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国家免疫规划疫苗说明书禁忌证分析及对策探讨
Analysis and Countermeasure Discussion of the National Immunization Program Vaccines Instructions
  
DOI:
中文关键词:  疫苗  禁忌证  聚类分析
英文关键词:Vaccines  Contraindications  Cluster analysis
基金项目:
作者单位
胡伟洁 福建省药品检验所(福州 350001) 
陈俊磊 福建省疾病预防控制中心 
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中文摘要:
      摘 要 目的:分析扩大国家免疫规划疫苗使用说明书禁忌证的描述状况,探索改进措施。方法:收集国家免疫规划常规免疫使用、且核准日期或修订日期在《中国药典》2010年版三部颁发后的10种第一类疫苗37份疫苗使用说明书。结果:37份疫苗使用说明书,来自17家疫苗生产企业;其中,17份为减毒活疫苗、5份为灭活疫苗、3份为基因工程疫苗、12份为类毒素及细胞成份类疫苗。所有说明书均将“发热”、“急性疾病、严重慢性疾病、慢性疾病急性发作期”、“未控制的癫痫、脑部疾患及其他进行性神经系统疾病”和“已知对该疫苗的任何成分过敏者(包括辅料)”列为禁忌证;聚类分析显示不同种类疫苗禁忌证界定不清。结论:建议疫苗生产企业在拟定疫苗禁忌证时应详细、明确注解相关内容,不同种类疫苗禁忌证应有各自特征,杜绝描述含糊的疫苗禁忌证。
英文摘要:
      ABSTRACT Objective:To analysis the instructions of national immunization program vaccines and to research the possible improvements. Methods:10 vaccines which used for the national routine immunization including 37 instructions were collected, and then analyzed using with cluster analysis. All these instructions approval or amendment date are in the Pharmacopoeia of People's Republic of China in 2010 edition (3rd). Results:The 37 instructions of national immunization program vaccines came from 17 vaccine manufactures. There were 17 instructions of attenuated live vaccine, 5 instructions of inactivated vaccine, 3 instructions of gene vaccine and 12 instructions of toxoid vaccine. Fever, acute/severe chronic disease and acute exacerbation of chronic disease, untreated epilepsy and brain disease and anaphylactic reaction to previous dose of vaccine were considered to be a contraindication in all of the vaccine instructions. Cluster analysis showed that different types of vaccine contraindication were classified not clear. Conclusion:Recommended that vaccine manufactures draft vaccine contraindications should be detailed, clear notes related the content, different types of vaccine contraindications should have its own characteristics, and vague description of vaccine contraindications should be eliminated.
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