中新网9月19日电 据国家食药监局网站消息，日前，国家食品药品监督管理局发布了第50期《药品不良反应信息通报》，提示关注门冬氨酸钾镁注射剂引起严重过敏反应及超适应症使用的问题。

Beijing on September 19, according to the national food, the administration's web site message,a,State food and drug administration issued the 50th period[Adverse drug reaction information bulletin],Prompt attention nmda potassium magnesium injection cause serious allergic reaction and super indications use problem.

　　门冬氨酸钾镁注射剂是门冬氨酸钾盐和镁盐的混合物，为电解质补充剂。2011年1月1日至2011年12月31日，国家药品不良反应监测中心病例报告数据库中有关门冬氨酸钾镁注射剂的病例报告共计718例。严重病例报告共计31例，其中严重过敏反应较突出，主要不良反应表现为过敏性休克、过敏样反应、呼吸困难等。

Nmda potassium magnesium injection is nmda potassium and magnesium salt mixture,For electrolyte supplements.On January 1, 2011 to December 31, 2011,The national drug adverse reaction monitoring center case report database relevant nmda potassium magnesium injection cases reported a total of 718 cases.A total of 31 cases of serious case report,The serious allergic reaction is more prominent,Major adverse reaction performance for allergic shock/Allergy sample reaction/Difficulty breathing, etc.

　　病例报告数据库中，有关门冬氨酸钾镁注射剂的严重ADR报告中，用药原因除了用于批准的低钾血症、心肌炎、冠心病等辅助治疗外，还有20%的病例用于急性胃肠炎、肝癌、肝炎、保肝、感冒等的治疗，存在超适应症情况。

Case report the database,Relevant nmda potassium magnesium injection serious ADR report,Use reason except for approval of hypokalemia/myocarditis/Coronary heart disease (CHD) and the adjuvant therapy,There are 20% of cases for acute gastroenteritis/Liver cancer/hepatitis/Protect liver/Such as the cold treatment,Existing super indications situation.

　　根据病例报告数据库信息分析情况，国家食品药品监督管理局建议：

According to the case report database information analysis conditions,State food and drug administration suggested:

　　一、门冬氨酸钾镁注射剂易发生过敏反应，医护人员在用药前应详细询问患者的过敏史，对本品所含成份过敏者禁用，过敏体质者慎用。给药期间应对患者密切观察，一旦出现过敏症状，则应立即停药或给予适当的救治措施。

a/Nmda potassium magnesium injection easy to produce allergic reaction,Medical personnel in the drug should be asked in detail about before patients with history of allergies,This product contains ingredients allergies are forbidden,Allergic constitution is used.During the drug to closely observe patients,Once appear allergy symptoms,It shall immediately stop drug or give appropriate treatment measures.

　　二、门冬氨酸钾镁仅作为电解质补充剂使用，不再用于病毒性肝炎、肝硬化和肝性脑病等的治疗。医护人员应严格按照说明书规定的适应症给药，不得超适应症使用。在使用门冬氨酸钾镁注射剂时尽量单独用药，并在使用过程中密切监测血钾和血镁浓度，及时调整剂量，以减少严重不良反应的发生。

two/Nmda potassium magnesium only as electrolyte supplement use,No longer be used to viral hepatitis/Cirrhosis and hepatic encephalopathy and treatment.Medical personnel should be strictly in accordance with the provisions of the manual indications to medicine,Shall not use super indications.In the use of nmda potassium magnesium injection as far as possible when drug alone,And in the use process closely monitoring the blood concentration of potassium and magnesium,Adjust dose,In order to reduce serious adverse events.

　　三、生产企业应加强药品不良反应监测，加大临床合理用药的宣传，将安全性信息及时传达给患者和医生，确保药品合理使用；完善生产质量管理、提高质量内控标准，开展相应的安全性研究。

three/Production enterprise should strengthen the adverse drug reaction monitoring,Increase clinical rational drug use propaganda,Will safety information timely communication to patients and doctors,To ensure the rational use of drugs;Perfect production quality management/Improve quality control standard,To carry out the corresponding safety research.