Le Bars P L, Katz M M, Berman N, Itil T M, Freedman A M, Schatzberg A F
New York Institute for Medical Research, Tarrytown 10591, USA.
JAMA. 1997;278(16):1327-32. doi: 10.1001/jama.278.16.1327.
EGb 761 is a particular extract of Ginkgo biloba used in Europe to alleviate symptoms associated with numerous cognitive disorders. Its use in dementias is based on positive results from only a few controlled clinical trials, most of which did not include standard assessments of cognition and behavior.
To assess the efficacy and safety of EGb in Alzheimer disease and multi-infarct dementia.
A 52-week, randomized double-blind, placebo-controlled, parallel-group, multicenter study.
Mildly to severely demented outpatients with Alzheimer disease or multi-infarct dementia, without other significant medical conditions.
Patients assigned randomly to treatment with EGb (120 mg/d) or placebo. Safety, compliance, and drug dispensation were monitored every 3 months with complete outcome evaluation at 12, 26, and 52 weeks.
Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog), Geriatric Evaluation by Relative's Rating Instrument (GERRI), and Clinical Global Impression of Change (CGIC).
From 309 patients included in an intent-to-treat analysis, 202 provided evaluable data for the 52-week end point analysis. In the intent-to-treat analysis, the EGbgroup had an ADAS-Cog score 1.4 points better than the placebo group (P=.04) and a GERRI score 0.14 points better than the placebo group (P=.004). The same patterns were observed with the evaluable data set in which 27% of patients treated with EGb achieved at least a 4-point improvement on the ADAS-Cog, compared with 14% taking placebo (P=.005); on the GERRI, 37% were considered improved with EGb, compared with 23% taking placebo (P=.003). No difference was seen in the CGIC. Regarding the safety profile of EGb, no significant differences compared with placebo were observed in the number of patients reporting adverse events or in the incidence and severity of these events.
EGb was safe and appears capable of stabilizing and, in a substantial number of cases, improving the cognitive performance and the social functioning of demented patients for 6 months to 1 year. Although modest, the changes induced by EGb were objectively measured by the ADAS-Cog and were of sufficient magnitude to be recognized by the caregivers in the GERRI.
EGb 761是银杏叶的一种特殊提取物，在欧洲用于缓解与多种认知障碍相关的症状。其在痴呆症治疗中的应用仅基于少数对照临床试验的阳性结果，其中大多数试验未纳入认知和行为的标准评估。
评估EGb在阿尔茨海默病和多发梗死性痴呆中的疗效和安全性。
一项为期52周的随机双盲、安慰剂对照、平行组、多中心研究。
患有阿尔茨海默病或多发梗死性痴呆的轻度至重度痴呆门诊患者，无其他重大疾病。
患者随机分配接受EGb（120毫克/天）或安慰剂治疗。每3个月监测安全性、依从性和药物配给情况，并在第12、26和52周进行全面结局评估。
阿尔茨海默病评估量表-认知分量表（ADAS-Cog）、亲属评定的老年评估工具（GERRI）和临床总体印象变化量表（CGIC）。
在一项意向性分析纳入的309例患者中，202例为52周终点分析提供了可评估数据。在意向性分析中，EGb组的ADAS-Cog评分比安慰剂组高1.4分（P = 0.04），GERRI评分比安慰剂组高0.14分（P = 0.004）。在可评估数据集中也观察到了相同的模式，其中接受EGb治疗的患者中有27%在ADAS-Cog上至少提高了4分，而服用安慰剂的患者为14%（P = 0.005）；在GERRI上，接受EGb治疗的患者中有37%被认为有所改善，而服用安慰剂的患者为23%（P = 0.003）。CGIC方面未见差异。关于EGb的安全性，报告不良事件的患者数量以及这些事件的发生率和严重程度与安慰剂相比均未观察到显著差异。
EGb是安全的，并且在相当多的病例中似乎能够稳定并改善痴呆患者的认知表现和社会功能6个月至1年。尽管EGb引起的变化不大，但ADAS-Cog对其进行了客观测量，并且GERRI中的变化幅度足以被护理人员识别。
