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目的 :在中国健康志愿者中评价多剂静滴甲磺酸加替沙星氯化钠注射液的安全性和耐受性。方法 :选择健康成年男性志愿者 10名 ,恒速静脉滴注甲磺酸加替沙星氯化钠注射液 ,qd ,每次 4 0 0mg ,连续 14d。观察指标为临床症状、生命体征、心电图、血常规、尿常规、肝功能、肾功能、凝血功能、电解质等。结果 :试验结束后 ,健康志愿者体温、脉搏、呼吸频率、血压、心电图、血常规、肾功能、电解质等各项指标测定值均在正常范围内。本试验过程中仅发现 4例次可能与药物有关的不良反应 ,分别表现为AST ,ALT或γ 谷氨酰转移酶轻度升高 ,均为轻度一过性 ,可耐受 ,于停药后 1周内自行恢复。结论 :多剂静滴甲磺酸加替沙星氯化钠注射液 ,耐受性较好 ,但在长时间用药过程中应注意检测肝功能
Objective: To evaluate the safety and tolerability of multidose intravenous gatifloxacin sodium chloride injection in Chinese healthy volunteers. Methods: Ten healthy adult male volunteers were selected, and gatifloxacin mesylate sodium chloride injection was given at a constant rate of qd of 400 mg for 14 days. Observed indicators of clinical symptoms, vital signs, ECG, blood, urine, liver function, renal function, coagulation, electrolytes and so on. Results: After the experiment, the body temperature, pulse, respiratory rate, blood pressure, electrocardiogram, blood routine, renal function, electrolytes and other indexes in healthy volunteers were within the normal range. In the course of this study, only 4 cases of drug-related adverse reactions were found, which were mildly elevated AST, ALT or γ-glutamyl transferase, were mild transient, tolerable, discontinued After 1 week to restore itself. Conclusion: Multi-dose intravenous infusion of gatifloxacin mesylate sodium chloride injection is well tolerated, but in the course of long-term medication should pay attention to the detection of liver function