摘要
以美敦力公司生产的Paradigm快易达712智能胰岛素泵及附件做阳性对照,验证威高集团医用高分子制品股份有限公司开发的智能胰岛素及附件的安全性和有效性。两组均采用短效胰岛素诺和锐U100,分别对120例糖尿病患者进行治疗6天,两组受试者的血糖达标率和两组器械的安全性、临床适用性差异不显著。试验证明,山东威高集团医用高分子制品股份有限公司开发的智能胰岛素泵及附件可安全用于治疗糖尿病患者。
Positive control was put into practice by Paradigm 712 insulin pump to verify the securities and availabilities of the intelligent insulin pump and its accessories manufactured by WEGO group.Total 120 diabetcs were treated for 6 days using regular insulin arspart U100,The otherness are unconspicuous that the ratio of subjects’blood sular are up to par.diversities are also inapparent about securities and clinical applicabilities between the two groups.So then,The intelligent insulin pump and its accessories manufactured by WEGO group can be uses to treat diabetes.
出处
《中国医疗器械信息》
2011年第3期16-19,45,共5页
China Medical Device Information
关键词
糖尿病
胰岛素泵及附件
胰岛素
血糖水平
diabetes
insulin pump and its accessories
insulin
sugar content of blood
