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
Cattle encephalon glycoside and ignotin(CEGI)injection is known as a multi-target neuroprotective drug that contains numerous liposoluble molecules,such as polypeptides,monosialotetrahexosyl ganglioside(GM-1),free ami...Cattle encephalon glycoside and ignotin(CEGI)injection is known as a multi-target neuroprotective drug that contains numerous liposoluble molecules,such as polypeptides,monosialotetrahexosyl ganglioside(GM-1),free amino acids,hypoxanthine and carnosine.CEGI has been approved by the Chinese State Food and Drug Administration and widely used in the treatments of various diseases,such as stroke and Alzheimer's disease.However,the neuroprotective effects of CEGI beyond the time window of thrombolysis(within 4.5 hours)on acute ischemic stroke remain unclear.This study constructed a rat middle cerebral artery occlusion model by suture-occluded method to simulate ischemic stroke.The first daily dose was intraperitoneally injected at 8 hours post-surgery and the CEGI treatments continued for 14 days.Results of the modified five-point Bederson scale,beam balance test and rotameric test showed the neurological function of ischemic stroke rats treated with 4 m L/kg/d CEGI improved significantly,but the mortality within 14 days did not change significantly.Brain MRI and 2,3,5-triphenyltetrazolium chloride staining confirmed that the infarct size in the 4 m L/kg/d CEGI-treated rats was significantly reduced compared with ischemic insult only.The results of transmission electron microscopy and double immunofluorescence staining showed that the hippocampal neuronal necrosis in the ischemic penumbra decreased whereas the immunopositivity of new neuronal-specific protein doublecortin and the percentage of Ki67/doublecortin positive cells increased in CEGI-treated rats compared with untreated rats.Our results suggest that CEGI has an effective neuroprotective effect on ischemic stroke when administered after the time window of thrombolysis.The study was approved by the Animal Ethics Committee of The Third Military Medical University,China.展开更多
Objective:To study the effect of edaravone combined with cattle encephalon glycoside and ignotin injection adjuvant therapy on nerve function impairment in patients with severe craniocerebral injury.Methods: A total o...Objective:To study the effect of edaravone combined with cattle encephalon glycoside and ignotin injection adjuvant therapy on nerve function impairment in patients with severe craniocerebral injury.Methods: A total of 68 patients with severe craniocerebral injury who were treated in our hospital between January 2013 and May 2016 were collected and divided into control group and observation group according to the random number table, 34 cases in each group. Control group of patients received conventional + cattle encephalon glycoside and ignotin injection therapy, and observation group of patients received conventional +cattle encephalon glycoside and ignotin injection + edaravone therapy. The differences in serum levels of nerve injury indexes, oxidative stress indexes and inflammatory mediators were compared between the two groups of patients before and after treatment.Results: Before treatment, the differences in serum levels of nerve injury indexes, oxidative stress indexes and inflammatory mediators were not statistically significant between two groups of patients. After treatment, serum nerve injury index BNP level in observation group was higher than that in control group while S-100B, GFAP and NSE levels were lower than those in control group;serum oxidative stress indicators MDA and MPO levels were lower than those in control group while SOD and GSH-Px levels were higher than those in control group;serum inflammatory mediators IL-6, IL-8 and TNF-α levels were lower than those in control group.Conclusion:Edaravone combined with cattle encephalon glycoside and ignotin injection adjuvant therapy can effectively reduce the nerve function impairment in patients with severe craniocerebral injury, and the specific mechanisms are related to its effect on reducing the oxidative stress and inflammation.展开更多
目的探讨益气活血方联合脑苷肌肽注射液对脑梗死(cerebral infarction,CI)恢复期患者炎症因子水平与神经功能指标的影响。方法选取2021年1月至2022年4月宜春市第二人民医院收治的70例CI患者作为研究对象,随机分为对照组与观察组,每组35...目的探讨益气活血方联合脑苷肌肽注射液对脑梗死(cerebral infarction,CI)恢复期患者炎症因子水平与神经功能指标的影响。方法选取2021年1月至2022年4月宜春市第二人民医院收治的70例CI患者作为研究对象,随机分为对照组与观察组,每组35例。对照组采用脑苷肌肽注射液治疗,观察组在对照组基础上联合益气活血方治疗。比较两组炎症因子[白细胞介素-8(interleukin-8,IL-8)、肿瘤坏死因子-α(tumor necrosis factor-α,TNF-α)]水平、神经功能[美国国立卫生研究院卒中量表(National Institute of Health stroke scale,NIHSS)、神经元特异性烯醇化酶(neuron specific enolase,NSE)]、生命质量[生命质量综合评定问卷(generic quality of life inventory-74,GQOLI-74)]、血液学相关指标[基质金属蛋白酶-9(matrix metalloproteinase-9,MMP-9)、超氧化物歧化酶(superoxide dismu-tase,SOD)和血清胱抑素C(cystatin C,Cys-C)]及临床疗效。结果治疗后,观察组TNF-α、IL-8水平均低于对照组,差异有统计学意义(P<0.05);治疗后,观察组NIHSS评分、NSE水平均低于对照组,差异有统计学意义(P<0.05);治疗后,观察组躯体功能、心理功能、物质生活、社会功能评分均高于对照组,差异有统计学意义(P<0.05);治疗后,观察组MMP-9、Cys-C水平均低于对照组,SOD水平高于对照组,差异有统计学意义(P<0.05);观察组治疗总有效率为97.14%,高于对照组的74.29%,差异有统计学意义(P<0.05)。结论脑苷肌肽基础上联合益气活血方治疗CI效果显著,可改善患者神经功能,降低炎症因子水平,提高机体抗氧化能力,使患者回归正常生活状态。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the 63rd Batch of First-Class Financing for Chinese Postdoctoral Science Foundation,No.2018M631061(to LT)Macao Youth Scholars Program,No.AM201918(to LT)。
