JAMA：糖尿病药物二甲双胍或对肾脏疾病患者是安全的

  近日，发表在国际杂志JAMA上的一篇研究论文中，来自耶鲁大学的研究人员通过进行一项系统性的回顾表示，常用于治疗2型糖尿病的药物—二甲双胍对于轻度及中度的肾脏疾病患者是安全的。
  在美国长达20年来，二甲双胍一直用于帮助2型糖尿病患者降低血糖水平，很多专家认为该药物是治疗血糖升高的最佳选择，尽管其具有强大的安全性保障，但FDA并不推荐二甲双胍用于治疗轻中度肾脏疾病患者，理由是二甲双胍会引发患者机体出现乳酸酸中毒的风险，而该疾病是一种潜在的严重疾病。
  本文中，研究人员Silvio E. Inzucchi博士对已经发表的研究进行了一项系统性回顾研究，评估了服用二甲双胍治疗轻中度肾脏疾病患者患乳酸酸中毒的风险，结果显示，相比不如用二甲双胍的患者来讲，服用二甲双胍的患者患乳酸酸中毒的风险极低。这项研究非常关键，因为医生们一般会避免向一些老年糖尿病患者开二甲双胍的处方。
  Inzucchi指出，很多专家都知道二甲双胍应当谨慎用于治疗患轻中度肾脏疾病的患者，但大多数专家往往都用该药物来治疗患者疾病；本文研究并不适用于患严重肾脏疾病的患者，而当前的指导方针也应该改变，如果FDA关于二甲双胍的指导方针及时更新的话，该药物或许就可以更加有效地用于治疗超过250万的美国2型糖尿病患者，促进患者的机体健康。（转化医学网360zhyx.com）

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Metformin in Patients With Type 2 Diabetes and Kidney Disease   A Systematic Review
JAMA   doi:10.1001/jama.2014.15298
Silvio E. Inzucchi, MD1; Kasia J. Lipska, MD, MHS1; Helen Mayo, MLS2; Clifford J. Bailey, PhD3; Darren K. McGuire, MD, MHSc4
Importance  Metformin is widely viewed as the best initial pharmacological option to lower glucose concentrations in patients with type 2 diabetes mellitus. However, the drug is contraindicated in many individuals with impaired kidney function because of concerns of lactic acidosis.
Objective  To assess the risk of lactic acidosis associated with metformin use in individuals with impaired kidney function.
Evidence Acquisition  In July 2014, we searched the MEDLINE and Cochrane databases for English-language articles pertaining to metformin, kidney disease, and lactic acidosis in humans between 1950 and June 2014. We excluded reviews, letters, editorials, case reports, small case series, and manuscripts that did not directly pertain to the topic area or that met other exclusion criteria. Of an original 818 articles, 65 were included in this review, including pharmacokinetic/metabolic studies, large case series, retrospective studies, meta-analyses, and a clinical trial.
Results  Although metformin is renally cleared, drug levels generally remain within the therapeutic range and lactate concentrations are not substantially increased when used in patients with mild to moderate chronic kidney disease (estimated glomerular filtration rates, 30-60 mL/min per 1.73 m2). The overall incidence of lactic acidosis in metformin users varies across studies from approximately 3 per 100 000 person-years to 10 per 100 000 person-years and is generally indistinguishable from the background rate in the overall population with diabetes. Data suggesting an increased risk of lactic acidosis in metformin-treated patients with chronic kidney disease are limited, and no randomized controlled trials have been conducted to test the safety of metformin in patients with significantly impaired kidney function. Population-based studies demonstrate that metformin may be prescribed counter to prevailing guidelines suggesting a renal risk in up to 1 in 4 patients with type 2 diabetes mellitus—use which, in most reports, has not been associated with increased rates of lactic acidosis. Observational studies suggest a potential benefit from metformin on macrovascular outcomes, even in patients with prevalent renal contraindications for its use.
Conclusions and Relevance  Available evidence supports cautious expansion of metformin use in patients with mild to moderate chronic kidney disease, as defined by estimated glomerular filtration rate, with appropriate dosage reductions and careful follow-up of kidney function.