Evaluation of the Efficacy and Safety of Semisynthetic Human Insulin in Diabetic Patients Treated Newly with Insulin:A Comparison with Purified Pork Insulin
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Patients with Type 1 and Type 2 diabetes who had never been given hsulin were treated either with semisynthetic human insulin (SHI), produced by a modification of pork insulin, or with purified pork insulin (PPI), and their efficacy, safety, and antigenicity were compared. Monotard and Actrapid insulins (Novo) were used. The choice of insulin preparations, number of insulin injections, and doses of insulin were decided by each physician. Blood and urine glucose, glycosylated hemoglobin and insulin antibodies were regularly measured.<BR>The SHI-treated patients (59 cases) and PPI-treated patients (35 cases) did not differ initially in the distribution of age, type of diabetes, fasting blood glucose, HbA<SUB>1</SUB>, obesity and diabetic complications. After 36 weeks of insulin treatment, there were no significant differences between the SHI and PPI groups in the doses of insulin, fasting blood glucose and HbA<SUB>1</SUB>. After 8 weeks of treatment, insulin antibodies began to appear in both groups. The titers of total anti-insulin antibodies increased gradually with time, while IgE antibodies were observed only temporarily in a few cases. There was no difference in antibody production between the SHI and PPI groups. No serious side effects were observed with either insulin. SHI thus appears to be as safe and as effective as PPI. A weak antigenicity was demonstrated by SHI as well as by PPI.
- 一般社団法人 日本糖尿病学会の論文
一般社団法人 日本糖尿病学会 | 論文
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