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释放二甲双胍:重新考虑肾功能损害患者的禁忌证。

Unleash metformin: reconsideration of the contraindication in patients with renal impairment.

机构信息

Central Texas Veterans Health Care System, Temple, TX, USA.

出版信息

Ann Pharmacother. 2013 Nov;47(11):1488-97. doi: 10.1177/1060028013505428. Epub 2013 Oct 10.

DOI:10.1177/1060028013505428
PMID:24259604
Abstract

OBJECTIVE

To evaluate the expanded use of metformin in renal impairment.

DATA SOURCES

The MEDLINE database via PubMed, Web of Science, and Cumulative Index to Nursing and Allied Health were searched in August 2013 and included studies from 1950 onward.

STUDY SELECTION AND DATA EXTRACTION

The search included comparative trials, observational cohort studies, and meta-analyses using the terms diabetes mellitus, metformin, renal insufficiency, and acidosis, lactic.

DATA SYNTHESIS

One randomized controlled trial, 1 meta-analysis, 1 case-control, and 3 prospective-cohort studies, representing about 150 000 patients, revealed that metformin is safe in patients with stable mild-moderate renal impairment. The incidence of lactic acidosis is low and similar to sulfonylureas. In addition, reduced risks of cardiovascular disease, all-cause mortality, or any acidosis/serious infection were seen with metformin use in mild-to-moderate renal impairment.

CONCLUSIONS

Data over the past decade refute the historical contraindication in patients with renal impairment and suggest that the risk of metformin-associated lactic acidosis is low in stable mild-to-moderate renal impairment and similar to the risk with other type 2 diabetes mellitus (DM2) medications with no renal impairment restrictions. Because of its unique impact on microvascular and macrovascular complications, it is advantageous to utilize metformin as the cornerstone in DM2 treatment for as long as possible, including in those patients with mild to moderate stages of renal impairment with no additional contraindications. A dosage reduction is recommended if estimated glomerular filtration rate (eGFR) is between 30 and 45 mL/min/1.73 m(2) and discontinuation if eGFR is <30 mL/min/1.73 m(2).

摘要

目的

评估二甲双胍在肾功能损害中的扩大应用。

资料来源

通过 MEDLINE 数据库(PubMed)、Web of Science 和 Cumulative Index to Nursing and Allied Health 进行检索,检索时间为 2013 年 8 月,纳入的研究时间从 1950 年开始。

研究选择和资料提取

检索词包括糖尿病、二甲双胍、肾功能不全和酸中毒、乳酸,包括对照试验、观察性队列研究和荟萃分析。

资料综合

1 项随机对照试验、1 项荟萃分析、1 项病例对照研究和 3 项前瞻性队列研究,涉及约 15 万名患者,结果表明二甲双胍在稳定的轻中度肾功能损害患者中是安全的。乳酸酸中毒的发生率低,与磺脲类药物相似。此外,在轻中度肾功能损害患者中使用二甲双胍可降低心血管疾病、全因死亡率或任何酸中毒/严重感染的风险。

结论

过去十年的数据否定了肾功能损害患者的历史禁忌,并提示在稳定的轻中度肾功能损害中,二甲双胍相关乳酸酸中毒的风险较低,与其他无肾功能损害限制的 2 型糖尿病(DM2)药物的风险相似。由于其对微血管和大血管并发症的独特影响,在 DM2 治疗中尽可能长期使用二甲双胍作为基石药物是有利的,包括在那些有轻度至中度肾功能损害且无其他禁忌证的患者中。如果估算肾小球滤过率(eGFR)在 30 至 45 mL/min/1.73 m2 之间,建议减少剂量,如果 eGFR <30 mL/min/1.73 m2,则停止使用。

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