Nalmefene improves prognosis in patients with a large cerebral infarction: study protocol for a randomized controlled prospective trial / 中国组织工程研究

ABSTRACT

BACKGROUND:Occlusion of the middle cerebral artery trunk can cause large infarctions.Clinically,thrombolytic therapy,defibrillation,vasodilation,and surgery are often used to treat these large infarctions.However,the therapeutic efficacy of these therapeutic interventions in promoting prognosis remains controversial.Nalmefene,an opioid receptor antagonist,exhibits a neuroprotective effect.Few clinical studies are reported on the therapeutic efficacy of nalmefene in the treatment of large cerebral infarctions.OBJECTIVE:To investigate the therapeutic efficacy of nalmefene in restoring the neurologic function of patients with middle cerebral artery trunk infarction in comparison with conventional treatment as a control.METHODS:A total of 236 patients with middle cerebral artery trunk infarction who will receive treatment at the First Hospital of Jilin University,China will be randomly divided into a control group (n=116) and a nalmefene group (n=120).Patients in the control group will receive conventional treatment.Patients in the nalmefene group will receive 10 successive days of intravenous nalmefene hydrochloride injection based on conventional treatment.The primary outcome of this study is the effective rate at 20 days (10 days after treatment).The secondary outcomes of this study include (1) the National Institutes of Health Stroke Scale (NIHSS) score at 20 days,used to evaluate neurologic function deficits;(2) Glasgow Coma Scale score at 0 (before treatment) and 10 days;(3) serum level of matrix metalloproteinase 9 at 0,5 and 10 days (before treatment and 5 and 10 days of treatment);(4) MRI perfusion imaging of the head at 0 and 10 days.This trial was ragistered with the Chinese Clinical Trial Registry (registration numberChiCTR-IOR-17013871).RESULTS AND CONCLUSION:Preliminary experiment results ravealed that compared with the control group,NIHSS score was signficiantly decreased,effective rate was increased,Glasgow Coma Scale score was significantly increased,serum level of matrix metalloproteinase 9 was significantly decreased,cerebral blood flow and cerebral blood volume on the lesion side were signficiantly increased,and the mean transit time of contrast agent on the lesion side was significantly shortened in the nalmefene group.Findings from this study will provide clinical evidence for use of nalmefene in combination with conventional treatment for large cerebral infarctions and provide data support that this combined therapy can improve the prognosis in patients with large cerebral infarctions.