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| 康莱特注射液致皮肤相关药品不良反应/事件的自动监测研究 |
| Study on Cutaneous Adverse Drug Reactions / Events Related to Kanglaite Injection by Automatic Surveillance |
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| DOI： |
| 中文关键词: 康莱特注射液 皮肤 药品不良反应/事件 自动监测 |
| 英文关键词:Kanglaite injection Skin Adverse drug reaction/event Automatic surveillance |
| 基金项目:2017年军事医学创新工程重点项目（编号17CXZ010） |
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| 中文摘要: |
| 摘 要 目的：研究住院患者使用康莱特注射液致皮肤相关药品不良反应/事件（ADR/ADE）的发生率及相关因素。方法：采用回顾性分析，利用“医疗机构ADE主动监测与智能评估警示系统”，对我院2015年6月1日～2017年5月31日使用康莱特治疗的住院患者开展自动监测，报警病例经人工评价后对康莱特致皮肤相关ADR/ADE的发生率及相关因素进行分析。结果：研究共纳入患者4 016例，其中10例发生康莱特皮肤相关ADR/ADE,正常用药皮肤相关ADR发生率为0.20%，超疗程用药致ADE发生率为2.13%，正常用药与超疗程用药差异有统计学意义（OR=10.431，95%CI：2.185～49.784，P=0.022）。有1例出现重度ADE。康莱特用药时长超过2周为皮肤相关ADR/ADE发生的独立危险因素（OR=12.831，95%CI：1.378～119.473）。结论：本研究利用系统高效对目标药物开展自动监测研究，为临床合理用药提供参考。康莱特致皮肤相关ADR/ADE发生率属偶见范围，临床使用过程中，要对用药时长引起足够重视，严格按照说明书规范用药。 |
| 英文摘要: |
| ABSTRACT Objective:To study the incidence and related factors of cutaneous adverse drug reactions/ events(ADR/ADE) caused by kanglaite injection in hospitalized patients. Methods: The research was analyzed retrospectively. The data of the hospitalized patients who received therapy with kanglaite injection between June 1, 2015 and May 31, 2017 were screened out by adverse drug events’ active surveillance and assessment system. The suspected cases were reviewed manually for further study on the incidence and related factors of cutaneous ADR/ADE caused by kanglaite injection. Results: A total of 4 016 cases were entered into the study. There were 10 cases with cutaneous ADR/ADE caused by kanglaite injection. The incidence of cutaneous ADR in normal drug use was 0.20% and the incidence of cutaneous ADE beyond the normal course of medication is 2.13%. There was a significant difference between them(OR=10.431, 95%CI:2.185 49.784, P=0.022). Its severe ADE occurred in 1 patient. The medication duration over 2 weeks was independent risk factors for cutaneous ADR/ADE caused by kanglaite injection (OR=12.831, 95%CI: 1.378 119.473). Conclusion:By using the autouatic serveillance system, pharmacists can efficiently carry out research on target drugs and make a guidance for rational drug use in clinical. The incidence of cutaneous ADR/ADE caused by kanglaite injection was not common. The medication duration should be pay attention to in clinical drug use and the use of kanglaite injection should strictly be in accordance with the specification. |
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