标准化螨过敏原提取物皮下冲击免疫治疗的短期疗效和安全性观察及相关因素探讨  

Short-term efficacy and safety observation of standardized mite allergen extract rush subcutaneous immunotherapy for allergic rhinitis:a prospective study

作　　者：黄晶煜 章薇[1] 向荣[1] 邓玉琴[1] 陶泽璋[1] 许昱[1] Huang Jingyu;Zhang Wei;Xiang Rong;Deng Yuqin;Tao Zezhang;Xu Yu(Department of Otorhinolaryngology Head and Neck Surgery,Department of Rhinology and Allergy,Research Institute of Otorhinolaryngology Head and Neck Surgery,Renmin Hospital of Wuhan University,Wuhan 430060,China)

机构地区：[1]武汉大学人民医院耳鼻咽喉头颈外科中心鼻科及变态反应科、武汉大学人民医院耳鼻咽喉头颈外科研究所,武汉430060

出　　处：《中华耳鼻咽喉头颈外科杂志》2023年第9期854-862,共9页Chinese Journal of Otorhinolaryngology Head and Neck Surgery

基　　金：国家自然科学基金(82271134,81770986,82071017);中央高校基本科研业务费专项资金项目(2042022kf1113)。

摘　　要：目的比较3种不同剂量递增模式的过敏原特异性免疫治疗早期的临床疗效、不良反应、炎性因子的变化,以期为临床更加安全有效地开展加速免疫治疗提供参考。方法纳入2019—2022年于武汉大学人民医院进行皮下免疫治疗(subcutaneous immunotherapy,SCIT)的变应性鼻炎患者进行前瞻性研究。按照自愿原则分别进行常规免疫治疗(conventional immunotherapy,CIT)23例、集群免疫治疗(cluster immunotherapy,CLIT)25例和冲击免疫治疗(rush immunotherapy,RIT)18例,RIT组的患者治疗前1周行单针次的150 mg奥马珠单抗皮下注射。记录并分析3组患者治疗前及治疗后1、7、15周的主观评价指标[药物症状评分、鼻部视觉模拟量表(VAS)评分、鼻部单项症状评分]、客观评价指标(血清sIgE、tIgE、Th1/2及Th17细胞因子等)和不良反应等情况。采用SPSS 22.0软件进行数据处理和分析。结果完成治疗的66例患者纳入研究,其中男37例,女29例。与治疗前相比,在治疗1、7、15周时3组患者的药物症状评分、鼻部VAS评分均有明显下降(P值均<0.05)。3组对比发现,治疗1周时,RIT组鼻部VAS评分低于CIT组和CLIT组[(4.33±0.94)分比(9.48±1.37)分比(9.44±1.33)分,P<0.05];治疗15周时,RIT组药物症状评分低于CIT组和CLIT组[(0.62±0.23)分比(1.54±0.21)分比(1.06±0.22)分,P<0.05];在达到维持剂量时,RIT组对鼻痒症状的改善优于CIT组和CLIT组[(0.61±0.20)分比(1.78±0.38)分比(1.56±0.32)分,P<0.05]。RIT组的局部不良反应发生率比CIT组和CLIT组低(11.76%比20.00%比16.53%,P<0.05)。3种SCIT均未发生3/4级全身不良反应,且全身不良反应发生率的差异没有统计学意义。白细胞介素(IL)-4、IL-5、IL-6、IL-17、sIgE、sIgE/tIgE、嗜酸粒细胞百分比在3组治疗后均有不同程度下降,IL-10、肿瘤坏死因子、干扰素γ在治疗后无明显变化。结论3种标准化螨过敏原提取物SCIT的临床疗效均较为可观。单次奥马珠单抗注Objective To conduct a comparative analysis of the efficacy,safety,and cytokine changes associated with three distinct dose escalation regimens of allergen-specific immunotherapy(AIT),and to provide valuable insights into the implementation of safer and more effective accelerated immunotherapy in clinical practice.Methods A prospective study of subcutaneous immunotherapy(SCIT)was conducted at Renmin Hospital of Wuhan University,involving patients with allergic rhinitis visited from 2019 to 2022.Participants were allocated to one of three treatment groups based on their preferences:conventional immunotherapy(CIT,23 cases),cluster immunotherapy(CLIT,25 cases),or rush immunotherapy(RIT,18 cases).The RIT group received a single subcutaneous injection of 150 mg of omalizumab one week before commencing treatment.Subjective evaluation indices,including the Combined Symptom and Medication Score(CSMS),Visual Analogue Scale(VAS),and single symptom score,were recorded alongside objective evaluation indices(e.g.,sIgE,tIgE,Th1/2 and Th17 cytokines)and adverse reactions.Assessments were conducted at baseline,and at 1,7,and 15 weeks after treatment.SPSS 22.0 software was used for data processing and analysis.Results The study included a total of 66 patients,comprising 37 males and 29 females,who completed the treatment regimen.In all three groups,CSMS and VAS scores showed significant reductions at 1,7,and 15 weeks post-treatment(all P<0.05).Notably,the RIT group demonstrated a significantly lower VAS score(4.33±0.94)compared to the CIT(9.48±1.37)and CLIT(9.44±1.33)groups at 1 week post-treatment(P<0.05).Additionally,the RIT group(0.62±0.23)exhibited a lower CSMS score than the CIT(1.54±0.21)and CLIT(1.06±0.22)groups at 15 weeks post-treatment(P<0.05).Furthermore,at the point of reaching the maintenance dose,the RIT group(0.61±0.20)demonstrated superior improvement in nasal itching symptoms compared to the CIT(1.78±0.38)and CLIT groups(1.56±0.32),with P<0.05.The incidence of local adverse reactions in the RIT group(36/

关 键 词：变应性鼻炎 皮下免疫治疗 疗效 安全性 细胞因子 

分 类 号：R765.21[医药卫生—耳鼻咽喉科]