利用全面触发工具建立住院患儿头孢菌素类药品不良反应主动监测预警模型

doi:10.19803/j.1672-8629.2021.07.14

摘要/Abstract

摘要： 目的应用全面触发工具建立住院患儿头孢菌素类药品不良反应（ADR）主动预警监测模型,为患儿使用头孢菌素类ADR的监测、防治提供参考。方法收集2017~2018年某院使用头孢菌素类药物发生过敏反应病例102例作为试验组,并随机抽取同期使用该药未发生过敏反应的病例269例作为对照组,利用全面触发工具对危险因素进行单因素分析、多因素二元Logistic回归分析,建立ADR主动监测模型,采用H-L检验模型校准度,应用受试者工作特征（ROC）曲线检验ADR监测模型的预测价值。结果 102例使用头孢菌素类药物后发生ADR患儿无明显年龄及性别差异,ADR临床表现以皮疹及低血压最为常见;以单因素分析结果中P≤0.2自变量因素建立患儿头孢菌素类药物ADR主动监测模型：Logit(p)=In$\frac{p}{-p}$1.822(神经系统疾病)-3.43(白细胞计数<3×10⁹/L)-4.162(使用激素类药物)-5.956(过度镇静/低血压/嗜睡)-5.041(皮疹);模型拟合优度检验结果显示预警模型具有较高的准确度、特异度及灵敏度。结论建立患儿头孢菌素类药物ADR主动监测预警模型有较高的预测价值,关注并积极干预患儿的原患疾病、白细胞计数、使用药物、血压、神志、皮疹等危险因素,对降低ADR的发生有益。

关键词: 儿童, 头孢菌素类药物, 全面触发工具, 主动监测预警模型, 药品不良反应

Abstract: Objective To establish an active monitoring model for adverse reactions of cephalosporins in hospitalized children using global trigger tools (GTT) in order to provide data for the prevention and treatment of related adverse reactions. Methods A total of 102 pediatric medical records of allergic reactions to cephalosporins in a hospital between 2017 and 2018 were collected as the test group, while another 269 patients who used the drug during the same period but without any allergic reactions were randomly selected as the control group. Single-factor analysis and multi-factor binary logistic regression analysis were conducted to establish an active monitoring model of adverse drug reactions (ADR). Then, the model's calibration was tested with the Hosmer-Lemeshow (HL) method, and the predictive value of the monitoring model was tested by the receiver operating characteristic (ROC) curve. Results There was no apparent difference in age and gender between the 102 cases with ADR after using cephalosporins. Skin rash and hypotension were the most common clinical manifestations in these cases. The independent variable factors with P≤0.2 in the results of the univariate analysis were selected to establish an active monitoring model of ADR of cephalosporins in pediatric patients: Logit(p)=In$\frac{p}{-p}$1.822=1.822 (neurological disease)-3.43 (white blood cell count<3×10⁹/L)-4.162(with hormone drugs)-5.956 (excessive sedation/hypotension/drowsiness)-5.041 (skin rash). The goodness-of-fit test results showed that the model was highly accurate, specific and sensitive. Conclusion The active monitoring model of ADR induced by cephalosporins in pediatrics is of high predictive value. Active intervention in a child's primary disease, white blood cell count, drug use, blood pressure, consciousness, rash and other risk factors can help reduce the chance of adverse drug reactions.

Key words: pediatrics, cephalosporins, global trigger tools, active monitoring model, adverse drug reaction

中图分类号:

熊代琴, 马雪英, 滕亮, 王捷. 利用全面触发工具建立住院患儿头孢菌素类药品不良反应主动监测预警模型[J]. 中国药物警戒, 2021, 18(7): 663-668.

XIONG Daiqin, MA Xueying, TENG Liang, WANG Jie. An Active Model for Monitoring and Early Warning of Cephalosporin Adverse Drug Reactions in Pediatrics Using Global Trigger Tools[J]. Chinese Journal of Pharmacovigilance, 2021, 18(7): 663-668.

