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 (10 000 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 between the novel dose adjustment schedule and the recommended dose adjustment schedule when SCIT interrupted injection for more than 16 weeks. Furthermore, SCIT discontinuation of injection for more than 16 weeks doesn't significantly impact on 3-year efficacy.
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（10 000 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。.