文章摘要
朱媛媛,李靖欣,朱凤才,梁 祁,戴启刚.无线体温监测系统在新型重组5型腺病毒载体埃博拉疫苗Ⅰ期临床试验中的应用[J].南京医科大学学报,2018,(5):643~647
无线体温监测系统在新型重组5型腺病毒载体埃博拉疫苗Ⅰ期临床试验中的应用
Application of continuous wireless remote temperature monitoring system in the phase Ⅰ trial of a novel recombinant adenovirus type⁃5 vector⁃based Ebola vaccine
投稿时间:2017-12-03  
DOI:10.7655/NYDXBNS20180514
中文关键词: 无线体温监测  埃博拉疫苗  发热
英文关键词: wireless remote body temperature continuous monitoring system  Ebola vaccine  fever
基金项目:中央高校基本科研业务费专项资金资助;江苏省普通高校研究生科研创新计划资助(SJZZ16_0041)
作者单位
朱媛媛 东南大学公共卫生学院江苏 南京 210009 
李靖欣 江苏省疾病预防控制中心疫苗临床评价所江苏 南京 210009 
朱凤才 东南大学公共卫生学院江苏 南京 210009 
梁 祁 江苏省疾病预防控制中心疫苗临床评价所江苏 南京 210009 
戴启刚 江苏省疾病预防控制中心疫苗临床评价所江苏 南京 210009 
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中文摘要:
      目的:介绍无线体温监测系统在新型重组5型腺病毒载体埃博拉疫苗(简称埃博拉疫苗)Ⅰ期临床试验中的应用,比较其与水银温度计测量体温的灵敏度,并探讨疫苗免疫后发热的影响因素。方法:本项随机、双盲、安慰剂对照Ⅰ期临床试验,以江苏省泰州市120例符合纳入标准的18~60岁健康受试者为研究对象。运用无线体温监测系统对埃博拉疫苗接种后6 h内受试者的体温进行监测,同时用传统水银温度计每天测量体温1次。结果:无线体温监测系统测量并记录接种后6 h内总发热发生率及1级发热发生率均大于水银温度计,且差异有统计学意义(P < 0.05)。影响因素的研究结果显示体重指数(body mass index,BMI)高是发热发生的保护因素(OR=0.752,P=0.001),免前5型腺病毒预存抗体高是发热发生的危险因素(OR=2.472,P=0.043)。结论:本研究首次将无线体温监测系统应用于埃博拉疫苗Ⅰ期临床试验。无线体温监测系统能连续监测体温,及时发现受试者体温异常改变情况。对于发热影响因素的探究有利于研究者正确解释发热的发生。
英文摘要:
      Objective:To introduce the application of the wireless remote temperature monitoring system in phase Ⅰ clinical trial of the new recombinant adenovirus vector Ebola vaccine,compare its sensitivity with the traditional mercury thermometer measurement,and discuss the vaccine immunization fever factors. Methods:This randomized,double?blind,placebo?controlled phase Ⅰ trial of 120 healthy subjects aged 18 to 60 years who met the inclusion criteria of Taizhou,Jiangsu Province,was conducted. Body temperature was monitored within 6 hours after the Ebola vaccination using a wireless remote temperature monitoring system while body temperature was measured daily using a conventional mercury thermometer. Results:The wireless remote temperature monitoring system continuously measured and recorded the incidence of total fever and the incidence of primary fever within 6 hours after inoculation than mercury thermometer,and the difference was statistically significant(P < 0.05). The study of influencing factors showed that high body mass index(BMI)was the protective factor of fever(OR=0.752,P=0.001). The high pre?existing antibody of pre?adenovirus type 5 was the risk factor of fever(OR=2.472,P=0.043). Conclusion:This study,for the first time,applied the wireless remote temperature monitoring system to the phase Ⅰ clinical trial of the novel recombinant adenovirus type?5 vector?based Ebola vaccine,which reduced the time interval of body temperature monitoring and found the abnormal changes of body temperature in time. To explore the factors that affect fever is conducive to the researchers to correctly explain the occurrence of fever.
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