无细胞耻垢分枝杆菌疫苗对结核杆菌感染者的预防作用研究

The study on preventive effect of M.smegmatis vaccine for people infected with M.tuberculosis

目的初步探讨无细胞耻垢分枝杆菌疫苗对结核杆菌感染者的预防作用。方法1.动物实验:将结核杆菌感染的豚鼠随机分为不同剂量的无细胞耻垢分枝杆菌疫苗组(A组:7.0μg/次,B组:35.0μg/次)和阴性对照组(C组),观察疫苗对豚鼠PPD皮肤反应、病变指数和活菌负荷的影响。2.人体试验:将31名PPD皮试强阳性者随机分为不同剂量的无细胞耻垢分枝杆菌疫苗组(D组:8.7μg/次、E组:17.5μg/次、F组:35.0μg/次),观察受试者注射疫苗前后PPD皮肤反应情况。结果1.动物实验:A、B、C组豚鼠PPD皮肤反应强度依次为(9.87±3.36、7.04±3.09、12.67±1.47)mm,A组、B组和C组比较,均有极显著性差异(P<0.01);A、B、C组豚鼠病变指数依次为34.6±13.7、29.6±12.3、49.6±16.7,A组、B组和C组比较,均有显著性差异(P<0.05);A、B、C组豚鼠脾脏分离的结核杆菌对数值依次为4.32±1.58、4.00±1.39、4.94±0.41,B组和C组相比有显著性差异(P<0.05)。2.人体实验:D、E、F组受试者注射疫苗前PPD皮试结果依次为(36.1±4.5、34.0±3.6、33.5±3.1)mm,注射疫苗后PPD皮试结果依次为(20.6±0.6、16.0±1.6、17.82±1.2)mm,各组注射疫苗前后PPD皮试结果比较均有显著性差异(P<0.05)。结论无细胞耻垢分枝杆菌疫苗对结核杆菌感染者有较好的预防效果。

Objective To study the preventive effect of M.smegmatis vaccine for people infected with M.tuberculosis. Methods 1.Animal Test： Guinea pigs infected with M.tuberculosis were randomized into two M.smegmatis vaccine groups（group A and B） and control group（group C）. Guinea pigs in A and B group were injected with 7.0μg and 35.0μg vaccine every week for 4 consecutive weeks. The effect of M.smegmatis vaccine was evaluated through PPD skin test,pathological index and load of M.tb. 2.Human Test： 31 volunteers with strongly positive reactions in PPD skin test were randomized into group D,E and F. They were injected with M.smegmatis vaccine 6 times at doses of 8.7μg, 17.5μg and 35.0μg respectively every two week. The PPD reactions of the volunteeres were observed before and after injection. Results 1.Animal Test： PPD reaction of Guinea pigs in group A,B and C was （9.87±3.36,7.04±3.09,12.67±1.47）mm respectively, both A and B group had significant difference when compared with group C （P〈0.01）. Pathological index in group A,B and C was 34.6 ± 13.7,29.6 ± 12.3,49.6 ± 16.7 respectively, and two vaccine groups had significant difference when compared with group C （P〈0.05）. The log of number of M.tb from Guinea pigs＇lungs in group A,B and C was 4.32 ± 1.58,4.00 ± 1.39,4.94 ± 0.41, and group B had significant difference when compared with group C（P〈0.05）. 2.Human Test： PPD reaction was （36.1±4.5,34.0±3.6,33.5±3.1）mm in group D,E,F respectively before injection of vaccine, and （20.6±0.6,16.0±1.6,17.82±1.2）mm after injection. There was significant difference （P〈0.05）for PPD reaction before and after injection for all the three groups. Conclusions M.smegmatis vaccine has good preventive effect for people infected with M.tuberculosis.