The Application of an Institutional Clinical Data Warehouse to the Assessment of Adverse Drug Reactions (ADRs)
The Application of an Institutional Clinical Data Warehouse to the Assessment of Adverse Drug Reactions (ADRs)
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DOI：
10.1160/me0374
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发表时间：
2007
影响因子：
1.7
通讯作者：
Qiyan Zhang;Y. Matsumura;Tadamasa Teratani;S. Yoshimoto;T. Mineno;K. Nakagawa;M. Nagahama;S. Kuwata;H. Takeda
中科院分区：
文献类型：
--
作者：
Qiyan Zhang;Y. Matsumura;Tadamasa Teratani;S. Yoshimoto;T. Mineno;K. Nakagawa;M. Nagahama;S. Kuwata;H. Takeda
目标摘要：将机构临床数据仓库（CDW）应用于药品不良反应（ADR）评价，并通过具体实例说明其实用性。研究方法：我们通过回顾性队列设计，使用大坂大学医院的CDW对评估ADR的过程进行建模，如下所示：1）我们定义了药物X，药物不良反应（ADR）Y和实验室测量Z，以评估给定研究期间的Y; 2）我们排除了Z值超过定义标准或在队列开始时不可用的患者; 3）我们根据暴露或不暴露于X将患者分为两组; 4）我们通过分层和随机化匹配两组之间的患者特征; 5）我们比较了两组之间在研究期间出现Y的患者的频率。氨基糖苷类和头孢菌素相关的肾毒性在儿科住院患者被用作一个例子，以证明这种方法的有效性。结果如下：我们的评估表明，有一个增加的肾毒性的儿科住院患者谁是处方头孢菌素单独或与氨基糖苷类药物联合使用的风险;此外，氨基糖苷类药物往往会增加头孢菌素相关的肾毒性。结论：我们的研究结果与其他研究的结果一致，表明应用机构CDW的方法对评估ADR是有用的。
Summary Objectives: To apply an institutional clinical data warehouse (CDW) to the assessment of adverse drug reactions (ADRs) and demonstrate its utility through a specific example. Methods: We modeled the process for assessing ADRs through retrospective cohort design by using CDW at the Osaka University Hospital as follows: 1) We defined a drug X, an adverse drug reaction (ADR) Y, and a laboratory measurement Z to assess Y during a given study period; 2) we excluded those whose Z value exceeded the defined criteria or were not available at the inception of the cohort; 3) we divided the patients into two groups based on exposure or non-exposure to X; 4) we matched the patient characteristics between the two groups through stratification and randomization; and 5) we compared the frequency of patients who presented Y during the study period between the two groups. Aminoglycoside and Cephalosporin associated nephrotoxicity in pediatric inpatients was used as an example to demonstrate the usefulness of this approach. Results: Our evaluation indicates that there is an increased risk of nephrotoxicity for pediatric inpatients who were prescribed cephalosporin either alone or in combination with aminoglycoside; further, aminoglycoside tends to increase the cephalosporin-associated nephrotoxicity. Conclusions: Our findings are consistent with those drawn from other studies, indicating thatthe method of a pplying an institutional CDW is useful for assessing ADRs.