Pharmacoepidemiological Examination for the Safety of the Oral laxatives in the Elderly Patients

Pharmacoepidemiological Examination for the Safety of the Oral laxatives in the Elderly Patients
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老年口服泻药安全性的药物流行病学调查

DOI:
10.11256/jjdi.18.179
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发表时间:
2016
期刊:
Iyakuhin Johogaku
影响因子:
--
通讯作者:
寺町 ひとみ
寺町 ひとみ
中科院分区:
--
文献类型:
--
作者:
野口 義紘; 林 勇汰; 吉田 阿希; 杉田 郁人; 江崎 宏樹; 齊藤 康介; 臼井 一将; 加藤 未紗; 舘 知也; 寺町 ひとみ

文献摘要

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目的:很多老年患者都患有便秘,都在使用口服泻药。但是,未对口服泻药进行风险评估。因此,我们使用日本不良药物事件报告数据库(JADER),并检查了口服泻药在老年患者中的安全性。方法:自分析目标药物; 12种口服泻药和目标ADE;“消化系统疾病”和“电解质异常”,JADER数据库2004年4月至2015年1月在年龄超过60岁的成年人中进行了分析。以报告比值比作为药物的一个安全性指标,采用报告比值比,当95%双侧可信区间的下限大于1时,为ADE的信号检测。结果:口服泻药检出“消化系统疾病”信号的有3种药物,检出“电解质异常”信号的有5种药物。特别是,对于电解质异常不仅会使血镁值升高,就像氧化镁一样,也会影响其他电解质的显示。结论:一些口服泻药也是为了检测附件中未列出的不良事件的信号,有必要注意老年患者的使用。
Objective: Many of the elderly patients are suffering from constipation, are using the oral laxative. However the risk assessment of the oral laxative is not performed. Therefore, we used Japanese Adverse Drug Event Report database (JADER) and examined for the safety of the oral laxative in the elderly patients.Methods: Since the analysis target medicines; 12 oral laxatives and target ADEs;“digestive disorders” and “electrolyte abnormality,” the JADER database for April 2004 to January 2015 were analyzed in adults of age exceeds 60. We used the reporting odds ratio for a safety index of drugs, using reporting odds ratio, when the Lower bound of the 95% two-sided confidence interval exceeds 1, it is the signal detection of ADE.Results: The oral laxatives detected the signal of “digestive disorders” were three medicines, and “electrolyte abnormality” were five medicines. Especially, for electrolyte abnormalities not only increases the blood magnesium values as magnesium oxide, that there is also affect other electrolyte revealed.Conclusion: Some oral laxatives were also intended to signal detections of the adverse events that are not listed in the attached document, it is necessary to pay attention to the use of them for the elderly patients.