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  • 1
    Online Resource
    Online Resource
    JSTOR ; 1992
    In:  Monumenta Nipponica Vol. 47, No. 2 ( 1992-22), p. 291-
    In: Monumenta Nipponica, JSTOR, Vol. 47, No. 2 ( 1992-22), p. 291-
    Type of Medium: Online Resource
    ISSN: 0027-0741
    Language: Unknown
    Publisher: JSTOR
    Publication Date: 1992
    detail.hit.zdb_id: 2002926-3
    SSG: 6,25
    SSG: 9,10
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  • 2
    In: International Forum of Allergy & Rhinology, Wiley, Vol. 2, No. 4 ( 2012-07), p. 271-279
    Abstract: Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) can be compromised by postoperative inflammation, polyposis, and adhesions, often requiring subsequent interventions. A bioabsorbable, steroid‐releasing sinus implant has been studied in 2 prospective, randomized clinical trials for its ability to preserve sinus patency and reduce medical and surgical interventions after ESS in patients with CRS. The objective of this study was to perform a meta‐analysis of the efficacy results from the 2 trials. Methods: The 2 prospective, randomized, double‐blinded, multicenter trials enrolled a total of 143 patients utilizing an intrapatient control design. Postoperative day 30 videos were obtained for each patient, randomly ordered, and presented to an independent panel of 3 otolaryngologists for grading of efficacy endpoints. The need for postoperative interventions, formation of polyposis, and adhesions were assessed. Results from the 2 studies were then pooled. Results: Implants were successfully placed in all 286 ethmoid sinuses. According to the grading done by the panel, drug‐releasing implants reduced postoperative interventions by 35% ( p = 0.0008), lysis of adhesions by 51% ( p = 0.0016), and oral steroid need by 40% ( p = 0.0023), compared to controls. The relative reduction in frank polyposis was 46% ( p 〈 0.0001). Conclusion: Early postoperative healing is a predictor of longer‐term success after sinus surgery. Evaluation of postoperative outcomes by a blinded independent panel demonstrates that steroid‐releasing implants that provide a sustained release of corticosteroid improve surgical outcomes by reducing frank polyp formation, sinus adhesions, and middle turbinate lateralization. Steroid‐releasing implants reduce the need for surgical intervention, and the need for oral steroid treatment. © 2012 ARS‐AAOA, LLC.
    Type of Medium: Online Resource
    ISSN: 2042-6976 , 2042-6984
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2012
    detail.hit.zdb_id: 2604059-1
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  • 3
    In: International Forum of Allergy & Rhinology, Wiley, Vol. 6, No. 6 ( 2016-06), p. 573-581
    Abstract: Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. Safety and efficacy were previously reported for a bioabsorbable sinus implant that elutes mometasone furoate for 3 months. Here we summarize longer‐term outcomes. Methods A randomized, controlled, blinded study with 100 chronic rhinosinusitis with nasal polyps (CRSwNP) patients who failed medical treatment and were considered candidates for revision ESS. Treated patients (n = 57) underwent in‐office implant placement. Control patients (n = 43) underwent a sham procedure. Endoscopic grading at 3 months by clinicians was corroborated by an independent review of randomized videoendoscopies by a panel of 3 sinus surgeons. Six‐month follow‐up included endoscopic grading and patient‐reported outcomes. Results At 6 months, treated patients experienced significant improvement in Nasal Obstruction Symptom Evaluation (NOSE) score ( p = 0.021) and 〉 2‐fold improvement in mean nasal obstruction/congestion score (−1.06 ± 1.4 vs −0.44 ± 1.4; p = 0.124). Endoscopically, treated patients experienced significant reduction in ethmoid sinus obstruction ( p 〈 0.001) and bilateral polyp grade ( p = 0.018) compared to controls. Panel review confirmed a significant reduction in ethmoid sinus obstruction ( p = 0.010) and 2‐fold improvement in bilateral polyp grade ( p = 0.099), which reached statistical significance ( p = 0.049) in a subset of 67 patients with baseline polyp burden ≥2 bilaterally. At 6 months, control patients were at 3.6 times higher risk of remaining indicated for ESS than treated patients. Conclusion The symptomatic and endoscopic improvements observed confirm the efficacy of the steroid‐eluting implant for in‐office treatment of CRSwNP after ESS. These longer‐term 6‐month study results demonstrate that the steroid‐eluting implant represents a durable, safe, and effective treatment strategy for this patient population.
