变应性鼻炎皮下过敏原特异性免疫治疗过长延迟注射的剂量调整新方案疗效分析  

Efficacy analysis of a novel dose-adjusting regimen for prolonged delayed injection allergen-specific immunotherapy for allergic rhinitis

作　　者：房丹丹 锡琳[1] 高云博 张媛[1] 张罗[2,3] Fang Dandan;Xi Lin;Gao Yunbo;Zhang Yuan;Zhang Luo(Department of Allergy,Beijing TongRen Hospital,Capital Medical University,Beijing 100730,China;Department of Otolaryngology Head and Neck Surgery,Beijing TongRen Hospital,Capital Medical University,Beijing 100730,China;Beijing Key Laboratory of Nasal Diseases,Beijing Institute of Otolaryngology,Beijing 100005,China)

机构地区：[1]首都医科大学附属北京同仁医院变态反应科,北京100730 [2]首都医科大学附属北京同仁医院耳鼻咽喉头颈外科,北京100730 [3]北京市耳鼻咽喉科研究所、鼻病研究北京市重点实验室,北京100005

出　　处：《中华耳鼻咽喉头颈外科杂志》2023年第9期863-870,共8页Chinese Journal of Otorhinolaryngology Head and Neck Surgery

基　　金：国家重点研发计划(2022YFC2504100);教育部长江学者创新团队(IRT13082);国家自然科学基金(81970849,82071022,82271141);中国医学科学院医学与健康科技创新工程项目(2019-I2M-5-022);首都临床特色诊疗技术研究及转化应用重点项目(Z211100002921057,Z211100002921060);首都卫生发展科研专项重点攻关项目(2022-1-1091)。

摘　　要：目的探究变应性鼻炎(AR)尘螨过敏原皮下免疫治疗(subcutaneous immunotherapy,SCIT)维持期中断治疗超过16周的新型剂量调整方案的有效性及安全性。方法2020年7—9月,在首都医科大学附属北京同仁医院变态反应科招募68例接受尘螨集群SCIT且在维持期治疗中断超过16周的AR患者,随机分为新方案组(n=34)和指南推荐方案组(n=34),另选取同期接受尘螨SCIT并按时治疗的患者作为对照,设为持续治疗组(n=34)。延迟注射后再次治疗时,新方案组直接进入4号瓶起始剂量(10000 SQ)注射,指南推荐方案组从最低剂量(10 SQ)重新治疗,持续治疗组按照原方案注射。采用完成3年SCIT后较基线的症状药物综合评分(combined symptom and medication score,CSMS)变化作为主要疗效指标,同时记录不同剂量调整方案的局部和全身不良反应以评估其安全性。采用SPSS 23.0软件进行统计学分析。结果完成3年SCIT后,3组患者的CSMS较基线均明显下降,新方案组和指南推荐方案组3年较基线的CSMS变化值差异无统计学意义[(-1.0±0.3)分比(-1.3±0.4)分,P=0.655]。两个进行剂量调整的延迟治疗组和持续治疗组之间的CSMS变化值亦无显著差异[(-0.8±0.3)分比(-1.3±0.3)分,P=0.156]。新方案组和指南推荐方案组在重新开始治疗后均无全身不良反应发生,不良反应的频次发生率差异无统计学意义(0.5%比0.5%,P=0.698)。结论SCIT中断注射超过16周时,相较于指南推荐剂量调整方案,新方案的有效性及安全性无显著差异。SCIT中断注射超过16周对3年疗效无显著影响。Objective To investigate the efficacy and safety of a novel dose adjustment schedule based on subcutaneous immunotherapy(SCIT)after a 16 weeks delayed injection during the maintenance period.Methods Sixty-eight patients with allergic rhinitis(AR)who received dust mite cluster SCIT and had interrupted treatment for more than 16 weeks during the maintenance period were recruited at Beijing TongRen Hospital,from July to September 2020.They were randomly divided into the novel schedule group(n=34)and the guideline recommended schedule group(n=34).In addition,34 patients who received dust mite SCIT at the same period were selected as the continuous treatment group(n=34).When receiving treatment again after delayed injection,the novel schedule group was injected directly with the initial dose of maintenance period(10000 SQ),and the guideline recommended schedule group started the dosage accumulation again from the lowest dose(10 SQ),while the continuous treatment group was injected according to the original schedule.Changes in the combined symptom and medication score(CSMS)from baseline after 3 years of SCIT were used as the primary efficacy evaluation index.Local and systemic adverse events were recorded to evaluate safety.SPSS 23.0 was used for statistical analysis.Results At the end of 3 years,CSMS in all three groups decreased significantly from baseline,and there was no significant difference in the 3-year change value of CSMS from baseline between the novel schedule group and the guideline recommended schedule group(-1.0±0.3 vs-1.3±0.4,P=0.655).There was also no significant difference in the change of CSMS between the two dose-adjusted groups and the continuous treatment groups(-0.8±0.3 vs-1.3±0.3,P=0.156).No systemic adverse events occurred between the novel schedule group and the guideline recommended schedule group after restarting treatment,and there was no significant difference in frequency of adverse events(0.5%vs 0.5%,P=0.698).Conclusion There is no significant difference in efficacy and safety betwee

关 键 词：变应性鼻炎 皮下免疫治疗 延迟治疗 剂量调整 

分 类 号：R765.21[医药卫生—耳鼻咽喉科]