A prospective single-arm study on the efficacy and safety of short-course oral corticosteroids followed by topical corticosteroids in patients with severe chronic rhinosinusitis with nasal polyps
A prospective single-arm study on the efficacy and safety of short-course oral corticosteroids followed by topical corticosteroids in patients with severe chronic rhinosinusitis with nasal polyps
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DOI：
10.1080/1744666x.2023.2209724
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发表时间：
2023-04
影响因子：
4.4
通讯作者：
Shan Shao;Yue Wang;Nan Zhang;Yan Zhao;Xue-Lian Zhang;Yutong Sima;Ping Wang;Yuan Xu;Tiezhu Wang;S. Bao;Yudan Cao;Xiangdong Wang;Luo Zhang;C. Bachert
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文献类型：
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作者：
Shan Shao;Yue Wang;Nan Zhang;Yan Zhao;Xue-Lian Zhang;Yutong Sima;Ping Wang;Yuan Xu;Tiezhu Wang;S. Bao;Yudan Cao;Xiangdong Wang;Luo Zhang;C. Bachert
背景：关于综合多维评价方法分析慢性鼻窦炎合并鼻息肉（CRSwNP）药物治疗的患者内部效果的证据很少。我们的目的是使用一个综合评估模型来分析短期口服皮质类固醇（OCS）后鼻内皮质类固醇喷雾（INCS）治疗严重CRSwNP患者的效果。方法在这项前瞻性单臂研究中，32例严重CRSwNP患者口服甲基强的松龙3周，随后鼻内布地奈德喷雾剂9周。纵向评价综合核心结局集（COS）、临床对照和最小临床重要差异（MCID）概念的评价模型。在OCS期间，所有未控制的患者在基线时均表现出类似的进行性改善，在核心结局中有超过1个mcd反应，在3周时，31例（96.9%）患者严重CRSwNP得到部分控制，1例（3.1%）患者未得到控制。在随后的INCS期间，14例（43.8%）患者在12周时逐渐恶化到不受控制的状态，而18例（56.2%）患者在12周前表现出部分控制的CRSwNP。在超过一半的患者中，通过最初的OCS和INCS治疗，严重的CRSwNP得到了部分控制。采用综合评价模型，便于对患者内反应进行综合评价，特别是对同一种治疗有不同反应的患者。试验注册ChiCTR1900024287。
ABSTRACT Background Little evidence exists regarding an integrated multidimensional evaluation methodology to analyze the within-patient effects of medical treatment for chronic rhinosinusitis with nasal polyps (CRSwNP). We aimed to use an integrated evaluation model to analyze the effects of short-course oral corticosteroid (OCS) followed by intranasal corticosteroid spray (INCS) therapy in patients with severe CRSwNP. Methods In all, 32 patients with severe CRSwNP received oral methylprednisolone for three weeks followed by intranasal budesonide spray for nine weeks in this prospective single-arm study. An evaluation model integrating the concepts of the core outcome set (COS), clinical control and minimum clinically important difference (MCID) was longitudinally evaluated. Results All uncontrolled patients at baseline showed similar progressive improvements from baseline and more than 1 MCID response across core outcomes during the OCS period, with severe CRSwNP being partly controlled in 31 (96.9%) patients and uncontrolled in 1 (3.1%) patient at 3 weeks. During the subsequent INCS period, 14 (43.8%) patients gradually deteriorated to an uncontrolled status at 12 weeks, whereas 18 (56.2%) exhibited partly controlled CRSwNP until 12 weeks. Conclusions In more than half of the patients, severe CRSwNP was partly controlled with the initial OCS followed by INCS therapy. An integrated evaluation model was used to facilitate the comprehensive evaluation of within-patient response, especially in patients with different responses to the same treatment. Trial registration ChiCTR1900024287.