经鼻导管高流量吸氧与经鼻气道正压通气在重症毛细支气管炎呼吸支持中的应用价值比较

目的：比较经鼻导管高流量吸氧（HFNC）与经鼻气道正压通气（nCPAP）在重症毛细支气管炎呼吸支持中的应用价值，为临床治疗方案的选择提供参考。方法：选取2016年12月至2018年12月我院儿科收治的重症毛细支气管炎患儿90例，采用随机数字表法分为观察组和对照组各45例。两组患儿入院后均给予常规综合治疗以保证呼吸道通畅，在此基础上观察组采用HFNC治疗，对照组采用nCPAP治疗，比较两组患儿治疗前和治疗24 h后呼吸频率、经皮血氧饱和度（TcSO2）、呼吸窘迫评分体系（CSS）评分、动脉血氧分压（PaO2）等呼吸相关指标及治疗前后临床症状体征改善情况。结果：两组患儿治疗24 h后呼吸频率、CSS评分均降低，且观察组降低程度更大，TcSO2、PaO2于治疗24 h后升高，观察组升高幅度较对照组明显；治疗后两组患儿咳嗽及肺部湿啰音、肺部炎症情况均改善，观察组症状体征消失时间早于对照组，差异均有统计学意义（P<0.05）。结论：重症毛细支气管炎患儿采用HFNC治疗可明显改善通气功能和临床症状，治疗效果优于nCPAP治疗，可扩大样本量进一步观察。     

Could non-HDL-cholesterol be a better marker of atherogenic dyslipidemia in obstructive sleep apnea?

Background/objectiveObstructive sleep apnea (OSA) is independently associated with dyslipidemia, a surrogate marker of atherosclerosis. Low-density lipoprotein (LDL)-cholesterol is accepted as a major independent risk factor for cardiovascular disease. However, non-high-density lipoprotein (HDL)-cholesterol is a better marker of atherogenic dyslipidemia and recommended as a target of lipid lowering therapy. We aimed to assess the prevalence of atherogenic dyslipidemia, and relationship between OSA severity and serum LDL-cholesterol and non-HDL cholesterol levels in OSA patients.MethodsWe retrospectively evaluated treatment naïve 2361 subjects admitted to the sleep laboratory of a university hospital for polysomnography. All subjects’ lipid profile including total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, and non-HDL-cholesterol were measured.ResultsOut of 2361 patients (mean age 49.6 ± 11.9 years; 68.9% male, apnea-hypopnea index 36.6 ± 28.4/h), 185 (7.8%) had no OSA and 2176 (92.2%) had OSA. Atherogenic dyslipidemia prevalence was high (57–66%) in OSA patients, and especially increased in severe OSA compared to other groups (p < 0.05). Though total and LDL-cholesterol did not differ between those with and without OSA, non-HDL-cholesterol (p = 0.020), and triglycerides (p = 0.001) were higher and HDL-cholesterol levels (p = 0.018) were lower in OSA patients than non-OSA. Non-HDL-cholesterol was significantly correlated with OSA severity (p < 0.001) and hypoxia parameters (p < 0.01), whereas LDL-cholesterol showed no correlation.ConclusionsAtherogenic dyslipidemia is highly prevalent and non-HDL-cholesterol levels are significantly increased, predominantly in severe OSA patients. Non-HDL-cholesterol but not LDL-cholesterol, is significantly correlated with OSA severity and hypoxia parameters. Therefore, it could be better to use non-HDL-cholesterol, which is a guideline recommended target of lipid therapy, as a marker of atherosclerotic cardiovascular risk in OSA patients.     

医疗器械口咽通气道产品注册的常见问题及改进建议

近年来,医疗器械口咽通气道产品的注册数量日益增加,针对该产品的相关咨询也逐渐增多。但该产品暂无相关的注册技术审查指导原则,以致该产品的注册申报资料经常出现一些共性问题。现根据医疗器械口咽通气道产品相关法规和标准,对日常工作中遇到的常见问题进行归纳,分析该产品注册申报中的技术审评要求及共性问题,并给出对策或建议。