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目的 在中国健康成年志愿者中评价静滴甲磺酸加替沙星氯化钠注射液的安全性、耐受性。方法 根据新药临床试验指导原则设计试验方案 ,并获得伦理委员会批准。受试者须自愿签署知情同意书。选择 4 8名 18～ 5 0岁健康成人进行单次静滴甲磺酸加替沙星氯化钠注射液耐受实验。用区组随机化设计方法 ,将受试者随机分配至 10 0、2 0 0、30 0、4 0 0、5 0 0、6 0 0、70 0和 80 0 mg剂量组中 ,每组 6名 ,男女各半。选择 10名健康成人进行多次静滴甲磺酸加替沙星氯化钠注射液耐受实验。观察指标为临床症状体征 ,实验室指标包括心电图、脑电图、血常规、凝血功能、尿常规、肝功能、肾功能、电解质等。严密观察记录试验期间发生的不良事件。结果 各组入选受试者体检及实验室检查各项指标测定值均在正常范围 ,条件均衡 ,具较好可比性。单次静滴甲磺酸加替沙星氯化钠注射液耐受实验中给药后体温、呼吸频率、脉搏、血压、血常规、尿常规、肾功能、电解质、心电图、脑电图等未见有临床意义的改变。试验中未见严重的临床不良反应 ,只发现 3例次可能与药物有关的轻度一过性不良反应 ,分别表现为面部瘙痒、皮疹、GOT或GPT升高。多次静滴甲磺酸加替沙星氯化钠注射液耐受实验中未见严重不良反应 ,仅见一过性 GOT或 GPT升高
Objective To evaluate the safety and tolerability of intravenous gatifloxacin mesylate injection in healthy adult volunteers in China. Methods According to the guidelines of clinical trial of new drugs, the experimental plan was designed and approved by Ethics Committee. Subjects must voluntarily sign the informed consent form. Forty-eight healthy adults aged 18-5 years were enrolled in this study. Single intravenous infusion of gatifloxacin sodium chloride injection was performed. In a randomized block design, subjects were randomly assigned to 10, 200, 300, 400, 500, 600, 7000, and 80 0 mg doses of 6 Name, men and women in half. Ten healthy adults were selected for multiple instillation trials of gatifloxacin sodium chloride injection. Observed indicators of clinical signs and symptoms, laboratory indicators including ECG, EEG, blood, coagulation, urine, liver function, renal function, electrolytes and so on. Closely observe the adverse events that occurred during the test. Results The subjects in each group were selected in the physical examination and laboratory tests of the indicators were measured in the normal range, the conditions are balanced, with better comparability. A single intravenous infusion of gatifloxacin mesylate sodium chloride injection tolerance in the experiment after administration of body temperature, respiratory rate, pulse, blood pressure, blood, urine, renal function, electrolytes, ECG, EEG and so on See clinically relevant changes. No serious clinical adverse reactions were observed in the trial. Only 3 cases were found to be minor transient drug-related adverse reactions, including pruritus, rashes, elevated GOT or GPT. Repeated intravenous infusion of gatifloxacin sodium chloride injection resistance test no serious adverse reactions, only seen a transient increase in GOT or GPT