Abstract: Objective    To explore the efficacy and safety of spleen aminopeptidase oral solution in treating children with allergic rhinitis combined with adenoidal hypertrophy. Methods    A total of 60 children with allergic rhinitis and adenoidal hypertrophy from the Children’s hospital of Fudan University were selected as the subjects of the study. They were randomly divided into two groups using the random number table method： spleen aminopeptidase oral solution group （loratadine for 1 month + isotonic saline solution for 2 months + spleen aminopeptidase oral solution for 2 months） and the control group （loratadine for 1 month + isotonic saline solution for 2 months）. The primary outcome measure was the ratio of adenoids to nasopharynx （A/N value），and secondary outcome measures included allergic rhinitis scores and adenoidal hypertrophy scores. The primary outcome measure was assessed before treatment and 2 months after treatment. Blood and urine routinewere detectedbefore treatment and 2 months after treatment for safety assessment. Results    Six children were lost，and a total of 54 individuals were included in the analysis，with 25 in the control group and 29 in the spleen aminopeptidase oral solution group. Baseline analysis showed no significant differences between the two groups in terms of gender，age，A/N value，rhinitis symptom scores （including sneezing，runny nose，nasal itching，and nasal congestion），and adenoidal hypertrophy scores （nasal congestion，snoring，mouth breathing，and restless sleep）（P>0.05）. There were no significant differences in the A/N baseline between the two groups before treatment. After 8 weeks of treatment，the A/N ratio in the spleen aminopeptidase oral solution group was significantly lower than that in the control group （Z=-3.534，P<0.001），indicating that spleen aminopeptidase oral solution can effectively reduce the size of the adenoids.Both groups showed improvement in nasal symptoms （including sneezing，runny nose，nasal itching，and nasal congestion），but there was no statistical difference between them （P>0.05）.After 8 weeks of treatment，the improvement in mouth breathing and restless sleep in the spleen aminopeptidase oral solution group was significantly better than in the control group （P=0.007 and P=0.006），while there were no differences between the two groups in nasal congestion and snoring （P=0.159 and P=0.169）. There were no significant differences in routine blood and urine indicators before and after medication use in both the control group and the spleen aminopeptidase oral solution group （P>0.05）. Conclusion    After 8 weeks of treatment with spleen aminopeptidase oral solution in children with allergic rhinitis and adenoidal hypertrophy，the size of the adenoids was significantly reduced，and clinical symptoms related to adenoidal hypertrophy were improved. In addition，its safety was good during the observation period.

Key words: allergic rhinitis, adenoid hypertrophy, spleen aminopeptidase oral solution

摘要： 目的    探讨脾氨肽口服溶液治疗儿童变应性鼻炎合并腺样体肥大的疗效和安全性。方法    以2021年6月至2022年6月复旦大学附属儿科医院收治的60例变应性鼻炎合并腺样体肥大患儿作为研究对象。采用随机数字表法将60例患儿随机分成两组：研究组（口服氯雷他定口服溶液1个月+等渗海盐水喷鼻2个月+口服脾氨肽口服溶液2个月）和对照组（口服氯雷他定口服溶液1个月+等渗海盐水喷鼻2个月）。主要结局指标为腺样体与鼻咽比值（A/N比值），次要结局指标包括鼻炎症状评分和腺样体肥大症状评分。在治疗前和治疗2个月后进行主要结局指标的评估。并检测患儿治疗前后的血常规和尿常规进行安全评估。结果    6例患儿失访，最终共纳入54例进入分析，其中对照组25例，研究组29例。基线分析显示，两组之间的性别、年龄、A/N比值、鼻炎症状评分（包括喷嚏、流涕、鼻痒、鼻塞）、腺样体肥大症状评分（鼻塞、打鼾、张口呼吸和睡眠不安）均差异无统计学意义（P>0.05）。治疗前两组的A/N基线差异无统计学意义，但治疗8周后，研究组的A/N比值显著低于对照组（Z=-3.534，P<0.001），提示脾氨肽能有效地缩小腺样体。两组的鼻炎症状评分（包括喷嚏、流涕、鼻痒、鼻塞）均有改善，但差异无统计学意义（P>0.05）。治疗8周后，研究组在张口呼吸和睡眠不安的改善显著优于对照组（P=0.007和P=0.006），但在鼻塞和打鼾，两组差异无统计学意义（P=0.159和P=0.169）。用药前后，对照组和研究组的血常规和尿常规指标均差异无统计学意义（P>0.05）。结论    脾氨肽口服溶液治疗儿童变应性鼻炎合并腺样体肥大8周后，能够显著减小腺样体的大小，并改善与腺样体肥大相关的临床症状，观察期间安全性良好。

关键词: 变应性鼻炎, 腺样体肥大, 脾氨肽口服溶液