    Type of Medium: Online Resource
    ISSN: 2042-6976 , 2042-6984
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2016
    detail.hit.zdb_id: 2604059-1
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  • 4
    In: International Forum of Allergy & Rhinology, Wiley, Vol. 9, No. 2 ( 2019-02), p. 131-139
    Abstract: Bioabsorbable steroid‐releasing implants (mometasone furoate, 370 μg) are effective for improving postsurgical outcomes in the frontal sinus ostia (FSO). In this study we evaluated the effect of these implants on frontal outcomes in various patient subgroups with chronic rhinosinusitis (CRS) using pooled data from 2 randomized, controlled trials (RCTs). Methods A total of 160 subjects were enrolled in 2 RCTs. After surgery, subjects were randomized to receive an implant in 1 FSO with the contralateral side as control. Data through day 90 from the 2 studies were pooled and subgroup analyses were performed. Results At day 30, relative to controls, steroid‐releasing implants significantly reduced the need for postoperative interventions by 46.8% (95% confidence interval [CI], −60.7 to −27.9), for surgical interventions by 51.2% (95% CI, −68.2 to −25.2), and for oral steroid interventions by 37.2% (95% CI, −54.6 to −13.1) in the pooled data set. At day 90, statistically significant reductions ( p 〈 0.05) in the need for postoperative interventions (relative reduction [RR], 30.2%), restenosis/occlusion rate (RR, 31.7%), and inflammation score (absolute difference, −6.0), and increase in estimated FSO diameter (absolute difference, 1 mm), favoring the treated side, were observed. Subgroup analyses of the pooled data showed statistically significant improvements ( p 〈 0.05) at day 90 in restenosis/occlusion rate, and estimated FSO diameter, favoring the treated side across subgroups, with no statistically significant subgroup‐by‐treatment interactions. Conclusion Bioabsorbable steroid‐releasing sinus implants improve outcomes of frontal sinus surgery through 90 days, irrespective of asthma status, previous endoscopic sinus surgery, extent of surgery, extent of polyps, or Lund‐Mackay computed tomography stage in the FSO.
    Type of Medium: Online Resource
    ISSN: 2042-6976 , 2042-6984
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2019
    detail.hit.zdb_id: 2604059-1
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  • 5
    In: Otolaryngology–Head and Neck Surgery, Wiley, Vol. 146, No. 6 ( 2012-06), p. 1004-1011
    Abstract: Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) may be compromised by postoperative inflammation, polyposis, and adhesions, often requiring subsequent intervention. To address this issue, the authors investigated the safety and effectiveness of controlled delivery of mometasone furoate to the sinus mucosa via bioabsorbable implants deployed at the time of ESS. Study Design Prospective, multicenter, randomized, controlled, double‐blind trial using an intrapatient control design. Setting Otolaryngology–head and neck surgery centers; both academic and private practices. Subjects and Methods The study enrolled 105 patients with CRS undergoing bilateral ethmoidectomy to compare the effect of drug‐releasing to non‐drug‐releasing implants using an intrapatient control design. Postoperative interventions, polyposis, and adhesions were assessed postoperatively. Efficacy was determined through independent analysis of randomized video‐endoscopies by 3 blinded sinus surgeons. Safety assessments included ocular examinations. Results Implants were successfully deployed in all 210 ethmoid sinuses. Compared with control sinuses with non‐drug‐releasing implants, the drug‐releasing implant provided a 29.0% relative reduction in postoperative interventions ( P =. 028) and a 52% ( P =. 005) decrease in lysis of adhesions. The relative reduction in frank polyposis was 44.9% ( P =. 002). Similar reductions were observed in real‐time grading performed by the clinical investigators. No clinically significant changes from baseline in intraocular pressure or cataracts were observed. Conclusion This study provides a high level of evidence that use of steroid‐releasing implants that apply a sustained release of corticosteroid improves surgical outcomes by reducing synechiae formation, polyposis, and the need for postoperative interventions, with no observable ocular safety risk.
