化疗加用卡介苗免疫治疗预防耐多药结核病的研究

目的 探讨卡介苗(BCG)免疫治疗对结核病化疗效果的影响及预防耐多药结核病形成的可能性能.方法 初治菌阳肺结核病志愿者360例,按年龄、性别、病灶范围、空洞和初始耐药等情况相近的原则,配对数字表法随机分成加用BCG的4个月短程化疗组、6个月单纯化疗组.比较两组的细菌学、影像学等临床疗效,以及对继发耐药病例形成的影响.结果 (1)两组结束疗程时痰菌阴转率分别是98.3%(177/t80)和97.2%(175/180),χ2=0.1278,P＞0.05.(2)5年随访痰菌复阳率BCG免疫治疗组2.3%(4/177),对照组6.9%(12/175),χ2=4.2864,P＜0.05.5年细菌学总成功率BCG免疫治疗组高出对照组5.5%,差异有统计学意义(96.1%,173/180;90.6%,163/180,χ2=4.4643,P＜0.05).(3)5年随访期内,两组病例影像学改变与细菌学结果相一致.(4)BCG免疫组继发性耐多药发生率2.3%(4/177),6个月单纯短化组病人中继发性耐多药发生率7.3%(13/178),两组差异有统计学意义,χ2=4.9513,P＜0.05.结论 化疗1个月后加用BCG免疫治疗可提高化疗效果和减少耐多药病例发生率.

Immunotherapeutic efficacy of BCG vaccine in pulmonary tuberculosis and its preventive effect on multidrug-resistant tuberculosis

OBJECTIVE: To evaluate the effect and safety of BCG vaccine on initially treated pulmonary tuberculosis and its controlling effect on multidrug-resistant tuberculosis. METHODS: All 360 volunteers with initially treated pulmonary tuberculosis of positive smear and culture were divided into immunotherapy group (180 cases, also BCG group) and control group (180 cases) at random pair. The patients in BCG group were treated with chemotherapy of a regimen of 2HRZ/2HR and immunotherapy with BCG for 4 months,and the first BCG vaccine was given a month after chemotherapy. Meanwhile, the patients in the control group were treated with chemotherapy of 2HRZ/4HR only. RESULTS: (1) The negative conversion rate of sputum smear in BCG group was 98.3% (177/180), and it was 97.2% (175/180) in control group. There was no significant difference between the two groups both at the ends of 4 and 6 months after treatment (chi2 = 0.1278, P > 0.05). (2) The positive conversion rate of sputum smear in BCG group was 2.3% (4/177), and it was 6.9% (12/175) in control group followed up for 5 years. The successful rate was 96.1% (173/180) in BCG group, and it was significantly higher than that of 90.6% (163/180) in control group (chi2 = 4.4643, P < 0.05). (3) In the 5-year follow up, bacteriologic result was similar to that of X-ray. (4) The occurrence rate of multidrug-resistant tuberculosis was 2.3% (4/177) in BCG group,significantly lower than that of 7.3% (13/178) in the control group (chi2 = 4.9513, P < 0.05). CONCLUSION: As an adjunct chemotherapy,immunotherapy with BCG vaccine should be helpful for patients with initially treated pulmonary tuberculosis. It would further strengthen the effects of chemotherapy and reduce the occurrence rate of multidrug-resistant tuberculosis.