重组人白细胞介素-2辅助治疗复治肺结核近期疗效观察

A controlled clinical study on the efficacy of recombinant human interleukin-2 in the treatment of pulmonary tuberculosis

目的 研究和评价重组人白细胞介素 2 (IL 2 )辅助治疗肺结核病的疗效。方法 将 2 0 9例复治菌阳肺结核患者 ,采用计算机随机分组方法分为 :治疗组 10 6例 ,采用 3PaZ(TH)L2 VE(AK) +IL 2 / 4PaL2 V方案化疗 (Pa :力克肺疾 ,Z :吡嗪酰胺 ,TH :丙硫异烟胺 ,L :利福喷汀 ,V :左氧氟沙星 ,AK :阿米卡星 ,E :乙胺丁醇 ) ;对照组 10 3例 ,采用 3PaZ(TH)L2 VE(AK) / 4PaL2 V方案进行短程化疗。结果 完成疗程可评价疗效者 2 0 3例 ,其中治疗组 10 3例 ,对照组 10 0例。治疗第 1、2个月治疗组和对照组痰菌阴转率分别为 33 3%、7 2 %和 6 9 4 %、4 4 9% ,差异有非常显著性意义 (P <0 0 1)。治疗结束时治疗组和对照组显效率分别为 6 4 1%和 36 0 % ,差异有非常显著性意义 (P <0 0 0 1)。治疗组治疗 3和 7个月时CD4、CD4/CD8和NK细胞较对照组提高 ,差异有非常显著性意义 (P <0 0 1)。治疗 3个月时治疗组IL 2可溶性受体 (sIL 2R)较对照组降低 ,两组比较差异有显著性 (P <0 0 5 )。无严重不良反应发生。结论 重组人IL 2可辅助治疗肺结核 ,是一种安全、可靠的生物制剂。

Objective To study and evaluate the efficacy and safety of recombinant human interleukin -2(IL-2) in the treatment of pulmonary tuberculosis. Methods Two hundred and nine cases with re-treated Mycobacterium tuberculosis -positive pulmonary tuberculosis were randomly divided into a trial group (106 cases, treated with 3PaZ(TH)L_2VE(AK)+IL-2/4PaL_2V) and a control group (103 cases, treated with 3PaZ(TH)L_2VE(AK)/4PaL_2V). The efficacy of 203 cases was available for evaluation when the course was completed (trial group 103 cases, control group 100 cases). Results The sputum smear-negative conversion rates at the 1st and the 2nd month of therapy were 33.3% and 69.4% in the trial group, and 7.2% and 44.9% in the control group ( P< 0.01). At the completion of the therapy, the X-ray resolution rates were 64.1% and 36.0% respectively for the trial and the control groups, the difference being significant ( P< 0.001). There were significant differences in CD_4 T cells, the ratio of CD_4/CD_8 and NK cells between the two groups ( P< 0.01). The level of soluble interleukin-2 receptor (sIL-2R)was significantly different between the two groups after treatment for 3 months ( P< 0.05). IL-2 associated side effects were rare and mild. Conclusion As an effective and relatively safe biological agent, IL-2 can be added to the standard chemotherapy for pulmonary tuberculosis.