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| 双黄连注射剂儿童不良反应病例对照研究 |
| A Matched Case-control Study of Adverse Drug Reactions of Shuanghuanglian Injection in Children |
| 投稿时间：2006-01-11 修订日期：2007-03-20 |
| DOI： |
| 中文关键词: 双黄连注射剂 儿童 药物不良反应 配比病例对照研究 |
| 英文关键词:Shuanghuanglian injection,Children,Adverse drug reaction,Matched case-control study |
| 基金项目: |
| 陈颖 毛宗福 任经天 |
| 武汉大学公共卫生学院，武汉大学公共卫生学院，国家食品药品监督管理局药品评价中心 武汉430071，武汉430071 |
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| 中文摘要: |
| 目的:探讨儿童使用双黄连注射剂发生不良反应的危险因素。方法:将某三级甲等医院2001年1月～2002年12月使用双黄连注射剂住院患儿列为调查对象,其中出现不良反应的39例患儿纳入病例组,采用1:2匹配病例对照,对照组为相匹配的78例患儿。选取既往史、过敏史、合并抗菌药、合并用药总数、出现时间、用药总天数、溶媒、滴速、剂量、生产批次等9项侯选危险因素进行调查分析,用SPSS13.0统计软件,采用配对单因素和多因素条件logistic回归分析,筛选出危险因素。结果:单因素条件logstic回归分析将用药总天数筛选为不良反应出现的"保护因素",OR值为0.097,P<0.05。合并用药总数筛选为不良反应出现的危险因素,OR值为2.449,P<0.05;多因素条件logstic回归分析显示,用药总天数是双黄连不良反应出现的"保护因素",OR值为0.089(95%CI:0.018～0.431)。合并用药总数是双黄连不良反应出现的危险因素,OR值为2.678(95%CI:1.199～5.979)。结论:合并用药总数是儿童使用双黄连注射剂发生不良反应的危险因素。 |
| 英文摘要: |
| Objective:To explore the risk factors of adverse drug reactions(ADRs)of shuanghuanglian(SHL) injection used in children.Method:1:2 standard matches were adopted to investigate child patients with ADRs of SHL in- jection in a 3-A hospital in Wuhan,Hubei Province from January 1st,2001 to December 31st,2002.The case group con- tained 39 sick children with ADRs and the controlled group contained 78 sick children with essential matching conditions. Nine risk factors to be selected to investigate were:past disease history,allergic history,combined antibiotics,the total number of combined medicines,season factor,the total days of taken medicine,solvent,speed,dosage and production lot number,etc.Univariate and multivariate conditional logistic regression analyses were carried out with SPSS 13.0 software. Result:The single factor conditional logistic regression analysis showed that the total days of taken medicine was a protec- tive factor with OR as 0.097,P < 0.05 and the total number of combined medicines was the risk factor of the ADBs of SHL injection with OR 2.449,P<0.05.The Multivariate conditional logistic regression analysis showed that the total days of taken medicine was a protective factor with OR as 0.089(95% CI:0.018-0.431)and the total number of combined medi- cines was the risk factor of ADBs of SHL injection with 2.678(95% CI:1.199-5.979).Conclusion:The study suppor- ted that the total number of combined medicines was the risk factor of the ADBs of SHL injection. |
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