2015年3月25日讯/生物谷BIOON/--近日，FDA就礼来用于治疗成人精神分裂症的长效注射剂奥氮平Zyprexa Relprevv致两名患者死亡的调查结果公布，结论却是无法确定。
去年六月，两名患者在使用此药物后三至四天死亡，FDA对此展开了调查。调查负责人表示，FDA无法排除肌注使药物快速大量进入血液造成的以外，因此并不会修改目前针对该药物处方的建议。
Zyprexa Relprevv的标签上已经加注了黑框警告，告诫患者警惕注射后谵妄镇静(PDSS)的风险，PDSS是一种严重情况，即肌内注射后药物入血过快而导致血药浓度急大幅升高，引起明显的镇静和(或)谵妄。这种情况的症状与过量服用奥氮平Zyprexa Relprevv有关。
为了减少注射后谵妄镇静(PDSS)的风险，近日出台了一项风险评估与控制策略，要求患者在具有专业资质的医护人员和设备的情况下注射奥氮平Zyprexa Relprevv。
关于奥氮平Zyprexa Relprevv
奥氮平是一种抗精神病药，对多种受体系统具有药理作用。动物试验表明，奥氮平对 5-HT、多巴胺D、α-肾上腺素、组胺H等多种受体有亲和力。动物行为研究表明，奥氮平具有5-HT、多巴胺和胆碱能拮抗作用，与其受体结合情况相符。奥氮平的体外和体内5-HT 2 受体亲和力大于其与多巴胺D 2 受体的亲和力。
奥氮平适用于精神分裂症和其它有严重阳性症状（例如：妄想、幻觉、思维障碍、敌意和猜疑）和/或阴性症状（例如：情感淡漠、情感和社会退缩、言语贫乏）的精神病的急性期和维持治疗。奥氮平亦可缓解精神分裂症及相关疾病常见的继发性情感症状。
原文 Deaths review of Lilly's long-acting antipsychotic 'inconclusive'
Results of US review into the deaths of two patients taking Eli Lilly’s long-acting antipsychotic Zyprexa Relprevv (olanzapine pamoate) are inconclusive.
The US Food and Drug Administration launched an investigation in June last year into the cause of high levels of the drug found in two patients who died three to four days after taking it.
“We are unable to exclude the possibility that the deaths were caused by rapid， but delayed， entry of the drug into the bloodstream following intramuscular injection，” the regulator said. However， on the basis of all of the information reviewed， it is not recommending any changes to current prescribing or use.
Zyprexa Relprevv’s label already carries a boxed warning for post-injection delirium sedation (PDSS)， a serious condition with signs and symptoms consistent with olanzapine overdose， after it was observed in clinical trials within three hours after administration.
To cut the risk of PDSS， a Risk Evaluation and Mitigation Strategy is in place to ensure that patients are observed by healthcare professionals at a certified facility following injection.