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23价肺炎球菌多糖疫苗临床试验

Clinical Effect of 23-valent Pneumococcal Polysaccharide Vaccine

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【作者】 杨耀栗克喜宋绍忠张云江山谢全海兰芳黄剑黎云东李凤祥袁曾麟郭淑英石继春何莉

【Author】 YANG Yao, Li Ke-xi, SONG Shao-zhong, et al.Chengdu Institute of Biological Products, Chengdu 610023, China.

【机构】 成都生物制品研究所中国药品生物制品检定所中国药品生物制品检定所 四川成都610023四川成都610023

【摘要】 目的评价23价肺炎球菌多糖疫苗的安全性和免疫原性。方法23价肺炎球菌多糖疫苗免疫不同年龄组人群,观察局部及全身反应,并检测血清抗体滴度。结果试验组接种后出现的注射部位总疼痛率为30.8%。2人注射部位出现弱、中反应的红肿,反应率为0.23%。全身反应主要为弱反应,反应率为0.6%。试验组免后抗体平均滴度4.03,阳性对照组为4.15;抗体阳转率试验组为86.4%,阳性对照组为72.5%。试验组与阳性对照组全身发热和局部疼痛反应差异无统计学意义。试验组与阳性对照组的免疫原性相近。结论23价肺炎球菌多糖疫苗是安全有效的。

【Abstract】 Objective To evaluate the safety and immunogenicity of 23-valent pneumococcal polysaccharide vaccine.Methods Persons of different ages were immunized by the vaccine, local and systemic reaction were observed, and the antibody titre determined.Results After injection, there were 30.8% of the persons felt the pain at the injection site.Two persons(0.23%) revealed weakness and medium erythema. Most of the systemic reaction was the weak reaction(0.6%).The titre of antibody average concentration was 4.03 in test group but 4.15 in positive control group.The test group’s positive conversion rate was 86.4%, and it was 72.5% in pesitive control group.The reaction of local pain and systemic temperature had no significant differences between the test group and the positive control group.Immunogenicity was close between the two groups.Conclusion 23-valent pneumococcal polysaccharide vaccine developed by us is safe and effective.

  • 【文献出处】 预防医学情报杂志 ,Journal of Preventive Medicine Information , 编辑部邮箱 ,2007年04期
  • 【分类号】R392.1
  • 【被引频次】38
  • 【下载频次】536
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