关键词: 变应性鼻炎, 腺样体肥大, 脾氨肽口服溶液

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