ABSTRACT
Objetivo: identificar a melhoria por meio da gestão de risco aplicada aos processos de aquisição e distribuição de insulinas humanas NPH. Método: O estudo foi realizado por etapas: em 1º momento foram realizadas reuniões (Brainstorming) e em 2º momento foi elaborado um formulário eletrônico em forma de questionário sendo mostrado os "eventos" de riscos com os pesos inerentes à probabilidade e ao impacto que geraram o risco inerente aos processos de aquisição e distribuição de insulinas humanas NPH e Regular pelo Ministério da Saúde. Resultados: Considerando os processos houve maior incidência de riscos médios. Não foi apontado risco muito baixo, não foi identificado risco extremo e foram apresentados apenas 02 (dois) riscos altos. Conclusão: A gestão de risco do referido estudo é uma ferramenta de melhoria para os processos de aquisição e distribuição de insulinas humanas NPH e Regular pelo Ministério da Saúde.(AU)
Objective: to identify improvement through risk management applied to the acquisition and distribution processes of NPH human insulins. Method: The study was carried out in stages: in the 1st moment, meetings were held (Brainstorming) and in the 2nd moment, an electronic form was elaborated in the form of a questionnaire, showing the risk "events" with the weights inherent to the probability and impact they generated the risk inherent in the acquisition and distribution processes of NPH and Regular human insulins by the Ministry of Health. Results: Considering the processes, there was a higher incidence of medium risks. No very low risk was indicated, no extreme risk was identified and only 02 (two) high risks were presented. Conclusion: The risk management of the aforementioned study is an improvement tool for the processes of acquisition and distribution of NPH and Regular human insulins by the Ministry of Health.(AU)
Subject(s)
Risk Management , Unified Health System , Insulin, Regular, Human , Insulin, IsophaneABSTRACT
Background: Type 2 Diabetes Mellitus is an emerging pandemic with number of patients increasing rapidly in both developed and developing nations. In patients with secondary failure of type 2 diabetes after oral hypoglycaemic agents (OHAs), Insulin is the treatment, which is available in various forms with respect to viable duration of action. Basal Insulins or background insulins are used commonly either alone or with short acting insulins. NPH insulin is intermediate acting insulin given once or twice daily whereas Glargine is long acting insulin given once daily. Methods: In this study, 120 patients of type 2 diabetes mellitus already on oral hypoglycaemic agents who were not optimally controlled with combination of 2 or 3 oral hypoglycaemic agents were included after excluding patients of Type 1 diabetes, gestational diabetes and those who were newly diagnosed or already on insulin therapy. Patients were divided into 2 groups of 60 patients each. Group A were put on NPH insulin and Group B on Glargine insulin for 12 weeks. Along with parameters of diabetes and side effects were compared with special reference to early morning hypoglycaemia (at 3 am).Results: Mean reduction in fasting blood glucose was 54.42 mg/dl in Group A as compared to 66.62 mg/dl in Group B, which was statistically significant with a p value < 0.0001. Regarding hypoglycaemia it was seen in 31.67% in Group A vs. 11.67% in Group B and was significant (p=0.0078). Nocturnal hypoglycaemia was also seen to be more in Group A than Group B with values of 21.67% and 5% respectively, which was significant. There was no significant difference in daily dose requirement. Conclusion: This study showed that Insulin Glargine was better than Insulin NPH in terms of glycemic control and less side effects with respect to hypoglycemic events and nocturnal hypoglycemia with no significant difference in daily dose requirements.
ABSTRACT
ABSTRACT Objective To compare the effects of the neutral protamine Hagedorn (NPH) recombinant human insulin formulations Gansulin and Humulin N® on the glycemic control of patients with type 2 diabetes mellitus (T2DM). Subjects and methods Prospective, double-blind, randomized, parallel, single-center study of 37 individuals with T2DM treated with NPH insulin formulations. The Tukey-Kramer test for multiple comparisons, the Wilcoxon paired comparison test and the Chi-Square test were used for the statistical analyses. The significance level was set at 5% (p < 0.05). Results The NPH insulin formulations Humulin and Gansulin similarly reduced the HbA1c levels observed at the end of the study compared with the values obtained at the beginning of the study. In the Humulin group, the initial HbA1c value of 7.91% was reduced to 6.56% (p < 0.001), whereas in the Gansulin group, the reduction was from 8.18% to 6.65% (p < 0.001). At the end of the study, there was no significant difference between the levels of glycated hemoglobin (p = 0.2410), fasting plasma glucose (FG; p = 0.9257) and bedtime plasma glucose (BG; p = 0.3906) between the two insulin formulations. There was no nt difference in the number of hypoglycemic events between the two insulin formulations, and no severe hyp episodes were recorded. Conclusion This study demonstrated similar glycemic control by NPH insulin Gansulin compared with human insulin Humulin N® in patients with T2DM.
