2020年国产口服轮状病毒活疫苗质量一致性研究  

Quality Consistency of Domestic Oral Rotavirus Vaccine in 2020

作　　者：刘艳[1] 石岩 高加梅 于晴川[1] 张永 王成宝 胡忠玉[1] 梁争论[1] Liu Yan;Shi Yan;Gao Jiamei;Yu Qingchuan;Zhang Yong;Wang Chengbao;Hu Zhongyu;Liang Zhenglun(National Institutes for Food and Drug Control,Beijing 102629,China;Lanzhou Institute of Biological Products Co,LTD,Lanzhou 730046,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]兰州生物制品研究有限责任公司,兰州730046

出　　处：《中国药事》2021年第11期1220-1224,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:评价口服轮状病毒疫苗(Oral Rotavirus Vaccine,ORV)的质量一致性,提升该疫苗的安全性和有效性,保证婴幼儿用药安全。方法:对2020年国产ORV的关键控制指标(病毒滴度)的检验结果进行趋势分析,并与其前一年结果进行比较;将中国食品药品检定研究院(简称中检院)检测结果与企业结果进行比较。结果:2020年度该疫苗病毒滴度趋势分析结果显示未见超趋势(Out of Trend,OOT)。2020年度和2019年度比较结果显示企业年度间具有较好的一致性。中检院与企业病毒滴度检测结果比较差异均无统计学意义(P=0.3263,P>0.05);Bland-Altman法统计显示,97.7%批次的检测结果在不同浓度范围内的差值位于2倍标准差(2SD)以内。结论:2020年国产口服轮状病毒活疫苗质量稳定、可控,具有良好的一致性。今后应加强趋势分析中对OOT结果的调查、反馈,加强年度间比较分析,以及中检院与企业不同实验室间的比对研究。Objective: To evaluate the quality consistency of Oral Rotavirus Vaccine(ORV), improve the safety and efficacy of the vaccine, and ensure the safety of infants. Methods: The test results of the key parameter index(virus titer) of Domestic ORV in 2020 were evaluated by trend analysis and compared with the results of the previous year. The test results of National Institutes for Food and Drug Control(NIFDC) were compared with those of enterprises. Results: Trend analysis of virus titers in 2020 shows that no out of trend(OOT) results was observed. The comparision between 2019 and 2020 shows that there was a good consistency in manufacturing process. There was no statistically significant difference between the test results of virus titer detection in NIFDC and the enterprise(P=0.3263, P>0.05). According to Bland-Altman method, the difference between the test results of 97.7% batches in different concentration ranges was within 2 times of standard deviation(2 SD).Conclusion: The quality of domestic ORV vaccine in the market of China in 2020 was stable, controllable and has good consistency. In the future, the investigation and feedback of OOT results in trend analysis the comparative analysis between years and the comparative study between different laboratories in NIFDC and enterprises should be strengthened.

关 键 词：轮状病毒 疫苗 质量一致性 病毒滴度 趋势分析 

分 类 号：R917[医药卫生—药物分析学]