国产Ⅲ型睡眠呼吸监测设备在非复杂成人受试者中诊断阻塞性睡眠呼吸暂停的准确性研究

Accuracy of type Ⅲ domestic portable monitor device in diagnosing OSA in uncomplicated adults

目的 在非复杂成人受试者中,评价国产Ⅲ型便携式睡眠呼吸监测仪诊断阻塞性睡眠呼吸暂停(OSA)的准确性。方法 研究共纳入121例疑患OSA、且无严重基础疾病的非复杂成年人,研究对象在睡眠实验室同步完成Ⅰ型(Philips Respironics,Alice 5/6)及Ⅲ型(怡和嘉业,PolyWatch YH-600B)睡眠呼吸监测。利用Pearson相关性分析、Bland-Altman一致性分析、Kendall相关系数、Kappa值等统计方法,评价两者监测结果的一致性。结果基于Ⅲ型监测仪判读的呼吸暂停低通气指数(AHI)与Ⅰ型监测结果相关性佳(r=0.904,P<0.001),但显著低于Ⅰ型监测结果(28.1次/h vs 37.2次/h,P<0.01),做Bland-Altman 图分析,AHI之间差值为(4.50±11.85)次/h,一致性界限为-18.73~27.72。区分OSA严重程度时(无、轻度、中度、重度),Kendall相关系数为0.925,一致性检验Kappa值为0.831,均提示诊断结果具有较好一致性。诊断中-重度OSA时,Ⅲ型监测仪的敏感度93.9%,特异度93.2%,阳性似然比13.81,受试者工作特征曲线下面积为0.925。结论 在非复杂成人受试者中,国产Ⅲ型便携式睡眠呼吸监测仪PolyWatch诊断OSA、尤其是中重度OSA时具有较好准确性,具有一定的临床应用价值。但同其他Ⅲ型设备一样,其倾向于低估OSA病情。

OBJECTIVE To evaluate the accuracy of domestic type Ⅲ portable monitor device(PMD) in diagnosing OSA in uncomplicated adults.METHODSA total of 121 uncomplicated adults suspected of OSA without serious underlying disease were included in the study.They underwent an in‐laboratory polysomnogram (PSG) test and domestic type Ⅲ PMD test simultaneously.Pearson correlation analysis,Bland-Altman analysis,Kendall correlation coefficient,Kappa value and other statistical methods were used to evaluate the consistency of the two monitoring results.RESULTS The correlation between PSG apnea hypopnea index(AHI) and PMD AHI was strong(r=0.904,P<0.001),though PMD AHI(28.1 times/h) significantly lower than PSG AHI(37.2 times/h,P<0.01).Bland-Altman analysis showed a mean difference of 4.50 events/h;limits of agreement was-18.73 to 27.72 events/h.When grading the severity of OSA (none,mild,moderate,severe),Kendall correlation coefficient is 0.925,and Kappa=0.831,suggesting that the diagnostic results had good consistency.When diagnosing moderate and severe OSA,PMD AHI had 93.9% sensitivity and 93.2% specificity,and positive likelihood ratio was 13.81,area under ROC curve was 0.925.CONCLUSION Domestic type Ⅲ PMD has good accuracy in diagnosing OSA,especially moderate and severe OSA in uncomplicated adults,and has certain clinical application value.But like other type Ⅲ devices,OSA tends to be underestimated.