奥马珠单抗辅助鼻内镜手术治疗过敏性哮喘伴鼻息肉患者的临床研究  

Clinical trial of omalizumab-assisted nasal endoscopic surgery in the treatment of patients with allergic asthma combined with nasal polyps

作　　者：周琳[1] 钟磊[2] 曹玲[2] 李模勇[1] 李艳钰 ZHOU Lin;ZHONG Lei;CAO Ling;LI Mo-yong;LI Yan-yu(Department of Pharmacy,Zigong Fourth People's Hospital,Zigong 643000,Sichuan Province,China;Department of Otolaryngology,Head and Neck Surgery,Zigong Fourth People's Hospital,Zigong 643000,Sichuan Province,China)

机构地区：[1]自贡市第四人民医院药剂科,四川自贡643000 [2]自贡市第四人民医院耳鼻咽喉头颈外科,四川自贡643000

出　　处：《中国临床药理学杂志》2023年第21期3087-3091,共5页The Chinese Journal of Clinical Pharmacology

基　　金：四川省医学科研课题计划基金资助项目(S21045)。

摘　　要：目的观察奥马珠单抗辅助鼻内镜手术治疗过敏性哮喘伴鼻息肉患者的临床疗效和安全性。方法将过敏性哮喘伴鼻息肉患者按治疗方法分为对照组和试验组。2组均给予鼻内镜手术。术后,对照组给予布地奈德鼻喷雾剂,每日早晚各1次;试验组给予奥马珠单抗治疗,根据基线免疫球蛋白E(IgE)和患者体质量确定注射剂量,皮下注射,每2周1次。2组患者均治疗16周。比较2组患者的临床疗效、鼻部症状评分、嗅觉功能评分、哮喘症状评分、第1秒用力呼气容积(FEV1)、过敏原特异性IgE抗体(sIgE),药物不良反应发生情况和鼻息肉复发情况。结果试验组和对照组分别入组88例和89例。治疗后,试验组和对照组的鼻息肉总有效率分别为93.18%(82例/88例)和69.66%(62例/89例),哮喘总有效率分别为95.45%(84例/88例)和75.28%(67例/89例),差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组的鼻部症状评分分别为(1.34±1.02)和(2.45±1.41)分,嗅觉功能评分分别为(3.24±1.21)和(4.51±1.36)分,日间哮喘症状评分分别为(0.51±0.11)和(0.71±0.14)分,夜间哮喘症状评分分别为(0.25±0.07)和(0.33±0.09)分,FEV1分别为(3.47±0.72)和(3.05±0.65)L,sIgE分别为(61.48±7.51)和(72.62±8.06)U·L^(-1),差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有恶心呕吐、头痛、注射部位疼痛,对照组的药物不良反应主要有头痛。试验组和对照组的总药物不良反应发生率分别为4.49%和1.14%,差异无统计学意义(P>0.05)。试验组和对照组的鼻息肉复发率分别为6.82%和16.85%,差异有统计学意义(P<0.05)。结论奥马珠单抗辅助鼻内镜手术比布地奈德鼻喷雾剂治疗过敏性哮喘伴鼻息肉患者的临床疗效更佳,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of omalizumab-assisted nasal endoscopic surgery in the treatment of patients with allergic asthma combined with nasal polyps.Methods Patients with allergic asthma combined with nasal polyps were divided into control group and treatment group according to the treatment methods.Two groups received nasal endoscopic surgery.After surgery,the control group was given budesonide nasal spray once in the morning and once in the evening,and the treatment group was given omalizumab treatment,its injection dose was determined the injection dose based on baseline immunoglobulin E(IgE)and patient body mass,subcutaneously once every 2 weeks.Two groups were treated for 16 weeks.The clinical fficacy,nasal symptom scores,olfactory function scores,asthma symptom scores,forceful expiratory volume in the first second(FEV1),allergen-specific IgE antibodies(sIgE),occurrence of adverse drug reactions,and recurrence of nasal polyps were compared between two groups.Results In the treatment and control groups,88 and 89 cases were enrolled,respectively.After treatment,the total effective rates of nasal polyps in the treatment and control groups were 93.18%(82 cases/88 cases)and 69.66%(62 cases/89 cases),the total effective rates of asthma were 95.45%(84 cases/88 cases)and 75.28%(67 cases/89 cases),and the differences between them were statistically significant(all P<0.05).After treatment,nasal symptom scores in the treatment and control groups were(1.34±1.02)and(2.45±1.41)points;olfactory function scores were(3.24±1.21)and(4.51±1.36)points;daytime asthma symptom scores were(0.51±0.11)and(0.71±0.14)points;nighttime asthma symptom scores were(0.25±0.07)and(0.33±0.09)points;FEV1 were(3.47±0.72)and(3.05±0.65)L;slgE were(61.48±7.51)and(72.62±8.06)U.L-1,respectively,and the differences were statistically significant(all P<0.05).The adverse drug reactions in the treatment group were nausea and vomiting,headache and injection site pain,while those in the control group were headache.T

关 键 词：奥马珠单抗 布地奈德鼻喷雾剂 过敏性哮喘 鼻息肉 临床疗效 安全性评价 

分 类 号：R974[医药卫生—药品]