Ginkgo Diterpene Lactone Meglumine(Ginkgo Diterpene Lactone Meglumine)

概要

基本信息

药物类型

中药

别名-

靶点-

作用方式-

作用机制-

治疗领域

神经系统疾病心血管疾病

在研适应症-

非在研适应症

急性缺血性卒中

原研机构

上海中医药大学附属岳阳中西医结合医院

在研机构-

非在研机构

上海中医药大学附属岳阳中西医结合医院

最高研发阶段无进展临床2/3期

首次获批日期-

最高研发阶段(中国)无进展

特殊审评-

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关联

3

项与 Ginkgo Diterpene Lactone Meglumine 相关的临床试验

ChiCTR2300070949

/ Suspended临床2期IIT

Efficacy and safety of Ginkgo biloba diterpene lactone glumine injection in patients with acute ischemic stroke: a randomized, double-blind, multi-dose, placebo-controlled Phase ? exploratory trial

开始日期2023-06-01

申办/合作机构-

NCT05663307

/ Unknown status临床2/3期IIT

The Effect of Ginkgolide on Clinical Improvement of Patients With Acute Ischemic: A Randomized, Double Blind, Placebo Parallel Controlled Clinical Study

The aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke

开始日期2021-01-01

申办/合作机构

上海中医药大学附属岳阳中西医结合医院

NCT05531942

/ Unknown status临床2/3期IIT

Antiplatelet Effect of Ginkgo Diterpene Lactone Meglumine Injection in Acute Ischemic Stroke:A Randomized, Double-blind, Placebo-controlled Clinical Trial

This study evaluates the addition of Ginkgo Diterpene Lactone Meglumine Injection to aspirin in the treatment of acute ischemic stroke.Half of patient will receive Ginkgo Diterpene Lactone Meglumine Injection(25mg once/day D1-D14) and aspirin(100mg once/day D1-D14) in combination, while the other half will receive aspirin(100mg once/day D1-D14).

开始日期2021-01-01

申办/合作机构

上海中医药大学附属岳阳中西医结合医院

100 项与 Ginkgo Diterpene Lactone Meglumine 相关的临床结果

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100 项与 Ginkgo Diterpene Lactone Meglumine 相关的转化医学

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100 项与 Ginkgo Diterpene Lactone Meglumine 相关的专利（医药）

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18

项与 Ginkgo Diterpene Lactone Meglumine 相关的文献（医药）

2025-02-01·Journal of Ethnopharmacology

Ginkgo diterpene lactone meglumine for functional recovery in patients with acute ischemic stroke: A systematic review and meta-analysis

Review

作者: Miao, Lina ; Wang, Liuding ; Lyu, Jian ; Wei, Jingjing ; Xu, Zhenmin ; Zhang, Yunling ; Chen, Yifan ; Zhang, Zixuan ; Liang, Xiao

ETHNOPHARMACOLOGICAL RELEVANCEThe clinical efficacy of ginkgo diterpene lactone meglumine (GDLM), a Chinese patent medicine, in acute ischemic stroke (AIS) has garnered attention. However, the impact of GDLM on functional recovery in AIS patients has not been systematically reviewed or meta-analyzed.AIM OF THE STUDYTo evaluate the functional outcomes of GDLM in AIS patients.MATERIALS AND METHODSWe conducted a search of seven databases from inception to July 10, 2024, for pertinent randomized controlled trials (RCTs). We performed trial selection, data extraction, and bias assessment. Meta-analysis was conducted to evaluate functional and safety outcomes. Quality of evidence was assessed.RESULTSWe included eight RCTs involving 4041 patients. Compared to those receiving only conventional treatments (CTs), patients treated with GDLM in combination with CTs exhibited a significantly higher proportion of patients achieving excellent (modified Rankin Scale [mRS] 0-1) or favorable functional outcomes (mRS 0-2) (risk ratio [RR] for excellent functional outcome = 1.16, 95% confidence interval [CI] 1.08 to 1.24, p < 0.001; RR for favorable functional outcome = 1.21, 95% CI 1.17 to 1.26, p < 0.001) and had lower mRS scores (mean difference [MD] = -0.66, 95% CI -0.73 to -0.59, p < 0.001) at 90 days. The evidence supporting GDLM's role in restoring functional independence was rated as moderate in certainty. Additionally, the incidences of adverse events and reactions did not differ significantly between the two groups.CONCLUSIONModerate-certainty evidence suggests that GDLM may be a beneficial adjunct therapy for improving functional outcomes in AIS patients. Nonetheless, further validation of GDLM's efficacy and safety in real-world settings is warranted through future practice.

