Abstract
Objective
The aim of this study was to evaluate the clinical efficacy and the effects on decreasing the recurrence of AFRS (allergic fungal rhinosinusitis) of a budesonide inhalation suspension delivered via transnasal nebulization to patients following endoscopic sinus surgery.
Subjects and methods
Thirty-five patients were recruited into this study. Final diagnoses were reached using Bent and Kuhn’s criteria. The eligible patients were randomly divided into two groups: the budesonide transnasal nebulization group (group A) and the topical nasal steroids group (group B). Nasal symptoms, Lund-Mackay scores, and Kupferberg grades were evaluated before surgery, after surgery and during the follow-up to assess the effects of these two approaches.
Results
A total of 30 patients with AFRS who were eligible were included in the study. Four of the 15 patients in group B (26.67%) developed recurrent disease, whereas no patients in group A developed recurrent disease. This difference was statistically significant ( p = 0.032).
Conclusion
Nebulized budesonide is an effective and safe treatment for patients with AFRS following endoscopic sinus surgery, as evidenced by the reduced recurrence rate observed in the budesonide transnasal nebulization group relative to the topical nasal steroids group.
1
Introduction
Since allergic fungal rhinosinusitis (AFRS) was initially described in the early 1980s by Millar et al. and Katzenstein et al. , otolaryngologists, immunologists, pulmonologists, and patients have struggled to manage this disease. The incidence of AFRS is estimated to be 5 to 10% in all chronic rhinosinusitis (CRS) patients who undergo sinus surgery . The variable incidence may be dependent on geographical variation and problems diagnosing the disease . In 1994, Bent III and Kuhn proposed five diagnostic criteria for AFRS: type I hypersensitivity, nasal polyposis, characteristic findings on computerized tomography (CT) scans, the presence of fungi on direct microscopy or culture, and allergic mucin containing fungal elements without tissue invasion. The diagnosis criteria show that the pathogenesis represents an allergic hypersensitive response to extramucosal fungi within the sinus cavity.
Although the management of AFRS has advanced tremendously with a better understanding of the underlying pathogenesis, an optimal treatment strategy is still far from clear. Once a diagnosis of AFRS has been established, a combination of surgery with a comprehensive postoperative medical regimen to manage the disease is almost always required.
AFRS is characterized by recidivism after surgery, with potentials for recidivism ranging from 10% to nearly 100% . The published rates of AFRS recurrence may be misleading and are highly dependent on the length of follow-up, but the high recidivism rate cannot be overlooked.
Based on available evidence in the literature , corticosteroids are typically regarded as the mainstay of medical treatment for this condition. Topical intranasal steroid sprays have proven to be an effective treatment for AFRS and have a minimal risk profile . However, in some conditions, topical sprays cannot reach the posterior nasal spaces and paranasal sinuses, which may underlie the high recurrence rate. Furthermore, despite providing more potent and rapid benefits to control the inflammation associated with AFRS systemic corticosteroids have significant side effects, such as hypothalamic-pituitary-adrenal axis dysfunction. Thus, a need has arisen for an alternative topical therapy in patients with AFRS.
Budesonide inhalation suspension (Pulmicort Respules; AstraZeneca, London, United Kingdom) is another form of corticosteroid therapy that has been demonstrated to be efficacious and safe in patients with asthma , chronic obstructive pulmonary disease , and CRS with NPs . Furthermore, budesonide inhalation suspension has been shown to enhance ventilation efficiency and drug deposition in the paranasal sinus . However, little information exists regarding the use of budesonide transnasal nebulization for the treatment of AFRS.
Thus, the aim of this study was first to evaluate the clinical efficacy and the effect of decreasing the recurrence of budesonide inhalation suspension delivered via transnasal nebulization in patients with AFRS and then to compare this effect with budesonide nasal pump sprays.
2
Patients and methods
Thirty-five patients were recruited into this historical, random and prospective study from the Department of Otolaryngology at the Eye, Ear, Nose, and Throat Hospital of Fudan University in Shanghai, China from November 2011 to February 2015. Informed consent was provided by all patients.
All cases of AFRS were evaluated with a detailed clinical history and a head and neck examination including anterior rhinoscopy. Nasal symptoms (including nasal obstruction, nasal discharge, loss of smell, and headache/facial pain) were assessed before surgery and postoperatively at the 4th, 12th, and 24th weeks of follow-up using visual analog scales with scores of 0–10 . The total nasal symptom score (TNSS) was calculated as the sum of the scores of the 4 individual symptoms simultaneously. CT of the axial and coronal planes of the nose and PNS was performed in all patients before surgery and at the 12th and 24th weeks of follow-up in the postoperative period using Lund-Mackay scores . Nasal endoscopy (NE) findings were graded based on Kupferberg grades at the 4th, 12th, and 24th weeks of follow-up in the postoperative period. An Aspergillus skin hypersensitivity test was performed in all patients. The final diagnosis was made using Bent and Kuhn’s criteria .
Both groups underwent functional endoscopic sinus surgery after diagnosis and preliminary investigation. In all cases, the surgical procedure included adequate decongestion of the nasal cavities and opening of all the sinuses, namely the maxillary, anterior and posterior ethmoids and the frontal and sphenoid sinuses, via removal of polyps and the fungal mucin from all these sinuses while preserving the normal mucosa. Operative findings were recorded, and surgical specimens were sent for fungal smears and histopathological examination. Histological evidence for the presence of allergic mucin, eosinophils, fungal hyphae and tissue invasion was recorded. Any patient with evidence of tissue invasion was excluded from the analysis.
