Cattle encephalon glycoside and ignotin(CEGI)injection is a compound preparation formed by a combination of muscle extract from hea lthy rabbits and brain gangliosides from cattle,and it is generally used as a neuropr...Cattle encephalon glycoside and ignotin(CEGI)injection is a compound preparation formed by a combination of muscle extract from hea lthy rabbits and brain gangliosides from cattle,and it is generally used as a neuroprotectant in the treatment of central and peripheral nerve injuries.However,there is still a need for high-level clinical evidence from large samples to support the use of CEGI.We therefore carried out a prospective,multicenter,randomized,double-blind,parallel-group,placebo-controlled study in which we recruited 319 patients with acute cerebral infarction from 16 centers in China from October 2013 to May 2016.The patients were randomized at a 3:1 ratio into CEGI(n=239;155 male,84 female;61.2±9.2 years old)and placebo(n=80;46 male,34 female;63.2±8.28 years old)groups.All patients were given standard care once daily for 14 days,including a 200 mg aspirin enteric-coated tablet and 20 mg atorvastatin calcium,both taken orally,and intravenous infusion of 250–500 mL 0.9%sodium chloride containing 40 mg sodium tanshinone IIA sulfonate.Based on conventional treatment,patients in the CEGI and placebo groups were given 12 mL CEGI or 12 mL sterile water,respectively,in an intravenous drip of 250 mL 0.9%sodium chloride(2 mL/min)once daily for 14 days.According to baseline National Institutes of Health Stroke Scale scores,patients in the two groups were divided into mild and moderate subgroups.Based on the modified Rankin Scale results,the rate of patients with good outcomes in the CEGI group was higher than that in the placebo group,and the rate of disability in the CEGI group was lower than that in the placebo group on day 90 after treatment.In the CEGI group,neurological deficits were decreased on days 14 and 90 after treatment,as measured by the National Institutes of Health Stroke Scale and the Barthel Index.Subgroup analysis revealed that CEGI led to more significant improvements in moderate stroke patients.No drug-related adverse events occurred in the CEGI or placebo groups.In conclusion,CEGI may be a safe and effective treatment for acute cerebral infarction patients,especially for moderate stroke patients.This study was approved by the Ethical Committee of Peking University Third Hospital,China(approval No.2013-068-2)on May 20,2013,and registered in the Chinese Clinical Trial Registry(registration No.ChiCTR1800017937).展开更多
Fluid-attenuated inversion recovery （FLAIR） vascular hyperintensity （FVH） is used to assess leptomeningeal collateral circulation, but clinical outcomes of patients with FVH can be very different. The aim of the p...Fluid-attenuated inversion recovery （FLAIR） vascular hyperintensity （FVH） is used to assess leptomeningeal collateral circulation, but clinical outcomes of patients with FVH can be very different. The aim of the present study was to assess a FVH score and explore its relationship with clinical outcomes. Patients with acute ischemic stroke due to middle cerebral artery M1 occlusion underwent magnetic resonance imaging and were followed up at 10 days （National Institutes of Health Stroke Scale） and 90 days （modified Rankin Scale） to determine short-term clinical outcomes. Effective collateral circulation indirectly improved recovery of neurological function and short-term clinical outcome by extending the size of the pial penumbra and reducing infarct lesions. FVH score showed no correlation with 90-day functional clinical outcome and was not sufficient as an independent predictor of short-term clinical outcome.展开更多
Fractional anisotropy values in diffusion tensor imaging can quantitatively reflect the consistency of nerve fibers after brain damage, where higher values generally indicate less damage to nerve fibers. Therefore, we...Fractional anisotropy values in diffusion tensor imaging can quantitatively reflect the consistency of nerve fibers after brain damage, where higher values generally indicate less damage to nerve fibers. Therefore, we hypothesized that diffusion tensor imaging could be used to evaluate the effect of mild hypothermia on diffuse axona[ injury. A total of 102 patients with diffuse axonal injury were randomly divided into two groups： normothermic and mild hypothermic treatment groups. Patient＇s modified Rankin scale scores 2 months after mild hypothermia were significant- ly lower than those for the normothermia group. The difference in average fractional anisotropy value for each region of interest before and after mild hypothermia was 1.32-1.36 times higher than the value in the normothermia group. Quantitative assessment of diffusion tensor imaging indicates that mild hypothermia therapy may be beneficial for patients with diffuse axonal injury.展开更多
Leukoaraiosis(LA)results from ischemic injury in small cerebral vessels,which may be attributable to decreased vascular density,reduced cerebrovascular angiogenesis,decreased cerebral blood flow,or microcirculatory dy...Leukoaraiosis(LA)results from ischemic injury in small cerebral vessels,which may be attributable to decreased vascular density,reduced cerebrovascular angiogenesis,decreased cerebral blood flow,or microcirculatory dysfunction in the brain.In this study,we enrolled 357 patients with mild intracerebral hemorrhage(ICH)from five hospitals in China and analyzed the relationships between LA and clinical symptom severity at admission,neurological function prognosis at 3 months,and 1-year stroke recurrence.Patients were divided into groups based on Fazekas scale scores:no LA(n=83),mild LA(n=64),moderate LA(n=98)and severe LA(n=112).More severe LA,larger hematoma volume,and higher blood glucose level at admission were associated with more severe neurological deficit.More severe LA,older age and larger hematoma volume were associated with worse neurological function prognosis at 3 months.In addition,moderate-to-severe LA,admission glucose and symptom-free cerebral infarction were associated with 1-year stroke recurrence.These findings suggest that LA severity may be a potential marker of individual ICH vulnerability,which can be characterized by poor tolerance to intracerebral attack or poor recovery ability after ICH.Evaluating LA severity in patients with mild ICH may help neurologists to optimize treatment protocols.This study was approved by the Ethics Committee of Ruijin Hospital Affiliated to Shanghai Jiao Tong University(approval No.12)on March 10,2011.展开更多
Bai et al investigate the predictive value of T lymphocyte proportion in Alzheimer's disease(AD)prognosis.Through a retrospective study involving 62 AD patients,they found that a decrease in T lymphocyte proportio...Bai et al investigate the predictive value of T lymphocyte proportion in Alzheimer's disease(AD)prognosis.Through a retrospective study involving 62 AD patients,they found that a decrease in T lymphocyte proportion correlated with a poorer prognosis,as indicated by higher modified Rankin scale scores.While the study highlights the potential of T lymphocyte proportion as a prognostic marker,it suggests the need for larger,multicenter studies to enhance generalizability and validity.Additionally,future research could use cognitive exams when evaluating prognosis and delve into immune mechanisms underlying AD progression.Despite limitations inherent in retrospective designs,Bai et al's work contributes to understanding the immune system's role in AD prognosis,paving the way for further exploration in this under-researched area.展开更多
