ABSTRACT
Objectives: To investigate the safety and efficacy of the delipid extracorporeal lipoprotein filter from plasma (DELP) system, a new low-density lipoprotein cholesterol (LDL-C) adsorption system, in acute ischemic stroke (AIS) patients. Patients and methods: In the present study, a total of 180 AIS patients were enrolled during March 2019 to February 2021. They were divided into DELP group (n1 = 90) and the control group (n2 = 90). The treatment protocol and vascular access of DELP treatment was established and evaluated. For the DELP group, clinical data and laboratory results including plasma lipid and safety parameters before and after the apheresis were collected and analyzed. For all participants, neurological scores were assessed and recorded. Results: For the DELP group, 90 patients including 70 males and 20 females were included. The mean LDL-C was significantly decreased from 3.15 ± 0.80 mmol/L to 2.18 ± 0.63 mmol/L (30.79%, p < 0.001) during a single DELP treatment, and decreased from 3.42 ± 0.87 mmol/L to 1.87 ± 0.48 mmol/L (45.32%, p < 0.001) after two DELP treatments. No clinically relevant changes were observed in hematologic safety parameters and blood pressure levels except for hematocrit and total protein throughout the whole period of DELP treatment. The DELP group showed improvement relative to the control group in National Institute of Health stroke scale scores (NIHSS) on the 14th and 90th day after stroke. Moreover, the DELP group had a significantly higher ratio of mRS 0 to 1 on the 90th day after stroke. Conclusion: The new LDL-C adsorption system, the DELP system, may provide a new option for intensive lipid lowering therapy in AIS patients in view of its safety, efficacy, and operation feasibility.
ABSTRACT
INTRODUCTION: The delipid extracorporeal lipoprotein filter from plasma (DELP) has been approved for the treatment of acute ischemic stroke (AIS) by the China Food and Drug Administration, but its effectiveness and mechanism are not yet fully determined. The purpose of this study was to evaluate the effect of DELP treatment on AIS patients after intravenous thrombolysis. METHODS: A retrospective study was performed on AIS patients with no improvement within 24 h after intravenous thrombolysis who were subsequently treated with or without DELP. Primary outcome was the proportion with a modified Rankin scale (mRS) of 0-1 at 90 days. Secondary outcomes were changes in National Institute of Health Stroke Scale (NIHSS) score from 24 h to 14 days after thrombolysis, and the rate of improvement in stroke-associated pneumonia (SAP). The main safety outcomes were the rates of symptomatic intracranial hemorrhage and mortality. To investigate its mechanisms, serum biomarkers were measured before and after DELP. RESULTS: A total of 252 patients were recruited, 63 in the DELP group and 189 matched patients in the NO DELP group. Compared with the NO DELP group, the DELP group showed an increase in the proportion of mRS 0-1 at 90 days (p = 0.042). More decrease in NIHSS from 24 h to 14 days (p = 0.024), a higher rate of improvement in SAP (p = 0.022), and lower mortality (p = 0.040) were shown in DELP group. Furthermore, DELP decreased levels of interleukin (IL)-1ß, E-selectin, malondialdehyde, matrix metalloprotein 9, total cholesterol, low-density lipoprotein, and fibrinogen, and increased superoxide dismutase (p< 0.05). CONCLUSIONS: DELP following intravenous thrombolysis should be safe, and is associated with neurological function improvement, possibly through multiple neuroprotective mechanisms. Prospective trials are needed.
Subject(s)
Blood Component Removal/instrumentation , Fibrinolytic Agents/administration & dosage , Filtration/instrumentation , Ischemic Stroke/therapy , Lipoproteins/blood , Thrombolytic Therapy , Tissue Plasminogen Activator/administration & dosage , Administration, Intravenous , Aged , Blood Component Removal/adverse effects , Databases, Factual , Female , Fibrinolytic Agents/adverse effects , Functional Status , Humans , Ischemic Stroke/blood , Ischemic Stroke/diagnosis , Male , Middle Aged , Recovery of Function , Retrospective Studies , Thrombolytic Therapy/adverse effects , Time Factors , Tissue Plasminogen Activator/adverse effects , Treatment OutcomeABSTRACT
Objective To explore the curative effect of extracorporeal lipoprotein filter from plasma Delipid Plus(DELP) system therapy on acute cerebral infarction(ACI). Methods 36 patients with ACI were divided into DELP group (12 cases) and control group (24 cases). All of them received basic treatment including Aspirin and Pravastatin sodium etc. The DELP group also treated by DELP therapy twice. The scores of National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI) and Modified Rankin Scale (mRS),and the levels of plasma fibrinogen (Fib),blood lipid and the indexes of hemorheology were compared pre and post treatment in the two groups.Results The reduction value of NIHSS between pre and post treatment in DELP group was bigger than this in control group(P
