我国不同品种在用电子血压计临床准确性验证情况调查

Investigation of Clinical Accuracy Verification of Different Varieties of In-Use Electronic Sphygmomanometers in China

目的 了解我国不同品种在用电子血压计经独立临床准确性验证的情况。方法 根据地理位置和经济水平选择北京市、深圳市、石家庄市、大同市及石河子市作为调查地区,从5个城市中分别选择1家三甲医院、2家社区卫生服务中心及20户拥有电子血压计的家庭,每家医院选择10台、每家社区卫生服务中心选择5台、每户家庭选择1台,共200台电子血压计,登记每台血压计的品牌、型号、生产企业等信息。通过查询Medaval、Stride BP等6个电子血压计独立临床准确性验证登记网站以及Pub Med、CNKI论文数据库,明确受调研电子血压计是否经过独立临床准确性验证。结果 受调研的200台在用电子血压计中,除1台在国外购买外,其余199台均在国内购买,分属109个品种。其中,经独立临床准确性验证合格的有23个品种,占所有品种的21.1%;三甲医院为37.5%,社区卫生服务中心为34.8%,家庭中为13.2%,且差异有统计学意义(P=0.011)。经独立临床准确性验证不合格的电子血压计品种占1.8%,其余77.1%未开展独立临床准确性验证评价。结论 我国医疗行业及家庭中在用电子血压计品种众多,但经独立临床准确性验证的比例较低,且存在经独立临床准确性验证不合格的品种。

Objective To understand the percentage of in-use electronic sphygmomanometers varieties that have passed independent clinical validation in China.Methods Beijing,Shenzhen,Shijiazhuang,Datong,and Shihezi were selected according to the geographical location and economic level as the study sites for the survey.In each site,aⅢgrade A hospital,two community health centers,and 20 families with electronic sphygmomanometers in use were chosen.The information of electronic sphygmomanometers including brand,model and manufacturer were obtained by the trained staff for 10 electronic sphygmomanometers from each hospital,5 electronic sphygmomanometers from each community health center,and 1 electronic sphygmomanometer from each family.By searching Medaval,Stride BP and other six registration websites and two research databases(PubMed and CNKI)were used to confirm whether the surveyed electronic sphygmomanometers have passed independent clinical validation.Results Among the 200 surveyed in-use electronic sphygmomanometers,one was purchased abroad,the remaining 199 were purchased in China which were classified into 109 varieties.Among the 109 varieties,only 23 varieties had passed independent clinical validation,accounting for 21.1%of all varieties.It was 37.5%inⅢgrade A hospital,34.8%in community health centers and 13.2%in families,and the difference was statistically significant(P=0.011).The number of electronic sphygmomanometers that were not qualified by independent clinical validation accounted for 1.8%,and the remaining 77.1%did not carry out independent clinical validation.Conclusion There are various varieties of electronic in-use sphygmomanometers in medical industry and families of China,however,the percentage of electronic sphygmomanometer varieties that have passed independent clinical validation is low,and there are electronic sphygmomanometer varieties that have failed to pass independent clinical validation.