<strong>Introduction:</strong> Malignant middle cerebral artery (MCA) infarction is a devastating entity that is associated with up to 80% mortality. Decompressive Hemicraniectomy has been utilized to trea...<strong>Introduction:</strong> Malignant middle cerebral artery (MCA) infarction is a devastating entity that is associated with up to 80% mortality. Decompressive Hemicraniectomy has been utilized to treat brain swelling and mass effect secondary to these infarctions in an attempt to improve functional outcome. <strong>Aim: </strong>To evaluate the functional outcome of decompressive hemicraniectomy in management of malignant MCA infarctions. <strong>Methods: </strong>The study included 30 patients with malignant MCA infarctions operated upon by decompressive hemicraniectomy and duroplasty with pericranium or fascia lata graft in the period from June 2016 to January 2019. Pre-operative neurological condition, associated morbidity, location and extent of the infarction were assessed. Surgery was performed within 48 hours of the onset of stroke or 12 hours within deterioration of conscious level. Pre-operative CT scan as well as sequential post-operative CT was done. Functional outcome was assessed by the modified Rankin Scale (mRS) at the time of discharge and 3 months following surgery. <strong>Results: </strong>The study included 18 males and 12 females with a mean age of 54.7 years. The pre-operative GCS was <8 (5 - 7) in 11 patients and 8 or higher (8 - 13) in 19 patients. Good functional outcome (mRS 0 - 3) was achieved in 13 (43.3%) cases while poor outcome (mRS 4 - 5) occurred in 8 (26.7%) cases and mortality (mRS 6) occurred in 9 (30%) cases. <strong>Conclusion:</strong> Decompressive hemicraniectomy improves functional outcome in cases of malignant MCA infarction. Pre-operative GCS, age, volume of infarction, degree of midline shift, timing of surgery and associated morbidity are the most important factors affecting the outcome.展开更多
<strong>Background:</strong> <span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">Worldwide, the prevalen...<strong>Background:</strong> <span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">Worldwide, the prevalence of sickle cell disease (SCD) as of 2016 was estimated at 2%;that is 300</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">,</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">000 births annually. This study was focused on homozygous sickle cell disease which leads to several complications notably hemolytic crises, aplastic crises and vaso-occlusive crises like stroke. Sickle cell disease is the most common cause of childhood stroke. Stroke occurs in 17</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">% </span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">- 24% of sickle cell children worldwide. </span><b><span style="font-family:Verdana;">Objectives: </span></b></span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">To</span><b> </b><span style="font-family:Verdana;">d</span></span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">etermine the risk factors for overt stroke and outcome at discharge in sickle cell disease patients admitted in two reference hospitals in Cameroon. </span><b><span style="font-family:Verdana;">Method: </span></b><span style="font-family:Verdana;">This was a case-control study in two reference hospitals in Yaounde and Douala, carried out over the duration of 4 months, covering a 5-year period (December 2013 to December 2018). Included in the study, were all homozygous sickle cell children aged 6 months to 16 years during that period with or without stroke. A total of 1734 patients fulfilled the inclusion criteria. Out of these, 49 stroke patients participated and 687 were selected as controls. Data was collected from the patients’ files and books on a pretested data collection form, then entered in the software C.S Pro 7.1 before analysis. Stroke outcome at discharge was assessed using the modified Rankin scale (mRs) with structured interview. A patient was classified as good outcome if mRs</span></span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"><</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">3 and poor outcome if mRs ≥</span></span></span><span><span><span style="font-family:""> </span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">3. Statistical analysis was done with SPSS software version 22.0 for Windows. </span><b><span style="font-family:Verdana;">Results: </span></b><span style="font-family:Verdana;">A total of 736 patients participated in the study. Out of these, 391</span></span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">(53.1%) were males and 345</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">(46.9%) were females. Overt stroke was found to have an estimated hospital prevalence of 3.29% in this population. Several risk and associated factors were identified such as frequent rate of acute chest syndrome (p</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">< 0.001), acute chest syndrome in the past 2 weeks (p</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">= 0.001), low steady state haemoglobin (p <</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">0.001) and previous stroke (p = 0.002). A poor outcome was observed in 16</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">(32.7%) of</span></span></span><span><span><span style="font-family:""> </span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">them. </span><b><span style="font-family:Verdana;">Conclusion: </span></b><span style="font-family:Verdana;">The occurrence of stroke in this population is 3.29% and several factors were associated with its occurrence.</span></span></span></span>展开更多
Cerebral blood perfusion and cerebrovascular lesions are important factors that can affect the therapeutic efficacy of thrombolysis.At present,the majority of studies focus on assessing the accuracy of lesion location...Cerebral blood perfusion and cerebrovascular lesions are important factors that can affect the therapeutic efficacy of thrombolysis.At present,the majority of studies focus on assessing the accuracy of lesion location using imaging methods before treatment,with less attention to predictions of outcomes after thrombolysis.Thus,in the present study,we assessed the efficacy of combined computed tomography（CT） perfusion and CT angiography in predicting clinical outcomes after thrombolysis in ischemic stroke patients.The study included 52 patients who received both CT perfusion and CT angiography.Patients were grouped based on the following criteria to compare clinical outcomes：（1） thrombolytic and non-thrombolytic patients,（2） thrombolytic patients with CT angiography showing the presence or absence of a vascular stenosis,（3） thrombolytic patients with CT perfusion showing the presence or absence of hemodynamic mismatch,and（4） different CT angiography and CT perfusion results.Short-term outcome was assessed by the 24-hour National Institution of Health Stroke Scale score change.Long-term outcome was assessed by the 3-month modified Rankin Scale score.Of 52 ischemic stroke patients,29 were treated with thrombolysis and exhibited improved short-term outcomes compared with those without thrombolysis treatment（23 patients）.Patients with both vascular stenosis and blood flow mismatch（13 patients） exhibited the best short-term outcome,while there was no correlation of long-term outcome with CT angiography or CT perfusion findings.These data suggest that combined CT perfusion and CT angiography are useful for predicting short-term outcome,but not long-term outcome,after thrombolysis.展开更多
