高危妊娠患者药品不良反应的临床特征及影响因素研究OA
Clinical Characteristics and Risk Factors of Adverse Drug Reactions in Patients with High-risk Pregnancy
背景 高危妊娠患者常合并多种并发症,其特殊生理状态下的药物安全性备受关注.目前针对该人群药品不良反应(ADR)的临床特征及影响因素研究有限,缺乏有针对性的用药风险评估依据.目的 分析住院高危妊娠患者 ADR 的临床特征及影响因素,为安全用药提供参考.方法 回顾性收集 2024 年 1 月—2025 年 5 月宁波大学附属妇女儿童医院收治的 402 例高危妊娠患者的临床资料,根据诺氏药物不良反应评估量表对可疑 ADR 进行评定,按照 ADR 发生情况分为 ADR 组和非 ADR 组,分析 ADR 发生的临床特征,并采用多因素 Logistic 回归探讨高危妊娠患者发生 ADR 的影响因素.结果 共 53 例患者发生 ADR,发生率为 13.18%,ADR 严重程度以轻度(50.94%,27/53)和中度(49.06%,26/53)为主.ADR 涉及 11 个怀疑药品,主要为生殖系统药物、内分泌系统药物及抗感染药物.主要致 ADR 药物为盐酸利托君注射液(72.22%,13/18)、硫酸镁注射液(47.06%,24/51)和人胰岛素注射液(19.05%,4/21).ADR 临床表现为胸闷、心动过速、恶心等,主要导致全身性疾病及各种给药部位反应、胃肠系统疾病及心脏器官疾病等.多因素 Logistic 回归分析结果显示,住院时间长(OR=1.085,95%CI=1.020~1.156)、处方数量多(OR=1.177,95%CI=1.027~1.349)为住院高危妊娠患者发生 ADR 的独立危险因素(P<0.05),高胎龄(OR=0.906,95%CI=0.854~0.962)是高危妊娠患者发生 ADR 的保护因素(P<0.05).结论 高危妊娠患者 ADR 发生率为 13.18%,以轻、中度为主;主要涉及药物为盐酸利托君注射液、硫酸镁注射液和人胰岛素注射液.住院时间、胎龄及处方数量,是诱发该类人群发生ADR的影响因素.临床用药管理中可根据影响因素,采取针对性的安全用药策略,以提升用药安全水平.
Background Patients with high-risk pregnancy often have multiple complications,and drug safety in this special physiological state has attracted increasing attention.At present,studies on the clinical characteristics and risk factors of adverse drug reactions(ADR)in this population remain limited,and evidence for targeted medication risk assessment is lacking.Objective To analyze the clinical characteristics and risk factors of ADR in hospitalized patients with high-risk pregnancy,and to provide a reference for safe medication use.Methods Clinical data from 402 hospitalized patients with high-risk pregnancy admitted to Women and Children's Hospital of Ningbo University from January 2024 to May 2025 were retrospectively collected.Suspected ADR were assessed using the Naranjo Adverse Drug Reaction Probability Scale.Patients were divided into an ADR group and a non-ADR group according to the occurrence of ADR.The clinical characteristics of ADR were analyzed,and multivariate Logistic regression was performed to identify factors associated with ADR occurrence in patients with high-risk pregnancy.Results A total of 53 patients experienced ADR,with an incidence of 13.18%.The severity of ADR was mainly mild(50.94%,27/53)and moderate(49.06%,26/53).ADR involved 11 suspected drugs,mainly drugs for the reproductive system,endocrine system,and anti-infective agents.The main drugs causing ADR were ritodrine hydrochloride injection(72.22%,13/18),magnesium sulfate injection(47.06%,24/51),and human insulin injection(19.05%,4/21).Clinical manifestations of ADR included chest tightness,tachycardia,and nausea,and mainly led to systemic diseases and various administration site reactions,gastrointestinal diseases,and cardiac disorders.Multivariate Logistic regression analysis showed that longer hospitalization duration(OR=1.085,95%CI=1.020-1.156)and a greater number of prescriptions(OR=1.177,95%CI=1.027-1.349)were independent risk factors for ADR in hospitalized patients with high-risk pregnancy(P<0.05),whereas higher gestational age(OR=0.906,95%CI=0.854-0.962)was a protective factor for ADR occurrence in patients with high-risk pregnancy(P<0.05).Conclusion The incidence of ADR in patients with high-risk pregnancy was 13.18%,and most cases were mild to moderate.The main implicated drugs were ritodrine hydrochloride injection,magnesium sulfate injection,and human insulin injection.Hospitalization duration,gestational age,and number of prescriptions were factors associated with ADR occurrence in this population.In clinical medication management,targeted strategies for safe drug use can be implemented according to these factors to improve medication safety.
李珊珊;苗彩云;毛佩芝;沈珑慧
315012 浙江省宁波市,宁波大学附属妇女儿童医院药剂科315012 浙江省宁波市,宁波大学附属妇女儿童医院药剂科315012 浙江省宁波市,宁波大学附属妇女儿童医院药剂科315012 浙江省宁波市,宁波大学附属妇女儿童医院药剂科
医药卫生
高危妊娠药品不良反应临床特征影响因素分析
High-risk pregnancyAdverse drug reactionsClinical characteristicsRoot cause analysis
《中国全科医学》 2026 (33)
4885-4890,6
浙江省药学会基层医院合理用药专项(2025JCYY04)宁波市妇科疾病临床医学研究中心(2024L002)
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