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首页> 外文期刊>Annals of Internal Medicine >Systematic Review: Comparative Effectiveness and Safety of Premixed Insulin Analogues in Type 2 Diabetes
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Systematic Review: Comparative Effectiveness and Safety of Premixed Insulin Analogues in Type 2 Diabetes

机译：系统评价：2型糖尿病中预混胰岛素类似物的比较有效性和安全性

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Background: Evidence comparing premixed insulin analogues (a mixture of rapid-acting and intermediate-acting insulin analogues) with other antidiabetic agents is urgently required to guide appropriate therapy. nnPurpose: To summarize the English-language literature on the effectiveness and safety of premixed insulin analogues compared with other antidiabetic agents in adults with type 2 diabetes. nnData Sources: The authors searched MEDLINE, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials from inception to February 2008 and sought unpublished data from the U.S. Food and Drug Administration, European Medicines Agency, and industry. nnStudy Selection: Studies with control groups that compared premixed insulin analogues with another antidiabetic medication in adults with type 2 diabetes. nnData Extraction: 2 reviewers using standardized protocols performed serial abstraction. nnData Synthesis: Evidence from clinical trials was inconclusive for clinical outcomes, such as mortality. Therefore, the review focused on intermediate outcomes. Premixed insulin analogues were similar to premixed human insulin in decreasing fasting glucose levels, hemoglobin A1c levels, and the incidence of hypoglycemia but were more effective in decreasing postprandial glucose levels (mean difference, −1.1 mmol/L; 95% CI, −1.4 to −0.7 mmol/L [−19.2 mg/dL; 95% CI, −25.9 to −12.5 mg/dL]). Compared with long-acting insulin analogues, premixed insulin analogues were superior in decreasing postprandial glucose levels (mean difference, −1.5 mmol/L; CI, −1.9 to −1.2 mmol/L [−27.9 mg/dL; CI, −34.3 to −21.5 mg/dL]) and hemoglobin A1c levels (mean difference, −0.39% [CI, −0.50% to −0.28%]) but were inferior in decreasing fasting glucose levels (mean difference, 0.7 mmol/L; CI, 0.3 to 1.0 mmol/L [12.0 mg/dL; CI, 6.0 to 18.1 mg/dL]) and were associated with a higher incidence of hypoglycemia. Compared with noninsulin antidiabetic agents, premixed insulin analogues were more effective in decreasing fasting glucose levels (mean difference, −1.1 mmol/L; CI, −1.7 to −0.6 mmol/L [−20.5 mg/dL; CI, −29.9 to −11.2 mg/dL]), postprandial glucose levels (mean difference, −2.1 mmol/L; CI, −3.4 to −0.8 mmol/L [−37.4 mg/dL; CI, −61.0 to −13.7 mg/dL]), and hemoglobin A1c levels (mean difference, −0.49% [CI, −0.86% to −0.12%]) but were associated with a higher incidence of hypoglycemia. nnLimitations: The literature search was restricted to studies published in English. Data on clinical outcomes were limited. The small number of studies for each comparison limited assessment of between-study heterogeneity. nnConclusion: Premixed insulin analogues provide glycemic control similar to that of premixed human insulin and may provide tighter glycemic control than long-acting insulin analogues and noninsulin antidiabetic agents.
机译：背景：迫切需要将预混胰岛素类似物（速效和中效胰岛素类似物的混合物）与其他抗糖尿病药进行比较的证据，以指导适当的治疗。目的：总结关于预混合胰岛素类似物与其他抗糖尿病药相比在2型糖尿病成人中的有效性和安全性的英文文献。 nn数据来源：作者从MEDLINE，EMBASE，CINAHL和Cochrane对照试验中央注册簿开始搜索，直到2008年2月，并从美国食品和药物管理局，欧洲药品管理局和工业界寻求未发表的数据。 nn研究选择：与对照组进行的研究比较了成人2型糖尿病患者中预混合的胰岛素类似物与另一种抗糖尿病药物的比较。 nn数据提取：2位审阅者使用标准化协议执行了串行抽象。 nn数据综合：临床试验的证据尚无临床结果，例如死亡率。因此，审查重点放在中间结果上。预混胰岛素类似物在降低空腹血糖水平，血红蛋白A1c水平和低血糖发生率方面与预混人胰岛素相似，但在降低餐后血糖水平方面更有效（平均差，-1.1 mmol / L； 95％CI，-1.4至-0.7 mmol / L [-19.2 mg / dL； 95％CI，-25.9至-12.5 mg / dL]）。与长效胰岛素类似物相比，预混胰岛素类似物在降低餐后血糖水平方面具有优越性（平均差异为-1.5 mmol / L； CI为-1.9至-1.2 mmol / L [-27.9 mg / dL； CI为-34.3- -21.5 mg / dL]）和血红蛋白A1c水平（平均差异，-0.39％[CI，-0.50％至-0.28％]），但空腹血糖水平下降较差（平均差异，0.7 mmol / L； CI，0.3）至1.0 mmol / L [12.0 mg / dL； CI为6.0至18.1 mg / dL]），且与低血糖发生率较高相关。与非胰岛素抗糖尿病药相比，预混胰岛素类似物在降低空腹血糖水平方面更有效（平均差异为-1.1 mmol / L； CI为-1.7至-0.6 mmol / L [-20.5 mg / dL； CI为-29.9至-餐后血糖水平（均值差，-2.1 mmol / L； CI，-3.4至-0.8 mmol / L [-37.4 mg / dL； CI，-61.0至-13.7 mg / dL]），和血红蛋白A1c水平（平均差异为-0.49％[CI，-0.86％至-0.12％]），但与低血糖发生率较高相关。 nnLimitations：文献检索仅限于以英语发表的研究。有关临床结果的数据有限。每个比较的研究较少，限制了研究之间异质性的评估。结论：预混胰岛素类似物提供的血糖控制与预混人胰岛素相似，并且比长效胰岛素类似物和非胰岛素抗糖尿病药提供更严格的血糖控制。

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