住院患者首次服用二甲双胍的不良反应监测与分析

Monitoring and analysis of ADRs of metformin for the first time in hospitalized patients

目的:调查二甲双胍的不良反应发生特点及临床表现,为临床合理用药提供参考。方法:对某院内分泌科二病区2010年11月–2011年11月收治患者进行ADR集中监测,对首次服用二甲双胍的病例发生ADR情况进行分析,同时对此ADR集中监测模式进行初步评价。结果:在首次服用二甲双胍的117例患者中,发生ADR的男性有29例(61.70%),女性18例(38.30%),平均年龄(48.21±12.62)岁;未发生ADR的男性有56例(80.00%),女性14例(20.00%),平均年龄(44.71±13.09)岁。ADR累及器官或系统主要为胃肠道损害(88.75%)、中枢神经系统损害(5.00%)、全身性损害(3.75%),皮肤及附件损害(2.50%)。二甲双胍普通片ADR发生率为40.74%,二甲双胍肠溶片为27.27%。结论:二甲双胍引起ADR可能存在性别差异,肠溶片ADR发生率低于普通片。病区集中监测是ADR监测模式的有益补充。

Objective： To investigate the characteristics of adverse drug reaction （ADR） of mefformin for rational medication. Methods： ADRs patients with diabetes hospitalized in endocrinology department ward during Nov. 2010 to Nov. 2011 were monitored. Retrospective research on the ADRs of mefformin for the first time use was carried out. The ADRs monitoring mode in endocrinology department ward was evaluated. Results： In 117 patients with first use of metformin, there were 47 patients with ADR, including 29 female （61.70%） and 18 male （38.30%）. New or serious ADRs were not found. The ADRs involving organs or systems contained gastrointestinal tract （88.75%）, central nervous system （5.00%）, body as a whole-general （3.75%）, skin and adnexa （2.50%）. The ADR incidence rate of the metformin conventional tablet was 40.74%, but the metformin enteric-coated tablets 27.27%. Conclusion： There may be gender differences in incidence rate of ADR induced by metformin. The enteric-coated tablets may have less ADRs than ordinary tablets. The intensive ward monitoring is beneficial to ADR monitoring mode.