2024-06-01·Journal of Neurology

Efficacy of ginkgo diterpene lactone meglumine on cognitive function in patients with acute ischemic stroke: a predefined exploratory analysis of a multicenter, double-blind, randomized controlled trial

Article

作者: Tian, Xue ; Zhang, Yijun ; Xu, Qin ; Xia, Xue ; Meng, Xia ; Wang, Anxin

BACKGROUNDGinkgo diterpene lactone meglumine (GDLM) could improve the functional outcome in patients with acute ischemic stroke (AIS). This study aimed to investigate the efficacy of GDLM on cognitive function in patients with AIS.METHODSThis is a predefined exploratory analysis of the Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke trial, which was primarily designed to investigate the efficacy and safety of GDLM versus placebo on functional outcome at 100 centers in China. Cognitive function was measured using the Montreal Cognitive Assessment (MoCA) test. The primary outcomes were changes of MoCA from baseline to Day 14 and Day 90 after randomization.RESULTSA total of 3163 patients with completed data on MoCA were enrolled. There was statistically significant difference of changes in MoCA scores between the GDLM group and the placebo group from baseline to Day 14 (mean difference, 0.31; 95% confidence interval [CI], 0.08-0.53; P = 0.007) and to Day 90 after randomization (mean difference, 0.47; 95% CI, 0.22-0.72; P < 0.001). Additionally, GDLM was associated with a higher proportion of patients who reached a clinically significant level of improvement in MoCA from baseline to Day 14 (odds ratio [OR], 1.25; 95% CI, 1.08-1.44; P = 0.002) and Day 90 after randomization (OR, 1.21; 95% CI, 1.03-1.41; P = 0.02). Specially, GDLM could significantly improve the scores of visuo-spatial and executive function and language.CONCLUSIONSIn this predefined analysis of patients with AIS, GDLM could improve the 14-day and 90-day cognitive function compared with the placebo.

2024-03-13·Open Medicine

Effectiveness of ginkgo diterpene lactone meglumine on cognitive function in patients with acute ischemic stroke

Article

作者: Zhang, Meini ; Hu, Xiao ; Liu, Xianghong ; Wang, Tao

AbstractObjectiveTo explore the efficacy of ginkgo diterpene lactone (GDLM) on cognitive function in patients with acute ischemic stroke (AIS).MethodsA total of 126 patients with AIS in Shaanxi Provincial People’s Hospital from July 2019 to December 2020 were collected and randomly divided into the control group and treatment group (n = 63). All patients received conventional treatment, on which 25 mg/day GDLM was administered in the treatment group. Coagulation and inflammation indexes, National Institutes of Health Stroke Scale (NIHSS) and activities of daily living scale (ADL) scores were measured before and 14 days after treatment. NIHSS and ADL scores were performed again after 3 months. Cognitive function was assessed by Montréal Cognitive Assessment (MoCA) score, Mini-Mental State Examination (MMSE) score, and potential P300.ResultsAfter 14 days of treatment, all biochemical indices were lower than before treatment (P < 0.05). The NIHSS and ADL scores of the treatment group were significantly better than those of the control group after treatment (P < 0.05). The MoCA and MMSE scores of the treatment group improved more significantly compared with the control group (P < 0.05). After treatment, the P300 indexes of both groups were significantly better than before treatment (P < 0.05).ConclusionConventional treatment of AIS combined with GDLM can effectively improve the cognitive function of patients, which is worthy of clinical recommendation.

100 项与 Ginkgo Diterpene Lactone Meglumine 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
急性缺血性卒中	临床3期	中国	上海中医药大学附属岳阳中西医结合医院	2021-01-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ISC2024	N/A	急性缺血性卒中	3,452	Ginkgo diterpene lactone meglumine	觸製繭積鑰鏇蓋簾鬱壓(憲構鹽醖鏇醖築顧顧鑰) = 積廠構築膚鹹醖糧願觸齋廠選鏇衊廠淵夢夢夢 (夢淵鏇衊淵鏇膚衊鏇窪, 17.51 ~ 18.81)	积极	2024-02-01