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二相性インスリンアナログ製剤(ノボラピッド(R)30ミックス,以下30ミックス)により,ヒトインスリン混合製剤30Rと同等の血糖コントロールが達成されることが示されている.今回は,ヒトインスリン混合製剤のうち40Rまたは50Rにて1日2回注射施行中の2型糖尿病患者8例を対象に,30ミックス1日2回食直前注射への切り換えを実施し,24週間経過を観察した.また同様に30Rから切り換えた症例ついても経過観察を行い,比較検討した.その結果,両群ともにHbA1C値に大きな変動を認めず,低血糖の発生頻度も増加しなかった.40Rまたは50Rからの切り替え症例では,30Rからの切り替え症例よりもインスリン投与量は増加していたが,SMBGを実施している5例の検討では血糖日内変動が改善していた.30ミックスは食直前投与となるメリットがあり,速効型を多く含むヒトインスリン混合製剤を必要とする患者に対しても,選択肢のひとつとなりうると考えられる.
To evaluate the efficacy and safety of biphasic insulin aspart 30(NovoRapid(R) 30 Mix),we conducted an open-labeled clinical study using biphasic insulin aspart 30 for 24 weeks of treatment in 8 Type 2 diabetic patients who had been treated with biphasic human insulin 40R or 50R. As a control group,patients who had been treated with biphasic human insulin 30R and switched to biphasic insulin aspart 30 were also observed. The changes in HbA1C,casual blood glucose,body weight,insulin dosage and results of self monitoring of blood glucose(SMBG)from baseline to endpoint(24 weeks)were evaluated.
Regarding HbA1C,casual blood glucose and body weight,there were no statistically significant changes after 24 weeks of treatment with biphasic insulin aspart 30. Total daily insulin dose significantly increased from baseline to endpoint(p<0.0005). In 5 patients in whom SMBG data were available,averages of blood glucose level before breakfast and dinner were significantly improved. Frequency of minor hypoglycemic episodes did not increase during the treatment period.
In conclusion,twice daily biphasic insulin aspart 30 had comparable efficacy and safety switching from biphasic human insulin 40R or 50R. Therefore,twice daily biphasic insulin aspart 30 can be considered as an alternative treatment in Type 2 diabetic patients treated with biphasic human insulin 40R or 50R,because biphasic insulin aspart 30 has the advantage of meal time dosing.
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