Eligible patients were randomly divided into two groups: the budesonide transnasal nebulization group (group A) and the topical nasal steroids group (group B). No patients received any preoperative oral steroids. The study was recorded using a single-blind approach; the doctor and recorder were different persons, and recorder did not know which group the patients were in. The patients were assigned in a ratio of 1:1 to receive 1 mg of budesonide transnasal nebulization (Pulmicort Respules; AstraZeneca, London, United Kingdom) with a Pari Sinus Nebulizer and Pari Master Compressor (PARI GmbH, Starnberg, Germany) or budesonide nasal pump sprays (Rhinocort; AstraZeneca, London, United Kingdom) twice daily for 2 weeks, once a day for the next 2 weeks, once every two days for the next 4 weeks, twice per week for the next 8 weeks, and then once a week to maintain treatment. Postoperatively, both groups were advised to perform regular alkaline nasal irrigation twice per day.
Follow-up was performed after surgery. Every patient came to the outpatient center for nasal endoscopy for cleaning of the nasal cavity at the 1-week follow-up visit. At each follow-up visit, a TNSS score, NE score (Kupferberg grade) and CT scan score (Lund-MacKay score) were calculated. The differences in the values for each parameter between those at the beginning of the study and those at each follow-up visit were calculated and compared between the two groups. Both groups were compared regarding the above parameters to assess the effect of the two therapies. Patients in both groups have been under continuous follow-up until the present date. The study was approved by the Institutional Review Board of the Eye, Ear, Nose and Throat Hospital of Fudan University, Shanghai, China.
Statistical analysis was performed using IBM SPSS statistics v20.0. The results are expressed as the means ± SD in the text and tables. The patients’ age, gender, Kupferberg grades, Lund-Mackay scores, and TNSS before surgery were obtained at baseline. Pearson’s correlation was used to analyze two-variable correlations. P < 0.05 was considered statistically significant.
2
Patients and methods
Thirty-five patients were recruited into this historical, random and prospective study from the Department of Otolaryngology at the Eye, Ear, Nose, and Throat Hospital of Fudan University in Shanghai, China from November 2011 to February 2015. Informed consent was provided by all patients.
All cases of AFRS were evaluated with a detailed clinical history and a head and neck examination including anterior rhinoscopy. Nasal symptoms (including nasal obstruction, nasal discharge, loss of smell, and headache/facial pain) were assessed before surgery and postoperatively at the 4th, 12th, and 24th weeks of follow-up using visual analog scales with scores of 0–10 . The total nasal symptom score (TNSS) was calculated as the sum of the scores of the 4 individual symptoms simultaneously. CT of the axial and coronal planes of the nose and PNS was performed in all patients before surgery and at the 12th and 24th weeks of follow-up in the postoperative period using Lund-Mackay scores . Nasal endoscopy (NE) findings were graded based on Kupferberg grades at the 4th, 12th, and 24th weeks of follow-up in the postoperative period. An Aspergillus skin hypersensitivity test was performed in all patients. The final diagnosis was made using Bent and Kuhn’s criteria .
Both groups underwent functional endoscopic sinus surgery after diagnosis and preliminary investigation. In all cases, the surgical procedure included adequate decongestion of the nasal cavities and opening of all the sinuses, namely the maxillary, anterior and posterior ethmoids and the frontal and sphenoid sinuses, via removal of polyps and the fungal mucin from all these sinuses while preserving the normal mucosa. Operative findings were recorded, and surgical specimens were sent for fungal smears and histopathological examination. Histological evidence for the presence of allergic mucin, eosinophils, fungal hyphae and tissue invasion was recorded. Any patient with evidence of tissue invasion was excluded from the analysis.
Eligible patients were randomly divided into two groups: the budesonide transnasal nebulization group (group A) and the topical nasal steroids group (group B). No patients received any preoperative oral steroids. The study was recorded using a single-blind approach; the doctor and recorder were different persons, and recorder did not know which group the patients were in. The patients were assigned in a ratio of 1:1 to receive 1 mg of budesonide transnasal nebulization (Pulmicort Respules; AstraZeneca, London, United Kingdom) with a Pari Sinus Nebulizer and Pari Master Compressor (PARI GmbH, Starnberg, Germany) or budesonide nasal pump sprays (Rhinocort; AstraZeneca, London, United Kingdom) twice daily for 2 weeks, once a day for the next 2 weeks, once every two days for the next 4 weeks, twice per week for the next 8 weeks, and then once a week to maintain treatment. Postoperatively, both groups were advised to perform regular alkaline nasal irrigation twice per day.
Follow-up was performed after surgery. Every patient came to the outpatient center for nasal endoscopy for cleaning of the nasal cavity at the 1-week follow-up visit. At each follow-up visit, a TNSS score, NE score (Kupferberg grade) and CT scan score (Lund-MacKay score) were calculated. The differences in the values for each parameter between those at the beginning of the study and those at each follow-up visit were calculated and compared between the two groups. Both groups were compared regarding the above parameters to assess the effect of the two therapies. Patients in both groups have been under continuous follow-up until the present date. The study was approved by the Institutional Review Board of the Eye, Ear, Nose and Throat Hospital of Fudan University, Shanghai, China.
Statistical analysis was performed using IBM SPSS statistics v20.0. The results are expressed as the means ± SD in the text and tables. The patients’ age, gender, Kupferberg grades, Lund-Mackay scores, and TNSS before surgery were obtained at baseline. Pearson’s correlation was used to analyze two-variable correlations. P < 0.05 was considered statistically significant.
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