【摘要】 目的:评价加替沙星注射液的疗效与安全性。方法:本研究为多中心、单盲、随机、对照试验,下呼吸道及尿路感染患者被随机分配接受加替沙星或左氧氟沙星静脉给药继以口服序贯治疗。结果:(1)试验组和对照组临床有效率分别为92.4％(110/119)和91.2%(114/125),其中下呼吸道感染两组有效率为94.2%(65/69)和90.2%(65/72),尿路感染两组有效率为90.0％(45/50)和92.5％(42/72),经统计学分析2组间差异无显著性;(2)两组总的细菌清除率分别为94.0％(78/83)和88.0%(81/92),其中尿路感染细菌清除率为89.2%(33/37)和92.9%(39/42),两组间差异无显著性;但试验组下呼吸道感染细菌清除率为97.8%(45/46),高于对照组的84.3%(43/51),差异有显著性;(3)试验组不良反应发生率为29.9%(38/127),显著高于对照组的10.1％(13/129);两组不良反应均系轻度,患者可耐受,无中途停药者。两组实验室检查异常者分别占24.8％(30/121)和22.1％(27/122),均系轻度并呈一过性,经统计学分析差异无显著性。结论:加替沙星注射剂静脉给药用于全身症状明显感染的初期治疗可使病情早期缓解,继以口服完成疗程,可获良好疗效;加替沙星组临床疗效与对照组相仿,虽不良反应多于对照组,但均属轻度并可为患者耐受。更多还原

【Abstract】 Objective: To evaluate the efficacy and safety of injectable gatifloxacin. Methods; In this multicenter, single-blind, randomized comparative study, patients with infection of lower respiratory tract and urinary tract were allocated randomly to gatifloxacin group or levofloxacin group. In each group patients were given gatifloxacin or levofloxacin intrevenously for 3-5 d followed by oral formulation. Results: (1)The clinical effective rates (gatifloxacin vs. levofloxacin) were 92.4%(110/119) vs. 91.2%(114/ 125), being 94.296(65/69) vs. 90.296(65/72) for lower respiratory tract infections and 90.0% (45/50) vs. 92.5%(42/72) for urinary tract infections, respectively, there was no statistically significant difference between the two groups; (2)The total bacterial eradication rates were 94.0% (78/83) vs. 88.0% (81/92), being 89.2% (33/37) vs. 92.9% (39/42) for urinary tract infections, there was no statistically significant difference between the two groups; however, the bacterial eradication rate of gatifloxacin (97.8% , 45/46) was higher than that of levofloxacin (84. 3% , 43/51) in lower respiratory tract infections, the difference was statistically significant. (3)Drug-related adverse effects were 29.9% (38/127) in gatifloxacin group, higher than that in levofloxacin group 10.1% (13/129). This is due to more patients with phlebitis and gastrointestinal symptoms in gatifloxacin group than those in levofloxacin group. These drug-related events could be alleviated by slowing down the speed of infusion; the adverse effects of both groups were mild and tolerable, no discontinuation of treatment due to adverse reaction. Drug-related abnormal laboratory findings oc- carred in gatifloxacin group and levefloxacin group were 24. 8% (30 /121) and 22. 1 % (27 /112) respectively. All were mild and transient, and there was no statistically significant difference between the two groups. Conclusions: Gatifloxacin given intravenously used as initial therapy in infectious patients with systemic clinical manifestations and followed by oral administration for the completion of therapy may get satisfactory results. The clinical efficacy of gatifloxacin is as good as that of levofloxacin. The adverse reaction rate of gatifloxacin was slightly higher than that of levofloxacin, but all the reactions are mild and tolerable.更多还原