165例中药注射剂药品不良反应报告分析(1)
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[摘要] 目的：了解我院中药注射剂药品不良反应(ADR)的相关情况。方法：收集2009年1月~2010年12月我院发生中药注射剂ADR患者165例，对患者性别、年龄、发生时间、涉及系统与临床表现、药品种类等方面进行分析。结果：165例患者中男性发病86例(52.12%)，女性发病79例(47.88%)；ADR的临床表现以用药部位为主，其次为皮肤及附件损害；发生ADR最多的药品为注射用七叶皂苷钠，其次是炎琥宁注射液；80例(48.48%)ADR发生的时间≤24 h。结论：中药注射剂容易发生ADR，应引起临床医生高度重视，及时、认真做好ADR预防和监测工作，可以提高临床用药安全性。
[关键词] 中药注射剂；药品不良反应；原因分析
[中图分类号] R969.3 [文献标识码] C [文章编号] 1673-7210(2011)11(c)-140-03
Analysis of 165 cases adverse drug reaction reports of traditional Chinese medicine injection
ZHANG Shuling, GUO Yihang, XU Maoxing
Department of Pharmacy, the People's Hospital of Pizhou City, Jiangsu Province, Pizhou 221300, China
[Abstract] Objective: To investigate the current situation of adverse drug reactions (ADR) of traditional Chinese medicine injection in our hospital. Methods: 165 cases of patients with ADR of traditional Chinese medicine injections in our hospital from January 2009 to December 2010 were selected. Sex, age of patients, occurrence time, systems involved and clinical manifestations, types of drugs were analyzed. Results: Among the 165 cases of ADR reports, 86 cases (52.12%) were male and 79 cases (47.88%) were female. ADR mainly occurred in administration site, damage of the skin and appendages were followed. The highest ADR incidence drug was Sodium Aescinate injection, followed by Yanhuning injection. 80 cases (48.48%) of ADR occurred in less than 24 h. Conclusion: Traditional Chinese medicine injections are prone to occurrence of ADR, thus in clinical practice, clinicians need to pay special attention to the prevention and monitoring of ADR to ensure the safety of clinical drug use.
[Key words] Traditional Chinese medicine injection; Adverse drug reaction; Cause analysis
在20世纪80年代由中药制剂引起的药品不良反应(adverse drug reaction，ADR)就已有报道，但未引起重视，随着中药制剂在临床应用越来越广泛，因其引起的ADR也越来越多。为了解中药制剂引起ADR的规律和相关因素，从而为临床提供科学安全的参考依据，减少或避免ADR的发生，本研究加强了对中药注射剂ADR的检测工作，总结了2009年1月~2010年12月我院相关的ADR报告165例。现报道如下：
1 资料与方法
1.1 一般资料
选择2009年1月~2010年12月我院中药注射剂引起ADR的报告165例，报告表质量评价均合格。
1.2 方法
采用回顾性研究方法，对发生ADR患者的性别、年龄、ADR发生时间、涉及系统及临床表现、药品种类等项目进行研究。
1.3 评价标准
ADR涉及的系统及主要临床表现，参照《WHO药品不良反应术语集》进行分类。
1.4 统计学方法
采用SPSS 15.0统计学软件进行数据分析，计数资料用率表示，组间比较采用χ2检验，以P<0.05为差异有统计学意义 ......
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