文摘Cattle encephalon glycoside and ignotin(CEGI)injection is known as a multi-target neuroprotective drug that contains numerous liposoluble molecules,such as polypeptides,monosialotetrahexosyl ganglioside(GM-1),free amino acids,hypoxanthine and carnosine.CEGI has been approved by the Chinese State Food and Drug Administration and widely used in the treatments of various diseases,such as stroke and Alzheimer's disease.However,the neuroprotective effects of CEGI beyond the time window of thrombolysis(within 4.5 hours)on acute ischemic stroke remain unclear.This study constructed a rat middle cerebral artery occlusion model by suture-occluded method to simulate ischemic stroke.The first daily dose was intraperitoneally injected at 8 hours post-surgery and the CEGI treatments continued for 14 days.Results of the modified five-point Bederson scale,beam balance test and rotameric test showed the neurological function of ischemic stroke rats treated with 4 m L/kg/d CEGI improved significantly,but the mortality within 14 days did not change significantly.Brain MRI and 2,3,5-triphenyltetrazolium chloride staining confirmed that the infarct size in the 4 m L/kg/d CEGI-treated rats was significantly reduced compared with ischemic insult only.The results of transmission electron microscopy and double immunofluorescence staining showed that the hippocampal neuronal necrosis in the ischemic penumbra decreased whereas the immunopositivity of new neuronal-specific protein doublecortin and the percentage of Ki67/doublecortin positive cells increased in CEGI-treated rats compared with untreated rats.Our results suggest that CEGI has an effective neuroprotective effect on ischemic stroke when administered after the time window of thrombolysis.The study was approved by the Animal Ethics Committee of The Third Military Medical University,China.
文摘Objective:To study the effect of edaravone combined with cattle encephalon glycoside and ignotin injection adjuvant therapy on nerve function impairment in patients with severe craniocerebral injury.Methods: A total of 68 patients with severe craniocerebral injury who were treated in our hospital between January 2013 and May 2016 were collected and divided into control group and observation group according to the random number table, 34 cases in each group. Control group of patients received conventional + cattle encephalon glycoside and ignotin injection therapy, and observation group of patients received conventional +cattle encephalon glycoside and ignotin injection + edaravone therapy. The differences in serum levels of nerve injury indexes, oxidative stress indexes and inflammatory mediators were compared between the two groups of patients before and after treatment.Results: Before treatment, the differences in serum levels of nerve injury indexes, oxidative stress indexes and inflammatory mediators were not statistically significant between two groups of patients. After treatment, serum nerve injury index BNP level in observation group was higher than that in control group while S-100B, GFAP and NSE levels were lower than those in control group;serum oxidative stress indicators MDA and MPO levels were lower than those in control group while SOD and GSH-Px levels were higher than those in control group;serum inflammatory mediators IL-6, IL-8 and TNF-α levels were lower than those in control group.Conclusion:Edaravone combined with cattle encephalon glycoside and ignotin injection adjuvant therapy can effectively reduce the nerve function impairment in patients with severe craniocerebral injury, and the specific mechanisms are related to its effect on reducing the oxidative stress and inflammation.
文摘目的探讨益气活血方联合脑苷肌肽注射液对脑梗死(cerebral infarction,CI)恢复期患者炎症因子水平与神经功能指标的影响。方法选取2021年1月至2022年4月宜春市第二人民医院收治的70例CI患者作为研究对象,随机分为对照组与观察组,每组35例。对照组采用脑苷肌肽注射液治疗,观察组在对照组基础上联合益气活血方治疗。比较两组炎症因子[白细胞介素-8(interleukin-8,IL-8)、肿瘤坏死因子-α(tumor necrosis factor-α,TNF-α)]水平、神经功能[美国国立卫生研究院卒中量表(National Institute of Health stroke scale,NIHSS)、神经元特异性烯醇化酶(neuron specific enolase,NSE)]、生命质量[生命质量综合评定问卷(generic quality of life inventory-74,GQOLI-74)]、血液学相关指标[基质金属蛋白酶-9(matrix metalloproteinase-9,MMP-9)、超氧化物歧化酶(superoxide dismu-tase,SOD)和血清胱抑素C(cystatin C,Cys-C)]及临床疗效。结果治疗后,观察组TNF-α、IL-8水平均低于对照组,差异有统计学意义(P<0.05);治疗后,观察组NIHSS评分、NSE水平均低于对照组,差异有统计学意义(P<0.05);治疗后,观察组躯体功能、心理功能、物质生活、社会功能评分均高于对照组,差异有统计学意义(P<0.05);治疗后,观察组MMP-9、Cys-C水平均低于对照组,SOD水平高于对照组,差异有统计学意义(P<0.05);观察组治疗总有效率为97.14%,高于对照组的74.29%,差异有统计学意义(P<0.05)。结论脑苷肌肽基础上联合益气活血方治疗CI效果显著,可改善患者神经功能,降低炎症因子水平,提高机体抗氧化能力,使患者回归正常生活状态。
