中国疫苗和免疫

目的 了解中国各级疾病预防控制中心(Center for disease control and prevention,CDC)疫苗冷链自动温度监测信息系统建设现状。方法 采用横断面调查方法收集截至2024年9月中国各省、市和县级CDC自动温度监测系统的部署、承建运维、硬件配置和参数设置、常用功能等信息，并进行描述性分析。结果 在所有调查CDC中，疫苗冷链自动温度监测系统总覆盖率为84.45%(2 710/3 209)，其中东部、中部、西部、东北地区分别为93.62%、73.96%、82.04%、95.00%。2 499家CDC自行部署了自动温度监测系统，其中冷库、冰箱、冷藏车覆盖率分别为98.40%、80.91%、89.84%;按照《药品经营质量管理规范》装备冷库温度探头、温度探头测量精确度设置为±0.5℃以内分别占62.99%、93.44%;温度正常时温度记录频次设置为≤30 min/次占99.64%;使用无线网络传输监测数据占78.95%;温度远程自动实时监测同时采用曲线和表格显示占90.92%;具有冷藏车位置、轨迹远程自动监测功能分别占67.51%、61.62%;具有温度异常报警功能占99.72%。结论 疫苗冷链自动温度监测系统已在中国各级CDC广泛部署和应用，系统硬件配置和参数设置存在多样性，系统常用功能配置存在一定地区差异。仍需进一步提高自动温度监测系统覆盖率并完善系统常用功能。

Objective To describe the status of vaccine cold chain automatic temperature monitoring systems in centers for disease control and prevention( CDC) of China. Methods We conducted a crosssectional survey to obtain data on deployment, construction/maintenance, hardware configuration,parameter settings,and common functions of automatic temperature monitoring systems in provincial,prefectural,and county-level CDCs of China as of September 2024 for a descriptive analysis.Results Overall,84. 45%( 2 710/3 209) of CDCs at all levels had vaccine cold chain automatic temperature monitoring systems: 93.62%,73.96%,82.04%,and 95.00% in eastern,central,western,and northeastern regions, respectively. A total of 2 499 CDCs independently deployed automatic temperature monitoring systems,in which 98. 40%,80. 91%,and 89. 84% monitored cold rooms,refrigerators,and refrigerated vehicles,and 62. 99% were equipped with temperature probes for cold rooms that were in compliance with Good Supply Practices for Pharmaceutical Products; 93. 44% of temperature probes were calibrated to a measurement accuracy within ±0.5 ℃; 99.64% had temperature recording intervals set to ≤ 30 minutes in situations of normal temperatures; 78. 95% used wireless networks for monitoring data transmission; 90.92% displayed remote real-time temperatures in graphs and tables; 67. 51% and 61. 62% had remote automatic monitoring of locations and paths of refrigerated vehicles; and 99. 72% had alarms for abnormal temperatures. Conclusions Automatic temperature monitoring systems for vaccine cold chains have been widely deployed and used at all levels of CDCs in China,with diverse hardware configurations and parameter settings and some regional differences in their common functions. It is necessary to increase coverage of automatic temperature monitoring systems and optimize common functions.