Evaluation of a worldwide spontaneous reporting system with cimetidine.
Evaluation of a worldwide spontaneous reporting system with cimetidine.
复制标题
西咪替丁全球自发报告系统的评估。
DOI：
10.1001/jama.1980.03300450026015
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发表时间：
1980
期刊：
影响因子：
--
通讯作者：
J. Schlosser
中科院分区：
文献类型：
--
作者：
T. Davis;D. L. Pickett;J. Schlosser
西咪替丁的不良反应已通过制造商的全球自发报告系统确定。临床试验中未观察到的反应精神错乱、间质性肾炎和口服抗凝剂的增强作用被确定并添加到西咪替丁的处方信息中，同时进行进一步的研究。对药物不良反应的监测正在进行中，以便能够识别新类型的反应。
Adverse reactions to cimetidine have been identified through the manufacturer's Worldwide Spontaneous Reporting System. Reactions not observed during clinical trials-mental confusion, interstitial nephritis, and potentiation of oral anticoagulants-were identified and added to the prescribing information for cimetidine while further studies were undertaken. The monitoring of the drug's adverse reaction profile is ongoing so that new types of reactions can be identified.