恩格列净治疗1型糖尿病患者的疗效和安全性:一项系统综述

S. Saha, Sujata Saha
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引用次数: 1

摘要

1型糖尿病(T1DM)主要是由胰腺细胞死亡引起的儿童期高血糖自身免疫性疾病。它是由遗传易感性(人类白细胞抗原等位基因如DQ和DR)或病毒或环境毒素以及其他未知因素引发的(1,2)。这些患者存在糖尿病视网膜病变、糖尿病肾病、糖尿病神经病变、糖尿病酮症酸中毒等高血糖并发症的风险。由于恩格列净在1型糖尿病(T1DM)患者中的疗效和安全性研究尚少,本综述旨在对其进行综述。在PubMed、Embase和Scopus数据库中检索了不同剂量恩格列净和安慰剂对上述研究的随机对照试验。数据库检索得到5个符合条件的试验,报告了来自45个国家的1870例T1DM患者的数据。在这些试验中测试的恩格列净剂量为2.5、10和25mg。这些试验总体显示偏倚风险较低或不明确(使用Cochrane工具)。现有的双盲随机对照试验主要表明,恩格列净治疗的T1DM患者糖化血红蛋白、体重和每周总胰岛素需用量均呈剂量依赖性降低。酮症酸中毒、尿路感染和因副作用而中止研究是恩格列净罕见的不良反应。生殖器感染主要发生在10或25毫克恩格列净的接受者中。
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Efficacy and Safety of Empagliflozin in Type 1 Diabetes Mellitus Patients: A Systematic Review
Introduction Type 1 diabetes mellitus (T1DM) is primarily a childhood-onset hyperglycemic autoimmune condition resulting from the death of pancreatic beta cells. It’s triggered by genetic predisposition (human leukocyte antigen alleles such as DQ and DR) or viruses or environmental toxins, and other unknown factors (1,2). These patients are at risk of hyperglycemic complications such as diabetic retinopathy, diabetic nephropathy, diabetic neuropathy, diabetic ketoacidosis, and As the efficacy and safety of empagliflozin remain poorly studied in Type 1 diabetes mellitus (T1DM) patients, this narrative-systematic review aims to review it. The randomized controlled trials studying the above across different empagliflozin dosages and placebo got searched in PubMed, Embase, and Scopus databases. The database searches yielded 5 eligible trials reporting data of about 1,870 T1DM patients from 45 countries. The empagliflozin dosages tested in these trials were 2.5, 10, and 25 mg. The trials collectively showed a low or unclear risk of bias (Cochrane tool used). The existing double-blinded randomized controlled trials mainly suggest a dose-dependent decrease in glycated hemoglobin, body weight, and total weekly insulin requirement in empagliflozin-treated T1DM patients. Ketoacidosis, urinary tract infection, and study discontinuation due to side effects were rare adverse effects of empagliflozin. Genital infection predominantly occurred among recipients of 10 or 25 mg empagliflozin.
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