二甲双胍不增加乳酸酸中毒危险
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美国斯坦福大学医学院Salpeter等的一项荟萃分析结果显示，没有证据表明二甲双胍治疗可增加乳酸酸中毒危险。
Salpeter等分析了194项比较研究或观察性群组研究，对二甲双胍治疗（单独或与其他药物联合用药）至少1个月的患者进行了评估。结果显示，二甲双胍组（36893人/年）和非二甲双胍组（30109人/年）都没有发生致命性或非致命性乳酸酸中毒的报告；根据泊松统计，二甲双胍组和非二甲双胍组乳酸酸中毒真实发病率的很可能上限分别为8.1/10万人/年和9.9/10万人/年；二甲双胍、安慰剂和非双胍类药物治疗时的乳酸水平都无差异。
Arch Intern Med. 2003 Nov 24;163(21):2594-602.
Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus: systematic review and meta-analysis.
Salpeter SR, Greyber E, Pasternak GA, Salpeter EE.
Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA. salpeter@stanford.edu
BACKGROUND: Metformin therapy for type 2 diabetes mellitus has been shown to reduce total mortality rates compared with other antihyperglycemic treatments but is thought to increase the risk of lactic acidosis. The true incidence of fatal and nonfatal lactic acidosis associated with metformin use is not known. METHODS: A comprehensive search was performed to identify all comparative trials or observational cohort studies published between January 1, 1959, and March 31, 2002, that evaluated metformin therapy, alone or in combination with other treatments, for at least 1 month. The incidence of fatal and nonfatal lactic acidosis was recorded as cases per patient-years for metformin treatment and for placebo or other treatments. In a second analysis, lactate levels were measured as a net change from baseline or as mean treatment values for metformin and comparison groups. RESULTS: Pooled data from 194 studies revealed no cases of fatal or nonfatal lactic acidosis in 36 893 patient-years in the metformin group or in 30 109 patients-years in the nonmetformin group. Using Poisson statistics with 95% confidence intervals, the probable upper limit for the true incidence of lactic acidosis in the metformin and nonmetformin groups was 8.1 and 9.9 cases per 100 000 patient-years, respectively. There was no difference in lactate levels for metformin compared with placebo or other nonbiguanide therapies. CONCLUSION: There is no evidence to date that metformin therapy is associated with an increased risk of lactic acidosis or with increased levels of lactate compared with other antihyperglycemic treatments if the drugs are prescribed under study conditions, taking into account contraindications.
Salpeter等分析了194项比较研究或观察性群组研究，对二甲双胍治疗（单独或与其他药物联合用药）至少1个月的患者进行了评估。结果显示，二甲双胍组（36893人/年）和非二甲双胍组（30109人/年）都没有发生致命性或非致命性乳酸酸中毒的报告；根据泊松统计，二甲双胍组和非二甲双胍组乳酸酸中毒真实发病率的很可能上限分别为8.1/10万人/年和9.9/10万人/年；二甲双胍、安慰剂和非双胍类药物治疗时的乳酸水平都无差异。
Arch Intern Med. 2003 Nov 24;163(21):2594-602.
Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus: systematic review and meta-analysis.
Salpeter SR, Greyber E, Pasternak GA, Salpeter EE.
Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA. salpeter@stanford.edu
BACKGROUND: Metformin therapy for type 2 diabetes mellitus has been shown to reduce total mortality rates compared with other antihyperglycemic treatments but is thought to increase the risk of lactic acidosis. The true incidence of fatal and nonfatal lactic acidosis associated with metformin use is not known. METHODS: A comprehensive search was performed to identify all comparative trials or observational cohort studies published between January 1, 1959, and March 31, 2002, that evaluated metformin therapy, alone or in combination with other treatments, for at least 1 month. The incidence of fatal and nonfatal lactic acidosis was recorded as cases per patient-years for metformin treatment and for placebo or other treatments. In a second analysis, lactate levels were measured as a net change from baseline or as mean treatment values for metformin and comparison groups. RESULTS: Pooled data from 194 studies revealed no cases of fatal or nonfatal lactic acidosis in 36 893 patient-years in the metformin group or in 30 109 patients-years in the nonmetformin group. Using Poisson statistics with 95% confidence intervals, the probable upper limit for the true incidence of lactic acidosis in the metformin and nonmetformin groups was 8.1 and 9.9 cases per 100 000 patient-years, respectively. There was no difference in lactate levels for metformin compared with placebo or other nonbiguanide therapies. CONCLUSION: There is no evidence to date that metformin therapy is associated with an increased risk of lactic acidosis or with increased levels of lactate compared with other antihyperglycemic treatments if the drugs are prescribed under study conditions, taking into account contraindications.
