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首页> 外文期刊>Clinical drug investigation >Biphasic Insulin Aspart in Type 2 Diabetes Mellitus: An Evidence-Based Medicine Review
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Biphasic Insulin Aspart in Type 2 Diabetes Mellitus: An Evidence-Based Medicine Review

机译：2型糖尿病中的双相胰岛素门冬：循证医学综述。

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The efficacy benefits of biphasic insulin aspart formulation (BIAsp 30) in patients with diabetes mellitus have been reported in several studies. BIAsp 30 has been shown to be more effective in terms of glycaemic control than standard biphasic human insulin 30 (BHI 30). In addition to gauging the treatment in terms of clinical evidence of benefits provided, it is also important to evaluate the strength of the evidence supporting the therapeutic improvements offered by BIAsp 30. In this paper, we evaluated the strength of the available data that relate to the use of BIAsp 30 in the treatment of patients with type 2 diabetes based on a comprehensive literature review. Selected publications that provided relevant data were obtained via a literature search and from the manufacturer, Novo Nordisk. These were graded in terms of the strength of the evidence they provided using the Oxford Centre for Evidence-Based Medicine (CEBM) system in the following categories: (i) twice-daily use versus basal insulin; (ii) twice-daily use versus other treatments; (iii) once-daily use; (iv) thrice-daily use; (v) use in combination with thiazolidinediones; and (vi) use in comparison with BHI 30. A total of 30 publications for BIAsp 30 were identified and graded. For the majority of categories (four out of six), the evidence supporting the use of BIAsp 30 was given an overall CEBM grade of A (highest quality); evidence supporting clinical efficacy in the other two categories (twice-daily use versus basal insulin and thrice-daily BIAsp 30 administration) was graded B. In most of the studies examined, the efficacy of BIAsp 30 was evaluated in terms of glycaemic control (glycosylated haemoglobin [HbA_(1c)] reduction, proportion of patients achieving HbAic target of <6.5% or < 7%, fasting blood glucose, blood glucose profile and/or prandial and postprandial glucose increments). In some studies, efficacy was further evaluated using plasma insulin and glucose infusion rates, plasma C-peptide levels, mean serum fructosamine levels, postprandial hyperlipidaemia, overall well-being, treatment satisfaction and quality of life. Safety was evaluated using physical and laboratory investigations and assessment of incidence of adverse events, including, in many of the studies reviewed, specific evaluation of those events known to be associated with antidiabetic treatment, hypoglycaemia and weight gain. Strong evidence was provided for better glycaemic control with BIAsp 30 without increases in the incidence of major hypoglycaemia or nocturnal hypoglycaemic episodes. Overall, weight gain with BIAsp 30 was minimal and not significantly greater than with basal insulin or BHI 30. Thus, we can confirm that the reported efficacy and tolerability of BIAsp 30 in the treatment of diabetes based on a variety of clinical endpoints is supported by a good body of evidence relating to its use in different dosage regimens and in comparison with other insulin treatment regimens.
机译：在几项研究中已经报道了双相门冬胰岛素制剂（BIAsp 30）对糖尿病患者的疗效。在血糖控制方面，BIAsp 30已显示出比标准双相人胰岛素30（BHI 30）更有效。除了根据所提供益处的临床证据来衡量治疗之外，评估支持BIAsp 30提供的治疗改进证据的强度也很重要。在本文中，我们评估了与以下方面相关的可用数据的强度：基于全面的文献综述，BIAsp 30在治疗2型糖尿病患者中的应用。提供相关数据的某些选定出版物是通过文献检索和制造商Novo Nordisk获得的。根据使用牛津循证医学中心（CEBM）系统提供的证据强度，对这些等级进行了分级：（i）每天两次使用基础胰岛素。 （ii）每日两次与其他治疗相比; （iii）每天使用一次; （iv）每天三次使用; （v）与噻唑烷二酮组合使用; （vi）与BHI 30进行比较。总共对BIAsp 30的30种出版物进行了鉴定和分级。对于大多数类别（六分之四），支持使用BIAsp 30的证据的CEBM总体等级为A（最高质量）;支持其他两类临床疗效的证据（每天两次使用对比基础胰岛素和三次BIAsp 30每天给药）被定为B级。在所检查的大多数研究中，BIAsp 30的疗效均从血糖控制（糖基化）评估血红蛋白[HbA_（1c）]降低，达到HbAic目标<6.5％或<7％，空腹血糖，血糖状况和/或餐后和餐后血糖增加的患者比例）。在一些研究中，使用血浆胰岛素和葡萄糖输注速率，血浆C肽水平，平均血清果糖胺水平，餐后高脂血症，整体健康状况，治疗满意度和生活质量进一步评估了疗效。通过物理和实验室调查以及不良事件发生率的评估来评估安全性，包括在许多回顾的研究中，对已知与抗糖尿病治疗，低血糖和体重增加有关的那些事件进行特定评估。有力的证据证明BIAs​​p 30可以更好地控制血糖，而不会增加主要低血糖或夜间低血糖发作的发生率。总体而言，BIAsp 30的体重增加极小，且不比基础胰岛素或BHI 30明显增加。因此，我们可以证实，BIAsp 30在多种临床终点基础上治疗糖尿病的报道的疗效和耐受性得到了以下方面的支持：与在不同剂量方案中的使用以及与其他胰岛素治疗方案相比的大量证据。

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