摘要
目的 对卫生部成都生物制品研究所研制的卡介菌纯蛋白衍生物 (BCG -PPD)安全性及有效性考核。方法 于 1998年 5～ 11月在四川省人民医院等 3家单位进行了 Ⅲ 期临床研究 ,考核其在婴幼儿卡介苗接种阳转率、青少年结核感染流行病学调查和结核病患者临床辅助诊断 3方面的安全性及有效性。结果 通过对12 84名婴儿接种卡介苗后进行皮试 ,接种阳转率为 90 %以上 ;对 12 4名青少年进行结核感染流行病学调查以及对 5 5例结核患者的临床辅助诊断 ,结果与卫生部兰州生物制品研究所正式生产的BCG -PPD比较 ,其符合率为在 95 96 %～ 10 0 % ,所有受试者无 1例出现全身和局部不良反应。结论 说明成都所试制的BCG -PPD在上述 3个方面的人体使用上是安全有效的。
Objective To make a further assessment in safty and efficieney of BCG-PPD in three aspects.Methods A phase Ⅲ clinical trail of BCG-PPD at three clinical units was conducted in November,1998,and this trail products was compared with the BCG-PPD produced by Lanzhow Institute of Biological Products.Results All the 1463 investigated subjects had no adverse reaction.The positive rate of BCG vaccination in 1284 infants was over 90%.In the epidemiological investigation in 124 adolescents and assistant diagnosis of 55 tuberculosis patients,the consistent rate of two products was between 95 96%～100%.Condusion The trail products of BCG-PPD is safe and effective in three aspects above mentioned when it is used in human.
出处
《预防医学情报杂志》
CAS
2000年第2期101-102,108,共3页
Journal of Preventive Medicine Information
