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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。
OBJECTIVE: To analyze and describe the status quo of contraindications for expanding the use of vaccines for national immunization programs and to explore improvements. Methods: The routine immunizations of national immunization program were collected, and 37 kinds of vaccine instructions of 10 kinds of first class vaccines after the date of approval or revision of Chinese Pharmacopoeia (2010 edition) were issued. RESULTS: There were 37 instructions for use of the vaccine from 17 vaccine manufacturers; 17 of them were attenuated live vaccines, 5 were inactivated vaccines, 3 were genetically engineered vaccines and 12 were toxoid-like and cell-component vaccines. All instructions will have “fever”, “acute illness, severe chronic disease, acute exacerbation of chronic disease”, “uncontrolled epilepsy, brain disorders and other progressive neurological diseases” and “have been Known to be allergic to any component of the vaccine (including excipients) ”as a contraindication; cluster analysis showed that different types of vaccine contraindications unclear. Conclusion: It is suggested that vaccine manufacturers should elaborate the relevant contents in the formulation of vaccine contraindications, and different types of vaccine contraindications should have their own characteristics to prevent vague vaccine contraindications.