Study on Testing Methods of Pen-injector's Dosing Accuracy / 中国医疗器械杂志

OBJECTIVE@#An accuracy test method is proposed to reduce the amount of reagents used in the test and reduce the cost of spot checks and self-tests.@*METHODS@#According to the requirements of dose accuracy test in standard atmospheric conditions in ISO 11608-1:2014, dose accuracy test is carried out for the same batch of reusable pen injector samples by using the test method proposed in this paper and the test method in relevant foreign research, and the data measured by the two methods are processed.@*RESULTS@#After experimental testing and analysis, the data measured by the two methods did not exceed the dose accuracy limit specified in the ISO standard. There was no significant difference between the two methods when the dose of 60 U and 30 U were tested, but there was significant difference when the dose of 1 U was tested.@*CONCLUSIONS@#Both methods can be used to evaluate dose accuracy, however, the method proposed in this paper can reduce the usage of drugs by 2/3, so it can reduce cost of supervised test.

OBSERVATION OF INSULIN INTENSIVE THERAPY BY INSULIN PEN INJECTORS ON IDDM PATIENTS / 中华内分泌代谢杂志

Seven cases of unstable Type 1 diabetic patients were treated with IIT (intensive insulin therapy) -multi-injection insulin regimen. The short-acting insulin (Actrapid HM) administered by insulin-pen injector (NOVO-Pen 1) before meals as meal-related incremental insulin. The long-acting insulin (Ultratard HM) injected at 10 p.m. as basal insulin. After run-in period of 4 weeks then the IIT-period ran for 12 weeks. The results showed that the mean fasting/post-prandial glucose concentration was normalized from 10.6?2.5/16.2?3.9 mmol/L to6.5?0.9/7.0?2.2mmol/L. The mean HbA, fell from 10.2% to 8.2% (normal 6-8%) during the three months period. It can be concluded that the IIT-multi-injecdon insulin regimen improves metabolic control. The NOVO-Pen seems to be better than the traditional syringe as besides its painless injection, it is easy to use and carry; thus makes the multiple injection regimen more attractive.