中新网9月3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49期《药品不良反应信息通报》，提醒关注盐酸氨溴索注射剂引起严重过敏反应的问题。

Beijing on September 3, according to the national food, the administration's web site message,a,State food and drug administration issued the 49th period[Adverse drug reaction information bulletin],Remind attention ambroxol hydrochloride injection cause serious allergic reaction problems.

　　氨溴索为溴已新在体内的活性代谢物。适用于急、慢性呼吸道疾病、早产儿及新生儿呼吸窘迫综合征和术后肺部并发症的预防性治疗。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共收到有关盐酸氨溴索注射剂药品不良反应/事件病例报告2973例，其中严重病例报告169例，主要不良反应表现依次为：过敏样反应、呼吸困难、过敏性休克。

Ambroxol as bromine has the new in the body active metabolites.Suitable for urgent/Chronic respiratory diseases/Premature and neonatal respiratory distress syndrome and postoperative pulmonary complications preventive treatment.On January 1, 2011 to December 31, 2011,The national drug adverse reaction monitoring center case report database were received relevant ambroxol hydrochloride injection adverse drug reaction/events case report 2973 cases,The 169 cases of serious case report,Major adverse reaction in performance:Allergy sample reaction/Difficulty breathing/Anaphylactic shock.

　　分析显示，盐酸氨溴索注射剂在临床上存在不合理使用现象，其中在儿童病例中尤为突出。在169例严重病例中，有79例为儿童用药病例，且用药剂量超出剂量范围为51例，占全部严重病例的64.56%。

Analysis showed that,Ambroxol hydrochloride injection in clinic some irrational use phenomenon,Among them in children cases is particularly prominent.In 169 cases with severe cases,There were 79 cases of drug cases for children,Dosage and beyond dose range for 51 cases,Accounted for 64.56% of all serious cases.

　　据悉，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共收到有关盐酸氨溴索注射剂药品不良反应/事件病例报告2973例，其中严重病例报告169例。严重不良反应/事件累及系统排名前三位的依次为：全身性损害、呼吸系统损害、心血管系统一般损害，三者合计占总例次的74.63%。此外还有皮肤损害、中枢及外周神经系统损害、胃肠系统损害等。严重病例中，79例为儿童病例(占46.75%)。

It is reported,On January 1, 2011 to December 31, 2011,The national drug adverse reaction monitoring center case report database were received relevant ambroxol hydrochloride injection adverse drug reaction/events case report 2973 cases,The 169 cases of serious case report.Serious adverse reaction/events involving the system the top three in order:Systemic damage/Respiratory damage/The cardiovascular system general damage,Combined the three total cases 74.63% of the time.In addition to the skin damage/Central and peripheral nerve system damage/Gastrointestinal system damage, etc.Serious cases,79 cases of cases for children(Accounted for 46.75%).

一、严重病例的临床表现 a/The clinical manifestations of serious cases

　　居前3位的不良反应表现依次为：过敏样反应(45例次，16.79%)、呼吸困难(31例次，11.57%)和过敏性休克(29例次，10.82%)。此外还有寒战、高热、紫绀、胸闷等。

The top 3 places in adverse reactions in performance:Allergy sample reaction(45 cases of time,16.79%)/Difficulty breathing(31 cases of time,11.57%)And allergic shock(29 cases of time,10.82%).In addition to chill/High fever/cyanosis/Bosom is frowsty etc.

二、儿童用药问题 two/Children's drug problem

　　国家药品不良反应监测中心病例报告数据库中，盐酸氨溴索注射剂不良反应/事件报告分析显示，该产品在临床上存在不合理使用的现象，此现象在儿童病例中尤为突出。79例儿童严重不良反应/事件的病例报告中，用药剂量超出盐酸氨溴索剂量范围的51例，占严重病例的64.56%。

The national drug adverse reaction monitoring center case report database,Ambroxol hydrochloride injection adverse reaction/incident report analysis showed that,The products are in the clinical rational use of phenomenon,This phenomenon in children cases is particularly prominent.79 cases of children serious adverse reaction/events in case report,Drug dose beyond hydrochloric acid ambroxol dose range of 51 cases,Accounted for 64.56% of the cases of serious.

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:

　　1. 鉴于与盐酸氨溴索注射剂相关的严重不良反应较多，除与药品本身特性有关外，还与多种因素如患者个体差异、超剂量使用、不合理给药途径、不当配伍用药、输液速度过快等有关，建议临床医生在使用盐酸氨溴索注射剂时，需注意用药剂量和特殊人群，避免超适应症用药，对有过敏史、高敏状态，如支气管哮喘等气道高反应患者慎用；严禁盐酸氨溴索注射剂与其他药品混合同瓶滴注，注意配伍用药，避免与偏碱性液体、头孢类抗生素、中药注射剂等配伍使用。

1. In view of and ambroxol hydrochloride injection related more serious adverse reactions,In addition to and drug itself characteristic of outer,Also with a variety of factors such as patients individual differences/Ultra dose use/Not reasonable route of administration/Improper drug compatibility/Infusion speed too fast and so on,Suggest clinicians in the use of ambroxol hydrochloride injection in,Attention should be paid to drug dose and special groups,Avoid super indications medication,Have allergy history to/Gao min state,Such as bronchial asthma and airway hyperresponsieness used patients;It is strictly prohibited to ambroxol hydrochloride injection and other drug mixed with bottle drip,Pay attention to drug compatibility,Avoid and alkaline liquid/Cephalosporin antibiotic/Traditional Chinese medicine injection, etc used compatibility.

　　2. 建议药品生产企业修改完善药品说明书相关内容，加强药品上市后不良反应监测，积极开展质量和工艺方面的研究，同时做好盐酸氨溴索注射剂安全用药宣传和培训，指导临床合理用药，保障公众用药安全。

2. Suggest a pharmaceutical production enterprise to revise and perfect the drug specifications related content,Strengthen the drug post-marketing aderse eents monitoring,Actively carry out quality and technology research,At the same time to ambroxol hydrochloride injection drug safety publicity and training,Guide clinical rational drug use,Safeguarding the drug use safety.