佛山市1782例孕产妇药物不良反应数据分析

Analysis of 1782 case of maternal adverse drug reaction in Foshan

目的探讨佛山市孕产妇药物不良反应(ADR)发生的规律和特点,为临床安全、合理用药提供参考。方法对佛山市药品不良反应监测中心2012—2023年收集到的1782例孕产妇ADR的病例报告进行回顾性分析。结果1782例孕产妇ADR中,以产褥期(48.82%)发生ADR最为普遍,21~35岁居多(81.59%);主要累及皮肤及皮下组织类疾病、全身性疾病及给药部位各种反应和胃肠系统疾病。导致ADR发生的主要药物品种排前三位为生殖系统药(38.51%)、抗微生物药(27.20%)和电解质、酸碱平衡及营养药(10.44%);引起严重ADR主要药物品种排第一位为生殖系统药;其中抗微生物药为引起过敏性休克的主要品种,以头孢菌素类为主;过敏性休克多发生在30 min内,其中14.81%孕产妇有药物过敏史。ADR报告中点评为不合理处方共254例,涉及严重ADR报告31例(12.20%)。不合理处方发生严重ADR频次最高为抗微生物药。结论临床应加强产褥期和高龄产妇的用药监测,特别是用药前30 min,重点监护生殖系统药和抗微生物药的ADR,加强围手术期抗微生物药的监测,减少不合理用药,严格遵守操作规程,促进孕产妇安全用药。

Objective To determine the characteristics and regularity of maternal adverse drug reactions(ADR)in Foshan,and to provide reference for safe and rational drug use.Methods A retrospective study was conducted to collect the data of 1782 cases of maternal ADRs from Foshan Adverse Drug Reaction Monitoring Center from 2012 to 2023.Results Among 1782 ADR cases in maternal,ADR in the puerperium was the most common(48.82%),with the majority ranging 21~35(81.59%)years old.ADRs mainly invovled the skin and subcutaneous diseases,systemic diseases and various reactions at the administration sites and gastrointestinal diseases.The top three drug catgories causing ADRs included reproductive system drugs(38.51%),antimicrobial drugs(27.20%),and electrolytes,acid-base balance and nutrition drugs(10.44%).The main drug type causing serious ADRs was reproductive system drugs.Antimicrobial drugs were the main type causing anaphylactic shock,mainly cephalosporins;anaphylactic shock usually occurred within 30 min,and about 14.81%of maternal had a history of drug allergy.Totally 254 cases of irrational drug use were found in ADR reports,with 31(12.20%)serious ADRs.The drug variety with the highest incidence of serious ADRs caused by irrational use of drugs was antimicrobial drugs.Conclusion We should strengthen the drug monitoring of maternal,especially 30 min before the medication,monitor the ADR of reproductive system drugs and antimicrobial drugs,and the monitor perioperative antimicrobial drugs to reduce irrational medication use.