肾康注射液人体耐受性临床研究

目的观察肾康注射液在人体的耐受性和安全性。方法采用随机分组的观察方法,共分6个剂量组,即单次和累积给药剂量组,其中单次给药剂量组4个,累积给药剂量组2个。单次给药剂量组观察服药24h后人体对药物的反应,累积给药剂量组连续给药7d后观察人体对药物的耐受性。结果肾康注射液用药前后比较,正常成人各项指标无明显变化,且无明显不良反应,人体可耐受,表明本药在人体使用安全。结论肾康注射液人体耐受性较好,未见明显不良反应,推荐Ⅱ期临床用量范围在80～100mL/次之间。

Clinical Study on Tolerance of Shenkang Injection on Human Body

Objective To determine the tolerance and safety of Shenkang injection on human body. Methods The healthy volunteers were divided into 6 different dose groups randomly for the clinical trial including 4 single dose groups and 2 multiple dose groups. The clinical symptoms were studied for 4 single dose groups after 24 hours for injection. The tolerance tests were given to the 2 multiple dose groups after 7-days continuous test. Shenkang injection was given by intravenous drip. The different doses of Shenkang injection were dissolved in 10%, 250 mL glucose solution. Result The comparison of before and after taking Shenkang injection and the statistical analysis showed that Shenkang injection had no obvious effect and adverse events on normal adults. Shenkang injection is tolerancable and therefore is safety to human body. Conclusion Shenkang injection was well tolerated in the tested healthy volunteers. It is recommended that the optimal dose for II clinical trial is 80-100 mLper time.