Background and purpose To date,no large cohort study has investigated the effects of intravenous thrombolysis(IVT)in Chinese patients aged over 80 years who had a stroke.This study aimed to assess the trends in the us...Background and purpose To date,no large cohort study has investigated the effects of intravenous thrombolysis(IVT)in Chinese patients aged over 80 years who had a stroke.This study aimed to assess the trends in the use of alteplase,the clinical characteristics and the outcomes of Chinese patients aged above 80 years who had an acute ischaemic stroke.Methods Data for this analysis were obtained from the China Stroke Center Alliance programme,a nationwide,multicentre,prospective registry encompassing 1751 hospitals across 31 provinces,covering the period from 1 January 2018 to 14 December 2022.The primary outcome was defined as a modified Rankin Scale(mRS)Score of 0-2 at discharge.Secondary outcomes included an mRS Score of 0-1 and independent ambulation on discharge.Safety outcomes assessed were in-hospital mortality and symptomatic intracranial haemorrhage(sICH).Results Out of 30902 patients over 80 years old who qualified for thrombolysis,8673(median age(IQR),84(82-87)years)received alteplase treatment.Patients administered alteplase demonstrated improved short-term functional outcomes,such as an mRS Score of 0-2(adjusted OR(aOR)1.12,95%CI,1.06 to 1.18,p<0.001),an mRS Score of 0-1(aOR 1.14,95%CI,1.08 to 1.19,p<0.001)and independent ambulation at discharge(aOR 1.14,95%CI,1.08 to 1.20,p<0.001).Moreover,no significant increase was observed in the risk of in-hospital mortality(aOR 1.12,95%CI,0.93 to 1.35;p=0.23).However,the risk of sICH was significantly higher among patients treated with alteplase(aOR 3.22,95%CI,2.77 to 3.75;p<0.001).Conclusions IVT with alteplase in elderly patients who had a stroke resulted in improved short-term functional outcomes without elevating the risk of in-hospital mortality.Nonetheless,this population remains at a higher risk of sICH.展开更多
Background Acute ischaemic stroke,due to its high mortality and disability rates,imposes a significant economic and social burden worldwide.Typically,endovascular treatment within the therapeutic window is provided to...Background Acute ischaemic stroke,due to its high mortality and disability rates,imposes a significant economic and social burden worldwide.Typically,endovascular treatment within the therapeutic window is provided to salvage the ischaemic penumbra;however,even when recanalisation is successful during endovascular treatment,the clinical outcomes may still be disappointing.This highlights the necessity of further research,so as to discover better solutions to futile recanalisation and improve patient outcomes.Objective To investigate the efficacy and safety of Y-6 sublingual tablets(cilostazol and dexborneol)compared with a placebo in the treatment of patients with acute ischaemic stroke caused by large vessel occlusion.Method The efficacy and safety of Y-6 sublingual tablets in patients with acute ischaemic stroke are evaluated in a phase Ⅱ,randomised,double-blind,double-dummy,placebo-controlled,parallel clinical trial.Eligible patients having provided informed consent are randomised into five groups for a 28-day treatment period.The primary outcome is the percentage of patients achieving the modified Rankin Scale score of 0-1 at 90 days.Discussion The EFfects of Y-6 SUblingual Tablets for PaTients with AcUte Ischemic StRokE trial assesses whether Y-6 sublingual tablets are effective and safe in improving the clinical outcomes of patients with acute ischaemic stroke caused by large vessel occlusion.展开更多
Background Despite successful reperfusion after thrombectomy for large vessel occlusion(LVO)stroke,up to half of patients are dependent or dead at 3-month follow-up.The aim of the current study is to demonstrate safet...Background Despite successful reperfusion after thrombectomy for large vessel occlusion(LVO)stroke,up to half of patients are dependent or dead at 3-month follow-up.The aim of the current study is to demonstrate safety and efficacy of administering adjunct intra-arterial(IA)tenecteplase in anterior circulation LVO patients who have achieved successful reperfusion defined as eTICI 2b50 to 3.Methods ANGEL-TNK is a multicentre,open-label,assessor-blinded endpoint,prospective randomised,controlled trial that will enrol up to 256 patients.Patients who meet inclusion criteria with anterior circulation LVO stroke and successful reperfusion will be randomised to receive IA tenecteplase or best medical management at 1:1 ratio.Results The primary endpoint is a 90-day excellent outcome defined as modified Rankin Scale(mRS)0–1.The primary safety endpoint is symptomatic intracranial haemorrhage within 48 hours from randomisation.Secondary endpoints include 90-day ordinal mRS,mRS 0–2,mRS 0–3,all-cause mortality and any intracranial haemorrhage.Conclusion In patients with anterior circulation LVO stroke,the ANGEL-TNK trial will inform whether adjunct IA tenecteplase administered after successful thrombectomy reperfusion improves patient outcomes.Trial registration number NCT05624190.展开更多
Objective The Antiplatelet versus R-tPA for Acute Mild Ischaemic Stroke trial has demonstrated the non-inferiority of dual antiplatelet therapy(DAPT)to alteplase in minor non-disabling stroke.This prespecified seconda...Objective The Antiplatelet versus R-tPA for Acute Mild Ischaemic Stroke trial has demonstrated the non-inferiority of dual antiplatelet therapy(DAPT)to alteplase in minor non-disabling stroke.This prespecified secondary analysis aimed to investigate whether the treatment effects were similar across stroke territories.Methods Participants were divided according to stroke territory,which were subdivided into DAPT and alteplase.An excellent functional outcome at 90 days defined as modified Rankin Scale scoring 0–1 was primary outcome.National Institutes of Health Stroke Scale(NIHSS)score change and early neurological improvement measured by a 2-point decline in NIHSS score at 24 hours were secondary outcomes.Symptomatic intracerebral haemorrhage(sICH)and bleeding events were safety outcomes.Primary analyses adjusted unbalanced baseline characteristics between treatments by multivariate logistic regression.Results A total of 719 patients were included:566 in anterior circulation stroke(ACS)and 153 in posterior circulation stroke(PCS).Primary outcome was 94.1%in DAPT and 91.7%in alteplase among ACS patients(adjusted risk difference(RD)and 95%CI,1.5%(−1.5%to 4.6%),p=0.32),while 91.2%in DAPT and 91.8%in alteplase among PCS patients(adjusted RD and 95%CI,−2.1%(−8.5%to 4.4%),p=0.53).Compared with alteplase,DAPT was associated with lower risk of sICH(p=0.03)and bleeding events(p<0.001)in ACS,but only lower risk of bleeding events(p=0.007)in PCS.Additionally,among ACS patients,the alteplase was superior to DAPT in terms of decrease in NIHSS score at 24 hours compared with admission(adjusted geometric mean ratio and 95%CI,−0.09(−0.16 to−0.03),p=0.005)and early neurological improvement(adjusted RD and 95%CI,−7.2%(−11.6%to−2.7%),p=0.001).Conclusion Among ischaemic stroke with minor non-disabling symptoms,DAPT was similar with intravenous alteplase regarding long-term functional outcome and better safety regardless of ACS or PCS.The potential benefit of intravenous alteplase regarding early neurological improvement in patients with ACS warrants further investigation.Trial registration number NCT03661411.展开更多
Background The benefit-risk profile of tenecteplase in the elderly patients with acute ischaemic stroke(AIS)is uncertain.We sought to investigate the efficacy and safety of 0.25 mg/kg tenecteplase compared with altepl...Background The benefit-risk profile of tenecteplase in the elderly patients with acute ischaemic stroke(AIS)is uncertain.We sought to investigate the efficacy and safety of 0.25 mg/kg tenecteplase compared with alteplase for AIS patients aged≥80 years.Methods We performed a post hoc analysis of the Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-2 Trial,a randomised,phase 3,non-inferiority clinical trial.Disabling AIS patients aged≥80 years who initiated intravenous thrombolytics within 4.5 hours of symptom onset were enrolled from June 2021 to May 2022 across 53 centres in China and were randomly allocated to receive 0.25 mg/kg tenecteplase or 0.9 mg/kg alteplase.The primary efficacy outcome was the proportion of participants with a modified Rankin Scale(mRS)score of 0-1 at 90 days.Symptomatic intracranial haemorrhage(sICH)within 36 hours was the safety outcome.Results Of 137 participants,mRS 0-1 at 90 days occurred in 37(49.3%)of 75 in the tenecteplase group vs 20(33.9%)of 59 in the alteplase group(risk ratio(RR)1.47,95%CI 0.96 to 2.23).sICH within 36 hours was observed in 3(4.0%)of 76 in the tenecteplase group and two(3.3%)of 61 in the alteplase group(RR 1.30,95%CI 0.20 to 8.41).Conclusions The risk-benefit profile of tenecteplase thrombolysis was preserved in the elderly patients,which lends further support to intravenous 0.25 mg/kg tenecteplase as an alternative to alteplase in these patients.展开更多
