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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。
Objective: To evaluate the efficacy and safety of gatifloxacin injection. METHODS: This multicenter, single-blind, randomized, controlled trial of patients with lower respiratory and urinary tract infections was randomized to receive gatifloxacin or levofloxacin intravenously followed by oral sequential therapy. Results: (1) The clinical effective rates of the experimental group and the control group were 92.4% (110/119) and 91.2% (114/125), respectively. The effective rates of the two groups were 94.2% (65/69) and 90.2% (65/72). The effective rate of urinary tract infection was 90.0% (45/50) and 92.5% (42/72) respectively. There was no significant difference between the two groups by statistical analysis. (2) The clearance rates were 94.0% (78/83) and 88.0% (81/92), respectively. The urinary tract bacterial clearance rates were 89.2% (33/37) and 92.9% (39/42), with no significant difference between the two groups However, the bacterial clearance rate of lower respiratory tract infection in the test group was 97.8% (45/46), which was significantly higher than that in the control group (84.3%, 43/51). (3) The incidence of adverse reactions in the test group was 29.9% (38/127), which was significantly higher than that of the control group (10.1%, 13/129). The adverse reactions in both groups were mild and the patients were tolerated without interruption. Two groups of laboratory abnormalities accounted for 24.8% (30/121) and 22.1% (27/122), respectively, were mild and transient, the statistical analysis showed no significant difference. CONCLUSION: Gatifloxacin intravenous injection can be used to treat early symptoms of systemic infection. Early treatment can make the disease relieve early. After oral administration of Gatifloxacin injection, good curative effect can be obtained. The clinical efficacy of gatifloxacin group is similar to that of the control group, More reactions than the control group, but are mild and can be patient tolerated.