转化糖注射液多中心临床应用研究70例

A multiple center clinical study on invert sugar injection in 70 patients

目的 :观察转化糖注射液对各种疾病病人血糖水平的影响 ,评价转化糖注射液临床应用的有效性及安全性。方法 :采用多中心临床试验设计 ,选用 18～ 6 5α病人共 139例 ,试验组 (70例 )静脉输注转化糖注射液 5 0 0mL·d- 1,对照组 (6 4例 )静脉输注葡萄糖注射液 5 0 0mL·d- 1,疗程皆为 3～ 5d(在此期间 ,2组病人皆不输注其他含糖制剂 )。结果 :转化糖组血糖波动小于葡萄糖组 (P <0 .0 5 )。 2组病人输液前后、输液后 2h血糖水平P >0 .0 5 ,试验前后血、尿常规 ,肝、肾功能 ,血尿酸均未出现与药物相关变化。结论 :转化糖注射液具有与葡萄糖注射液相当的安全性 。

AIM: To observe the effect of invert sugar injection on blood glucose of patients, to evaluate the effect and safety on the application of invert sugar injection. METHODS: One hundred and thirty-nine patients were divided into study group and control group. Invert sugar injection were intravenously administered to study group with the dose of 500 mL·d -1 and the course of treatment was 3 d to 5 d. Glucose injection were intravenously administered to control group with the dose of 500 mL·d -1 and the course of treatment was 3 d to 5 d. The blood glucose level was detected before injection, after the injection immediately and 2 h. Blood regular test, urine test, function of liver and kidney, and uric acid of all patients were detected before and after the treatment. RESULTS: The changes of the blood glucose level of study group were lower than that of control group, the differences were significant. There were no significant differences in blood glucose level before injection, after immediate injection and 2 h between two groups. The results of blood regular test, urine test, function of liver and kidney, and uric acid had no significant change before and after the treatment in both groups. CONCLUSION: Invert sugar injection is as safe as glucose injection when appling to patients. It has slighter effect on blood glucose than glucose injection.