Background GD-11,a novel brain cytoprotective drug,was designed to be actively taken up and transported across the blood-brain barrier via the glucose transporter.This study aimed to evaluate the safety and efficacy o...Background GD-11,a novel brain cytoprotective drug,was designed to be actively taken up and transported across the blood-brain barrier via the glucose transporter.This study aimed to evaluate the safety and efficacy of GD-11 for improving the recovery of patients with acute ischaemic stroke(AIS).Methods A double-blind,randomised,placebo-controlled,phase 2 trial was conducted at 15 clinical sites in China.Patients aged 18-80 years with AIS within 48 hours were randomly assigned(1:1:1)to receive 160 mg GD-11,80 mg GD-11 and placebo,two times a day for 10 days.The primary endpoint was a modified Rankin Scale(mRS)score of 0-1 at 90 days after treatment.The safety outcome was any adverse events within 90 days.Results From 17 November 2022 to 22 March 2023,a total of 80 patients in the 160 mg GD-11 group,79 patients in the 80 mg GD-11 group and 80 patients in the placebo group were included.The proportion of an mRS score of 0-1 at day 90 was 77.5%in the 160 mg GD-11 group,72.2%in the 80 mg GD-11 group and 67.5%in the placebo group.Though no significant difference was found(p=0.3671),a numerically higher proportion was observed in the GD-11 group,especially in the 160 mg GD-11 group.The incidence of adverse events was similar across the three groups(p=0.1992).Conclusion GD-11 was safe and well-tolerated.A dosage of GD-11160 mg two times a day was recommended for a large trial to investigate the efficacy.展开更多
Objectives Endovascular therapy(EVT)now penetrates the once obscure realm of large infarct core volume acute ischaemic stroke(LICV-AIS).This research aimed to investigate the potential correlation between different an...Objectives Endovascular therapy(EVT)now penetrates the once obscure realm of large infarct core volume acute ischaemic stroke(LICV-AIS).This research aimed to investigate the potential correlation between different anaesthetic approaches and post-EVT outcomes in LICV-AIS patients.Methods Between October 2020 and May 2022,the China ANGEL-Alberta Stroke Programme Early CT Score(ASPECT)trial studied patients with LICV-AIS,randomly assigning them to the best medical management(BMM)or BMM with EVT.This post hoc subgroup analysis categorised subjects receiving BMM with EVT into general anaesthesia(GA)and non-GA groups based on anaesthesia type.We applied multivariable logistic regression to evaluate the relationship between anaesthesia during EVT and patient functional outcomes,as measured by the modified Rankin scale(mRS),in addition to the occurrence of complications.Further adjustment for selection bias was achieved through propensity score matching(PSM).Results In total,230 patients with LICV-AIS were enrolled(GA 84 vs Non-GA 146).No significant difference was observed between the two groups in terms of the proportion of patients who achieved an mRS score of 0-2 at 90 days(27.4%for the GA group vs 31.5%for the non-GA group,p=0.51).However,the GA group had significantly longer median surgical times(142 min vs 122 min,p=0.03).Furthermore,GA was associated with an increased risk of postoperative pneumonia(adjusted OR 2.03,95%CI 1.04 to 3.98).The results of PSM analysis agreed with the results of the multivariate regression analysis.No significant difference in intracranial haemorrhage incidence or mortality rate was observed between the groups.Conclusion This post hoc analysis of subgroups of the ANGEL-ASPECT trial suggested that there may be no significant association between the choice of anaesthesia and neurological outcomes in LICV-AIS patients.However,compared with non-GA,GA prolongs the duration of EVT and is associated with a greater postoperative pneumonia risk.展开更多
Objectives Our study aims to examine the value of endovascular therapy(EVT)and its comparison to medical management(MM)in ischaemic stroke patients accompanied by large artery atherosclerosis(LAA)and non-LAA Methods m...Objectives Our study aims to examine the value of endovascular therapy(EVT)and its comparison to medical management(MM)in ischaemic stroke patients accompanied by large artery atherosclerosis(LAA)and non-LAA Methods modified Rankin scale score(mRS)was evaluated at 90 days post the stroke attack and was considered as the primary outcome.Other outcomes measured in this study included score changes of 0-2 and 0-3 on the mRS.The occurrence of symptomatic intracranial haemorrhage at 24 hours after EVT was also measured as a safety endpoint.Logistic regression analysis was used to determine the associations.Results In the LAA group,no significant difference in mRS at 90-day(median IQR 3(2-5)vs 4(3-4),95%CI 0.53 to 2.00,p=0.924),mRS 0-2 and mRS 0-3 was observed between EVT and MM groups.However,in the non-LAA group,patients who underwent EVT had lower 90-day mRS scores(4(2-5)vs 4(3-5),generalised OR 1.47,95%CI 1.14 to 1.88,p<0.001).No interaction effect on the primary outcomes between treatment options and aetiology.More intracranial haemorrhage events within 48 hours were identified in the EVT group for both LAA and non-LAA cohorts(LAA:40.98%vs 9.62%,relative risk(RR)4.26,95%CI 1.76 to 10.34,p<0.001;non-LAA,52.07%vs 19.65%,RR 2.65,95%CI 1.90 to 3.70,respectively).Conclusions For large infarcts,EVT may be more effective than MM for patients with non-LAA aetiology,but not for those with LAA stroke.As no interaction effect was found,the benefit of EVT compared with MM did not vary by stroke subtypes.展开更多
文摘Cattle encephalon glycoside and ignotin(CEGI)injection is a compound preparation formed by a combination of muscle extract from hea lthy rabbits and brain gangliosides from cattle,and it is generally used as a neuroprotectant in the treatment of central and peripheral nerve injuries.However,there is still a need for high-level clinical evidence from large samples to support the use of CEGI.We therefore carried out a prospective,multicenter,randomized,double-blind,parallel-group,placebo-controlled study in which we recruited 319 patients with acute cerebral infarction from 16 centers in China from October 2013 to May 2016.The patients were randomized at a 3:1 ratio into CEGI(n=239;155 male,84 female;61.2±9.2 years old)and placebo(n=80;46 male,34 female;63.2±8.28 years old)groups.All patients were given standard care once daily for 14 days,including a 200 mg aspirin enteric-coated tablet and 20 mg atorvastatin calcium,both taken orally,and intravenous infusion of 250–500 mL 0.9%sodium chloride containing 40 mg sodium tanshinone IIA sulfonate.Based on conventional treatment,patients in the CEGI and placebo groups were given 12 mL CEGI or 12 mL sterile water,respectively,in an intravenous drip of 250 mL 0.9%sodium chloride(2 mL/min)once daily for 14 days.According to baseline National Institutes of Health Stroke Scale scores,patients in the two groups were divided into mild and moderate subgroups.Based on the modified Rankin Scale results,the rate of patients with good outcomes in the CEGI group was higher than that in the placebo group,and the rate of disability in the CEGI group was lower than that in the placebo group on day 90 after treatment.In the CEGI group,neurological deficits were decreased on days 14 and 90 after treatment,as measured by the National Institutes of Health Stroke Scale and the Barthel Index.Subgroup analysis revealed that CEGI led to more significant improvements in moderate stroke patients.No drug-related adverse events occurred in the CEGI or placebo groups.In conclusion,CEGI may be a safe and effective treatment for acute cerebral infarction patients,especially for moderate stroke patients.This study was approved by the Ethical Committee of Peking University Third Hospital,China(approval No.2013-068-2)on May 20,2013,and registered in the Chinese Clinical Trial Registry(registration No.ChiCTR1800017937).
