daily were assessed in a cross-sectional study to evaluate adrenal function in patients on long term budesonide irrigations over 22 months (mean). 1601 The patients underwent 250 μ g cosyntropin stimulation test, of which, 11 (23%) had abnormally low stimulated cor tisol levels. None of these patients reported any symptoms. The only risk factor noted to be associated was the con comitant use of corticosteroid inhalers ( p = 0.024; OR = 30.4; 95% CI, 1.57-588). Patients were evaluated for evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression after using budesonide irrigations, 2 mg total per day, for a minimum of 12 months. None of the patients undergoing cosyntropin stimulation tests had abnormal results, con cluding that regular use of budesonide for > 2 years did not lead to HPA axis suppression. 1602 Intransal Corticosteroids (Nonstandard Delivery) for CRSwNP Aggregate Grade of Evidence (Versus standard delivery): Corticosteroid Irrigation: A (Level 1: 5 studies, level 3: 1 study). Exhalation delivery: A (Level 1: 4 studies). Atomization/nebulization: A (Level 1: 4 studies). Direct injection: N/A (Level 1: 1 study; Table X-19). Benefit: Corticosteroid Irrigation: Benefit over INCS. Exhalation delivery: Benefit only over placebo. Atomization/nebulization: Benefit over INCS. Direct injection: Potential avoidance of oral corti costeroid. Harm: Some evidence of systemic absorption with first generation corticosteroid especially with mul tiple modalities of therapy (see Table II-1). Cost: Moderate. Exhalation system costs are signif icantly higher than standard therapy. Benefits-Harm Assessment: Negligible side effects compared with oral corticosteroids but caution in patients on multiple topical therapies. Value Judgments: Corticosteroid irrigations and atomization are likely to be of value in those patients not controlled with standard delivery. Exhalation has not been proven to be better than standard delivery. Direct injection needs more safety data. Policy Level: Corticosteroid Irrigation: Strong Recommenda tion. Exhalation delivery: Option.