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目的:评价中国健康成年志愿者连续静脉滴注乳酸卡德沙星注射液的安全性和耐受性。方法:2009年4至7月选出12名健康成年志愿者纳入试验,其中男、女各6名,年龄25~35岁,平均(31.8±2.8)岁,体重指数(BMI)为19.8~24.1(22.2±1.3)kg/m2。给予乳酸卡德沙星氯化钠注射液400 mg,2 h内恒速静脉滴注,1次/d,共用药7 d。观察记录受试者的生命体征和出现的不良反应,测定血、尿常规和血生化指标,重点监测每天给药前1 h和给药开始后3、6 h的QT间期、校正QT(QTc)间期的变化以及给药开始后第3、5、8天葡萄糖耐量试验变化。结果:除1名受试者给药第3天因月经期停药外,11名受试者完成7 d连续给药。受试者的体温、脉搏、呼吸频率和血压等生命体征给药后均在正常值范围。出现的7例次不良反应中,其中5例次甘油三酯(TG)水平和1例次总蛋白(TP)水平轻度升高,1例次短暂血糖降低(2.96 mmol/L);7例次的不良反应经分析可能与药物无关。有1名受试者给药开始后第2、5、8天白细胞(WBC)计数分别为2.75×109/L、3.07×109/L和2.95×109/L,中性粒细胞(N)分别为0.39、0.33、0.39,均低于正常值,停药后2 d恢复正常,可能与药物相关。受试者的天冬氨酸氨基转移酶(AST)、总胆红素(TB)和尿素(Urea)连续给药的7 d中个别日间值差异有统计学意义(均P<0.05),但无临床意义。给药第2、3、4、7天,给药后QT间期较给药前有所延长,但QTc间期绝对值<450 ms,未见有临床意义的异常改变。给药开始后第5天11名受试者空腹血糖为(4.21±0.35)mmol/L,低于给药前1 d[(4.74±0.59)mmol/L],给药开始后第3、5天餐后1 h血糖为(6.20±1.58)、(6.07±1.19)mmol/L,均低于给药前1 d[(8.47±2.51)mmol/L],虽然差异有统计学意义(P<0.05),但均无临床意义。其他血、尿常规及血生化指标给药前后均无明显变化。结论:乳酸卡德沙星注射液连续静脉滴注,有良好的耐受性及安全性。
OBJECTIVE: To evaluate the safety and tolerability of continuous intravenous drip-laction of cadafloxacin lactate in healthy volunteers in China. METHODS: Twelve healthy adult volunteers were recruited from April to July in 2009, including 6 males and 6 females aged 25-35 years with an average of (31.8 ± 2.8) years and a body mass index (BMI) of 19.8-24.1 (22.2 ± 1.3) kg / m2. Give lactic acid carbexacin sodium chloride injection 400 mg, 2 h constant speed intravenous infusion, 1 / d, a total of 7 d. The vital signs and adverse reactions of the subjects were observed and recorded. The blood, urine and blood biochemical parameters were measured. The QT interval of 1 h before administration and 3 h and 6 h after the start of administration were monitored. QTc ) And the changes of glucose tolerance test on the 3rd, 5th, 8th days after the start of administration. RESULTS: Eleven subjects completed consecutive 7-day dosing except one subject whose medication was discontinued on menstrual flow on the third day. The subject’s body temperature, pulse, respiratory rate and blood pressure and other vital signs after administration in the normal range. Among the seven adverse reactions, 5 cases had mild triglyceride (TG) and 1 case TP (TP), one case had transient hypoglycemia (2.96 mmol / L), and 7 cases Secondary adverse reactions may have nothing to do with the analysis. The number of white blood cells (WBC) on the 2nd, 5th, and 8th day after the start of administration in one subject was 2.75 × 109 / L, 3.07 × 109 / L and 2.95 × 109 / L respectively, and neutrophils 0.39,0.33,0.39, were lower than normal, returned to normal 2 d after stopping, may be related to drugs. There were significant differences in the individual daytime values of aspartate aminotransferase (AST), total bilirubin (TB) and urea in the 7th day of continuous administration (all P <0.05) But no clinical significance. On the 2nd, 3rd, 4th and 7th days after administration, the QT interval after administration was longer than that before administration, but the absolute value of QTc interval was <450 ms. There was no clinically significant abnormal changes. The fasting blood glucose of 11 subjects was (4.21 ± 0.35) mmol / L on the fifth day after the start of administration, which was lower than that on the first day before administration [(4.74 ± 0.59) mmol / L] The blood glucose was (6.20 ± 1.58) and (6.07 ± 1.19) mmol / L at 1 hour after day feeding, respectively, which were all lower than those on the 1st day before administration [(8.47 ± 2.51) mmol / L] 0.05), but no clinical significance. Other blood, urine and blood biochemical indicators before and after administration had no significant change. Conclusion: Continuous injection of lactic acid carbefloxacin injection has good tolerability and safety.