孟鲁斯特钠抑制半胱氨酸白三烯表达治疗阻塞性睡眠呼吸暂停低通气综合征远期疗效分析:前瞻性单中心单臂临床研究

Long Term Efficacy of Montelukast Sodium in Inhibiting the Expression of CysLTs for OSAHS:A Prospective Single Center Single Arm Clinical Study

目的:探讨孟鲁斯特钠治疗治疗阻塞性睡眠呼吸暂停低通气综合征(OSAHS)的远期临床疗效安全性及其对患儿血清半胱氨酸白三烯(CysLTs)表达的影响。方法:入选2018年3月年至2020年6月天津市武清区第二人民医院经多导睡眠仪确诊为OSAHS患儿62例为研究对象。患儿入组后给予孟鲁司特钠5 mg口服,连续应用12周后进行为期1年的随访。分析比较治疗前后患儿的临床症状评分及血清CysLTs表达水平有无差别。结果:治疗12周后患儿响鼾、不安宁睡眠或频繁醒觉、鼻阻塞而张口呼吸等症状评分显著低于治疗前且差异有统计学意义(P<0.05);治疗前血清CysLTs为(698.23±78.66)ng/L,治疗12周后为(456.88±60.12)ng/L,治疗后显著降低(P<0.05);1年随访,症状复发者(症状评分>治疗12周时1.5倍)18例,无复发者44例。复发组治疗12周时CysLTs水平显著高于对照组[(478.3±54.2)vs(431.2±65.9),P<0.05];以治疗12周时CysLTs水平为参考预测患儿复发的敏感性为72.73%(95%CI:57.21%~85.04%),特异性为66.67%(95%CI:40.99%~86.66%),ROC曲线下面积为0.75(95%CI:0.6258~0.8705);根据治疗12周后CysLTs水平中位数(445.10 ng/L)分为CysLTs高表达(n=30)和低表达(n=32)组,高表达组治疗后12个月复发12例,低表达组复发6例,高表达组复发风险(HR=0.38,95%CI:0.15~0.97)显著高于低表达组(P<0.05)。结论:孟鲁斯特钠可显著缓解OSAHS患儿临床症状,降低复发风险,其作用机制可能与降低血清CysLTs水平有关。

Objective:To analysis efficacy of montelukast for OSAHS and affection to serum cyslts.Methods:From March 2018 to June 2020,recruited 62 cases of OSAHS in the Tianjin Wuqing Second People's Hospital.All the subjects were given montelukast 5 mg,took orally for 12 weeks.After treatment,the symptom score and serum level of cyslts were compared to before treatment.Results:12 weeks of treatment,score of loud snoring,restless sleep or frequent awaking and nasal obstruction and mouth breathing were significant decreased compared to before treatment(P<0.05);The serum cyslts were(698.23±78.66)ng/L and(456.88±60.12)ng/L before and after treatment(P<0.05).12 weeks follow-up,18 patients with symptom recurrence(symptom score>1.5 times at 12 weeks of treatment)and 44 patients without recurrence.The level of CysLTs in the recurrence group was significantly higher than that in the control group at 12 weeks[(478.3±54.2)vs(431.2±65.9),P<0.05];Taking the level of CysLTs at 12 weeks of treatment as a reference,the sensitivity of predicting recurrence was 72.73%(95%CI:57.21%to 85.04%),the specificity was 66.67%(95%CI:40.99%to 86.66%),and AUC was 0.75(95%CI:0.6258 to 0.8705);According to the median score of CysLTs level(445.10 ng/L)after 12 weeks of treatment,12 cases recurred in the high expression group and 6 cases recurred in the low expression group.The recurrence risk in the high expression group(HR=0.38,95%CI:0.15~0.97)was higher than low expression group(P<0.05).Conclusion:Montelukast can significant reduce the symptom of OSAHS by reducing the serum level of CysLTs and decrease the risk of recurrence.