浙江省部分地区水痘减毒活疫苗全程冷链温度监测情况

Investigation on the cold-chain temperature of vaccine in some areas of Zhejiang Province

目的对浙江省部分地区水痘减毒活疫苗全程冷链温度监测情况进行调查。方法于2016年10—12月，采用方便抽样方法选取浙江省温州市苍南县、金华市永康市和杭州市江干区的各1家预防接种门诊为调查现场。分别采用温度记录仪和疫苗温度标签（VVM），全程监测水痘减毒活疫苗依次通过省、市和县级疾病预防控制中心，最终到达接种门诊各环节出／入库、存储运输过程中的冷链温度变化和标签变化情况。对杭州市江干区水痘减毒活疫苗在省、市和县级疾病预防控制中心每次出库时及接种门诊存储期间，每周使用光密度仪检测20个VVM的颜色变化。结果3家接种门诊共记录有效温度数据54958个，其中275个（0．5％）为超温数据，〉8℃的超温记录为270个（98．2％），〈2cC的超温记录为5个（1．9％）；超温记录主要发生在运输途中，占38．2％（105个）；其次为各级疾病预防控制中心冷库储存过程，占26．2％（72个）；各级疾病预防控制中心出入库过程，占20．7％（50个）；接种门诊冰箱储存过程，占14．9％（41个）。疫苗从浙江省疾病预防控制中心出库到接种门诊使用完毕，VVM芯片与参比区的光密度平均差值从0．404下降到0．344。到疫苗使用完毕前，肉眼观察所有VVM均无明显颜色变化。结论浙江省3家接种门诊疫苗冷链潜在风险是超温，薄弱环节包括冷链运输途中、储运过程及出入库。

Objective To investigation the situation of cold chain on vaccine in parts of Zhejiang Province and to provide recommendations for the management. Methods From October to December, 2016, we each selected an immunization clinic in Cangnan County of Wenzhou, Yongkang City of Jinhua, Jianggan District of Hangzhou. Temperature recorder and vaccine viral monitor （VVM） labels were used to monitor the cold chain during all the storage and transportation process. In Jianggan District, we use optical density sensor to detected 20 VVM labels every time when the vaccine was stock in and out. Results In total, 54 958 records were collected by temperature recording devices in all the three immunization clinic. 275 records exceeded the temperature limit required for store and transportation, of which 270 （98.2%） were above 8℃ and 5 （1.9%） were under 2℃. Excessive temperature exposure mainly occurred during the transportation （38.2%, n=105）, fallowed by storage process in CDCs at different levels （26.2%, n=72）, stock in and out （20.7%, n=50） and storage in the refrigerators in immunization clinics （14.9%, n=41）. The average optical density difference between VVM labels and the reference circular decreased from 0.404 to 0.344 when the vaccines were delivered from the Zhcjiang provincial CDC to immunization clinics. The color of VVMs did not significantly changed before use. Conclusions The potential risk of vaccine cold chain in the monitoring sites is over-temperature. The weak links of cold chain management include the transportation, storage process, and stock in and out.