参考文献

[1] Kavita Dhar1, Akanksha Sinha, Preeti Gauret al. Pattern of adverse drug reactions to antibiotics commonly prescribed in department of medicine and pediatrics in a tertiary care teaching hospital Ghaziabad[J]. Journal of Applied Pharmaceutical Science, 2015, 5(4): 78-82.
[2] Hall V, Wong M, Munsif M, et al.Antimicrobial anaphylaxis:the changing face of severe antimicrobial allergy[J]. J Antimicrob Chemother, 2020, 75(1): 229-235.
[3] Abrams E, Netchiporouk E, Miedzybrodzki B, et al.Antibiotic allergy in children: more than just a label[J]. Int Arch Allergy Immunol, 2019, 180(2): 103-112.
[4] Lazarou J, Pomeranz BH, Corey PN.Incidence of adverse drug reactions in hospitalized patients: a metaanalysis of prospective studies[J]. JAMA, 1998, 279(15): 1200-1205.
[5] Classen DC, Pestotnik SL, Evans RS, et al. Description of a computerized adverse drug event monitor using a hospital information system[J]. Hosp Pharm, 1992, 27(9): 774, 776-779, 783.
[6] Evans RS, Classen DC, Stevens LE, et al.Using a hospital information system to assess the effects of adverse drug events[J].Proc Annu Symp Comput Appl Med Care, 1993: 161-165.
[7] Kirkendall ES, Kloppenborg E, Papp J, et al.Measuring adverse events and levels of harm in pediatric inpatients with the Global Trigger Tool[J]. Pediatrics, 2012, 130(5): 1206-1214.
[8] Resar RK, Rozich JD, Classen D.Methodology and rationale for the measurement of harm with trigger tools[J]. Qual Saf Health Care, 2003, 12(2): 39-45.
[9] Rozich JD, Haraden CR, Resar RK.Adverse drug event trigger tool: a practical methodology for measuring medication related harm[J].Qual Saf Health Care, 2003, 12(3): 194-200.
[10] XU J, HU Q, XU T.Using global trigger tool to monitor adverse drug events in inpatients with psychiatric disorders[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2019, 16(6): 352-359.
[11] Stockwell DC, Bisarya H, Classen DC, et al.A trigger tool to detect harm in pediatric inpatient settings[J]. Pediatrics, 2015, 135(6): 1036-1042.
[12] Landrigan CP, Stockwell D, Toomey SL, et al. Performance of the global assessment of pediatric patient safety (GAPPS) tool[J/OL].Pediatrics, 2016, 137(6). [2020-07-07].https://pubme-d.ncbi.n-lm.nih.gov.
[13] Stockwell DC, Bisarya H, Classen DC, et al.Development of an electronic pediatric all cause harm measurement tool using a modified delphi method[J]. J Patient Saf, 2016, 12(4): 180-189.
[14] Stroupe LM, Patra KP, Dai Z, et al. Measuring harm in hospitalized children via a trigger tool[J/OL]. Journal of pediatric nursing, 2018, 41:9-15 [2020-07-07].https://pubmed.ncbi.nlm.nih.gov.
[15] Fajreldines A, Schnitzler E,Torres S, et al.Measurement of the incidence of care-associated adverse events at the Department of Pediatrics of a teaching hospital[J]. Arch Argent Pediatr, 2019, 117(2): 106-109.
[16] Wu J, Hu Y, Xu N.Effectiveness study on global trigger tool in detecting adverse drug events for children[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2017, 14(2): 119-122.
[17] World Health Organization. World health statistics2017: monitoring health for the SDGs,sustainable development goals[M/OL]. Geneva.: World Health Organization ,2017[2020-07-07]. https://www.who.int/gho/publications/world_health_statistics/2017/EN_WHS2017_TOC.pdf.
[18] Khan DA, Banerji A, Bernstein JA, et al.Cephalosporin allergy: current understanding and future challenges[J]. J Allergy Clin Immunol Pract, 2019, 7(7): 2105-2114.
[19] Qin WW.Retrospective analysis of hematological toxicity of cephalosporins[J]. Internal Medicine(内科), 2018, 13(3): 419-421.
[20] Dai X, Huang WX.Research progress on neurotoxicity of cephalosporins[J]. Journal of Frontiers of Medicine(医药前沿), 2014, (24): 230-230.
[21] Xu Z, Dong SQ.Research progress on adverse drug reactions of cephalosporins for injection[J]. Evaluation and Analysis of Drug-Use in Hospitals of China(中国医院用药评价与分析), 2019, 19(01): 122-123, 125.
[22] Lyu YN, Wen JH, Wei XH.Relationship between mechanism of adverse reactions and chemical structures of cephalosporins[J]. Chinese Journal of Hospital Pharmacy(中国医院药学杂志), 2015, 35(11): 1050-1054.