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48名18～50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100、200、300、400、500、600、700和800mg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,停药后恢复正常.结论健康受试者单次静滴甲磺酸加替沙星氯化钠注射液,最大剂量至800mg,比较安全、耐受性较好.推荐临床使用剂量为400mg/qd.%Objective To evaluate the safety and tolerance of gatifloxacin methanesulfonate in Chinese healthy volunteers treated by intravenous infusion.Methods The clinical trial protocol was designed according to the GCP principle after approved by ethics committee.It′s necessary that all volunteers sign the informed consent.After physical examination and laboratory tests were performed,48 healthy volunteers in 18～50 years old were divided into 100mg,200mg,300mg,400mg,500mg,600mg,700mg and 800mg groups respectively to have single-dose test.10 healthy voluntee rs were selected in multi-dose test.Clinical symptoms,vital signs,routine blood tests,routine urine tests,hepatic function,renal function,clotting function,blood electrolytes,electrocardiogram,electroencephalogram were observed or examined before and after administration.Results It was shown that after single-dose intravenous infusion from 100mg to 800mg of gatifloxacin methanesulfonate,the vital signs,clinical symptoms and laboratory tests were mainly in the normal range,only 3 cases of ADRs were found after drug administration,such as pruritus,rash or light increase of GOT or GPT increasing slightly.After multi-dose intravenous infusion of 400mg gatifloxacin,the vital signs,clinical symptoms and laboratory tests were mainly in the normal range,but there were some slight ADRs that were concerned with the drug,such as GOT,GPT or GGT increasing,but the ADRs were found vanishing in one week.Conclusion Chinese healthy volunteers treated by intravenous infusion from 100mg up to 800mg of gatifloxacin methanesulfonate were safe and tolerable.The dosing schedule of 400mg,once daily of gatifloxacin methanesulfonate is recommended in further clinical therapy.
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