国产双时相低精蛋白锌人胰岛素注射液50R治疗糖尿病多中心随机开放对照临床试验

目的 比较国产与进口双时相低精蛋白锌人胰岛素注射液50R（优思灵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 自2007年9月至2008年8月,采用多中心随机开放阳性平行对照的试验设计,纳入220例糖尿病患者,采用区组随机化方法分为A组（国产药物治疗,111例）和B组（进口药物治疗,109例）.治疗12周后,观察两组空腹血糖（FBG）、餐后2 h血糖（PBG）、糖化血红蛋白（HbA1c）较基线下降情况.组间数据比较采用t检验.结果 用药12周后,A组HbA1c、FBG、PBG分别由9.3%±1.8%、（9.9±3.4）mmol/L、（16.0±4.7）mmol/L降至7.5%±1.2%、（7.6±2.1） mmol/L、（10.9±3.6） mmol/L（治疗前后比较t值分别为-11.55、-7.36、-10.12,均P〈0.05）,分别下降了1.8%、2.9 mmol/L和5.0 mmol/L;B组则分别由9.3%±1.7%、（9.9±3.0）mmol/L、（15.9±4.3） mmol/L降至7.8%±1.3%、（8.0±2.2） mmol/L、（11.4±3.9） mmol/L（治疗前后比较t值分别为-9.37、-6.91和-9.34,均P〈0.05）,分别下降了1.5%、1.9 mmol/L和4.5 mmol/L.两组间各指标比较F值分别为4.04、2.50和0.97,P值分别为0.046、0.116、0.325.两组低血糖事件发生率比较差异无统计学意义（χ^2=0.36,P=0.551）.两组均无严重不良反应事件发生.协方差分析表明,A组药物对糖尿病的效果非劣于B组药物.结论 国产双时相低精蛋白锌人胰岛素注射液50R（优思灵50R）与同种进口药物在治疗1型和2型糖尿病方面具有相当的安全性和有效性,并均有良好的耐受性.

A multicenter, randomized, open, controlled clinical trial of isophane protamine biosynthetic human insulin injection in the treatment of diabetes mellitus

Objective To evaluate the efficacy and safety of isophane protamine biosynthetic human insulin injection in the treatment of diabetes mellitus. Methods A randomized, open, Novolin 50R-controlled, and multicenter clinical trial was conducted from September 2007 to August 2008. In this study, a total of 220 patients with diabetes mellitus were enrolled and were randomly divided into two groups: group A were treated with domestic drug (Yousilin 50R, n=111), group B were treated with imported drug (Novolin 50R, n=109). The fasting blood glucose(FBG), 2-hour past-meal blood glucose(PBG), blood hematoglobin A1C(HBA1c) and complications were recorded and compared between the two groups and in the same group before and after 12-week of treatment with the experimental drugs. The t test was implied in the comparison of data between the two groups. Results After the 12-week of treatment, the levels of HBA1c, FBG and PBG in group A were all decreased significantly compared with baselines (from 9.3%±1.8%, (9.9±3.4) mmol/L, (16.0±4.7) mmol/L to 7.5%±1.2%,(7.6±2.1) mmol/L, (10.9±3.6) mmol/L, respectively; and t value was -11.55, -7.36, -10.12, respectively; all P<0.05), and decreased for 1.8%, 2.9 mmol/L and 5.0 mmol/L, respectively. And those indicators were all significantly declined too in group B (from 9.3%±1.7%, (9.9±3.0) mmol/L, (15.9±4.3)mmol/L to 7.8%±1.3%,(8.0±2.2) mmol/L, (11.4±3.9) mmol/L, respectively; and t value was -9.37, -6.91, -9.34, respectively; all P<0.05), and declined for 1.5%, 1.9 mmol/L and 4.5 mmol/L, respectively. The differences in reductions of HBA1c, FBG and PBG level between the two groups were all not statistically significant (F value was 4.04, 2.50 and 0.97, P value was 0.046, 0.1156 and 0.3248, respectively). The incidence of hypoglycemia in the tow groups was similar(χ2=0.36, P=0.551). No serious complications occurred in the two groups. Covariance analysis showed the two drugs had a similar efficacy on diabetes mellitus. Conclusion Yousilin 50R and Novolin 50R have similar efficacy and safety profiles in treating diabetes mellitus.