基于真实世界数据的丹参注射液不良反应调查分析
Investigation and Analysis of Adverse Reactions of Danshen Injection Based on Real-World Data
杨逢春 1贾莎莎 1张娜娜 1董瑞红2
作者信息
- 1. 焦作卫生医药学校附属医院 药剂科,河南 焦作 454000
- 2. 焦作卫生医药学校附属医院 药械科,河南 焦作 454000
- 折叠
摘要
目的 基于真实世界数据调查分析丹参注射液的不良反应.方法 回顾性分析焦作卫生医药学校附属医院自2021 年 6 月至 2023 年 6 月使用丹参注射液的 463 例病患的临床资料.统计不良反应.据此将其分为不良反应发生组与未发生组,比较二者资料,Logistic回归分析不良反应的影响因素.结果 使用丹参注射液的患者中不良反应发生率为 9.72%,其中皮肤及其附件损害不良反应发生率最高,其次为消化系统损害不良反应;年龄(OR=1.896,95%CI:1.262～2.851)、原发疾病为心脑血管疾病(OR=1.842,95%CI:1.081～3.140)、用药剂量(OR=1.573,95%CI:1.159～2.136)、用药时间(OR=1.737,95%CI:1.245～2.423)、有过敏史(OR=1.813,95%CI:1.367～2.404)均为丹参注射液不良反应的影响因素.结论 丹参注射液可引起不同程度的不良反应,年龄、原发疾病为心脑血管疾病、用药剂量、用药时间、有过敏史均为丹参注射液不良反应的影响因素.临床应规范其应用,并加强不良反应监测,减少不良反应发生.
Abstract
Objective To investigate and analyze the adverse reactions of Danshen injection based on real-world data.Methods Clinical data of 463 patients who received Danshen injection at the Affiliated Hospital of Jiaozuo Health School from June 2021 to June 2023 were retrospectively analyzed.Adverse reactions were statistically analyzed.Patients were divided into adverse reaction occurrence group and non-occurrence group,and the data between the two groups were compared.Logistic regression analysis was performed to identify the influencing factors of adverse reactions.Results The incidence of adverse reactions in patients using Danshen injection was 9.72%,with skin and appendage damage having the highest incidence followed by gastrointestinal damage.Age(OR=1.896,95%CI:1.262～2.851),primary disease of cardiovascular and cerebrovascular diseases(OR=1.842,95%CI:1.081～3.140),dosage(OR=1.573,95%CI:1.159～2.136),duration of medication(OR=1.737,95%CI:1.245～2.423),and history of allergies(OR=1.813,95%CI:1.367～2.404)were identified as influencing factors of adverse reactions to Danshen injection.Conclusion Danshen injection can cause adverse reactions of varying degrees.Age,primary disease of cardiovascular and cerebrovascular diseases,dosage,duration of medication,and history of allergies are influencing factors of adverse reactions to Danshen injection.Clinical application should be standardized,and adverse reaction monitoring should be strengthened to reduce adverse reactions.
关键词
真实世界数据/丹参注射液/不良反应Key words
real-world data/Danshen injection/adverse reactions引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
维普
万方数据