本文選題：鹽酸索西沙星 + 單次口服��； 參考：《中國臨床藥理學雜志》2015年16期

【摘要】：目的評價健康受試者單次口服不同劑量鹽酸索西沙星的安全性和耐受性。方法 72名受試者隨機進入7個遞增劑量組,50 mg劑量組8人(受試制劑與安慰劑比為3∶1),予以鹽酸索西沙星50 mg;100,200,300 mg劑量組各10人(受試制劑與安慰劑比為4∶1),分別予以鹽酸索西沙星100,200,300 mg;400,600 mg劑量組各12人(受試制劑與安慰劑比為2∶1),分別予以鹽酸索西沙星400,600 mg;800 mg劑量組10人(受試制劑與安慰劑比為3∶2),予以鹽酸索西沙星800 mg。用藥后觀察受試者的生命體征,定時進行實驗室檢查、心電圖和腦電圖描記。結(jié)果 72名受試者全部完成了研究,400 mg劑量組1例受試者在服藥第3天左踝部碰傷,伴肌酸激酶升高,與研究藥物無關;600 mg劑量組出現(xiàn)1例輕度頭暈,800 mg劑量組2例受試者出現(xiàn)輕度惡心,與研究藥物可能有關。其他受試者無不良事件。結(jié)論在50~800 mg劑量范圍內(nèi)單次口服鹽酸索西沙星耐受性良好。
[Abstract]:Objective to evaluate the safety and tolerance of a single oral dose of Sosifloxacin hydrochloride in healthy volunteers. Methods Seventy-two subjects were randomly assigned to 7 incremental dose groups with a dose of 50 mg (the ratio of the test preparation to the placebo was 3: 1), and 10 subjects were given Sosifloxacin hydrochloride 50 mg / L 100200300 mg / mg group (the ratio of the test preparation to the placebo was 4: 1). 12 patients in each group were given Soxifloxacin hydrochloride 100200300 mg / kg 400600mg group (the ratio of test preparation to placebo was 2: 1), and 10 patients were given Sosifloxacin hydrochloride 400600 mg / L 800mg / mg group (the ratio of test preparation to placebo was 3: 2) and the dose of Sosifloxacin hydrochloride was 800mg / g. After medication, the vital signs of the subjects were observed, laboratory examination, electrocardiogram and electroencephalography were performed regularly. Results all 72 subjects completed the study. One patient in the 400mg group was injured in the left malleolus on the 3rd day, accompanied by the increase of creatine kinase. There was 1 case of mild dizziness in the 600mg group and 2 subjects in the 800mg group had mild nausea, which might be related to the drug study. Other subjects had no adverse events. Conclusion Susifloxacin hydrochloride has good tolerance in the dose range of 50 mg / 800 mg.
【作者單位】： 北京大學第一醫(yī)院臨床藥理研究所;浙江醫(yī)藥股份有限公司新昌制藥廠;
【分類號】：R969.1

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