母牛分支杆菌菌苗在初治肺结核治疗中的作用

目的 观察和评价母牛分支杆菌菌苗（微卡菌苗）在初治肺结核免疫治疗中的疗效及安全性。方法 采用随机配对分组法将342例初治菌阳肺结核患者分入微卡菌苗治疗组（M组，171例）和对照组（C组，171例）。M组化疗方案为2HRZE／2HR，C组为2HRZE／4HR。M组加用微卡菌苗治疗6个月，C组不用微卡菌苗。结果 M组第1个月涂片阴转率36．8％，培养转率19．3％；第2个月涂片阴转率80．1％，培养阴转率85．9％。C组第1个月涂片阴转率19．9％，培养阴转率19．3％；第2个月涂片阴转率54．4％，培养阴转率67．8％。头2个月痰菌阴转率M组显著高于C组（P＜0．01）。疗程满6个月后M组涂片阴转率98．2％，培养阴转率99．4％；C组涂片阴转率98．8％，培养阴转率98．8％。M组与C组治疗6个月痰菌阴转率无显著性差异（P＞0．05）。病灶吸收好转及空洞缩小关闭速度，M组优于C组。M组的细胞免疫功能显著改善。1年后随访M组和C组的的细菌学复发率分别是3．0％和5．6％（P＞0．05）。结论 微卡菌苗能改善初治肺结核患者的细胞免疫功能，加快痰菌阴转、病灶吸收及空洞缩小关闭的速度，缩短短程化疗疗程。不良反应少且较轻微。复发率底。微卡菌苗可用作初治肺结核的免疫治疗和短化的辅助治疗。

The immunotherapeutic effect of Mycobacterium vaccae vaccine on initially treated pulmonary tuberculosis

Objective To evaluate the effect and safety of Mycobacterium vaccae vaccine (M vaccae vaccine) on initially treated pulmonary tuberculosis. Methods 342 cases of initially treated pulmonary tuberculosis with smear and culture positive were divided into immunotherapy (M, 171 cases) group and control (C, 171 cases) group at random pair. The group M were treated by chemotherapy with a regimen of 2HRZE/2HR and immunotherapy with M vaccae vaccine for 6 months The group C were treated only by chemotherapy with a regimen of 2HRZE/4HR. Results The sputum smear negative conversion rates in group M 1, 2 and 6 months after treatment were 36 8%, 80 1% and 98 2% respectively; those in group C were 19 9%, 54 4% and 98 8% respectively. The sputum culture negative conversion rates in group M 1,2 and 6 months after treatment were 47 4%, 85 9% and 99 4% respectively; those in group C were 19 3%, 67 8% and 98 8% respectively. The sputum negative conversion rates of group M were significantly higher than those of group C after 1 and 2 months treatment ( P <0 01), but there were no statistically significant differences between the two groups at the end of 6 months after treatment ( P >0 05) Compared with group C, group M were better in improving of X ray manifestation, increasing of the percentage of CD 3 and CD 4 T cell and the ratio CD 4/CD 8 and closing of cavity ( P <0 01). The side effects of M vaccae vaccine were rare and slight The bacteriological relapse rates in group M, C were 3.0%, 5 6% respectively ( P >0 05). Conclusions As an adjunct to chemotherapy, immunotherapy with M vaccae vaccine is helpful for patient with initially treated pulmonary tuberculosis, and it is possible to futher shorten the duration of short course chemotherapy with a combination of chemotherapy and M vaccae vaccine.