健康志愿者静滴甲磺酸加替沙星氯化钠注射液耐受性研究

The clinical tolerance of gatifloxacin mesilate after intravenous infusion in Chinese health volunteers

目的 :在中国健康成年志愿者中评价单次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 1 8～ 5 0岁健康成人 ,用区组随机化设计方法 ,将受试者随机分为 1 0 0 ,2 0 0 ,30 0 ,4 0 0 ,5 0 0 ,6 0 0 ,70 0 ,80 0mg剂量组。观察临床症状体征并严密观察记录试验期间发生的不良事件。结果 :各组受试者体检及实验室检查各项指标均在正常范围 ,具较好可比性。给药后生命体征和各种实验室检查等未见有临床意义的改变。试验中未见严重不良反应。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 80 0mg,比较安全 ,耐受性较好。推荐临床使用剂量为每次 4 0 0mg,qd。

OBJECTIVE To evaluate the safety and tolerance of gatifloxacin mesilate in Chinese healthy volunteers treated by single dose intravenous infusion. METHODS The clinical trial protocol was designed according to the Good Clinical Practice and passed by the ethics committee. It's necessary that all volunteers sign the informed consent. The 48 selected healthy volunteers of 18～50 years old were divided into 100,200,300,400,500,600,700 and 800 mg groups respectively by Latin method. Clinical symptoms were observed or examined before and after single dose intravenous infusion of gatifloxacin mesilate. RESULTS After single dose intravenous infusion from 100mg to 800 mg of gatifloxacin mesilate for the volunteers, the clinical symptoms were observed. The laboratory testing results were in the normal range, no serious ADRs were found, which were involved in the drug during the trial. CONCLUSIONS The single dose intravenous infusion to the Chinese healthy volunteers up to 800 mg of gatifloxacin mesilate is safe and tolerable.The dosing schedule of 400 mg /d of gatifloxacin mesilate,once a day, is recommended for clinical therapy.