基金supported by the National Natural Science Foundation of China,No.81371521
文摘Fluid-attenuated inversion recovery （FLAIR） vascular hyperintensity （FVH） is used to assess leptomeningeal collateral circulation, but clinical outcomes of patients with FVH can be very different. The aim of the present study was to assess a FVH score and explore its relationship with clinical outcomes. Patients with acute ischemic stroke due to middle cerebral artery M1 occlusion underwent magnetic resonance imaging and were followed up at 10 days （National Institutes of Health Stroke Scale） and 90 days （modified Rankin Scale） to determine short-term clinical outcomes. Effective collateral circulation indirectly improved recovery of neurological function and short-term clinical outcome by extending the size of the pial penumbra and reducing infarct lesions. FVH score showed no correlation with 90-day functional clinical outcome and was not sufficient as an independent predictor of short-term clinical outcome.
基金supported by the Natural Science Foundation of Guangdong Province in China,No.10151600101000002
文摘Fractional anisotropy values in diffusion tensor imaging can quantitatively reflect the consistency of nerve fibers after brain damage, where higher values generally indicate less damage to nerve fibers. Therefore, we hypothesized that diffusion tensor imaging could be used to evaluate the effect of mild hypothermia on diffuse axona[ injury. A total of 102 patients with diffuse axonal injury were randomly divided into two groups： normothermic and mild hypothermic treatment groups. Patient＇s modified Rankin scale scores 2 months after mild hypothermia were significant- ly lower than those for the normothermia group. The difference in average fractional anisotropy value for each region of interest before and after mild hypothermia was 1.32-1.36 times higher than the value in the normothermia group. Quantitative assessment of diffusion tensor imaging indicates that mild hypothermia therapy may be beneficial for patients with diffuse axonal injury.
基金supported by the National Natural Science Foundation of China,Nos.81771281(to FXS),81471177(to FXS)the Natural Science Foundation of Shanghai of China,No.20ZR1434200(to YF)。
文摘Leukoaraiosis(LA)results from ischemic injury in small cerebral vessels,which may be attributable to decreased vascular density,reduced cerebrovascular angiogenesis,decreased cerebral blood flow,or microcirculatory dysfunction in the brain.In this study,we enrolled 357 patients with mild intracerebral hemorrhage(ICH)from five hospitals in China and analyzed the relationships between LA and clinical symptom severity at admission,neurological function prognosis at 3 months,and 1-year stroke recurrence.Patients were divided into groups based on Fazekas scale scores:no LA(n=83),mild LA(n=64),moderate LA(n=98)and severe LA(n=112).More severe LA,larger hematoma volume,and higher blood glucose level at admission were associated with more severe neurological deficit.More severe LA,older age and larger hematoma volume were associated with worse neurological function prognosis at 3 months.In addition,moderate-to-severe LA,admission glucose and symptom-free cerebral infarction were associated with 1-year stroke recurrence.These findings suggest that LA severity may be a potential marker of individual ICH vulnerability,which can be characterized by poor tolerance to intracerebral attack or poor recovery ability after ICH.Evaluating LA severity in patients with mild ICH may help neurologists to optimize treatment protocols.This study was approved by the Ethics Committee of Ruijin Hospital Affiliated to Shanghai Jiao Tong University(approval No.12)on March 10,2011.
文摘Bai et al investigate the predictive value of T lymphocyte proportion in Alzheimer's disease(AD)prognosis.Through a retrospective study involving 62 AD patients,they found that a decrease in T lymphocyte proportion correlated with a poorer prognosis,as indicated by higher modified Rankin scale scores.While the study highlights the potential of T lymphocyte proportion as a prognostic marker,it suggests the need for larger,multicenter studies to enhance generalizability and validity.Additionally,future research could use cognitive exams when evaluating prognosis and delve into immune mechanisms underlying AD progression.Despite limitations inherent in retrospective designs,Bai et al's work contributes to understanding the immune system's role in AD prognosis,paving the way for further exploration in this under-researched area.
文摘<strong>Introduction:</strong> Malignant middle cerebral artery (MCA) infarction is a devastating entity that is associated with up to 80% mortality. Decompressive Hemicraniectomy has been utilized to treat brain swelling and mass effect secondary to these infarctions in an attempt to improve functional outcome. <strong>Aim: </strong>To evaluate the functional outcome of decompressive hemicraniectomy in management of malignant MCA infarctions. <strong>Methods: </strong>The study included 30 patients with malignant MCA infarctions operated upon by decompressive hemicraniectomy and duroplasty with pericranium or fascia lata graft in the period from June 2016 to January 2019. Pre-operative neurological condition, associated morbidity, location and extent of the infarction were assessed. Surgery was performed within 48 hours of the onset of stroke or 12 hours within deterioration of conscious level. Pre-operative CT scan as well as sequential post-operative CT was done. Functional outcome was assessed by the modified Rankin Scale (mRS) at the time of discharge and 3 months following surgery. <strong>Results: </strong>The study included 18 males and 12 females with a mean age of 54.7 years. The pre-operative GCS was <8 (5 - 7) in 11 patients and 8 or higher (8 - 13) in 19 patients. Good functional outcome (mRS 0 - 3) was achieved in 13 (43.3%) cases while poor outcome (mRS 4 - 5) occurred in 8 (26.7%) cases and mortality (mRS 6) occurred in 9 (30%) cases. <strong>Conclusion:</strong> Decompressive hemicraniectomy improves functional outcome in cases of malignant MCA infarction. Pre-operative GCS, age, volume of infarction, degree of midline shift, timing of surgery and associated morbidity are the most important factors affecting the outcome.
