Abstract:

Objective　To analyze the risk factors of gastrointestinal adverse reactions in patients with type 2 diabetes mellitus (T2DM) treated with metformin. Methods　A total of 318 patients with T2DM admitted to Department of Internal Medicine, Jinan Second People's Hospital from December 2018 to August 2022 were selected for the retrospective study. After receiving metformin for the first time, according to whether the patients had gastrointestinal adverse reactions within 1 treatment course (3 months), they were divided into a gastrointestinal adverse reaction group (61 cases) and a non-gastrointestinal adverse reaction group (257 cases). The risk factors of gastrointestinal adverse reactions in the patients were analyzed by univariate analysis and multivariate logistic regression analysis. t and χ² tests were applied. Results　Sixty-one cases (19.18%) of the 318 patients complicated with gastrointestinal adverse reactions. The body mass index (BMI) of the gastrointestinal adverse reaction group was lower than that of the non-gastrointestinal adverse reaction group [(21.47±1.15) kg/m² vs. (22.89±1.01) kg/m²]; the metformin dosage and the proportions the patients who drank, took insulin treatment, and took the combination with alpha glycosidase inhibitor in the gastrointestinal adverse reaction group were higher than those in the non-gastrointestinal adverse reaction group [(1 379.12±122.03) mg/d vs. (1 184.12±112.16) mg/d, 29.51% (18/61) vs. 16.73% (43/257), 34.43% (21/61) vs. 21.01% (54/257), and 47.54%(29/61) vs. 26.46%(68/257)]; there were statistical differences (t=9.605 and 12.000; χ²=5.191, 4.922, and 10.336; all P<0.05). The results of multivariate logistic analysis showed that increased BMI was a protective factor for gastrointestinal adverse reactions in the patients (OR=0.520, P<0.05); increased dose of metformin, alcohol consumption, and combination with alpha-glucosidase inhibitors were risk factors for gastrointestinal adverse events in the patients (OR=2.008, 2.179, and 1.933; all P<0.05). Conclusions　Patients with T2DM mellitus treated with metformin are at risk of gastrointestinal adverse reactions. The risk factors include decreased BMI, increased dose of metformin, alcohol consumption, and combination with alpha-glucosidase inhibitors. For high-risk patients with gastrointestinal adverse reactions, intervention strategies should be timely adjusted according to the above factors.

Key words:

Type 2 diabetes mellitus, Gastrointestinal adverse reactions, Metformin, Clinical characteristics, Risk factors

摘要：

目的　分析二甲双胍治疗2型糖尿病（T2DM）患者发生胃肠道不良反应的风险因素。方法　回顾性分析2018年12月至2022年8月在济南市第二人民医院内科初次接受二甲双胍治疗的318例T2DM患者，依据1个疗程（3个月）内是否发生胃肠道不良反应，将患者纳入胃肠道不良反应组（61例）和非胃肠道不良反应组（257例）。胃肠道不良反应组男33例、女28例，年龄>60岁27例、≤60岁34例，病程（9.03±1.17）个月；非胃肠道不良反应组男126例、女131例，年龄>60岁106例、≤60岁151例，病程（8.95±1.18）个月。通过单因素及多因素logistic回归分析T2DM患者发生胃肠道不良反应的风险因素。统计学方法采用t检验、χ²检验。结果　318例T2DM并发胃肠道不良反应发生61例，发生率为19.18%。胃肠道不良反应组体质量指数（BMI）低于非胃肠道不良反应组［（21.47±1.15）kg/m²比（22.89±1.01）kg/m²］，二甲双胍剂量及饮酒、胰岛素治疗、联用α-糖苷酶抑制药比例均高于非胃肠道不良反应组［（1 379.12±122.03）mg/d比（1 184.12±112.16）mg/d、29.51%（18/61）比16.73%（43/257）、34.43%（21/61）比21.01%（54/257）、47.54%（29/61）比26.46%（68/257）］，差异均有统计学意义（t=9.605、12.000，χ²=5.191、4.922、10.336；均P<0.05）。多因素logistic分析结果显示，BMI升高为T2DM患者胃肠道不良反应的保护因素（OR=0.520，P<0.05）；二甲双胍剂量升高、饮酒、联用α-糖苷酶抑制药为T2DM患者胃肠道不良反应的风险因素（OR=2.008、2.179、1.933，均P<0.05）。结论　二甲双胍治疗T2DM具有胃肠道不良反应风险，其保护因素为BMI升高，风险因素为二甲双胍剂量升高、饮酒、联用α-糖苷酶抑制药，对胃肠道不良反应的高危患者，应及时根据以上因素调整干预策略。

关键词:

2型糖尿病, 胃肠道不良反应, 二甲双胍, 风险因素, 临床特点, 风险因素