Vázquez-Alvarez Alan O, Brennan-Bourdon Lorena Michele, Rincón-Sánchez Ana Rosa, Islas-Carbajal María Cristina, Huerta-Olvera Selene G
Instituto de Terapéutica Experimental y Clínica (INTEC). Departamento de Fisiología. Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Jalisco, Mexico.
Comisión para la Protección contra Riesgos Sanitarios del Estado de Jalisco (COPRISJAL), Guadalajara, Jalisco, Mexico.
BMC Pharmacol Toxicol. 2017 Dec 8;18(1):79. doi: 10.1186/s40360-017-0186-x.
The aim of this study was to detect and analyze Adverse Drug Reactions (ADRs) through Intensive Pharmacovigilance (IPV) in hospitalized pediatric patients to improve drug safety.
A prospective 6-month cross-sectional study was performed in the pediatric service of a regional hospital in Mexico in order to assess hospitalized children from 1 day to 18 years old. The inclusion criteria were: both genders, all hospitalization causes, and at least one prescribed medication (indistinct drug group). Notifications were performed through medical visits, phone calls, or spontaneous reports. ADR suspicions were assessed with severity scales: Naranjo algorithm, Schumock & Thornton and Hartwig and Siegel.
From a total of 1083 hospital admissions, 19 ADRs were recorded. The average age of patients in years was 7.2 (±5.9). The causality assessment in this study showed that most of the ADRs were probable (68.4%) and 4 certain (8.2%); causality was mainly attributed to antibiotics (AB) and an antiepileptic drug. We found a relationship of AB with ADRs (p < 0.05) with an increased risk at the third day of prescription (p < 0.05). The average severity was level 2 and 21% were classified as "preventable". Lastly, an increase in hospital stay associated with ADRs (p < 0.05) and with concomitant medications (p < 0.05), was also found. The most severe ADRs were hemolysis and toxic epidermal necrolysis.
IPV was an effective tool for ADR prevention, detection, and treatment in hospitalized patients. The intensive monitoring approach in pharmacovigilance amplifies ADR detection and this translates into the improvement of drug safety in children.
本研究的目的是通过强化药物警戒（IPV）检测和分析住院儿科患者的药物不良反应（ADR），以提高用药安全性。
在墨西哥一家地区医院的儿科进行了一项为期6个月的前瞻性横断面研究，以评估1天至18岁的住院儿童。纳入标准为：男女不限，所有住院原因，以及至少一种处方药物（不限药物类别）。通过门诊、电话或自发报告进行上报。使用严重程度量表评估ADR疑似病例：纳朗霍算法、舒莫克和桑顿量表以及哈特维希和西格尔量表。
在总共1083例住院病例中，记录到19例ADR。患者的平均年龄为7.2岁（±5.9）。本研究中的因果关系评估表明，大多数ADR为“很可能”（68.4%），4例为“肯定”（8.2%）；因果关系主要归因于抗生素（AB）和一种抗癫痫药物。我们发现AB与ADR之间存在关联（p<0.05），在处方第三天风险增加（p<0.05）。平均严重程度为2级，21%被归类为“可预防的”。最后，还发现与ADR相关（p<0.05）以及与合并用药相关（p<0.05）的住院时间延长。最严重的ADR是溶血和中毒性表皮坏死松解症。
IPV是住院患者ADR预防、检测和治疗的有效工具。药物警戒中的强化监测方法可提高ADR的检测率，这有助于改善儿童用药安全性。
