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银杏叶提取物761不影响可能患有阿尔茨海默病痴呆患者的凝血和出血时间——一项随机、双盲、安慰剂对照试验的二次分析

EGb 761 Does Not Affect Blood Coagulation and Bleeding Time in Patients with Probable Alzheimer's Dementia-Secondary Analysis of a Randomized, Double-Blind Placebo-Controlled Trial.

作者信息

Kloft Charlotte, Hoerr Robert

机构信息

Institute of Pharmacy, Freie Universität Berlin, 12169 Berlin, Germany.

Research & Development, Dr. Willmar Schwabe GmbH & Co. KG, 76227 Karlsruhe, Germany.

出版信息

Healthcare (Basel). 2021 Dec 3;9(12):1678. doi: 10.3390/healthcare9121678.

Abstract

Following reports of bleeding upon Ginkgo intake, we assessed whether Ginkgo extract EGb 761 affects coagulation or platelet function or increases the risk of bleeding. In a double-blind, placebo-controlled trial, prothrombin time, activated partial thromboplastin time, international normalized ratio and bleeding time were measured in patients with Alzheimer's dementia at baseline, weeks 6 and 26. A total of 513 patients were randomized to 120 mg ( = 169) or 240 mg EGb 761 ( = 170) or placebo ( = 174). No relevant changes were found for coagulation parameters and bleeding time. Numbers of bleeding-related adverse events were similar in all groups. Concomitant intake of acetylsalicylic acid was documented for 68 patients in the placebo group and 105 in the EGb 761 groups. Within these groups, the means at baseline and week 26 differed by less than 1 unit for prothrombin time and bleeding time and less than 0.1 unit for international normalized ratio. Data on warfarin treatment in nine patients each taking placebo or EGb 761 did not indicate enhancement of warfarin effects by EGb 761. No evidence was found that EGb 761 affects hemostasis or increases the bleeding risk. No pharmacodynamic interactions with warfarin or acetylsalicylic acid were found.

摘要

在有摄入银杏后出血的报告之后,我们评估了银杏提取物EGb 761是否会影响凝血或血小板功能,或增加出血风险。在一项双盲、安慰剂对照试验中,对患有阿尔茨海默病痴呆症的患者在基线、第6周和第26周测量凝血酶原时间、活化部分凝血活酶时间、国际标准化比值和出血时间。共有513名患者被随机分为服用120毫克EGb 761(n = 169)或240毫克EGb 761(n = 170)或安慰剂(n = 174)组。未发现凝血参数和出血时间有相关变化。所有组中与出血相关的不良事件数量相似。安慰剂组有68名患者和EGb 761组有105名患者记录了同时摄入乙酰水杨酸。在这些组中,凝血酶原时间和出血时间在基线和第26周的均值差异小于1个单位,国际标准化比值差异小于0.1个单位。关于9名服用安慰剂或EGb 761的患者接受华法林治疗的数据未表明EGb 761增强了华法林的效果。未发现EGb 761影响止血或增加出血风险的证据。未发现与华法林或乙酰水杨酸存在药效学相互作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d3b/8701823/3735bfde585b/healthcare-09-01678-g001.jpg

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