分析不同剂型异烟肼血药浓度监测结果，指导临床合理用药。

将2016年5月至2017年6月昆明市第三人民医院耐药与重症结核病科住院的128例初治肺结核患者分为注射异烟肼组和口服异烟肼组，其中注射组65例，口服组63例。规范用药7 d后采集并检测2组患者7个不同时间点异烟肼的血药浓度，注射组7次采血时间分别为异烟肼输注完0、1、2、3、4、8、24 h；口服组7次采血时间分别为服药后0.5、1、2、3、4、8、24 h。应用秩和检验比较2组间不同采血点血药浓度及峰浓度、谷浓度和血药浓度均值的差异，采用χ²检验比较组间异烟肼达到最低抑菌浓度时例数的差异。

注射组异烟肼最高浓度出现在异烟肼输注完0 h，其浓度为2.78（1.86，4.81）μg/ml，口服组最高浓度出现在服药后2 h，浓度为1.00（0.67，2.54）μg/ml；注射组在第1、2、3采血点浓度均高于口服组［2.78（1.86，4.81）μg/ml vs 0.35（0.04，2.28）μg/ml；2.05（1.41，2.49）μg/ml vs 0.76（0.06，3.03）μg/ml；1.02（1.49，2.22）μg/ml vs 1.00（0.67，2.54）μg/ml］，差异均具有统计学（Z=-5.354、-3.394、-2.155，P<0.001、=0.001、=0.031）。注射剂型异烟肼峰浓度、谷浓度、血药浓度均值均高于口服剂型［3.334（2.187，5.310）μg/ml vs 1.179（0.869，1.754）μg/ml；0.009（0.003，0.056）μg/ml vs 0.003（0.001，0.144）μg/ml；1.179（0.869，1.754）μg/ml vs 0.680（0.431，1.836）μg/ml］，且峰浓度和均值浓度比较差异具有统计学意义（Z=-4.631、-1.205、-3.414，P<0.001、=0.228、=0.001）。注射组总的达到最低抑菌浓度患者为88.5%，口服组为87.8%，组间差异无统计学意义（χ²=0.114，P=0.736）。

注射剂型异烟肼的血药浓度高于口服剂型，对重症肺结核患者，建议使用注射剂型异烟肼，提高其血药浓度，增加临床疗效。

To evaluate the plasma concentrations of isoniazid in different dosage forms among tuberculosis patients to guide clinical therapy of this infectious disease.

A total of 128 patients who were hospitalized for initial treatment of tuberculosis at the Department of Drug Resistant and Severe Tuberculosis, the Third People′s Hospital of Kunming from May 2016 to June 2017 were randomly divided into either an injection group (n=65) or an oral group (n=63) according to the dosage form of isoniazid. After 7 days of standardized medication, plasma isoniazid concentrations were tested at seven different time points in the two groups. In the injection group, the time points of blood collection were 0, 1, 2, 3, 4, 8, and 24 hours after the completion of isoniazid infusion. In the oral group, the time points were 0.5, 1, 2, 3, 4, 8, and 24 hours after taking isoniazid. The rank sum test was used to compare the differences of blood drug concentration, peak concentration, trough concentration, and mean blood drug concentration between the two groups at different blood sampling points. The chi-square test was used to compare the differences in the number of cases in whom isoniazid reached the minimum inhibitory concentration between the two groups.

For the injection group, the highest concentration of isoniazid occurred immediately after injection, and the concentration was 2.78 (1.86, 4.81) μg/ml; for the oral group, it occurred 2 hours after taking the medicine [1.00 (0.67, 2.54) μg/ml]. Plasma concentrations of isoniazid in the injection group were significantly higher than those of the oral group at the 1st, 2 nd, and 3 rd sampling points [2.78 (1.86, 4.81) μg/ml vs 0.35 (0.04, 2.28) μg/ml; 2.05 (1.41, 2.49) μg/ml vs 0.76 (0.06, 3.03) μg/ml; 1.02 (1.49, 2.22) μg/ml vs 1.00 (0.67, 2.54) μg/ml; Z=-5.354, -3.394, -2.155; P<0.001, P=0.001, P=0.031]. The peak concentration, trough concentration, and mean concentration of isoniazid were higher in the injection group than in the oral group [3.334 (2.187, 5.310) μg/ml vs 1.179 (0.869, 1.754) μg/ml; 0.009 (0.003, 0.056) μg/ml vs 0.003 (0.001, 0.144) μg/ml; 1.179 (0.869, 1.754) μg/ml vs 0.680 (0.431, 1.836) μg/ml]; the peak concentration and mean concentration in the injection group were statistically different from those in the oral group (Z=-4.631, -1.205, -3.414; P<0.001, P=0.228, P=0.001). The percentage of cases who achieved minimum inhibitory concentration (MIC) in the injection group and oral group was 88.5% and 87.8%, respectively, and there was no statistical difference between the two groups (χ²=0.114, P=0.736).

Plasma concentrations of isoniazid in the injection group are higher than those in the oral group. For patients with severe pulmonary tuberculosis, we suggest that injection of isoniazid be used to increase the concentration of plasma and improve the clinical effects.