| 江莹,张锦文,何艳,等.热毒宁注射液不良反应 325例分析[J].安徽医药,2025,29(1):205-209. |
| 热毒宁注射液不良反应 325例分析 |
| Analysis of 325 cases of adverse drug reaction of Reduning injection |
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| DOI：10.3969/j.issn.1009-6469.2025.01.042 |
| 中文关键词: 药物相关性副作用和不良反应 抗病毒药 中草药 热毒宁注射液 安全用药 分析 |
| 英文关键词: Drug-related side effects and adverse reactions Antiviral agents Drugs, Chinese herbal Reduning injection Safe medication Analysis |
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| 中文摘要: |
| 目的探讨热毒宁注射液不良反应发生的规律及特点，为临床合理用药提供依据。方法对 2012年 1月至 2022年 12月武汉市药品不良反应监测中心数据库中收集的 325例热毒宁注射液药物不良反应(ADR)报告进行统计分析。结果 325例热毒宁注射液 ADR报告中， 6岁以下儿童发生 ADR居多，多数为联合用药( 52.62%)；不合理用药导致 ADR的影响因素为用药剂量不合理( 14.77%)、超适应证用药( 1.54%)、溶媒不合理( 1.54%)； ADR主要发生在用药 30 min内，累及系统 -器官与临床表现主要为皮肤及其附件损害(52.71%)，全身性损害次之( 21.26%)。结论临床上需加强儿童病人(尤其是 6岁以下)使用热毒宁注射液的 ADR风险管理，应尽量避免循证医学证据不足的超剂量用药、超适应证及联合用药等不合理使用，避免增加 ADR发生风险，保障热毒宁注射液的安全有效使用。 |
| 英文摘要: |
| Objective To investigate the rules and characteristics of adverse drug reactions (ADR) of Reduning injection, so as to pro-vide evidence for clinical rational drug use. Methods Three hundred and twenty-five cases of ADR related to Reduening injectionwhich were collected from January 2012 to December 2022 based on database of Center for ADR Monitoring of Wuhan city were ana-lyzed statistically.Results In 325 cases of Reduning injection ADR, the majority of ADR occurred in children under 6 years old, mostof which were combined medication (52.62%). The influencing factors of irrational drug use leading to ADR were unreasonable dose (14.77%), off-label drug use (1.54%) and unreasonable solvent (1.54%). ADR mainly occurred within 30 min of medication, and themain systematic-organ and clinical manifestations were skin and accessory damage (52.71%), followed by systemic damage (21.26%). Conclusion In clinical practice, it is necessary to strengthen ADR risk management of Reduning injection in children (especially un-der 6 years old), and avoid unreasonable use of excessive dosage, off-label and combined drug use with insufficient evidence of evi-dence-based medicine, so as to avoid increasing the risk of ADR and ensure the safe and effective use of Reduning injection. |
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