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新型冠状病毒感染疫情期间一种新的延误注射剂量调整方案在变应性鼻炎皮下免疫治疗中的应用
Application study of a new dose adjustment schedule for delayed injections in conventional subcutaneous immunotherapy for allergic rhinitis during the outbreak of Corona Virus Disease 2019
【摘要】 目的 探索新型冠状病毒感染(简称新冠感染疫情期间一种新的延误注射剂量调整方案在尘螨过敏变应性鼻炎(AR)患者常规皮下免疫治疗(subcutaneous immunotherapy,SCIT)中的应用。方法 收集2020-01-01~2020-06-01新冠感染疫情期间广东省佛山市第一人民医院耳鼻咽喉头颈外科门诊行阿罗格常规SCIT延误注射的AR患者,将其数量与2017~2019年同期延误注射的AR患者数量进行比较;并将2020-01-01~2020-06-01疫情期间不伴哮喘的早期延误注射患者(剂量累加阶段延误2~4周以及维持阶段延误6~8周的患者)随机分为观察组和对照组两组,观察组采用本团队设计的新剂量调整方案,对照组采用阿罗格常规SCIT参考剂量调整方案,比较两组患者剂量调整时严重局部不良反应、全身不良反应发生率;剂量调整前及调整后治疗6个月时患者鼻眼部总症状评分、药物评分差异;患者对所采用剂量调整方案的满意度评分。结果2020-01-01~2020-06-01疫情期间阿罗格常规SCIT延误注射患者共83例,显著高于2017~2019年同期数量。疫情期间不伴哮喘且完成连续6个月及以上治疗的早期延误注射患者60例,共发生72次延误注射,其中观察组30例,共发生37次延误注射,对照组30例,共发生35次延误注射,两组延误注射患者进行剂量调整时均无严重局部不良反应发生,全身不良反应发生率差异无统计学意义(P=0.486);两组患者剂量调整前、调整后6个月时症状总评分差异均无统计学意义(P=0.424,P=0.773),相应时间的药物评分差异均无统计学意义(P=0.593,P=0.571);观察组对新剂量调整方案的满意度评分显著高于对照组对参考剂量调整方案的满意度评分(P=0.000)。结论 疫情期间阿罗格常规SCIT延误注射患者数量明显高于往年同期;新剂量调整方案在延误注射患者中应用安全性高、满意度评分高,其安全性、调整后短期临床疗效与参考剂量调整组相当。当延误时间在一定范围内,当次注射可以重复使用末次耐受剂量,将注射液平分两臂先后注射,之后常规步伐继续免疫治疗,避免减量、重新剂量累加的过程,达到治疗效率和安全性的良好平衡,但该方案仅适用于很好耐受末次注射剂量的患者。
【Abstract】 OBJECTIVE To explore the application of a new dose adjustment schedule for delayed injection in the conventional subcutaneous immunotherapy(SCIT) for allergic rhinitis during the outbreak of Corona Virus Disease 2019(COVID-19). METHODS Allergic rhinitis patients with delayed injections during Allergopharma conventional subcutaneous immunotherapy in our outpatient department from January 1 to June 1, 2020 were collected, and the number of patients was compared with that of patients with delayed injections in the same period from 2017 to 2019. Nonasthmatic patients with early delayed injections during the epidemic period were randomly divided into the observation group and control group, and patients in the observation group underwent new dose adjustment schedule, while their counterparts underwent reference dose adjustment schedule for Allergopharma conventional subcutaneous immunotherapy.Severe local adverse reactions and systemic adverse reactions during dose adjustment of two groups were recorded. The scores of nasal and ocular symptoms, drug scores were recorded for statistical analysis before and 6 months after dose adjustment, and the patients’ satisfaction score of respective dose adjustment in two groups were also recorded. RESULTS During the epidemic period from January 1 to June 1, 2020,there were 83 patients with delayed injections during the subcutaneous immunotherapy, which was significantly higher than the number in the same period from 2017 to 2019. 60 out of 83 patients were non-asthmatic, with early delayed injections and completed 6 months and above consecutive immunotherapy. 30 patients in the observation group had 37early delayed injections while other 30 patients in the control group had 35 early delayed injections. There was no serious local adverse reaction when dose was adjusted, and there was no significant difference in systemic adverse reactions in two groups(P=0.486). There was no significant difference in the total nasal and ocular symptoms between the two groups before and 6 months after dose adjustment(P=0.344, P=0.465), and there was no significant difference in the drug score between the two groups before and 6 months after dose adjustment(P =0.593,P=0.571). The satisfaction score of the observation group for the new dose adjustment schedule was higher than that of the control group for the reference dose adjustment schedule(P =0.000).CONCLUSION During the epidemic period, the number of patients with delayed injections during Allergopharma conventional subcutaneous immunotherapy was significantly higher than that of the same period from 2017 to 2019. The new dose adjustment schedule showed high safety, and its safety and short-term clinical efficacy in the observation group are equivalent to those of the reference dose adjustment group. When the delay interval is within a certain range, we repeat the last injection dose for the current injection, by giving two arms equal half dose with half an hour interval in order to avoid dose decrease and additional buildup process, thereby achieving a good balance between safety and treatment efficiency, and improving patient’s satisfaction for immunotherapy, but this schedule is only suitable for patients who had favorable tolerance for the last injection.
【Key words】 Injections,Subcutaneous; Immunotherapy; Drug-Related Side Effects and Adverse Reactions; Dose adjustment; late injections;
- 【文献出处】 中国耳鼻咽喉头颈外科 ,Chinese Archives of Otolaryngology-Head and Neck Surgery , 编辑部邮箱 ,2022年12期
- 【分类号】R765.21
- 【下载频次】12