连续口服甲磺酸加替沙星片耐受性试验研究.pdfVIP

药物与临床 2003 年第 18 卷第 5 ,6 期合刊 连续 口服 甲磺酸加 替沙星片耐受性试验研 究 方 翼 王 春 装 斐 柴 栋 朱 曼 梁蓓蓓 王锡萍 解放军总医院药材处临床药理药学研究室，北京 100853 摘要 目的:在中国健康成年志愿者中评估连续 口服 甲磺酸加替沙星片的安全性、耐受性。方法:根据 GCP 原则设计试验 方案 ，选择10名18 - 40 岁健康男性受试者参加连续 口服 甲磺酸加替沙星片耐受性试验 ，口服 甲磺酸加替沙星片每次 400mg ，每 日1次，连续10 日。观察指标为临床症状、体征，包括体温、脉搏、呼吸频率、血压等，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。结果:人选受试者给药后及给药期间体征、症状及实验室检查均 未见有临床意义的改变 ，试验 中未见严重的临床不 良反应 ，有两例受试者出现 GPT, GOT 轻度升高 ，可能与药物有关 ，停药 一周后恢复正常。结论: 10名健康受试者连续次口服甲磺酸加替沙星片10 日，每 日400 mg ，可安全耐受。 关键词 甲磺酸加替沙星;连续 ;耐受性 The Study on Toler an e of Gatifloxa in Meh anesulfan ae after taking or ally mu lti 一Dosein Chin ese Health Volunteer s FANG Yi WANG Rui PEI Fei CHAI Dong ZHU Man LIANG Bei-bei WANG Xi-ping Depart ment of Clini al Pharma ology, Chinese PL4 General Hospital, Beji ing 100853 ABSTRACT Obj e tive: To evaluate the toleran e of Gatilf oxa in mehanesulfanae after taking orally multi 一dose in Chinese healthy volunteers. Methods : The proto ol was designed a ording to GCP pri n iple. After physi al examination and laboratory tests were performed, 10 volunteers ( 18 一40 years old) were invited to attend the lini al tri al that evaluate the toleran e of Gat- ilf oxa in mehanesulfanae in 400mg qd in ontinuous 10 days. Clini al symptoms, vital signs, routine blood tests, lotting fun - tion, routine uri ne tests, hepati fun tion, renal fun tion, blood ele trolytes, ele tro ardiogram, ele troen ephalogram were ob- served or examined before and after administration. Results: There were no lini al signifi ant hange in 10 volunteers before and after administration. There were no seri ous ADRs duri ng the tri al, and only 2 volunteers were found the slightly in rease of GPT and GOT whi h maybe asso iate