母牛分枝杆菌菌苗应用于涂阴肺结核超短程治疗方案的临床观察

Clinical observation on the application of 2HRZE/2HR therapeutic regimen combined with mycobacterium vaccae in the treatment of smear negative tuberculosis

目的观察母牛分枝杆菌菌苗应用于2HRZE/2HR超短程化疗方案治疗涂阴肺结核的疗效、患者免疫功能状况及预后。方法400例涂阴肺结核患者随机分成对照组和微卡组,每组200例。对照组采用2HRZE/4HR方案治疗,微卡组采用2HRZE/2HR方案联合母牛分枝杆菌菌苗(微卡)注射方案治疗。对比两组化疗2个月、化疗结束时病灶吸收情况,以及治疗前和化疗2、4个月患者CD4^+T淋巴细胞水平,治疗后6、12、24个月的复发率。结果最终306例患者配合完成治疗,对照组152例,微卡组154例。化疗2个月,微卡组病灶吸收情况优于对照组(P<0.01)。化疗2、4个月,微卡组CD4+水平高于同期的对照组(P<0.01);两组6、12、24个月复发率的差异无统计学意义(P>0.05)。结论母牛分枝杆菌菌苗应用于2HRZE/2HR超短程化疗方案治疗涂阴肺结核可以改善患者的免疫功能,促进结核病灶吸收。

Objective To evaluate the effect of 2HRZE/2HR therapeutic regimen combined with mycobacterium vaccae (VACCE) in the treatment of smear negative tuberculosis and its influence on cellular immunologic status and prognosis of patients. Methods 400 patients with smear negative TB were randomly divided into the Control Group and VACCE Group (n=200). The Control Group was treated with 2HRZE/4HR therapeutic regimen while the VACCE Group was treated with 2HRZE/2HR therapeutic regimen combined with the VACCE injection. The two groups were compared in terms of the lesion absorption after 2-month chemotherapy and after the completion of chemotherapy, CD4+T cell level of patients before the treatment and after 2-month and 4-month chemotherapy and the recurrence rate at 6, 12 and 24 months after the chemotherapy.Treatment group received 2HRZE/2HR plus VACCE therapy while the control group received 2HRZE/4HR therapy. The absorptivity and recurrent rate in 24 months were analyzed. Results A total of 306 patients completed the treatment, 152 cases in the Control Group and 154 cases in the VACCE Group. After 2-month chemotherapy, the VACCE Group had the lesion absorption superior to the Control Group (P<0.01). After 2-month chemotherapy and 4-month chemotherapy, the VACCE Group had the CD4+ level higher than the Control Group at the same period (P<0.01);there was no statistical difference at 6, 12 and 24 months after the chemotherapy (P>0.05). Conclusion 2HRZE/2HR combined VACCE can effectively improve the immunologic function of patients and accelerate the absorption of tuberculosis lesions.