诺和笔3注射剂量准确度的研究

目的:研究诺和笔3使用时间对其注射剂量准确度的影响。方法:收集糖尿病患者正在使用的诺和笔3,根据已使用时间分为A组(使用时间在2年以下)、B组(使用时间2～5年)和C组(使用时间5～8年),每组6支。分别使用称重法对3组诺和笔3在注射10IU和30IU时的实际剂量进行测定,观察是否符合国际标准组织(ISO)对其准确性的要求。结果:18支笔的准确度均符合ISO的要求。注射10IU时,A、B组的绝对离差百分数相当([1.86±0.79)%vs(.1.93±0.86)%,P>0.05],2组均优于C组([3.45±1.54)%,均P<0.01]。注射30IU时,A、B、C组的绝对离差百分数相当[分别为(0.89±0.32)%、(0.87±0.65)%、(0.92±0.72)%,P>0.05]。A、B、C组注射10IU时,分别有1.8%、1.3%、2.4%的注射次数超出了ISO允许的下限,注射30IU时分别有0.6%、1.9%、1.9%超出了ISO允许的下限。结论:使用8年以下的诺和笔3其准确性仍符合标准。使用5年以上的诺和笔3注射小剂量时准确度下降。

Study of Dose Accuracy of Novo Pen 3

OBJECTIVE：To investigate the effect of using time on dose accuracy of novo pen 3 which is commonly used in the clinic. METHODS： Novo pen 3 used by diabetic patients were divided into group A （had been used blow 2 years）, group B （had been used 2～5 years）, and group C （had been used 5～8 years） with 6 novo pen 3 in each group. The dose of 10 IU and 30 IU injected by novo pen 3 in 3 groups were tested by weighing method to investigate whether the pens complied with the acceptable limits of International Organization for Standardization （ISO）. Accuracy was compared using the absolute percent difference of measured value from the target dose. RESULTS： All 18 novo pen 3 were in line with the requirement of ISO. In 10 IU, there was no difference in absolute deviation percentage between group A and B [（1.86±0.79）% vs. （1.93±0.86）%, P0.05]. They were more accurate than group C（3.45%±1.54）%, group A vs. group B, P0.01）in 10 IU. In 30 IU, there were no difference in absolute deviation percentage among 3 groups[（0.89%±0.32）%, （0.87%±0.65）%, （0.92%±0.72）%, P0.05]. For 10 IU, 1.8%, 1.3% and 2.4% of doses in group A , B and C were below the lowest limit of ISO, respectively. For 30 IU, 0.6%, 1.9% and 1.9% of doses were below the lowest limit of ISO, respectively. CONCLUSIONS： The accuracy of novo pen 3, which have been used below 8 years, is complied to requirement. Beyond 5 years, the accuracy of novo pen 3 drops for small dose injection.