Background Stroke-induced transient immune suppression is believed to contribute to post-stroke infections.Theβ-adrenergic receptor antagonist,propranolol,has been shown to prevent stroke-associated pneumonia(SAP)via...Background Stroke-induced transient immune suppression is believed to contribute to post-stroke infections.Theβ-adrenergic receptor antagonist,propranolol,has been shown to prevent stroke-associated pneumonia(SAP)via reversing post-stroke immunosuppression in preclinical studies and in retrospective analysis in stroke patients.However,whether propranolol can reduce the risk of SAP has not been tested in prospective,randomised controlled trials.Aim To describe the rationale and design of a multicentre,prospective,open-label,endpoint-blinded,randomised controlled study to evaluate the safety and efficacy of propranolol hydrochloride injection for the prevention of SAP in patients with intracerebral haemorrhage(ICH)(PROCHASE).Design In this investigator-initiated trial,we compare the safety of the standard medical treatment to standard medical treatment plus intravenous propranolol hydrochloride administration(5 mg daily on days 1–7)in patients with ICH and the efficacy of this intervention to reduce the occurrence of SAP.All patients will be followed up for 90±7 days.Study outcomes The primary efficacy outcome is SAP within 7±1 days diagnosed by the defined algorithm based on a diagnosis of SAP recommendations from the pneumonia in stroke consensus group.The primary safety outcome is defined as severe or moderate bradycardia within 7±1 days.The secondary outcome is a modified Rankin score of 0–3 at 90±7 days after randomisation.Discussion The PROCHASE trial aims to generate clinical evidence regarding the safety and efficacy of propranolol in preventing SAP in patients with ICH.展开更多
背景和目的下呼吸道感染常并发于卒中并对转归造成不利影响。对于并发于卒中的下呼吸道感染性疾病，目前尚无公认的专业术语或诊断金标准，这导致临床诊疗和研究受到影响。本共识旨在提出急性卒中并发下呼吸道感染的标准化术语和可操作...背景和目的下呼吸道感染常并发于卒中并对转归造成不利影响。对于并发于卒中的下呼吸道感染性疾病，目前尚无公认的专业术语或诊断金标准，这导致临床诊疗和研究受到影响。本共识旨在提出急性卒中并发下呼吸道感染的标准化术语和可操作性诊断标准。方法对多个文献数据库进行系统检索，经过证据回顾和2轮讨论，最后于2014年9月在英国曼彻斯特召开共识会议，经75％以上共识小组成员达成一致意见后形成共识。结果达成的共识如下：（1）推荐使用卒中相关性肺炎（stroke－associated pneumonia, SAP ）作为卒中发病后7 d内发生的下呼吸道感染性疾病的专业术语。（2）提议对 SAP 使用经过改良的美国疾病控制预防中心（Centers for Disease Control and Prevention, CDC）诊断标准：①很可能的 SAP：符合 CDC 诊断标准，但复查或动态监测胸部 X 片仍缺乏典型改变；②确诊的 SAP：符合 CDC 诊断标准，且胸部 X 片有典型改变。（3）关于白细胞计数或 C反应蛋白在 SAP 诊断中的作用证据有限。（4）其他生物学标记物（如降钙素原）的证据不足。结论提议根据 CDC 诊断标准对 SAP 的术语和诊断制定可操作性的共识标准，需要在卒中患者中进行前瞻性研究来确定其信度、效度以及对医生行为（包括抗生素选择）和临床转归的影响。展开更多
文摘Background Stroke-induced transient immune suppression is believed to contribute to post-stroke infections.Theβ-adrenergic receptor antagonist,propranolol,has been shown to prevent stroke-associated pneumonia(SAP)via reversing post-stroke immunosuppression in preclinical studies and in retrospective analysis in stroke patients.However,whether propranolol can reduce the risk of SAP has not been tested in prospective,randomised controlled trials.Aim To describe the rationale and design of a multicentre,prospective,open-label,endpoint-blinded,randomised controlled study to evaluate the safety and efficacy of propranolol hydrochloride injection for the prevention of SAP in patients with intracerebral haemorrhage(ICH)(PROCHASE).Design In this investigator-initiated trial,we compare the safety of the standard medical treatment to standard medical treatment plus intravenous propranolol hydrochloride administration(5 mg daily on days 1–7)in patients with ICH and the efficacy of this intervention to reduce the occurrence of SAP.All patients will be followed up for 90±7 days.Study outcomes The primary efficacy outcome is SAP within 7±1 days diagnosed by the defined algorithm based on a diagnosis of SAP recommendations from the pneumonia in stroke consensus group.The primary safety outcome is defined as severe or moderate bradycardia within 7±1 days.The secondary outcome is a modified Rankin score of 0–3 at 90±7 days after randomisation.Discussion The PROCHASE trial aims to generate clinical evidence regarding the safety and efficacy of propranolol in preventing SAP in patients with ICH.
文摘背景和目的下呼吸道感染常并发于卒中并对转归造成不利影响。对于并发于卒中的下呼吸道感染性疾病，目前尚无公认的专业术语或诊断金标准，这导致临床诊疗和研究受到影响。本共识旨在提出急性卒中并发下呼吸道感染的标准化术语和可操作性诊断标准。方法对多个文献数据库进行系统检索，经过证据回顾和2轮讨论，最后于2014年9月在英国曼彻斯特召开共识会议，经75％以上共识小组成员达成一致意见后形成共识。结果达成的共识如下：（1）推荐使用卒中相关性肺炎（stroke－associated pneumonia, SAP ）作为卒中发病后7 d内发生的下呼吸道感染性疾病的专业术语。（2）提议对 SAP 使用经过改良的美国疾病控制预防中心（Centers for Disease Control and Prevention, CDC）诊断标准：①很可能的 SAP：符合 CDC 诊断标准，但复查或动态监测胸部 X 片仍缺乏典型改变；②确诊的 SAP：符合 CDC 诊断标准，且胸部 X 片有典型改变。（3）关于白细胞计数或 C反应蛋白在 SAP 诊断中的作用证据有限。（4）其他生物学标记物（如降钙素原）的证据不足。结论提议根据 CDC 诊断标准对 SAP 的术语和诊断制定可操作性的共识标准，需要在卒中患者中进行前瞻性研究来确定其信度、效度以及对医生行为（包括抗生素选择）和临床转归的影响。