文摘<strong>Background:</strong> <span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">Worldwide, the prevalence of sickle cell disease (SCD) as of 2016 was estimated at 2%;that is 300</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">,</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">000 births annually. This study was focused on homozygous sickle cell disease which leads to several complications notably hemolytic crises, aplastic crises and vaso-occlusive crises like stroke. Sickle cell disease is the most common cause of childhood stroke. Stroke occurs in 17</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">% </span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">- 24% of sickle cell children worldwide. </span><b><span style="font-family:Verdana;">Objectives: </span></b></span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">To</span><b> </b><span style="font-family:Verdana;">d</span></span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">etermine the risk factors for overt stroke and outcome at discharge in sickle cell disease patients admitted in two reference hospitals in Cameroon. </span><b><span style="font-family:Verdana;">Method: </span></b><span style="font-family:Verdana;">This was a case-control study in two reference hospitals in Yaounde and Douala, carried out over the duration of 4 months, covering a 5-year period (December 2013 to December 2018). Included in the study, were all homozygous sickle cell children aged 6 months to 16 years during that period with or without stroke. A total of 1734 patients fulfilled the inclusion criteria. Out of these, 49 stroke patients participated and 687 were selected as controls. Data was collected from the patients’ files and books on a pretested data collection form, then entered in the software C.S Pro 7.1 before analysis. Stroke outcome at discharge was assessed using the modified Rankin scale (mRs) with structured interview. A patient was classified as good outcome if mRs</span></span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"><</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">3 and poor outcome if mRs ≥</span></span></span><span><span><span style="font-family:""> </span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">3. Statistical analysis was done with SPSS software version 22.0 for Windows. </span><b><span style="font-family:Verdana;">Results: </span></b><span style="font-family:Verdana;">A total of 736 patients participated in the study. Out of these, 391</span></span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">(53.1%) were males and 345</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">(46.9%) were females. Overt stroke was found to have an estimated hospital prevalence of 3.29% in this population. Several risk and associated factors were identified such as frequent rate of acute chest syndrome (p</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">< 0.001), acute chest syndrome in the past 2 weeks (p</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">= 0.001), low steady state haemoglobin (p <</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">0.001) and previous stroke (p = 0.002). A poor outcome was observed in 16</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">(32.7%) of</span></span></span><span><span><span style="font-family:""> </span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">them. </span><b><span style="font-family:Verdana;">Conclusion: </span></b><span style="font-family:Verdana;">The occurrence of stroke in this population is 3.29% and several factors were associated with its occurrence.</span></span></span></span>
基金supported by the Science and Technical Committee of Shanghai Municipality of China,No.16QA1400900the Outstanding Youth Grant from Shanghai Municipal Commission of Health and Family Planning of China,No.XYQ2013107+1 种基金the China Postdoctoral Science Foundation,No.2016M592595the National Key Research and Development Program of China,No.2016YFA0203700
文摘Cerebral blood perfusion and cerebrovascular lesions are important factors that can affect the therapeutic efficacy of thrombolysis.At present,the majority of studies focus on assessing the accuracy of lesion location using imaging methods before treatment,with less attention to predictions of outcomes after thrombolysis.Thus,in the present study,we assessed the efficacy of combined computed tomography（CT） perfusion and CT angiography in predicting clinical outcomes after thrombolysis in ischemic stroke patients.The study included 52 patients who received both CT perfusion and CT angiography.Patients were grouped based on the following criteria to compare clinical outcomes：（1） thrombolytic and non-thrombolytic patients,（2） thrombolytic patients with CT angiography showing the presence or absence of a vascular stenosis,（3） thrombolytic patients with CT perfusion showing the presence or absence of hemodynamic mismatch,and（4） different CT angiography and CT perfusion results.Short-term outcome was assessed by the 24-hour National Institution of Health Stroke Scale score change.Long-term outcome was assessed by the 3-month modified Rankin Scale score.Of 52 ischemic stroke patients,29 were treated with thrombolysis and exhibited improved short-term outcomes compared with those without thrombolysis treatment（23 patients）.Patients with both vascular stenosis and blood flow mismatch（13 patients） exhibited the best short-term outcome,while there was no correlation of long-term outcome with CT angiography or CT perfusion findings.These data suggest that combined CT perfusion and CT angiography are useful for predicting short-term outcome,but not long-term outcome,after thrombolysis.
基金grants 2022YFC2504902,2022YFC2504904 from the Ministry of Science and Technology of the People’s Republic of China,grant Z200016 from the Beijing Natural Science。
文摘Background and purpose To date,no large cohort study has investigated the effects of intravenous thrombolysis(IVT)in Chinese patients aged over 80 years who had a stroke.This study aimed to assess the trends in the use of alteplase,the clinical characteristics and the outcomes of Chinese patients aged above 80 years who had an acute ischaemic stroke.Methods Data for this analysis were obtained from the China Stroke Center Alliance programme,a nationwide,multicentre,prospective registry encompassing 1751 hospitals across 31 provinces,covering the period from 1 January 2018 to 14 December 2022.The primary outcome was defined as a modified Rankin Scale(mRS)Score of 0-2 at discharge.Secondary outcomes included an mRS Score of 0-1 and independent ambulation on discharge.Safety outcomes assessed were in-hospital mortality and symptomatic intracranial haemorrhage(sICH).Results Out of 30902 patients over 80 years old who qualified for thrombolysis,8673(median age(IQR),84(82-87)years)received alteplase treatment.Patients administered alteplase demonstrated improved short-term functional outcomes,such as an mRS Score of 0-2(adjusted OR(aOR)1.12,95%CI,1.06 to 1.18,p<0.001),an mRS Score of 0-1(aOR 1.14,95%CI,1.08 to 1.19,p<0.001)and independent ambulation at discharge(aOR 1.14,95%CI,1.08 to 1.20,p<0.001).Moreover,no significant increase was observed in the risk of in-hospital mortality(aOR 1.12,95%CI,0.93 to 1.35;p=0.23).However,the risk of sICH was significantly higher among patients treated with alteplase(aOR 3.22,95%CI,2.77 to 3.75;p<0.001).Conclusions IVT with alteplase in elderly patients who had a stroke resulted in improved short-term functional outcomes without elevating the risk of in-hospital mortality.Nonetheless,this population remains at a higher risk of sICH.
