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| 2020年国产口服轮状病毒活疫苗质量一致性研究 |
| Quality consistency of Oral Rotavirus Vaccine of China in 2020 |
| 投稿时间：2021-07-30 修订日期：2021-10-22 |
| DOI： |
| 中文关键词: 轮状病毒 疫苗 质量一致性 批签发 |
| 英文关键词: Oral Rotavirus ,Vaccine, quality consisitency ,trend analysis |
| 基金项目: |
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| 中文摘要: |
| 目的 ：评价口服轮状病毒疫苗（Oral Rotavirus Vaccine，ORV）是应用于婴幼儿腹泻的预防性疫苗，的质量一致性对于，提升评价该疫苗的安全性和有效具有重要意义性，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；并将中国食品药品检定研究院（National Institutes for Food and Drug Control, NIFDC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。NIFD中检院C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减毒活疫苗质量稳定、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NIFDC中检院与企业不同实验室间的比对研究。 |
| 英文摘要: |
| Objective：To study the quality of Oral Rotavirus（ORV） Vaccinein the market of China for ensuring the safety and efficacy of the vaccine. Methods Methods：The key parameter (virus titer) of ORV produced by one Chinese manufacture in 2020 were evaluated by Trend analysis.The tendencies in 2020 were compared with those in 2019 and results of National Institutes for Food and Drug Control(NIFDC) were compared with that from the manufacture. Result Results：Trend analysis of virus titers in 2020 showed that no out of trend (OOT) results was abserved. Comparision between 2019 and 2020 showed a good consistency in manufacturing process. There were no significant differences between the results from NIFDC and those from each of the manufactory (P=0.3263).Bland-Altman difference difference analysis showed a high consisitence(97.7%) ,and only 1 values fell outside mean±2SD. Conclusions Conclusion：The quality of domestic ORV vaccine in the market of China was stable and controllable. |
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