左氧氟沙星治疗呼吸系统感染病人不同给药方案的比较

 目的对左氧氟沙星(levofloxacin,LVFX)在治疗呼吸系统感染病人中不同给药方案进行比较。方法病人被分为2组,按照不同给药方案给药,组1为静脉输注给药200mg,每12h1次;组2为左氧氟沙星400mg,静脉输注给药,每24h1次。高效液相色谱法测定病人血药浓度。根据不同给药方案中左氧氟沙星的PK-PD特点,评价2种不同给药方案临床疗效。结果药动学研究结果表明,组1的药物峰浓度(c_max)明显低于组2(P<0.001),组1的谷浓度明显高于组2(P<0.001)。PK-PD研究结果表明,与体外抗菌活性研究结果比较,c_max/MIC₉₀值显示,组1给药方案对于肺炎克雷伯菌和变形杆菌抗菌作用较强,组2对肺炎克雷伯菌、肠杆菌、变形杆菌、β-溶血链球菌和不动杆菌可产生有效的抗菌作用(c_max/MIC₉₀≥10)。2组临床疗效如体温,白细胞检查及X-光学检查方面,无明显差异。2组间不良反应发生率无差异。结论组1的给药方案血药浓度波动较小,组2的给药方案峰浓度较高,抗菌作用较强,给药次数少,2组临床疗效及不良反应发生率无差异。

Comparison of dosage regimen of levofloxacin in patients with respiratory tract infections

OBJECTIVE To compare the pharmacokinetic and pharmacodynamic characteristics of levofloxacin(LVFX) 200 mg q12 h vs 400 mg qd in the treatment of patients with respiratory tract infections.METHODS 24 patients were divided into two groups. 200 mg LVFX was administered to the patients in group 1 twice a day with in travenous infusion. 400 mg LVFX was administered to the patients in groups 2 every 24 h with intravenous infusion. Serum concentrations of LVFX were measured by HPLC. Clinical efficacy of two dosage regimen was e-valuated by PK-PD characteristics of two regimens of LVFX. RESULTS Pharmacokinetic study showed that the peak concentration of group 1 was significantly lower than that of group 2 (P<0.001) , but trough concentration of LVFX of group 1 was higher than that of group 2 (P<0.001). The ratio of LVFX peak concentration to MIC₉₀ in vitro ( c_max/MIC₉₀≥10) showed LVFX in group 1 (had) more powerful activity a-gainst Klebsiella pneumoniae and Proteus species, LVFX in group 2 appeared more powerful activity against Klebsiella pneumoniae, Enterobacter species, Proteus species, β-hemophilus streptococcus and acinetobacter. Clinical efficacy and incidence rate of adverse drug reaction in two groups were not significant different, as well as body temperature, white blood cell and X-radiodiagnostics. CONCLUSION The fluctuation of LVFX concentratioas in group 1 was smaller. The peak level of LVFX in group 2 was higher, antibiotic activity was more powerful and the interval of infusion was longer (qd). The clinical efficacy in two groups was satisfactory in treatment of respiratory tract infections.