莫达非尼对阻塞性睡眠呼吸暂停综合征患者持续气道正压通气治疗后残余嗜睡的疗效及安全性分析  

Efficacy and safety of modafinil on residual sleepiness in patients with obstructive sleep apnea syndrome treated by continuous positive airway pressure

作　　者：朱先极[1] 曹娟[2] 张希龙[1] 

机构地区：[1]南京医科大学第一附属医院呼吸内科,江苏南京210029 [2]南京医科大学附属无锡市人民医院呼吸科,江苏无锡214043

出　　处：《南京医科大学学报（自然科学版）》2015年第11期1585-1589,共5页Journal of Nanjing Medical University(Natural Sciences)

基　　金：江苏省科技创新与成果转化专项基金(BL2012012)

摘　　要：目的 :评价莫达非尼治疗阻塞性睡眠呼吸暂停综合征(obstructive sleep apnea syndrome,OSAS)经有效持续气道正压通气(continuous positive airway pressure,CPAP)治疗后仍残余嗜睡的疗效及安全性。方法:随机选取自2014年7月—12月就诊于南京医科大学第一附属医院睡眠呼吸障碍中心,患有中重度OSAS且经有效CPAP治疗仍残余白天嗜睡的32例男性患者,Epworth嗜睡量表(Epworth sleepiness scale,ESS)评分>10分。研究包括3个阶段:T1阶段行基线检测并将受试者随机分配至莫达非尼组和安慰剂组;T2阶段口服莫达非尼或安慰剂,每日1次,剂量为100 mg,共7 d;T3阶段口服莫达非尼或安慰剂,每日1次,剂量为200 mg,共28 d,T3阶段的最后1 d行最终评价。T1、T3阶段的检测指标包括:血常规、血生化、尿常规、心电图检测,夜间多导睡眠监测、多发小睡实验,此外在T1、T2、T3阶段持续检测ESS。结果:药物治疗前后所有受试者呼吸暂停指数、CPAP每晚使用时间无明显变化。药物治疗后,与安慰剂组比较,莫达非尼治疗组平均入睡潜伏期延长、ESS评分下降,差异均有统计学意义(P均<0.05);此外,在莫达非尼治疗组中,T3(200 mg剂量)较T2(100 mg剂量),ESS下降更加显著(F=0.719,P=0.015);莫达非尼治疗组有62.5%患者出现口干、恶心、头痛等不良反应,所有不良反应均介于轻中度之间,差异无统计学意义(P=0.41)。结论:莫达非尼可以改善中重度OSAS患者经有效CPAP治疗仍残余的白天嗜睡,患者对该药具有良好的耐受性。Objective： To evaluate the efficacy and safty of modafinil for residual sleepiness（RS） in patients with obstructive sleep apnea syndrome（OSAS） treated by continuous positive airway pressure（CPAP）. Methods： Thirty-two male patients with mild-to-moderate OSAS under CPAP treatment were selected. All of them had Epworth seepiness scale（ESS）10. The study included three stages（T1,T2 and T3）. Following baseline evaluation（T1）,patients were randomly allocated to the modafinil or placebo group. The second stage（T2）： all subjects were instructed to take a piece of modafinil or placebo（100 mg） for 7 days. The third stage（T3）： patients were instructed to take two pieces of modafinil or placebo（200 mg） for 28 days. Patients underwent a final evaluation on the last day of the third stage. The evaluations at T1 and T3consisted of routine blood, blood biochemical tests, routine urine, electrocardiogram, nocturnal polysomnography（PSG） and multiple sleep latency test（MSLT）. In addition, ESS was constantly detected during T1, T2 and T3. Results：Before and after treatment, there were no significant changes both in Apnea Hyponea Index（AHI） and the per-night use time of CPAP between the modafinil and placebo groups. After treatment, comparing with the placebo group,the mean sleep leatency was lengthened and ESS score was decreased in the modafinil group,and both differences had statistical significance（P〈0.05）. Inaddition,in the modafinil group,changes of ESS was significantly greater in T3 with 200 mg than that in T2 with 100 mg（F=0.719,P=0.015）. Adverse drug reactions occurred in 62.5% patients in the modafinil group, such as dry mouth, nausea,headache and so on. there was no significant difference between the reactions（P=0.41）,and all of these adverse drug reactions were mild to moderate in severity.Conclusion： Modafinil was effective and well tolerated for improving RS in OSAS patients under CPAP treatment.

关 键 词：残余白天嗜睡 阻塞性睡眠呼吸暂停综合征 持续气道正压通气 莫达非尼 

分 类 号：R563.9[医药卫生—呼吸系统]