CAJ | 학술논문

目的对两个工作种子批菌种D2-甲12制备的两批冻干卡介苗接种人体后的安全性和效果进行临床考核.方法对100名结核杆菌纯化蛋白衍生物(PPD)皮肤试验阴性的3月龄～50岁健康对象和205名新生儿分别接种上述两个批次的观察疫苗和一个对照疫苗.观察接种后的局部和全身反应,测量卡痕,并对新生儿进行PPD皮肤试验.采用x2检验和t检验对新生儿各组间的卡痕和PPD试验结果进行比较.结果所有对象接种后均未发现接种部位和全身不良反应.新生儿卡痕均值≥4.6 mm,PPD硬结均值≥6.8 mm.卡痕和PPD试验阳性率均超过90％,两者在新生儿各组间的差异均无统计学意义(x2=0.001～1.713,P=0.191～1.000).卡痕均值和PPD硬结均值在两个观察疫苗组间的差异无统计学意义(t=0.773,P=0.441；t=0.226,P=0.822),而对照疫苗组与两个观察疫苗组间的差异均有统计学意义(t =2.645～3.361,P =0.001～0.010).结论两个工作种子批菌种D2-甲12制备的卡介苗接种人体是安全的,并具有良好的接种效果.
목적 대량개공작충자비균충D2-갑12제비적량비동간잡개묘접충인체후적안전성화효과진행림상고핵.방법 대100명결핵간균순화단백연생물(PPD)피부시험음성적3월령～50세건강대상화205명신생인분별접충상술량개비차적관찰역묘화일개대조역묘.관찰접충후적국부화전신반응,측량잡흔,병대신생인진행PPD피부시험.채용x2검험화t검험대신생인각조간적잡흔화PPD시험결과진행비교.결과 소유대상접충후균미발현접충부위화전신불량반응.신생인잡흔균치≥4.6 mm,PPD경결균치≥6.8 mm.잡흔화PPD시험양성솔균초과90％,량자재신생인각조간적차이균무통계학의의(x2=0.001～1.713,P=0.191～1.000).잡흔균치화PPD경결균치재량개관찰역묘조간적차이무통계학의의(t=0.773,P=0.441；t=0.226,P=0.822),이대조역묘조여량개관찰역묘조간적차이균유통계학의의(t =2.645～3.361,P =0.001～0.010).결론 량개공작충자비균충D2-갑12제비적잡개묘접충인체시안전적,병구유량호적접충효과.
Objective To investigate safety and immune effect of lyophilized BCG vaccines produced by 2 working seed lots in a clinical trial.Methods One hundred healthy subjects aged 3 months to 50 years old with negative purified protein derivative (PPD) skin test and 205 neonates were immunized with the 2 test vaccines and a control vaccine.Local and systemic reactions were investigated and BCG scar size was measured.PPD skin test was performed in the neonatal infants.x2 and t tests were adopted for comparison of BCG scar sizes and PPD test results among 3 neonatal groups.Results No local or systemic adverse reactionswere observed in all subjects.In the neonates,the average diameters of BCG scar and PPD induration were ≥4.6 mm and ≥6.8 mm,respectively.Both the positive rates of BCG scar and PPD test were ＞90％.No statistically significant differences in the positive rates of BCG scar and PPD test were found among 3 neonatal groups (x2 =0.001 ～ 1.713,P =0.191 ～ 1.000).The average diameters of BCG scar and PPD induration were no significantly different between 2 test vaccine groups (t =0.773,P =0.441 ; t =0.226,P =0.822),but the statistical differences were observed between the control group and 2 test groups (t =2.645 ～ 3.361,P=0.001～0.010).Conclusion The lyophilized BCG vaccines prepared by two working seed lots are proved to be safe and immunologically effective for human immunization.