河西学院学报

目的：探讨安特诺新片联合盐酸左西替利嗪片用于儿童IgA血管炎治疗的疗效观察.方法：本研究为随机对照试验(RCT)，筛选2020年1月至2023年12月就诊于甘肃中医药大学附属医院的104例儿童IgA血管炎患儿，采用随机数字表法按1∶1比例分为观察组和对照组(每组52例).对照组口服小儿罗红霉素片(合并感染时使用)、泼尼松片及盐酸左西替利嗪片治疗，观察组在对照组基础上加服安特诺新(剂量按1mg/kg调整)，比较两组临床疗效、症状缓解时间、炎症指标(WBC、ESR、CRP)、淋巴细胞亚群(CD₃~+、CD₄~+、CD₈~+)及不良反应.结果：观察组总有效率显著高于对照组(98.08%vs 84.62%,P<0.05).观察组紫癜、腹痛、关节肿痛消失时间分别为3.42±0.15d、3.42±0.18d、4.52±0.26d，均短于对照组(P<0.05).治疗后观察组WBC(8.41±0.78×10⁹/L)、ESR(17.42±1.18mm/h)、CRP(1.42±1.13mg/L)及CD₈~+(30.42±2.36%)显著低于对照组(P<0.05),CD₃~+(65.41±4.73%)、CD₄~+(44.42±3.28%)显著高于对照组(P<0.05).两组不良反应无显著差异(11.54%vs 13.46%,P=0.437).结论：安特诺新联合盐酸左西替利嗪可快速缓解儿童IgA血管炎临床症状，通过调节Th1/Th2免疫平衡减轻炎症反应，且安全性良好，为临床治疗提供了新策略.

Objective:To evaluate the clinical efficacy of Antenoxin tablets combined with levocetirizine hydrochloride in the treatment of children with immunoglobulin A(IgA)vasculitis. Methods:This randomized controlled trial(RCT)included 104 children diagnosed with IgA vasculitis who were treated at the Affiliated Hospital of Gansu University of Chinese Medicine between January 2020 and December 2023. Patients were randomly assigned 1:1 to an observation group or a control group,with 52 cases in each. The control group received oral pediatric roxithromycin(for cases with concurrent infection),prednisone,and levocetirizine hydrochloride. The observation group received additional Antenoxin tablets(dose adjusted to 1 mg/kg)on top of the same regimen.Clinical efficacy,symptom relief time,inflammatory markers(WBC,ESR,CRP),lymphocyte subsets(CD₃~+,CD₁~+,CD₈~+),and adverse reactions were compared between the two groups. Results:The overall effective rate in the observation group was significantly higher than that in the control group(98.08% vs 84.62%,P < 0.05). The durations for purpura resolution,abdominal pain relief,and joint swelling relief in the observation group(3.42 ± 0.15 days,3.42 ± 0.18 days,4.52 ± 0.26 days,respectively)were all shorter than those in the control group(P < 0.05). After treatment,WBC(8.41 ± 0.78 × 10⁹/L),ESR(17.42 ± 1.18 mm/h),CRP(1.42 ±1.13 mg/L),and CD₈~+(30.42 ± 2.36%)levels in the observation group were significantly lower than those in the control group(P <0.05),whereas CD₃~+(65.41 ± 4.73%)and CD₄~+(44.42 ± 3.28%)levels were significantly higher(P < 0.05). The incidence of adverse reactions did not differ significantly between groups(11.54% vs 13.46%,P = 0.437). Conclusion:Antenoxin combined with levocetirizine hydrochloride can rapidly alleviate clinical symptoms in children with IgA vasculitis,likely by modulating Th1/Th2 immune balance and reducing inflammatory responses. The regimen demonstrates good safety and provides a promising new therapeutic strategy for clinical management.