Qayyum Rehan, Bolen Shari, Maruthur Nisa, Feldman Leonard, Wilson Lisa M, Marinopoulos Spyridon S, Ranasinghe Padmini, Amer Muhammed, Bass Eric B
Evidence-based Practice Center, Johns Hopkins University, Baltimore, Maryland, USA.
Ann Intern Med. 2008 Oct 21;149(8):549-59. doi: 10.7326/0003-4819-149-8-200810210-00242. Epub 2008 Sep 15.
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.
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.
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EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials from inception to February 2008 and sought unpublished data from the U.S. Food and Drug Administration, European Medicines Agency, and industry.
Studies with control groups that compared premixed insulin analogues with another antidiabetic medication in adults with type 2 diabetes.
2 reviewers using standardized protocols performed serial abstraction.
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 A(1c) 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 A(1c) 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 A(1c) levels (mean difference, -0.49% [CI, -0.86% to -0.12%]) but were associated with a higher incidence of hypoglycemia.
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.
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.
迫切需要有证据来比较预混胰岛素类似物（速效和中效胰岛素类似物的混合物）与其他抗糖尿病药物，以指导合理治疗。
总结英文文献中关于预混胰岛素类似物与其他抗糖尿病药物相比在成年2型糖尿病患者中的有效性和安全性。
作者检索了MEDLINE、EMBASE、CINAHL以及Cochrane对照试验中心注册库，检索时间从建库至2008年2月，并向美国食品药品监督管理局、欧洲药品管理局及制药企业索取未发表的数据。
设有对照组，比较预混胰岛素类似物与另一种抗糖尿病药物在成年2型糖尿病患者中的研究。
两名评价者按照标准化方案进行系列提取。
临床试验证据对于死亡率等临床结局尚无定论。因此，本综述聚焦于中间结局。预混胰岛素类似物在降低空腹血糖水平、糖化血红蛋白A1c水平及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（平均差值，-1.1 mmol/L；95%置信区间，-1.4至-0.7 mmol/L [-19.2 mg/dL；95%置信区间，-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（平均差值，-1.5 mmol/L；置信区间，-1.9至-1.2 mmol/L [-27.9 mg/dL；置信区间，-34.3至-21.5 mg/dL]）和糖化血红蛋白A1c水平（平均差值，-0.39% [置信区间，-0.50%至-0.28%]）方面更优，但在降低空腹血糖水平方面较差（平均差值，0.7 mmol/L；置信区间，0.3至1.0 mmol/L [12.0 mg/dL；置信区间，6.0至18.1 mg/dL]），且低血糖发生率更高。与非胰岛素抗糖尿病药物相比，预混胰岛素类似物在降低空腹血糖水平（平均差值，-1.1 mmol/L；置信区间，-1.7至-0.6 mmol/L [-20.5 mg/dL；置信区间，-29.9至-11.2 mg/dL]）、餐后血糖水平（平均差值，-2.1 mmol/L；置信区间，-3.4至-0.8 mmol/L [-37.4 mg/dL；置信区间，-61.0至-13.7 mg/dL]）和糖化血红蛋白A1c水平（平均差值，-0.49% [置信区间，-0.86%至-0.12%]）方面更有效，但低血糖发生率更高。
文献检索仅限于英文发表的研究。临床结局数据有限。每次比较的研究数量较少，限制了对研究间异质性的评估。
预混胰岛素类似物提供的血糖控制与预混人胰岛素相似，且可能比长效胰岛素类似物和非胰岛素抗糖尿病药物提供更严格的血糖控制。
