欧盟终止羟乙基淀粉注射液上市许可

1、The European Medicines Agencys Main navigation PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl-starch欧洲药监局主导的药物安全风险评估委员会建议含有羟乙基淀粉输液暂停上市许可。The European Medicines Agencys Pharmacovigilance Risk Assessment Committee (PRAC) has concluded following a rev

2、iew of the available evidence that the benefits of infusion solutions containing hydroxyethyl-starch (HES) no longer outweigh their risks and therefore recommended that the marketing authorisations for these medicines be suspended. 欧洲药监局药物安全风险评估委员会（PRAC）通过对有效证据评估，得出如下结论：含有羟乙基淀粉（HES）的注射液风险大于利益，因此建议将暂

3、停这些药品营销授权。The review of infusion solutions containing HES was triggered by the German medicines agency, the Federal Institute for Drugs and Medical Devices (BfArM), following three recent studies 1, 2, 3 that compared HES with other products used for volume replacement called crystalloids in critica

4、lly ill patients. The studies showed that patients with severe sepsis treated with HES were at a greater risk of kidney injury requiring dialysis. Two of the studies1,2 also showed that in patients treated with HES there was a greater risk of mortality. The PRAC was therefore requested to assess the

5、 available evidence and how it impacts on the risk-benefit balance of HES infusion solutions in the management of hypovolaemia and hypovolaemic shock. 对羟乙基淀粉（HES）注射液的审查起于德国药品管理局。美国联邦药品和医疗器械研究所（BfArM）在危重病人中使用羟乙基淀粉（HES）注射液与使用其他结晶体注射液做了三个方面最新的对比研究(1,2,3)。研究表明，对羟乙基淀粉（HES）注射液治疗严重败血症患者时，对需要透析治疗的肾损伤者的风险更大。

6、两个研究1，2还表明，使用羟乙基淀粉（HES）注射液的患者中，有更大的死亡风险。因此，要求欧洲药监局药物安全风险评估委员会评估现有的证据，以及它是如何影响在治疗低血容量症和低血容量性休克的HES输液治疗方案上的风险和收益平衡。The PRAC assessed data from the scientific literature and the data submitted by the companies, and took advice from a group of external experts. The PRAC was of the opinion that, when com

7、pared with crystalloids, patients treated with HES were at a greater risk of kidney injury requiring dialysis and had a greater risk of mortality. The PRAC also considered that the available data only showed a limited benefit of HES in hypovolaemia, which did not justify its use considering the know

8、n risks. The PRAC therefore concluded that the marketing authorisations for these medicines be suspended.欧洲药监局药物安全风险评估委员会(PRAC)依据科技文献和公司所提交的数据，结合征询外部专家的意见认为，与其他结晶体注射液相比， 羟乙基淀粉（HES）注射液对需要透析治疗的肾损伤者的患者风险更大，有更大的死亡危险。 PRAC还认为，现有的数据统计调查仅显示出羟乙基淀粉（HES）注射液使有限的低血容量患者受益，这些数据没有证明其使用时考虑到的已知风险。 PRAC因此得出结论，暂停这些药品的

9、市场营销授权。The suspension should remain in place unless the marketing authorisation holder can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks.暂停上市许证可持有者应该留在原地，除非其能提供有说服力的数据，能确定大量使用羟乙基淀粉（HES）注射液的患者的利益大于风险。The PRAC recommendation will be

10、considered by the Coordination Group for Mutual Recognition and Decentralised Procedures Human (CMDh). PRAC的建议将提交人类用药品相互承认和分散评审程序协调组(CMDh)More about the medicineInfusion solutions containing HES are frequently used for volume replacement and belong to the class known as colloids. There are two main

11、types of medicines used for volume replacement: crystalloids and colloids. Colloids contain large molecules such as starch, whereas crystalloids, such as saline (salt) solutions or Ringer acetate, contain smaller molecules. In the European Union (EU), HES-containing solutions for infusion have been

12、approved via national procedures and are available in all Member States under various trade names.药物简介含有羟乙基淀粉（HES）的注射液是作为大容量替代输液被频繁的使用，被归类为胶体。目前大容量替代输液主要有两种类型：结晶体液和胶体液。含有大分子量的胶体液如淀粉；而晶体溶液，如盐水（盐）溶液或醋酸林格氏液，含有更小的分子量。在欧洲联盟，含有羟乙基淀粉的输注溶液已通过国家程序批准，可以在所有成员国以各种商标使用。More about the procedureThe review of HES s

13、olutions for infusion was initiated on 29 November 2012 at the request of the German medicines agency, under Article 31 of Directive 2001/83/EC.The review has been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for

14、 human medicines, which has made a set of recommendations. The marketing authorisation holders may request a re-examination within 15 days of being notified of the PRAC recommendation.As these medicines are all authorised nationally, the PRAC recommendation will now be forwarded to the Co-ordination

15、 Group for Mutual Recognition and Decentralised Procedures Human (CMDh), which will adopt a final position. The CMDh is a medicines regulatory body representing the EU Member States.If the CMDh position is agreed by consensus, the agreement will be directly implemented by the Member States where the

16、 medicines are authorised. Should the CMDh position be adopted by majority vote, the CMDh position will be sent to the European Commission, for the adoption of an EU-wide legally binding decision. 有关程序对含羟乙基淀粉注射液的审查始于2012年11月29日，由德国药监管理局根据指令2001/83/EC第31条进行。该审查由欧洲药监局药物安全风险评估委员会(PRAC)执行，该委员会负责对人类的药品安全

17、问题进行评估，目前已提出了一系列建议。并要求市场准入审查部门根据PRAC建议在15日内重新审查。由于这些药物使用都是国家授权，因此PRAC建议将被转发到欧盟成员国的药品监管机构人类用药品相互承认和分散评审程序协调组(CMDh)最终确定。如果人类用药品相互承认和分散评审程序协调组一致同意，该协议将直接由成员国授权药物实施。采取投票方式通过后，意见将被发送到欧盟委员会，在欧盟范围内实施具有法律约束力的决定。1 Perner, A. et al. Hydroxyethyl Starch 130/0.42 versus Ringers acetate in severe sepsis. N Engl J Med 2012; 367(2):124-134.2 Brunkhorst, F.M. et al. Intensive insulin therapy and pentastarch resuscitation in severe sepsis