皮内注射卡介苗接种效果的评价

Study on the efficacy of BCG vaccine for intradermal injection

目的研究卡介苗接种效果及可能的影响因素。方法采用多中心、无对照、开放式、前瞻性队列研究，选取我国北京市、江苏省和重庆市的4个区（市）出生3个月内的婴儿或PPD试验阴性儿童（〈1岁）为研究对象，总共纳入研究对象27517例，评价卡介苗接种效果和研究可能影响卡介苗接种效果的因素。结果（1）卡介苗接种卡痕均径中位数4．50mm，四分位数3．50～5．00mm。卡痕均径〈1mm223例（0．81%，223／27517），卡痕均径≥1mm27294例（99．19％，27294／27517）；（2）PPD硬结均径中位数8．50mm，四分位数6．50～11．00mm。PPD硬结均径95mm26838例（97．53％，26838／27517）；PPD硬结均径〈5mm679例（2．47％，679／27517）；（3）城镇医疗机构PPD阴性率（2．28％，571／25004）低于乡村（4．30％，108／2513）（X2=38．487，P（0．001）；三级医院PPD阴性率（4．18％，199／4760）较一级医疗机构（3．22％，217／6733）、二级医疗机构（1．64oS，263／16024）高（X2=119．464，P（0．001）；北京市PPD阴性率（0．53％，57／10679）较江苏省（4．15％，383／9239）、重庆市（3．15％，239／7599）低（X2=288．511，P（0．001）；（4）本研究共发生不良反应19例，不良反应发生率为6．90／万。不同省（直辖市）卡介苗不良反应率[北京市0，江苏省19．48／万（18／9239），重庆市1．32／万（1／7599）]差异有统计学意义（X2=32．005，P〈0．001）。结论卡介苗接种效果可能与城乡差别、医院级别、地区等因素有关；应加强卡介苗接种监测，尽力提高卡介苗接种成功率。

Objective To study the immune efficacy and the influencing factors of BCG. Methods Multi- center, no control, open, prospective cohort study was used to select the study population. The effect and influen- cing factors of BCG were studied for the baby （〈3 months） or the children （〈1 years old） PPD negative in 4 dis- tricts （city） in Beijing, Jiangsu and Chongqing. The qualified study population was 27 517. Results （1） The me- dian of BCG scar was 4.50 mm, the quartile of BCG scar was 3.50--5.00 mm. The BCG scar ≥1 mm was 223 （0.81~, 223/27 517） and ≥1 mm 27 294（99.19%, 27 294/27 517）. （2）The median of PPD was 8.50 ram, the quartile was 6.50--11.00 mm. The positive reaction was 26 838（97.53%, 26 838/27 517） and the negative reaction 679（2.47%, 679/27 517）. （3） The negative rate of PPD was lower in urban（2.28% ,571/25 004）than rural hospi- tals（4. 30%, 108/2513） X2=38. 487, P〈0. 001）. The negative rate of PPD was higher in tertiary hospital（4. 18%, 199/4760）than others （X2= 119. 464, P〈0. 001）. The negative rate of PPD was lower in Beijing（0. 53%, 57/10 679） than others areaX2 =288. 511, P〈0. 001）. （4） There was 19 cases adverse reaction in the study, the rate of ad- verse reaction of BCG was 6.90/10 000. The rate of adverse reaction of BCG was different in the three provinces （X2 =32. 005, P〈0. 001）. Conclusion The effect of BCG may be related with urban-rural difference, hospitallevel, area, et al. The monitoring of ~ vaccine effect should be strengthened. The effect of BCG vaccine should be improved in order to control the tuberculous meningitis and TB.