Effect of postoperative systemic prednisolone on short-term and long-term outcomes in chronic rhinosinusitis with nasal polyps: A multi-centered randomized clinical trial

被引：7

作者：

Mueller, Sarina K. ^{[1
]}

Wendler, Olaf ^{[1
]}

Mayr, Susanne ^{[1
]}

Traxdorf, Maximilian ^{[1
]}

Hosemann, Werner ^{[2
]}

Olze, Heidi ^{[3
]}

Steinhart, Helmut ^{[4
]}

Wiegand, Susanne ^{[5
,6
]}

Teymoortash, Afshin ^{[5
]}

Kuehnel, Thomas ^{[7
]}

Hackenberg, Stephan ^{[7
,8
]}

Hummel, Thomas ^{[9
]}

Ambrosch, Petra ^{[10
]}

Fazel, Azita ^{[10
]}

Schick, Bernhard ^{[11
]}

Baenkler, Hanns-Wolf ^{[12
]}

Koch, Michael ^{[1
]}

Buerner, Harald ^{[4
]}

Mantsopoulos, Konstantinos ^{[1
]}

Grundtner, Philipp ^{[1
]}

Nocera, Angela ^{[13
]}

Agaimy, Abbas ^{[14
]}

Bleier, Benjamin ^{[13
]}

Iro, Heinrich ^{[1
]}

机构：

[1] Friedrich Alexander Univ Erlangen Nurnberg, Dept Otolaryngol Head & Neck Surg, Erlangen, Germany

[2] Helios Hanseklinikum Stralsund, Dept Otolaryngol Head & Neck Surg, Stralsund, Germany

[3] Univ Klinikum Berlin, Dept Otolaryngol Head & Neck Surg, Berlin, Germany

[4] Marienhosp Stuttgart, Dept Otolaryngol Head & Neck Surg, Stuttgart, Germany

[5] Phillips Univ Marburg, Dept Otolaryngol Head & Neck Surg, Marburg, Germany

[6] Univ Klinikum Leipzig, Dept Otolaryngol Head & Neck Surg, Leipzig, Germany

[7] Univ Klinikum Regensburg, Dept Otolaryngol Head & Neck Surg, Regensburg, Germany

[8] Univ Klinikum Aachen, Dept Otorhinolaryngol Head & Neck Surg, Aachen, Germany

[9] Univ Klinikum Carl Gustav Carus Dresden, Dept Otolaryngol Head & Neck Surg, Smell & Taste Clin, Dresden, Germany

[10] Christian Albrechts Univ CAU Kiel, Dept Otolaryngol Head & Neck Surg, Kiel, Germany

[11] Univ Klinikum Saarlandes, Dept Otolaryngol Head & Neck Surg, Homburg, Germany

[12] Friedrich Alexander Univ Erlangen Nurnberg, Dept Rheumatol & Immunol, Erlangen, Germany

[13] Harvard Med Sch, Massachusetts Eye & Ear Infirm, Dept Otolaryngol, Boston, MA USA

[14] Friedrich Alexander Univ Erlangen Nurnberg, Dept Pathol, Erlangen, Germany

来源：

FRONTIERS IN IMMUNOLOGY | 2023年 / 14卷

关键词：

nasal polyp (NP); prednisolone; chronic rhinosinusitis; postoperative; long-term; randomized controlled trial; ENDOSCOPIC SINUS SURGERY; QUALITY-OF-LIFE; ADULT CHRONIC RHINOSINUSITIS; ODOR IDENTIFICATION; ORAL STEROIDS; DOUBLE-BLIND; CORTICOSTEROIDS; HEALTH; EFFICACY; IMPACT;

D O I：

10.3389/fimmu.2023.1075066

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

IntroductionThe objective of this study was to determine whether postoperative additive systemic steroid administration in chronic rhinosinusitis with nasal polyps (CRSwNP) impacted selected endoscopic, subjective and objective outcome measures. MethodsThis was a prospective, randomized, double-blind, placebo-controlled, noninferiority multicenter trial of n=106 patients with CRSwNP. All patients underwent primary functional endoscopic sinus surgery (FESS) followed by topical nasal steroids. Patients were randomized to a systemic steroid or placebo for 1 month. Patients were followed up for 2 years over 9 time points. The primary outcome measures were the differences between groups with respect to the nasal polyp score (NPS) and sinonasal quality of life (SNQoL). Secondary outcome measures included interactions with respect to the Lund-Kennedy score (LKS), sinonasal symptoms, general quality of life (GQoL), 16-item odor identification test scores, recurrence rates, need for revision surgery and mucus biomarker levels. Results106 patients were randomized to either the placebo or the systemic steroid group (n=53 per group). Postoperative systemic steroids were not superior to placebo with respect to all primary (p= 0.077) and secondary outcome measures (p>0.05 for all). Reported adverse events were similar between the two groups. ConclusionIn conclusion, the addition of postoperative systemic steroids after primary FESS did not confer a benefit over topical steroid nasal spray alone with respect to NPS, SNQOL, LKS, GQOL, sinonasal symptoms, smell scores, recurrence rates, the need for revision surgery or biomarkers over a short-term follow-up of up to 9 months and a long-term follow-up of up to 24 months in CRSwNP patients. Functional endoscopic surgery did, however, show a strong effect on all outcome measures, which remained relatively stable up to the endpoint at 2 years.

引用

页数：16

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