Kuller Lewis H, Ives Diane G, Fitzpatrick Annette L, Carlson Michelle C, Mercado Carla, Lopez Oscar L, Burke Gregory L, Furberg Curt D, DeKosky Steven T
Department of Epidemiology, University of Pittsburgh, 130 N Bellefield Ave, Room 550, Pittsburgh, PA 15213, USA.
Circ Cardiovasc Qual Outcomes. 2010 Jan;3(1):41-7. doi: 10.1161/CIRCOUTCOMES.109.871640. Epub 2009 Nov 24.
Cardiovascular disease (CVD) was a preplanned secondary outcome of the Ginkgo Evaluation of Memory Study. The trial previously reported that Ginkgo biloba had no effect on the primary outcome, incident dementia.
The double-blind trial randomly assigned 3069 participants over 75 years of age to 120 mg of G biloba EGb 761 twice daily or placebo. Mean follow-up was 6.1 years. The identification and classification of CVD was based on methods used in the Cardiovascular Health Study. Differences in time to event between G biloba and placebo were evaluated using Cox proportional hazards regression adjusted for age and sex. There were 355 deaths in the study, 87 due to coronary heart disease with no differences between G biloba and placebo. There were no differences in incident myocardial infarction (n=164), angina pectoris (n=207), or stroke (151) between G biloba and placebo. There were 24 hemorrhagic strokes, 16 on G biloba and 8 on placebo (not significant). There were only 35 peripheral vascular disease events, 12 (0.8%) on G biloba and 23 (1.5%) on placebo (P=0.04, exact test). Most of the peripheral vascular disease cases had either vascular surgery or amputation.
There was no evidence that G biloba reduced total or CVD mortality or CVD events. There were more peripheral vascular disease events in the placebo arm. G biloba cannot be recommended for preventing CVD. Further clinical trials of peripheral vascular disease outcomes might be indicated.
clinicaltrials.gov Identifier: NCT00010803.
心血管疾病（CVD）是银杏叶记忆评估研究的一项预先设定的次要结局。该试验先前报告称，银杏叶对主要结局即新发痴呆无影响。
这项双盲试验将3069名75岁以上的参与者随机分为两组，一组每日两次服用120毫克银杏叶提取物EGb 761，另一组服用安慰剂。平均随访时间为6.1年。CVD的识别和分类基于心血管健康研究中使用的方法。使用Cox比例风险回归对年龄和性别进行校正，评估银杏叶组和安慰剂组之间至事件发生时间的差异。研究中有355例死亡，其中87例死于冠心病，银杏叶组和安慰剂组之间无差异。银杏叶组和安慰剂组在新发心肌梗死（n = 164）、心绞痛（n = 207）或中风（151例）方面无差异。有24例出血性中风，银杏叶组16例，安慰剂组8例（无统计学意义）。仅有35例周围血管疾病事件，银杏叶组12例（0.8%），安慰剂组23例（1.5%）（P = 0.04，确切概率检验）。大多数周围血管疾病病例接受了血管手术或截肢。
没有证据表明银杏叶能降低总死亡率或CVD死亡率，也不能降低CVD事件发生率。安慰剂组的周围血管疾病事件更多。不推荐使用银杏叶来预防CVD。可能需要进一步开展关于周围血管疾病结局的临床试验。
clinicaltrials.gov标识符：NCT00010803