基金supported by grants from the National Natural Science Foundation of China(No.82425101)Beijing Municipal Science&Technology Commission(No.Z231100004823036)+8 种基金Capital's Funds for Health Improvement and Research(2022-2-2045)National Key R&D Program of China(2024YFC3044800,2022YFF1501500,2022YFF1501501,2022YFF1501502,2022YFF1501503,2022YFF1501504,2022YFF1501505)Youth Beijing Scholar Program(No.010)Beijing Laboratory of Oral Health(PXM2021_014226_000041)Beijing Talent Project-Class A:Innovation and Development(No.2018A12)National Ten-Thousand Talent Plan"-Leadership of Scientific and Technological InnovationNational Key R&D Program of China(No.2017YFC1307900,2017YFC1307905)Beijing Outstanding Young Scientist Program(No.BJJWZYJH01201910025030)Noncommunicable Chronic Diseases-National Science and Technology Major Project(2023ZD0504800,2023ZD0504801,2023ZD0504802,2023ZD0504803,2023ZD0504804)。
文摘Background Acute ischaemic stroke,due to its high mortality and disability rates,imposes a significant economic and social burden worldwide.Typically,endovascular treatment within the therapeutic window is provided to salvage the ischaemic penumbra;however,even when recanalisation is successful during endovascular treatment,the clinical outcomes may still be disappointing.This highlights the necessity of further research,so as to discover better solutions to futile recanalisation and improve patient outcomes.Objective To investigate the efficacy and safety of Y-6 sublingual tablets(cilostazol and dexborneol)compared with a placebo in the treatment of patients with acute ischaemic stroke caused by large vessel occlusion.Method The efficacy and safety of Y-6 sublingual tablets in patients with acute ischaemic stroke are evaluated in a phase Ⅱ,randomised,double-blind,double-dummy,placebo-controlled,parallel clinical trial.Eligible patients having provided informed consent are randomised into five groups for a 28-day treatment period.The primary outcome is the percentage of patients achieving the modified Rankin Scale score of 0-1 at 90 days.Discussion The EFfects of Y-6 SUblingual Tablets for PaTients with AcUte Ischemic StRokE trial assesses whether Y-6 sublingual tablets are effective and safe in improving the clinical outcomes of patients with acute ischaemic stroke caused by large vessel occlusion.
文摘Background Despite successful reperfusion after thrombectomy for large vessel occlusion(LVO)stroke,up to half of patients are dependent or dead at 3-month follow-up.The aim of the current study is to demonstrate safety and efficacy of administering adjunct intra-arterial(IA)tenecteplase in anterior circulation LVO patients who have achieved successful reperfusion defined as eTICI 2b50 to 3.Methods ANGEL-TNK is a multicentre,open-label,assessor-blinded endpoint,prospective randomised,controlled trial that will enrol up to 256 patients.Patients who meet inclusion criteria with anterior circulation LVO stroke and successful reperfusion will be randomised to receive IA tenecteplase or best medical management at 1:1 ratio.Results The primary endpoint is a 90-day excellent outcome defined as modified Rankin Scale(mRS)0–1.The primary safety endpoint is symptomatic intracranial haemorrhage within 48 hours from randomisation.Secondary endpoints include 90-day ordinal mRS,mRS 0–2,mRS 0–3,all-cause mortality and any intracranial haemorrhage.Conclusion In patients with anterior circulation LVO stroke,the ANGEL-TNK trial will inform whether adjunct IA tenecteplase administered after successful thrombectomy reperfusion improves patient outcomes.Trial registration number NCT05624190.
基金Science and Technology Project Plan of Liaoning Province(2023-MSLH-348,2022JH2/101500020)。
文摘Objective The Antiplatelet versus R-tPA for Acute Mild Ischaemic Stroke trial has demonstrated the non-inferiority of dual antiplatelet therapy(DAPT)to alteplase in minor non-disabling stroke.This prespecified secondary analysis aimed to investigate whether the treatment effects were similar across stroke territories.Methods Participants were divided according to stroke territory,which were subdivided into DAPT and alteplase.An excellent functional outcome at 90 days defined as modified Rankin Scale scoring 0–1 was primary outcome.National Institutes of Health Stroke Scale(NIHSS)score change and early neurological improvement measured by a 2-point decline in NIHSS score at 24 hours were secondary outcomes.Symptomatic intracerebral haemorrhage(sICH)and bleeding events were safety outcomes.Primary analyses adjusted unbalanced baseline characteristics between treatments by multivariate logistic regression.Results A total of 719 patients were included:566 in anterior circulation stroke(ACS)and 153 in posterior circulation stroke(PCS).Primary outcome was 94.1%in DAPT and 91.7%in alteplase among ACS patients(adjusted risk difference(RD)and 95%CI,1.5%(−1.5%to 4.6%),p=0.32),while 91.2%in DAPT and 91.8%in alteplase among PCS patients(adjusted RD and 95%CI,−2.1%(−8.5%to 4.4%),p=0.53).Compared with alteplase,DAPT was associated with lower risk of sICH(p=0.03)and bleeding events(p<0.001)in ACS,but only lower risk of bleeding events(p=0.007)in PCS.Additionally,among ACS patients,the alteplase was superior to DAPT in terms of decrease in NIHSS score at 24 hours compared with admission(adjusted geometric mean ratio and 95%CI,−0.09(−0.16 to−0.03),p=0.005)and early neurological improvement(adjusted RD and 95%CI,−7.2%(−11.6%to−2.7%),p=0.001).Conclusion Among ischaemic stroke with minor non-disabling symptoms,DAPT was similar with intravenous alteplase regarding long-term functional outcome and better safety regardless of ACS or PCS.The potential benefit of intravenous alteplase regarding early neurological improvement in patients with ACS warrants further investigation.Trial registration number NCT03661411.
基金funded by Beijing Municipal Science&Technology Committee(Z211100003521019)China Shijiazhuang Pharmaceutical Company Recomgen Pharmaceutical(Guangzhou)Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences(2019-I2M 5-029)National Natural Science Foundation(82111530203,82171272).