    Type of Medium: Online Resource
    ISSN: 0194-5998 , 1097-6817
    Language: English
    Publisher: Wiley
    Publication Date: 2012
    detail.hit.zdb_id: 2008453-5
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  • 6
    Online Resource
    Online Resource
    Wiley ; 2011
    In:  International Forum of Allergy & Rhinology Vol. 1, No. 1 ( 2011-01), p. 23-32
    In: International Forum of Allergy & Rhinology, Wiley, Vol. 1, No. 1 ( 2011-01), p. 23-32
    Type of Medium: Online Resource
    ISSN: 2042-6976
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2011
    detail.hit.zdb_id: 2604059-1
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  • 7
    In: International Forum of Allergy & Rhinology, Wiley, Vol. 8, No. 4 ( 2018-04), p. 471-481
    Abstract: Topical intranasal corticosteroid sprays (INCSs) are standard treatment for nasal polyps (NPs), but their efficacy is reduced by poor patient compliance and impaired access of drug to the sinus mucosa. A corticosteroid‐eluting sinus implant was designed to address these limitations in patients with recurrent polyposis after sinus surgery by delivering 1350 μg of mometasone furoate (MF) directly to the ethmoid sinus mucosa over approximately 90 days. Methods A randomized, sham‐controlled, double‐blind trial was undertaken in 300 adults with refractory chronic rhinosinusitis with NPs (CRSwNP), who were candidates for repeat surgery. Eligible patients were randomized (2:1) and underwent in‐office bilateral placement of 2 implants or a sham procedure. All patients used the MF INCS 200 μg once daily. Co‐primary efficacy endpoints were the change from baseline in nasal obstruction/congestion score and bilateral polyp grade, as determined by an independent panel based on centralized, blinded videoendoscopy review. Results Patients treated with implants experienced significant reductions in both nasal obstruction/congestion score ( p  = 0.0074) and bilateral polyp grade ( p  = 0.0073) compared to controls. At day 90, implants were also associated with significant reductions in 4 of 5 prespecified secondary endpoints compared to control: proportion of patients still indicated for repeat sinus surgery ( p  = 0.0004), percent ethmoid sinus obstruction ( p  = 0.0007), nasal obstruction/congestion ( p  = 0.0248), and decreased sense of smell ( p  = 0.0470), but not facial pain/pressure ( p  = 0.9130). One patient experienced an implant‐related serious adverse event (epistaxis). Conclusion Significant improvements over a range of subjective and objective endpoints, including a reduction in the need for sinus surgery by 61%, suggest that MF sinus implants may play an important role in management of recurrent NP.
    Type of Medium: Online Resource
    ISSN: 2042-6976 , 2042-6984
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2018
    detail.hit.zdb_id: 2604059-1
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  • 8
    In: JAMA Otolaryngology–Head & Neck Surgery, American Medical Association (AMA)
    Type of Medium: Online Resource
    ISSN: 2168-6181
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2017
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  • 9
    In: American Journal of Rhinology & Allergy, SAGE Publications, Vol. 33, No. 5 ( 2019-09), p. 545-558
    Abstract: A mometasone furoate (MF) sinus implant (1350 mcg) was evaluated in 2 randomized controlled trials (RCTs) in 400 adults with nasal polyps (NP) who were candidates for revision endoscopic sinus surgery (RESS). We conducted a pooled analysis to evaluate the efficacy of MF implant in specific subgroups of NP patients. Methods Pooled data from 2 RCTs for 375 patients were analyzed across prespecified subjective and objective end points through day 90. Results At day 90, patients receiving implants and MF nasal spray (MFNS) experienced significant improvements in nasal obstruction/congestion (NO/C) score ( P = .0095), bilateral polyp grade (BPG, P = .0008), and ethmoid sinus obstruction ( P  〈  .0001) compared to control using MFNS alone. Fewer treatment than control patients remained candidates for RESS (41.0% vs 69.3%, P  〈  .0001). All subgroups experienced significant treatment effects, except NO/C in smokers ( P = .0509) and patients without altered smell ( P = .1873). Subgroups without asthma and with only 1 prior ESS experienced largest treatment effect on NO/C, and those with recent surgery 〈 24 months and BPG 〉 5 showed largest effect on endoscopic end points and RESS. Control patients with ESS 〈 24 months were at 7 times highest risk for RESS ( P  〈  .0001). One (0.4%) patient experienced implant-related serious adverse event (epistaxis). Conclusion On pooled analysis, MF implants with MFNS showed more favorable results than MFNS alone across several subjective and objective end points at day 90 and may play an important role in management of NP patients, especially those who have allergic rhinitis, expanded polyposis, altered smell, or had most recent ESS  〈  24 months.
