含异烟肼凝胶药物介入治疗肺结核病安全性分析

Safety Analysis of isoniazid gel interventional therapy against pulmonary tuberculosis

目的对异烟肼凝胶联合体介入治疗的安全性进行分析和临床效果进行评价。方法利用最小抑菌浓度(MIC)和最小杀菌浓度(MBC)法测定异烟肼单体及异烟肼药物凝胶的抗结核效果,并用家兔进行经支气管的介入注药试验,进行了582例临床治疗。结果异烟肼凝胶对H37Rv标准株、牛型结核分枝杆菌、草分枝杆菌MIC值分别为10、5.0、5.0mg/L,MBC值分别为100.10和100mg/L;异烟肼凝胶与异烟肼单体MIC、MBC值无显著差异;家兔动物实验表明该药无任何毒副作用,临床治疗的显效率为73.88%。结论异烟肼凝胶具有与异烟肼单体相同的抗结核菌药效,介入用药以10～100mg/L为宜。

Objective To evaluate the clinical application effect and safety of isoniazid gel combination against Mycobacterium tuberculosis by intervention therapy. Methods The anti-tuberculosis effect of isoniazid monomer and isoniazid gel were measured by the methods of MIC and MBC. The rabbits bronchial intervention therapy were done by injecting drug, and the clinical treatment of 582 cases suffered from mycobacterium tuberculosis by bronchial intervention therapy was observed at the same time. Results The MIC of isoniazid gel to M. tuberculo H37 Rv, M. boris and M. phlei was 0. 1,0. 1 and 0. 4 mg/L, the MBC of isoniazid gel to M. tuberculosis H37 Rv, M. bevis and M. phlei was 0. 2,0.2 and 1.6 mg/L, respectively. The MIC and MBC of isoniazid gel and pasinigel and had no significant difference, without any harmful effect of rabbits animal experiment,The total effective rate of clinical treatment was 73.88%. Conclusion The results suggest that isoniazid has the same affect on the activity of isoniazid gel against Myeobactefium tuberculosis, and the best quantity of medicine of intervention therapy is 10 - 100 mg/L.