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目的评价头孢他啶/他唑巴坦(3∶1)注射剂在中国健康人体内单次及连续给药的耐受性和安全性。方法单次给药试验,用单一剂量递增方法,从1200,2400,3600,4800 mg依次进行。在前一剂量组完成观察并证实药物安全后,再进行下一个较高剂量组的试验。连续给药试验,给予头孢他啶/他唑巴坦注射剂2400 mg,每日2次,连续6 d。结果所有受试者对药物耐受良好,无不适主诉。单次给药2400 mg组有1例受试者的丙氨酸氨基转移酶(ALT)(用药前后分别是41,49,46 U.L-1)和天门冬氨酸氨基转移酶(ALT)异常(用药前后分别是50,63,55 U.L-1),单次给药4800 mg组有1例ALT升高(用药前中后分别是32,45,53 U.L-1)。连续给药组有1例AST升高(用药前中后分别是34,44,45 U.L-1),其他受试者的各项化验均正常。结论头孢他啶/他唑巴坦注射剂2400 mg,每日2次,安全耐受。
Objective To evaluate the tolerability and safety of ceftazidime / tazobactam (3: 1) injection in single and continuous administration in Chinese healthy volunteers. Methods Single-dose trials, using a single dose-escalation method, proceeded sequentially from 1200, 2400, 3600, 4800 mg. After the previous dose group completed the observation and confirmed the drug safety, the next higher dose group was tested again. Continuous administration test, given ceftazidime / tazobactam injection 2400 mg, 2 times a day for 6 days. Results All subjects were well tolerated with no complaints of discomfort. In a single dose of 2,400 mg group, 1 patient had alanine aminotransferase (ALT) (41, 49, 46 UL-1, respectively) and aspartate aminotransferase (ALT) abnormalities Before and after treatment were 50,63,55 UL-1), a single administration of 4800 mg group had 1 case of ALT increased (before and after treatment were 32,45,53 UL-1). In the continuous group, one case of AST was elevated (34, 44, 45 U.L-1 before and after treatment), and other tests were normal. Conclusion Ceftazidime / tazobactam injection 2400 mg, 2 times a day, safe and tolerable.