摘要
目的多中心、随机、开放、平行、阳性药物对照的三期临床研究比较两种预混人胰岛素(甘舒霖50R与诺和灵50R)治疗1型和2型糖尿病的有效性和安全性。方法拟入选480例1型和2型糖尿病患者,按3∶1的比例随机进入甘舒霖50R组(360例)或诺和灵50R组(120例),比较治疗12周前后受试者HbA1c、FPG、2hPG水平以及低血糖事件和不良事件的发生率。结果治疗12周后,甘舒霖50R组与诺和灵50R组HbA1c分别下降了0.91%和0.92%,FPG分别从10.05mmol/L和10.20mmol/L降至8.44mmol/L和8.64mmol/L,2hPG分别从14.72mmol/L和15.35mmol/L降至11.38mmol/L和11.81mmol/L。两组各指标治疗前后比较P均<0.01,但组间比较差异均无统计学意义(P均>0.05)。两组低血糖事件(31.94%和30.25%)、夜间低血糖事件(13.33%和12.61%)及不良事件发生率(19.17%和23.53%)差异均无统计学意义(P均>0.05)。结论诺和灵50R与甘舒霖50R在治疗1型和2型糖尿病方面有相同的安全性和有效性,并均有良好的耐受性。
Objective A multicenter, randomized, opened and controlled clinical trial was performed to compare the efficacy and safety of Gansulin 50R and Novolin 50R in type 1 and type 2 diabetes. Methods 480 cases were randomized into two groups（3 ： 1）treated with Gansulin 50R versus Novolin 50R for 12 weeks respectively. Results Compared with pretreatment,at the endof 12 weeks ＇ treatment , the decreased values of HbA1c（0.91% vs 0.94%）, FPG（1.56 mmol/L vs 1.61 retool/L） and 2hPG （3.35 mmol/L vs 3.53 mmol/L） were all proved significantly in both Gansulin 50R group and Novolin 50R group（all P〈0. 05）. And the changes of HbA1c from baseline to endpoint were similar between the two treatment groups （P〉0.05）. Overall, all adverse events, including hypoglycemic events and the incidence of nocturnal hypoglycemia were similar between both groups （P 〉 0.05）. Conclusions Gansulin 50R and Novolin 50R have similar efficacy and salty profiles in the treatment of diabetic patients.
出处
《中国糖尿病杂志》
CAS
CSCD
北大核心
2008年第10期629-632,共4页
Chinese Journal of Diabetes
