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银杏叶提取物EGb 761®治疗痴呆症的疗效和耐受性:随机安慰剂对照试验的系统评价和荟萃分析

Efficacy and tolerability of Ginkgo biloba extract EGb 761® in dementia: a systematic review and meta-analysis of randomized placebo-controlled trials.

作者信息

Gauthier Serge, Schlaefke Sandra

机构信息

Alzheimer Disease Research Unit, Memory Clinic, McGill Centre for Studies in Aging, McGill University, Verdun, QC, Canada.

Clinical Research Department, Dr Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.

出版信息

Clin Interv Aging. 2014 Nov 28;9:2065-77. doi: 10.2147/CIA.S72728. eCollection 2014.

Abstract

The objective of this systematic review was to evaluate current evidence for the efficacy of Ginkgo biloba extract EGb 761(®) in dementia. Seven of 15 randomized, placebo-controlled trials in patients with dementia identified by database searches met all our selection criteria and were included in the meta-analysis. In these trials, patients were treated with 120 mg or 240 mg per day of the defined extract EGb 761 or placebo. Efficacy was assessed using validated tests and rating scales for the cognitive domain, the functional domain (activities of daily living), and global assessment. Tolerability was evaluated by risk differences based on incidences of adverse events and premature discontinuation rates. Of 2,684 outpatients randomized to receive treatment for 22-26 weeks, 2,625 represented the full analysis sets (1,396 for EGb 761 and 1,229 for placebo). Standardized mean differences for change in cognition (-0.52; 95% confidence interval [CI] -0.98, -0.05; P=0.03), activities of daily living (-0.44; 95% CI -0.68, -0.19; P<0.001), and global rating (-0.52; 95% CI -0.92, -0.12; P=0.01) significantly favored EGb 761 compared with placebo. Statistically significant superiority of EGb 761 over placebo was confirmed by responder analyses as well as for patients suffering from dementia with neuropsychiatric symptoms. Treatment-associated risks in terms of relative risks of adverse events and premature withdrawal rates did not differ noticeably between the two treatment groups. In conclusion, meta-analyses confirmed the efficacy and good tolerability of Ginkgo biloba extract EGb 761 in patients with dementia.

摘要

本系统评价的目的是评估银杏叶提取物EGb 761(®)治疗痴呆症疗效的现有证据。通过数据库检索确定的15项针对痴呆症患者的随机、安慰剂对照试验中,有7项符合我们所有的纳入标准,并被纳入荟萃分析。在这些试验中,患者接受每天120毫克或240毫克的特定提取物EGb 761或安慰剂治疗。使用针对认知领域、功能领域(日常生活活动)和整体评估的经过验证的测试和评分量表评估疗效。通过基于不良事件发生率和过早停药率的风险差异评估耐受性。在随机接受22 - 26周治疗的2684名门诊患者中,2625名代表完整分析集(EGb 761组1396名,安慰剂组1229名)。与安慰剂相比,EGb 761在认知变化(标准化均数差为-0.52;95%置信区间[CI] -0.98,-0.05;P = 0.03)、日常生活活动(标准化均数差为-0.44;95% CI -0.68,-0.19;P < 0.001)和整体评分(标准化均数差为-0.52;95% CI -0.92,-0.12;P = 0.01)方面显著更优。反应者分析以及患有神经精神症状的痴呆症患者中,EGb 761在统计学上显著优于安慰剂。在不良事件相对风险和过早停药率方面,两个治疗组的治疗相关风险没有明显差异。总之,荟萃分析证实了银杏叶提取物EGb 761在痴呆症患者中的疗效和良好耐受性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/76cb/4259871/b3acde88bc80/cia-9-2065f1.jpg

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