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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 evaluate the safety and efficacy of BCG-PPD developed by Chengdu Institute of Biological Products of Ministry of Health. Methods From May to November 1998, Phase Ⅲ clinical trials were conducted in 3 units such as Sichuan Provincial People’s Hospital to assess the prevalence of BCG vaccination in infants and young children, the epidemiological investigation of TB infection in adolescents and the clinical diagnosis of TB patients The safety and effectiveness. Results A total of 12 84 infants were vaccinated with BCG for a skin test and the positive rate of inoculation was over 90%. Epidemiological investigation of TB infection in 12 4 adolescents and clinically assisted diagnosis of 55 tuberculosis patients were carried out. Results and health Department of Lanzhou Institute of Biological Products formally produced BCG-PPD compared with the compliance rate of 95 96% ~ 100%, all subjects without systemic and regional adverse reactions. The conclusion shows that the BCG-PPD trial in Chengdu is safe and effective for human use in the above three aspects.