Gumprecht Janusz, Zurawska Gajane, Wolnik Bogumił, Dzida Grzegorz
Department of Internal Diseases, Diabetology and Nephrology, Medical University of Silesia, Zabrze.
Endokrynol Pol. 2008 Nov-Dec;59(6):460-6.
Observational studies are valuable tools for assessing the applicability of results from randomised controlled trials to broader patient populations. They are especially important in chronic diseases such as diabetes, as they can provide a comprehensive picture of the safety and effectiveness of a particular therapy across cultures and phenotypes.
Patients with type 2 diabetes who required insulin and whose physician had decided to initiate biphasic insulin aspart 30 (BIAsp 30) were eligible. A total of 4117 type 2 diabetic patients were recruited to the study in Poland, and 809 primary and secondary care physicians were involved. The aim of this study was to assess the safety and effectiveness of BIAsp 30 treatment in type 2 diabetes in routine clinical practice.
Baseline glycaemic control was poor in the Polish cohort enrolled in the IMPROVE(TM) study, with a mean HbA(1c) value of 9.0 +/- 1.7%. A very high proportion of patients were thus at risk of macrovascular and microvascular complications. A twice-daily regimen for the start of BIAsp 30 therapy was the most common choice, including 72.2% of patients at baseline. HbA(1c) was significantly reduced by 1.66% for the total cohort and by 3.07% and 1.55% in the pre-study no-therapy or oral antidiabetic drug group respectively (p < 0.001). The rates (episodes per subject year) of overall major hypoglycaemia were 0.012 and 0.12 at follow-up and final visits respectively. For minor hypoglycaemia rates of 5.12 per subject per year at follow-up visit and 4.54 episodes per subject per year at final visit were recorded.
BIAsp 30 appears to be an effective and flexible treatment approach and can be safely intensified to achieve glycaemic control in a majority of patients with type 2 diabetes.
观察性研究是评估随机对照试验结果在更广泛患者群体中适用性的重要工具。它们在糖尿病等慢性疾病中尤为重要，因为它们可以全面呈现特定疗法在不同文化和表型患者中的安全性和有效性。
符合条件的患者为需要胰岛素治疗且医生决定起始门冬胰岛素30（BIAsp 30）治疗的2型糖尿病患者。波兰共有4117名2型糖尿病患者被纳入该研究，涉及809名初级和二级护理医生。本研究的目的是评估BIAsp 30治疗在2型糖尿病常规临床实践中的安全性和有效性。
参与IMPROVE(TM)研究的波兰队列患者基线血糖控制较差，平均糖化血红蛋白（HbA(1c)）值为9.0±1.7%。因此，很大比例的患者存在大血管和微血管并发症风险。BIAsp 30治疗起始时每日两次给药方案是最常见的选择，基线时72.2%的患者采用该方案。整个队列的HbA(1c)显著降低了1.66%，在研究前未治疗组和口服降糖药组分别降低了3.07%和1.55%（p<0.001）。随访和末次访视时总体严重低血糖发生率（每患者年发作次数）分别为0.012和0.12。随访时轻度低血糖发生率为每年每患者5.12次，末次访视时为每年每患者4.54次。
BIAsp 30似乎是一种有效且灵活的治疗方法，在大多数2型糖尿病患者中可安全强化治疗以实现血糖控制。
