Grupo de Investigación en Farmacoepidemiología y Farmacovigilancia, Universidad Tecnológica de Pereira - Audifarma, S. A., Pereira, Colombia; Grupo de Investigación Biomedicina, Fundación Universitaria Autónoma de las Américas, Pereira, Colombia.
Grupo de Investigación Biomedicina, Fundación Universitaria Autónoma de las Américas, Pereira, Colombia.
Biomedica. 2020 Jun 15;40(2):382-390. doi: 10.7705/biomedica.5103.
Introduction: There is evidence of the indiscriminate use of antibiotics for different pathologies. Objective: To determine the prescription patterns and indications for the use of fluoroquinolones in a group of outpatients in Colombia. Materials and methods: We conducted a descriptive pharmaco-epidemiological study on prescription-indication using a population database where patients with outpatient fluoroquinolone prescriptions were included from May to October, 2018. We obtained the information on sociodemographic, pharmacological, and clinical variables, as well as on the diagnosis according to the International Classification of Diseases, version 10, and we established if the use was approved by the regulatory agencies or if it was off-label. Results: A total of 23,373 patients were identified who were using fluoroquinolones; their mean age was 47.9 ± 18.1 years and women predominated (n=15,767, 67.5%). Ciprofloxacin was the medication most commonly prescribed (n=19,328, 82.7%), followed by norfloxacin (n=3076, 13.2%), levofloxacin (n=573, 2.5%), and moxifloxacin (n=394; 1.7%). The main indications were urinary tract infection in unspecified site (n=10,777, 46.1%), diarrhea and gastroenteritis of presumed infectious origin (n=3077, 13.2%), and acute cystitis (n=956; 4.2%). The prescriptions followed approved indications in 76% (n=17,759) of cases while the rest were used off-label or without indication for nasopharyngitis or soft-tissue infections, for example. Being male (OR=1.26, 95%CI:1.18-1.34) and under 35 years of age (OR=1.92, 95%CI:1.48-1.50) were associated with a greater probability of using fluoroquinolones in unapproved indications. Conclusions: Fluoroquinolones, particularly ciprofloxacin, are being prescribed especially to women with urinary tract infections, but up to a quarter of the patients received them for unapproved indications by regulatory agencies.
有证据表明抗生素被滥用于多种病症。目的:确定在哥伦比亚一组门诊患者中氟喹诺酮类药物的处方模式和用途。材料与方法:我们进行了一项基于人群的药物流行病学研究,使用了一个数据库,其中包括 2018 年 5 月至 10 月间开氟喹诺酮处方的门诊患者。我们获取了社会人口统计学、药理学和临床变量的信息,以及根据国际疾病分类第十版的诊断信息,并确定了使用是否获得监管机构的批准或是否属于超适应证用药。结果:共确定了 23373 名正在使用氟喹诺酮类药物的患者,其平均年龄为 47.9±18.1 岁,女性居多(n=15767,67.5%)。最常开的药物是环丙沙星(n=19328,82.7%),其次是诺氟沙星(n=3076,13.2%)、左氧氟沙星(n=573,2.5%)和莫西沙星(n=394,1.7%)。主要适应证为未特指部位的尿路感染(n=10777,46.1%)、腹泻和胃肠炎,推测为感染性起源(n=3077,13.2%)和急性膀胱炎(n=956,4.2%)。76%(n=17759)的处方符合批准的适应证,其余的则是用于未经批准的适应证,例如鼻咽炎或软组织感染等。男性(OR=1.26,95%CI:1.18-1.34)和 35 岁以下(OR=1.92,95%CI:1.48-1.50)与氟喹诺酮类药物超适应证使用的可能性更大有关。结论:氟喹诺酮类药物,尤其是环丙沙星,主要用于治疗女性尿路感染,但多达四分之一的患者使用该药是未经监管机构批准的适应证。