孟鲁司特钠联合糠酸莫米松治疗儿童腺样体肥大的随机对照研究

A randomized controlled study on montelukast sodium combined with mometasone furoate for treatment of children with pediatric adenoid hypertrophy

  • 摘要:
    目的 探讨孟鲁司特钠联合糠酸莫米松鼻喷雾剂对儿童腺样体肥大的免疫调控及症状改善的效果。
    方法 选取2022年6月—2024年3月河北省儿童医院/河北省儿童健康与疾病临床医学研究中心耳鼻喉科诊治的107例腺样体肥大患儿为研究对象,根据计算机生成的随机数字序列,采用区组随机化、不透光的密封信封法分为联合组53例和单药组54例。单药组予以糠酸莫米松鼻喷雾剂治疗,联合组予以孟鲁司特钠联合糠酸莫米松鼻喷雾剂治疗,治疗8周,门诊随访12个月。比较2组临床疗效、鼻部症状评分、腺样体厚度与鼻咽宽度比值(A/N)、免疫指标、炎症反应、不良反应以及随访期间复发率。
    结果 治疗8周后,联合组总有效率为98.11%, 高于单药组的85.19%, 差异有统计学意义(P < 0.05)。治疗8周后, 2组鼻部相关症状评分与A/N均降低,且联合组鼻部相关症状评分、A/N均低于单药组,差异有统计学意义(P < 0.05)。治疗8周后, 2组转化生长因子β1(TGF-β1)、辅助性T细胞17与调节性T细胞比值(Th17/Treg)均降低,且联合组TGF-β1、Th17/Treg均低于单药组,差异有统计学意义(P < 0.05)。治疗8周后, 2组白细胞介素(IL)-4、IL-5、IL-7、白三烯B4(LTB4)均降低,且联合组IL-4、IL-5、IL-7、LTB4均低于单药组,差异有统计学意义(P < 0.05)。联合组与单药组不良反应发生率分别为9.43%(5/53)、5.56%(3/54), 随访期复发率分别为3.77%(2/53)、7.41%(4/54), 差异均无统计学意义(P>0.05)。
    结论 孟鲁司特钠与糠酸莫米松鼻喷雾剂联合用药方案可有效改善腺样体肥大患儿鼻痒、鼻塞等鼻部症状,缩小腺样体体积,调节免疫平衡,减轻炎症反应。

     

    Abstract:
    Objective To investigate the effects of montelukast sodium combined with mometasone furoate nasal spray on immune regulation and symptom improvement of children with adenoid hypertrophy.
    Methods A total of 107 children with adenoid hypertrophy treated in the Department of Otolaryngology, Hebei Children's Hospital/Hebei Provincial Clinical Research Center for Child Health and Disease from June 2022 to March 2024 were selected as the study subjects. According to a computer-generated random number sequence, block randomization and an opaque sealed envelope method were used to divide them into combination group (n=53) and monotherapy group (n=54). The monotherapy group was treated with mometasone furoate nasal spray, while the combination group was treated with montelukast sodium combined with mometasone furoate nasal spray. The treatment was lasted for 8 weeks, and outpatient follow-up was conducted for 12 months. The clinical efficacy, scores of nasal symptoms, adenoid thickness to nasopharyngeal width ratio (A/N), immune indicators, inflammatory response, adverse reactions, and recurrence rate during the follow-up period were compared between the two groups.
    Results After 8 weeks of treatment, the total effective rate in the combination group was 98.11%, which was significantly higher than 85.19% in the monotherapy group (P < 0.05). After 8 weeks of treatment, the scores of nasal-related symptoms and A/N in both groups decreased significantly, and the scores of nasal-related symptoms and A/N in the combination group were significantly lower than those in the monotherapy group (P < 0.05). After 8 weeks of treatment, the level of transforming growth factor-β1 (TGF-β1) and the ratio of helper T cell 17 to regulatory T cell (Th17/Treg) decreased significantly in both groups, and the level of TGF-β1 and Th17/Treg in the combination group were significantly lower than those in the monotherapy group (P < 0.05). After 8 weeks of treatment, the levels of interleukin (IL)-4, IL-5, IL-7, and leukotriene B4 (LTB4) decreased significantly in both groups, and the levels of IL-4, IL-5, IL-7, and LTB4 in the combination group were significantly lower than those in the monotherapy group (P < 0.05). The incidence rate of adverse reactions in the combination group and the monotherapy group was 9.43% (5/53) and 5.56% (3/54) respectively, and the recurrence rates during the follow-up period were 3.77% (2/53) and 7.41% (4/54) respectively, and there were no significant differences between groups (P>0.05).
    Conclusion The combination therapy of montelukast sodium and mometasone furoate nasal spray can effectively improve nasal symptoms such as nasal itching and nasal congestion, reduce adenoid volume, regulate immune balance, and alleviate inflammatory response in children with adenoid hypertrophy.

     

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