背景:盐酸二甲双胍是一种使用多年的抗糖尿病药,目前,它被认为是治疗2型糖尿病(T2D)的首选。它降低胰岛素抵抗,不会诱发低血糖,增加肝脏和骨骼肌的葡萄糖利用率,并减少肝脏葡萄糖的产生。其不良反应(AE)是胃肠道,维生素B12吸收减少,血象异常,很少有皮肤反应。这项研究的目的是报告在阿尔及利亚SidiBel-Abbès医疗中心和糖尿病之家收治的T2D患者的治疗管理中使用的盐酸二甲双胍AE的类型和频率。
方法:进行了为期四个月的横断面描述性研究,从1月1日,2017年4月30日,2017年,涉及在SidiBel-Abbès镇的MimounCity糖尿病之家和Gambetta糖尿病中心接受盐酸二甲双胍咨询的130名患者。主要结果指标是确定与T2D中正常剂量或过量使用盐酸二甲双胍相关的AE的类型和频率。数据来自患者记录,使用问卷,并使用社会科学统计软件包进行分析,版本20软件。
结果:纳入130例患者,包括82名女性,平均年龄51.08±8.85岁(30-66岁)。报告了一百九十八(198)个不良事件,每位患者平均1.52次不良事件。其中,95(47.98%)AE是消化系统疾病(30.77%的患者患有腹泻,10.77%有恶心呕吐,8.46%患有腹痛和腹胀,3.85%失去了味道,7.69%抱怨上腹部痉挛和11.54%厌食症),29(14.65%)不良事件是低血糖,73(36.87%)AE是其他症状,1(0.50%)EI是维生素B12缺乏症,没有报告乳酸酸中毒或过敏反应的病例。5例(3.85%)患者对二甲双胍盐酸盐有完全和持久的不耐受,导致持续性腹泻后停药。
结论:在医疗中心和SidiBel-Abbès糖尿病之家咨询的T2D患者管理中使用盐酸二甲双胍的不良事件是常见的。消化系统疾病是最常见的,腹泻非常频繁,导致3.85%的T2D患者停止治疗,接着是恶心和呕吐,然后腹痛,腹胀和上腹部痉挛,很少有金属味。低血糖与胰岛素相关后频繁出现,头痛和疲劳的发作很频繁,但未报告乳酸性酸中毒或过敏反应。由于缺乏手段,在水平低于200ng/mL的患者中,尚未进行同型半胱氨酸和甲基丙二酸的剂量以确认维生素B12缺乏.有必要对报告的AE的可归性进行精确评估。
BACKGROUND: MetforminHydrochloride is an antidiabetic used for many years, currently; it considered the first choice in treatment of type 2 diabetes (T2D). It decreases insulin resistance, does not induce hypoglycaemia, increases glucose utilization in the liver and skeletal muscle, and decreases hepatic glucose production. Its adverse effects (AE) are gastrointestinal, decrease in vitamin B12 absorption, abnormalities of hemogram and rarely skin reactions. The objective of this
study was to report the type and frequency of AEs of Metformin Hydrochloride used in the therapeutic management of T2D patients admitted to the medical center and the diabetes home of Sidi Bel-Abbès in Algeria.
METHODS: A cross-sectional descriptive
study was carried out over a period of four months, from January 1st, 2017 to April 30th, 2017, involving 130 patients treated with Metformin Hydrochloride consulting at Mimoun City Diabetes Home and Gambetta Diabetes Center in the town of Sidi Bel-Abbès. The primary outcome measure was the determination of the type and frequency of AEs related to normal dosages or overdose use of Metformin Hydrochloride in T2D. Data were collected from patient records, using a questionnaire, and analyzed using Statistical Package for the Social Sciences, version 20 software.
RESULTS: 130 patients were included, including 82 women, with a mean age of 51.08±8.85 years (30-66). One hundred and ninety-eight (198) AEs were reported, an average of 1.52 AEs per patient. Among them, 95 (47.98%) AEs are digestive disorders (30.77% of patients suffered from diarrhea, 10.77% had nausea and vomiting, 8.46% suffered from abdominal pain and bloating, 3.85% lost their taste, 7.69% complained of epigastric cramps and 11.54% of anorexia), 29 (14.65%) AEs are hypoglycaemia, 73 (36.87%) AEs are other symptoms and 1 (0.50%) EI is vitamin B12 deficiency and no cases of lactic acidosis or allergic reaction were reported. Five (3.85%) patients had a total and lasting intolerance to Metformin Hydrochloride leading to its discontinuation following persistent diarrhoea.
CONCLUSIONS: AEs of Metformin Hydrochloride used in the management of T2D patients consulting at the medical center and the Diabetes home of Sidi Bel-Abbès are frequent. Digestive disorders were the most frequent, diarrhea was very frequent and led to discontinuation of treatment in 3.85% of T2D patients, followed by nausea and vomiting, then abdominal pain, bloating and epigastric cramps, and rarely taste metallic. Hypoglycaemia was frequent following its association with insulin, the onset of headaches and fatigue were frequent, but no case of lactic acidosis or allergic reaction was reported. Due to a lack of means, the dosage of homocysteine and methylmalonic acid had not been carried out to confirm the vitamin B12 deficiency in the patient whose level was less than 200ng/mL. A precise assessment of the imputability of reported AEs is necessary.