对氨基水杨酸异烟肼联合左氧氟沙星方案治疗首次复治涂阳肺结核的近期疗效评估

Evaluation of the short-term efficacy of the therapy of P-aminosalicylate of isoniazid combined with levofloxacin against the first time retreated smear-positive pulmonary tuberculosis

目的观察和评价对氨基水杨酸异烟肼联合左氧氟沙星方案治疗首次复治涂阳肺结核的近期疗效及安全性,为临床治疗复治肺结核提供参考。方法选取2017年9月~2019年3月广东省汕头市结核病防治所门诊确诊为首次复治涂阳肺结核患者80例,按照随机数字表法分为试验组和对照组,每组各40例,试验组采用3对氨基水杨酸异烟肼+利福平+吡嗪酰胺+左氧氟沙星/6对氨基水杨酸异烟肼+利福平+左氧氟沙星(3PaRZLfx/6PaRLfx)方案,对照组采用2异烟肼+利福平+吡嗪酰胺+乙胺丁醇+链霉素/6异烟肼+利福平+乙胺丁醇或3异烟肼+利福平+吡嗪酰胺+乙胺丁醇/6异烟肼+利福平+乙胺丁醇(2HRZES/6HRE或3HRZE/6HRE)标准化方案,所有患者均常规加用葡醛内酯片进行保肝治疗。管理方式为全程督导。对两组治疗后不同时期的痰菌阴转率、影像学好转率、治疗转归及不良反应等进行分析比较。结果完成疗程时,试验组的痰菌阴转率、病灶吸收率和空洞缩小率分别为80.00%、67.50%和74.07%,均高于对照组的52.50%、45.00%和42.86%,两组比较差异均有统计学意义(P<0.05)。试验组的治疗成功率为87.50%,显著高于对照组的62.50%,差异有统计学意义(P<0.01)。两组在不良反应发生率比较差异无统计学意义(P>0.05)。结论对氨基水杨酸异烟肼联合左氧氟沙星方案治疗首次复治涂阳肺结核,能够加快痰菌转阴,促进病灶吸收及空洞闭合,提高治疗成功率,且无严重不良反应发生。

Objective To observe and evaluate the short-term efficacy and safety of the therapy of P-aminosalicylate of isoniazid combined with levofloxacin against the first time of retreated smear-positive pulmonary tuberculosis(PTB),so as to provide reference for clinical treatment of retreated PTB.Methods A total of 80 patients diagnosed with the first time retreated smear-positive PTB by the outpatient service of Shantou Institute of Tuberculosis Control and Prevention,Guangdong Province from September 2017 to March 2019 were selected and divided into the experimental group and the control group according to random number table method,with 40 patients in each group.The experimental group was treated with the therapeutic regimen of 3-P-aminosalicylate of isoniazid+rifampicin+pyrazinamide+levofloxacin/6-P-aminosalicylate of isoniazid+rifampicin+levofloxacin(3PaRZLfx/6PaRLfx),while the control group was treated with the standard therapeutic regimen of 2-isoniazid+rifampicin+pyrazinamide+ethambutol+streptomycin/6-isoniazid+rifampicin+ethambutol or 3-isoniazid+rifampicin+pyrazinamide+ethambutol/6-isoniazid+rifampicin+ethambutol(2HRZES/6HRE or 3HRZE/6HRE).All the patients were conventionally treated with glucurolactone tablets for liver protection.For the management,full supervision was chosen.The sputum negative conversion rate,imaging improvement rate,therapeutic outcomes and adverse reactions(ADRs)of the two groups in different periods after treatment were analyzed and compared.Results At the end of the course of treatment,the sputum negative conversion rate,focus absorption rate and cavity reduction rate of the experimental group were respectively 80.00%,67.50%and 74.07%,which were higher than the 52.50%,45.00%and 42.86%of the control group,and the differences between the two groups were statistically significant(P<0.05).The success rate of treatment in the experimental group was 87.50%,significantly higher than the 62.50%in the control group,with statistically significant difference between the two groups(P<0.01).There was no significant difference in the incidence of ADRs between the two groups(P>0.05).Conclusion The therapy of P-aminosalicylate of isoniazid combined with levofloxacin against the first time retreated smear-positive PTB can accelerate sputum negative conversion,promote focus absorption and cavity closure,and improve the success rate of treatment,incurring no serious ADRs.