    Type of Medium: Online Resource
    ISSN: 1945-8924 , 1945-8932
    RVK:
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2019
    detail.hit.zdb_id: 2554548-6
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  • 10
    In: JAMA, American Medical Association (AMA), Vol. 329, No. 5 ( 2023-02-07), p. 376-
    Abstract: Anti–vascular endothelial growth factor (VEGF) injections in eyes with nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) reduce development of vision-threatening complications from diabetes over at least 2 years, but whether this treatment has a longer-term benefit on visual acuity is unknown. Objective To compare the primary 4-year outcomes of visual acuity and rates of vision-threatening complications in eyes with moderate to severe NPDR treated with intravitreal aflibercept compared with sham. The primary 2-year analysis of this study has been reported. Design, Setting, and Participants Randomized clinical trial conducted at 64 clinical sites in the US and Canada from January 2016 to March 2018, enrolling 328 adults (399 eyes) with moderate to severe NPDR (Early Treatment Diabetic Retinopathy Study [ETDRS] severity level 43-53) without CI-DME. Interventions Eyes were randomly assigned to 2.0 mg aflibercept (n = 200) or sham (n = 199). Eight injections were administered at defined intervals through 2 years, continuing quarterly through 4 years unless the eye improved to mild NPDR or better. Aflibercept was given in both groups to treat development of high-risk proliferative diabetic retinopathy (PDR) or CI-DME with vision loss. Main Outcomes and Measures Development of PDR or CI-DME with vision loss (≥10 letters at 1 visit or ≥5 letters at 2 consecutive visits) and change in visual acuity (best corrected ETDRS letter score) from baseline to 4 years. Results Among participants (mean age 56 years; 42.4% female; 5% Asian, 15% Black, 32% Hispanic, 45% White), the 4-year cumulative probability of developing PDR or CI-DME with vision loss was 33.9% with aflibercept vs 56.9% with sham (adjusted hazard ratio, 0.40 [97.5% CI, 0.28 to 0.57] ; P   & amp;lt; .001). The mean (SD) change in visual acuity from baseline to 4 years was −2.7 (6.5) letters with aflibercept and −2.4 (5.8) letters with sham (adjusted mean difference, −0.5 letters [97.5% CI, −2.3 to 1.3]; P  = .52). Antiplatelet Trialists’ Collaboration cardiovascular/cerebrovascular event rates were 9.9% (7 of 71) in bilateral participants, 10.9% (14 of 129) in unilateral aflibercept participants, and 7.8% (10 of 128) in unilateral sham participants. Conclusions and Relevance Among patients with NPDR but without CI-DME, at 4 years treatment with aflibercept vs sham, initiating aflibercept treatment only if vision-threatening complications developed, resulted in statistically significant anatomic improvement but no improvement in visual acuity. Aflibercept as a preventive strategy, as used in this trial, may not be generally warranted for patients with NPDR without CI-DME. Trial Registration ClinicalTrials.gov Identifier: NCT02634333
    Type of Medium: Online Resource
    ISSN: 0098-7484
    RVK:
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2023
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    SSG: 5,21
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