文摘Background The benefit-risk profile of tenecteplase in the elderly patients with acute ischaemic stroke(AIS)is uncertain.We sought to investigate the efficacy and safety of 0.25 mg/kg tenecteplase compared with alteplase for AIS patients aged≥80 years.Methods We performed a post hoc analysis of the Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-2 Trial,a randomised,phase 3,non-inferiority clinical trial.Disabling AIS patients aged≥80 years who initiated intravenous thrombolytics within 4.5 hours of symptom onset were enrolled from June 2021 to May 2022 across 53 centres in China and were randomly allocated to receive 0.25 mg/kg tenecteplase or 0.9 mg/kg alteplase.The primary efficacy outcome was the proportion of participants with a modified Rankin Scale(mRS)score of 0-1 at 90 days.Symptomatic intracranial haemorrhage(sICH)within 36 hours was the safety outcome.Results Of 137 participants,mRS 0-1 at 90 days occurred in 37(49.3%)of 75 in the tenecteplase group vs 20(33.9%)of 59 in the alteplase group(risk ratio(RR)1.47,95%CI 0.96 to 2.23).sICH within 36 hours was observed in 3(4.0%)of 76 in the tenecteplase group and two(3.3%)of 61 in the alteplase group(RR 1.30,95%CI 0.20 to 8.41).Conclusions The risk-benefit profile of tenecteplase thrombolysis was preserved in the elderly patients,which lends further support to intravenous 0.25 mg/kg tenecteplase as an alternative to alteplase in these patients.
基金supported by Beijing Municipal Science&Technology Commission(Z221100007422050)Capital's Funds for Health Improvement and Research(2020-1-2041,2022-2G 2049).
文摘Background GD-11,a novel brain cytoprotective drug,was designed to be actively taken up and transported across the blood-brain barrier via the glucose transporter.This study aimed to evaluate the safety and efficacy of GD-11 for improving the recovery of patients with acute ischaemic stroke(AIS).Methods A double-blind,randomised,placebo-controlled,phase 2 trial was conducted at 15 clinical sites in China.Patients aged 18-80 years with AIS within 48 hours were randomly assigned(1:1:1)to receive 160 mg GD-11,80 mg GD-11 and placebo,two times a day for 10 days.The primary endpoint was a modified Rankin Scale(mRS)score of 0-1 at 90 days after treatment.The safety outcome was any adverse events within 90 days.Results From 17 November 2022 to 22 March 2023,a total of 80 patients in the 160 mg GD-11 group,79 patients in the 80 mg GD-11 group and 80 patients in the placebo group were included.The proportion of an mRS score of 0-1 at day 90 was 77.5%in the 160 mg GD-11 group,72.2%in the 80 mg GD-11 group and 67.5%in the placebo group.Though no significant difference was found(p=0.3671),a numerically higher proportion was observed in the GD-11 group,especially in the 160 mg GD-11 group.The incidence of adverse events was similar across the three groups(p=0.1992).Conclusion GD-11 was safe and well-tolerated.A dosage of GD-11160 mg two times a day was recommended for a large trial to investigate the efficacy.
基金funded by Covidien Healthcare International Trading(Shanghai),Johnson&Johnson MedTech,Genesis MedTech(Shanghai)and Shanghai HeartCare Medical Technologysupported by the Clinical Medicine Development of Special Funding Support(ZYLX201708+2 种基金DFL20180502)the Beijing Municipal Science&Technology Commission(Z19110700660000)the Capital’s Funds for Health Improvement and Research(CFH 2024-2-2046).
文摘Objectives Endovascular therapy(EVT)now penetrates the once obscure realm of large infarct core volume acute ischaemic stroke(LICV-AIS).This research aimed to investigate the potential correlation between different anaesthetic approaches and post-EVT outcomes in LICV-AIS patients.Methods Between October 2020 and May 2022,the China ANGEL-Alberta Stroke Programme Early CT Score(ASPECT)trial studied patients with LICV-AIS,randomly assigning them to the best medical management(BMM)or BMM with EVT.This post hoc subgroup analysis categorised subjects receiving BMM with EVT into general anaesthesia(GA)and non-GA groups based on anaesthesia type.We applied multivariable logistic regression to evaluate the relationship between anaesthesia during EVT and patient functional outcomes,as measured by the modified Rankin scale(mRS),in addition to the occurrence of complications.Further adjustment for selection bias was achieved through propensity score matching(PSM).Results In total,230 patients with LICV-AIS were enrolled(GA 84 vs Non-GA 146).No significant difference was observed between the two groups in terms of the proportion of patients who achieved an mRS score of 0-2 at 90 days(27.4%for the GA group vs 31.5%for the non-GA group,p=0.51).However,the GA group had significantly longer median surgical times(142 min vs 122 min,p=0.03).Furthermore,GA was associated with an increased risk of postoperative pneumonia(adjusted OR 2.03,95%CI 1.04 to 3.98).The results of PSM analysis agreed with the results of the multivariate regression analysis.No significant difference in intracranial haemorrhage incidence or mortality rate was observed between the groups.Conclusion This post hoc analysis of subgroups of the ANGEL-ASPECT trial suggested that there may be no significant association between the choice of anaesthesia and neurological outcomes in LICV-AIS patients.However,compared with non-GA,GA prolongs the duration of EVT and is associated with a greater postoperative pneumonia risk.
基金supported by unrestricted grants from Covidien Healthcare International Trading(Shanghai)Johnson&Johnson MedTech,Genesis MedTech(Shanghai)+4 种基金Shanghai HeartCare Medical TechnologyNational Health Commission Capacity Building and Continuing Education Center Nervous System and Minimally Invasive Intervention Program.No.GWJJ2022100106.Tianjin Health Science and Technology Project No.MS20015Beijing-Tianjin Hebei Basic Research Cooperation Project(Grant number:22JCZXJC00190)Beijing Postdoctoral Research Foundation,Grant/Award Number:2021-ZZ 029Tianjin Key Research and Development Program in Science and Technology,No.19YFZCSY00260.
文摘Objectives Our study aims to examine the value of endovascular therapy(EVT)and its comparison to medical management(MM)in ischaemic stroke patients accompanied by large artery atherosclerosis(LAA)and non-LAA Methods modified Rankin scale score(mRS)was evaluated at 90 days post the stroke attack and was considered as the primary outcome.Other outcomes measured in this study included score changes of 0-2 and 0-3 on the mRS.The occurrence of symptomatic intracranial haemorrhage at 24 hours after EVT was also measured as a safety endpoint.Logistic regression analysis was used to determine the associations.Results In the LAA group,no significant difference in mRS at 90-day(median IQR 3(2-5)vs 4(3-4),95%CI 0.53 to 2.00,p=0.924),mRS 0-2 and mRS 0-3 was observed between EVT and MM groups.However,in the non-LAA group,patients who underwent EVT had lower 90-day mRS scores(4(2-5)vs 4(3-5),generalised OR 1.47,95%CI 1.14 to 1.88,p<0.001).No interaction effect on the primary outcomes between treatment options and aetiology.More intracranial haemorrhage events within 48 hours were identified in the EVT group for both LAA and non-LAA cohorts(LAA:40.98%vs 9.62%,relative risk(RR)4.26,95%CI 1.76 to 10.34,p<0.001;non-LAA,52.07%vs 19.65%,RR 2.65,95%CI 1.90 to 3.70,respectively).Conclusions For large infarcts,EVT may be more effective than MM for patients with non-LAA aetiology,but not for those with LAA stroke.As no interaction effect was found,the benefit of EVT compared with MM did not vary by stroke subtypes.