Subject(s)
Adult , Female , Humans , Male , Middle Aged , /drug therapy , Hypoglycemic Agents/therapeutic use , Isophane Insulin, Human/therapeutic use , Blood Glucose/analysis , Chemistry, Pharmaceutical , Double-Blind Method , Glycated Hemoglobin/analysis , Hypoglycemia/chemically induced , Hypoglycemic Agents/economics , Insulin, Regular, Human/therapeutic use , Isophane Insulin, Human/economics , Prospective Studies , Recombinant Fusion Proteins , Statistics, Nonparametric , Treatment OutcomeABSTRACT
Objetivo: Evaluar comportamiento de hemoglobina glicosilada (HbA1c) y frecuencia de hipoglicemias sintomáticas con esquema basal con insulina NPH comparado con insulina glargina en diabéticos tipo 2 (DM2), atendidos en un programa de riesgo cardiovascular. Materiales y métodos: Estudio observacional de cohorte retrospectivo. Se revisaron 613 historias clínicas de pacientes con DM2 manejados con esquema basal con insulina NPH o glargina, de los cuales 76 cumplieron los criterios de inclusión. Se revisó historia clínica al momento de inclusión (consulta No. 1), a los seis (consulta No. 2) y a los doce meses (consulta No. 3). Resultados: Se analizaron 13 pacientes del grupo glargina y 63 del grupo NPH (edad 64,9 [± 10,9 años], 54 porciento mujeres). En la consulta No. 1 el promedio de HbA1c fue 7.8 porciento en grupo con NPH y 7.5 porciento en grupo glargina. Al final del seguimiento los niveles de HbA1c fueron 7.5 porciento en grupo NPH y 7.9 porciento en grupo glargina (p= 0.4). Los eventos de hipoglucemia fueron 3 en la primera consulta y 4 en la tercera, todos recibían NPH. En la segunda consulta se presentaron 5 eventos en pacientes con NPH y 1 caso con glargina (p=0.9). Las variables más fuertemente asociadas con niveles bajos de HbA1c fueron enfermedad renal crónica y sexo femenino. Conclusiones: Los pacientes con DM2 de este estudio no presentaron diferencia estadísticamente significativa en valores de HbA1c de acuerdo al tipo de insulina recibida.Se observó menor frecuencia de hipoglucemias en pacientes que utilizaban insulina glargina sin encontrarse diferencia estadísticamente significativa.
To evaluate performance of glycosylated hemoglobin (HbA1c) and frequencyof symptomatic hypoglycemia scheme with basal insulin glargine compared toNPH insulin in type 2 diabetics (DM2), served in a program of cardiovascularrisk. Materials and methods: Observational retrospective cohort. 613 medicalrecords of patients with DM2 managed scheme with basal insulin NPHor glargine, of which 76 met the inclusion criteria were reviewed. medicalrecords were reviewed at the time of inclusion (see No. 1), six (see No. 2)and twelve months (see No. 3). Results: 13 patients in the glargine group and63 in the NPH group (age 64.9 [± 10.9 years], 54% female) were analyzed.The consultation No. 1 mean HbA1c was 7.8% with NPH group and 7.5% inglargine group. At follow-up HbA1c levels were 7.5% in NPH group and 7.9%in glargine group (p = 0.4). Hypoglycemic events were 3 in the first visit and 4in the third, all received NPH. In the second consultation five events occurredin patients with NPH and 1 case with glargine (p = 0.9). The variables moststrongly associated with low levels of HbA1c were chronic kidney disease andwomen. Conclusions: Patients with DM2 of this study showed no statisticallysignificant difference in HbA1c values according to the type of insulinreceived. Lower frequency of hypoglycemia in patients using insulin glargineno statistically significant difference was observed.
Subject(s)
Humans , Hypoglycemia , Insulin, IsophaneABSTRACT
Objective:To observe therapeutic effects of blood glucose control by using acarbose in combination with different insulin.Method:58 patients were randomly divided into two groups treated with either insulin glargine (Lan- tus;Aventis) or human NPH insulin (Novolin;NovoNordisk).Subcutaneous injection of insulin before sleep and oral acar- bose were carried out for the treatment,which lasted three weeks.The degree of blood control,the amount of insulin used, and the cases of hypoglycemia for both groups were observed at the end of the experiments.Result:The fasting blood glu- cose showed its normal and stable result,and the average blood glucose values at different time slots per day in the group treated with insulin glarglne were lower than those in the group treated with human NPH insulin.The maximum difference of blood glucose values occurred after dinner while no significant variance appeared after breakfast and after lunch.Conclu- sion:The therapeutic effects are quite efficient and stable in controlling 24-hour blood glucose in type 2 diabetes by using acarbose in combination with either insulin glargine or human NPH insulin (Novolin;NovoNordisk).In addition,the oc- currence rates of hypoglycemia with both methods are low whereas the therapeutic effects for the first group are superior to those for the latter group.