| 摘要: |
| 目的：探讨儿童地高辛用药情况及安全性，为临床合理用药提供参考。方法：回顾性调查我院2017年1月至2019年5月使用地高辛的347例患儿，对其年龄、性别、科室分布、用药剂型及维持剂量、原发疾病、联合用药情况等进行统计分析。结果：最终纳入323例患儿，其中年龄<2岁占91.33%，男性多于女性。主要科室为新生儿重症监护病房（NICU，30.03%）、小儿心脏内科病房（22.91%）、外科重症监护病房（SICU，20.43%）及儿科重症监护病房（PICU，19.50%）。口服溶液（65.63%）多于片剂（34.37%）。地高辛维持剂量低于推荐用药剂量下限共246例（76.16%），在说明书推荐范围内63例（19.50%），超过推荐用药上限14例（4.33%）。原发疾病情况符合说明书适应症，联合用药种类按使用频率依次为利尿剂、抗菌药物、血管紧张素转化酶抑制剂（ACEI）、β受体阻滞剂、钙通道阻滞药，包含6种使地高辛血药浓度增加的药物。323例患儿临床结局治愈率67.80%，死亡率1.24%，不同剂量组治愈率和病死率比较差异无统计学意义。地高辛片剂与口服溶液说明书患儿年龄分段情况和用药剂量不完全一致，维持剂量最大相差10倍，不利于临床使用的计算。不良反应发生率0.62%。结论：为保障儿童安全用药，建议开展地高辛已上市剂型儿童群体药动学研究，统一不同剂型说明书中儿童用法用量，促进临床合理用药。监测血清地高辛浓度，并由药师全面分析并跟踪用药情况，提供个体化用药指导。 |
| 关键词: 地高辛 儿童 安全性 早产儿 |
| DOI：doi:10.13407/j.cnki.jpp.1672.108X.2020.12.013 |
|
| 基金项目:2020 年成都市医学科研课题,编号2020019。 |
|
| Application and Safety of Digoxin in 323 Children |
| Chen Wenwen1,2, Jiang Yongxian1, Tao Wanjun1, Li Li1, Qin Min1, Li Gen1 |
| ((1. Affiliated Hospital of School of Medicine, University of Electronic Science and Technology of China, Chengdu Women’s & Children’s Central Hospital, Sichuan Chengdu 610091, China; 2. College of Pharmacy, Chengdu University of Traditional Chinese Medicine, Sichuan Chengdu 611137, China)) |
| Abstract: |
| Objective: To investigate the application and safety of digoxin in children, so as to provide reference for rational application in clinic. Methods: Retrospective analysis was performed on 347 children with digoxin in our hospital from Jan. 2017 to May 2019. Age, gender, department distribution, dosage form and maintenance dose, primary diseases and drug combination were statistically analyzed. Results: Totally 323 children were enrolled, of which 91.33% were younger than 2 years old, and there were more males than females. The main departments were neonatal intensive care unit (NICU, 30.03%), pediatric cardiology unit (22.91%), surgical intensive care unit (SICU, 20.43%) and pediatric intensive care unit (PICU, 19.50%). The proportion of cases taking oral solution (65.63%) was higher than that of tablets (34.37%). A total of 246 cases (76.16%) of digoxin maintenance dose was lower than the lower limit of recommended dosage, 63 cases (19.50%) were within the recommended range of instructions, and 14 cases (4.33%) were above the upper limit of the recommended dosage. The primary diseases of these cases were in line with the instructions. According to the frequency of use, combination drug were respectively diuretics, antibiotics, angiotensin-converting enzyme inhibitors (ACEI), β-receptor blockers and calcium channel blockers in order of frequency of use, including 6 types that could increase the blood concentration of digoxin. The clinical outcome of 323 children had a cure rate of 67.80% and a mortality rate of 1.24%, there was no statistically significant difference in the cure rate and mortality in different dose groups. Digoxin tablets were not completely consistent with the oral solution instructions in terms of age and dosage, and the maximum difference of maintenance dose was 10 times, which was not conducive to the calculation of clinical use. The incidence of adverse drug reactions was 0.62%. Conclusion: In order to ensure the safe application of drugs for children, it is suggested to carry out pharmacokinetic study on children with the marketed dosage form of digoxin, unify the usage and dosage of children in different dosage form instructions, and promote rational clinical application of drugs. The concentration of digoxin should be monitored, and the pharmacists should comprehensively analyze and track the application of digoxin and provide individualized medication guidance. |
| Key words: digoxin children safety preterm neonates |
