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目的评价正常人群接种母牛分枝杆菌疫苗的安全性和细胞免疫学效果,探讨母牛分枝杆菌疫苗用于大龄儿童加强免疫,预防结核病的可行性。方法随机选择5~7岁的健康儿童,先进行结核菌素纯蛋白衍生物(TB-PPD)试验,然后分成TB-PPD试验阳性组和阴性组,每组分别接种母牛分枝杆菌疫苗3针,每针间隔2周。分别采集接种前和接种后1个月的血标本,用流式细胞仪检测各项细胞免疫学指标,观察两组免疫前后细胞免疫学指标的变化情况和接种后不良反应的发生率。结果观察300人次的接种,未发现任何不良反应。TB-PPD试验阴性组免疫前后淋巴细胞、Th细胞(CD4)、Ts细胞(CD8)、T细胞数均比免疫前显著增加,差异有显著的统计学意义。90%的TB-PPD试验阴性者细胞数的增长≥2个标准差,增长率92%~96%。TB-PPD试验阳性者免疫前后淋巴细胞数、Th细胞数均比接种疫苗前增加,差异有显著的统计学意义。TB-PPD试验阳性组免疫前后呈现出良好的双向免疫调节功能,淋巴细胞数、Th细胞数的增长率近70%,且增长幅度在1个标准差左右。结论对TB-PPD试验阴性或阳性者进行母牛分枝杆菌疫苗接种,均显示了较好的安全性和细胞免疫学效果,因此探讨用母牛分枝杆菌疫苗预防结核病,尤其是用于大龄儿童及青少年免疫预防有非常积极的意义。
Objective To evaluate the safety and immunological efficacy of vaccination of Mycobacterium vaccae in normal population and to explore the feasibility of using the Mycobacterium vaccae vaccine in strengthening immunity and preventing tuberculosis in older children. Methods A random sample of healthy children aged 5 to 7 years was subjected to the TB-PPD test. The TB-PPD test was divided into TB-PPD test positive group and negative group, and each group was vaccinated with M. vaccae vaccine 3 Needles, each needle interval of 2 weeks. The blood samples were collected before inoculation and 1 month after inoculation. The cellular immunological indexes were detected by flow cytometry. The changes of immunological indexes before and after immunization and the incidence of adverse reactions after immunization were observed. The results observed 300 vaccinations, did not find any adverse reactions. The number of lymphocytes, Th cells (CD4), Ts cells (CD8) and T cells in TB-PPD negative group before and after immunization were significantly higher than before immunization, the difference was statistically significant. 90% of the TB-PPD test negative cell number increased by 2 standard deviations, an increase of 92% to 96%. Before TB-PPD test, the number of lymphocytes and the number of Th cells before immunization increased compared with that before vaccination, the difference was statistically significant. The TB-PPD test positive group showed a good two-way immunomodulatory function before and after immunization. The number of lymphocytes and the number of Th cells increased nearly 70%, and the growth rate was about 1 standard deviation. Conclusion Mycobacterium vaccae vaccination against TB-PPD test negative or positive patients showed good safety and cellular immunological effects. Therefore, to explore the use of Mycobacterium vaccae vaccine to prevent tuberculosis, especially for older Immunization of children and adolescents has a very positive meaning.