兰索拉唑临床应用的安全性评价与风险管理

Clinical Safety Evaluation and Risk Management of Lansoprazole

目的:了解兰索拉唑不同产品说明书内容的区别、不良反应发生的特点及其与不合理用药之间的相关性,加强兰索拉唑临床应用的风险管理。方法:比较国内外兰索拉唑药品说明书在主要内容上的异同点;检索中国期刊全文数据库及Pub Med,获得自数据库建立至2014年6月收录的国内外有关兰索拉唑不良反应的文献报道,进行汇总分析,并对其中的个案报道进行不合理用药分析。结果:不同口服剂型兰索拉唑药品说明书间未存在明显差异,仅适应证、不良反应、药物相互作用方面稍有不同,而注射剂型兰索拉唑药品说明书间在配制方法上存在一定差异;共检索到兰索拉唑致不良反应国内报道73篇、国外报道16篇,其中消化系统不良反应发生率均居首位,所占比例分别为57.4%、69.1%,均主要表现为腹泻、恶心、肝功能异常等;17例不良反应个案报道中有10例存在不合理用药,其中超适应证用药发生率最高。结论:兰索拉唑正确使用安全性较高,多数不良反应轻微且可自行缓解,而不合理使用时较易引起不良反应的发生,尤其是超适应证用药。为提高兰索拉唑临床应用的安全性,医师应严格遵守说明书适应证、谨慎对待特殊人群用药,药师应积极协助临床个体化用药、加强不良反应监测及做好超说明书用药管理。

OBJECTIVE：To understand the difference of drug instructions of lansoprazole,the characteristics of ADR and its correlation with irrational drug use,and to give the risk management suggestions for the clinical application of lansoprazole. METHODS：The drug instructions of domestic and foreign lansoprazole were compared in content similarities and differences. Retrieved from CNKI and Pub Med,domestic and foreign literature reports about lansoprazole-induced ADR were collected during the time of database establishment to Jun. 2014. Those reports were summarized and analyzed,and irrational drug use of case reports was analyzed. RESULTS：No significant difference was found in drug instructions of lansoprazole among different oral dosage forms;only indications,ADR and drug interactions had a slightly differences. For the drug instructions of lansoprazole injection,there are some differences in the preparation methods. Moreover,73 domestic and 16 foreign related ADR reports of lansoprazole were searched,and in these reports,the incidence of digestive system ADR ranked the first,accounting for 57.4% and 69.1%,respectively;in addition,diarrhea,nausea and abnormal liver function etc were all their clinical features. Among 17 cases of ADR case reports,irrational drug use was found in 10 cases,and super indications medication had the highest rate. CONCLUSIONS：When used properly,lansoprazole is relatively safe,and most ADR are mild and can alleviate by themselves. Then when used unreasonably,lansoprazole can cause ADR,especially super indications medication. In order to improve the safety of clinical application of lansoprazole,physicians should strictly abide by the instructions indications,and be cautious to use for special populations;pharmacists should actively assist the clinical individualized medication,strengthen ADR monitoring and the management of off-label drug use.