根据新的ISO 11608-1:2012要求，两种一次性胰岛素笔的给药准确性
Dosing Accuracy of Two Disposable Insulin Pens According to New ISO 11608-1: 2012 Requirements.
作者信息
Abdel-Tawab Mona, Schmitz Mario, Kamlot Stefan, Schubert-Zsilavecz Manfred
机构信息
Central Laboratory of German Pharmacists, Eschborn, Germany
sanofi-aventis Deutschland GmbH, Site Frankfurt Devices, Frankfurt, Germany.
出版信息
J Diabetes Sci Technol. 2015 Jul 17;10(1):157-61. doi: 10.1177/1932296815595983.
OBJECTIVE
The aim was to compare 2 disposable insulin pens, FlexTouch® (Novo Nordisk, insulin aspart) and SoloSTAR® (Sanofi, insulin glulisine), according to new ISO 11608-1:2012 requirements for dosing accuracy.
METHODS
Sixty pens of each type were tested at 1, 40, and 80 U doses. Following the new ISO requirements, each dose was delivered from the front, middle, and rear one-third of the pen. Statistical analysis was performed using Student's t test.
RESULTS
Both pens delivered all doses within ISO limits. The difference between the average measured dose and the target dose was significantly smaller for SoloSTAR than FlexTouch at 40 U (P = .009) and 80 U (P = .008), but not at 1 U (P = .417).
CONCLUSION
Both insulin pens fulfilled the dosing accuracy requirements defined by ISO 11608-1:2012 at all 3 dosage levels.
目的
根据ISO 11608-1:2012关于给药准确性的新要求，比较两种一次性胰岛素笔，即诺和锐特充（诺和诺德公司，门冬胰岛素）和优伴笔®（赛诺菲公司，赖脯胰岛素）。
方法
每种类型的60支笔分别在1、40和80单位剂量下进行测试。按照新的ISO要求，每个剂量从笔的前三分之一、中间三分之一和后三分之一处注射。采用学生t检验进行统计分析。
结果
两种笔的所有剂量均在ISO限度内。在40单位（P = 0.009）和80单位（P = 0.008）时，优伴笔®的平均测量剂量与目标剂量之间的差异显著小于诺和锐特充，但在1单位时差异不显著（P = 0.417）。
结论
两种胰岛素笔在所有3个剂量水平上均符合ISO 11608-1:2012规定的给药准确性要求。
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