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药物的安全性监测——我们目前的状况如何?

Safety monitoring of drugs--where do we stand?

作者信息

Palaian S, Mishra P, Shankar P R, Dubey A K, Bista D, Almeida R

机构信息

Department of Pharmacology, Manipal Teaching Hospital, Manipal College of Medical Sciences, Pokhara, Nepal.

出版信息

Kathmandu Univ Med J (KUMJ). 2006 Jan-Mar;4(1):119-27.

PMID:18603884
Abstract

Drug related complications, a major cause of hospitalizations, lead to huge economic burden and significant human suffering. New chemical entities enter the market without sufficient safety data on patient population making rare (Adverse Drug Reactions) ADRs undetected in the clinical trials. ADR monitoring helps in detecting the occurrence of rare and unknown ADRs and helps in prevention of further occurrence. Several methods are adopted for effective monitoring of ADRs. An effective ADR monitoring program requires adequate infrastructure and trained manpower. In developed countries, the ADR monitoring system is well established. In Nepal, the concept of ADR monitoring is in the infant stage. A simple approach for ADR monitoring may be helpful in starting an ADR monitoring program in hospital setups in Nepal. Though it is difficult to prevent ADRs, a systematic approach will definitely helps in minimizing the further occurrence of similar ADRs.

摘要

药物相关并发症是住院的主要原因,会导致巨大的经济负担和巨大的人类痛苦。新化学实体进入市场时,没有关于患者群体的足够安全数据,使得罕见的(药品不良反应)ADR在临床试验中未被发现。ADR监测有助于检测罕见和未知ADR的发生,并有助于预防其进一步发生。采用了几种方法来有效监测ADR。有效的ADR监测计划需要适当的基础设施和训练有素的人力。在发达国家,ADR监测系统已经建立完善。在尼泊尔,ADR监测的概念尚处于起步阶段。一种简单的ADR监测方法可能有助于在尼泊尔的医院建立ADR监测计划。虽然很难预防ADR,但系统的方法肯定有助于最大限度地减少类似ADR的进一步发生。

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