Schneider L S, Farlow M R, Henderson V W, Pogoda J M
Department of Psychiatry and the Behavioral Sciences, School of Medicine, University of Southern California, Los Angeles 90033, USA.
Neurology. 1996 Jun;46(6):1580-4. doi: 10.1212/wnl.46.6.1580.
To examine whether estrogen replacement therapy (ERT) affects clinical and cognitive responses to tacrine in women with Alzheimer's disease (AD).
A 30-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial of tacrine in which a subgroup of women were receiving ERT prior to randomization.
Women with mild to moderate-stage AD, at least 50 years of age, who were enrolled in the previously reported trial.
Randomized assignment to placebo or to one of three ascending-dosage regimens of tacrine: maximum dosages of 80 mg/d, 120 mg/d or 160 mg/d.
Alzheimer's Disease Assessment Scale-Cognitive Scale (ADASc), Clinician Interview-Based Impression of change (CIBI), Mini-Mental State Examination (MMSE), Caregiver's Impression of Change (CIC).
Of 318 women with evaluable data 14.5% were receiving ERT. Women completing the trial taking ERT and tacrine improved more than women not receiving ERT who were randomly assigned to tacrine or to placebo as assessed by the ADASc (p < 0.01), the CIBI (p = 0.02), the CIC (p = 0.006), and the MMSE (p = 0.07). They improved significantly on the ADASc (p = 0.01) using an intent-to-treat analysis.
Prior and continuing ERT may enhance response to tacrine in women with AD. Randomized trials are needed.
研究雌激素替代疗法（ERT）是否会影响患有阿尔茨海默病（AD）的女性对他克林的临床及认知反应。
一项为期30周的他克林随机、双盲、安慰剂对照、平行组、多中心临床试验，其中一组女性在随机分组前接受ERT治疗。
年龄至少50岁、患有轻度至中度AD且参加过先前报道试验的女性。
随机分配至安慰剂组或他克林的三种递增剂量方案之一：最大剂量分别为80mg/天、120mg/天或160mg/天。
阿尔茨海默病评估量表-认知量表（ADASc）、基于临床医生访谈的变化印象（CIBI）、简易精神状态检查表（MMSE）、照料者变化印象（CIC）。
在318例有可评估数据的女性中，14.5%正在接受ERT治疗。根据ADASc（p<0.01）、CIBI（p=0.02）、CIC（p=0.006）和MMSE（p=0.07）评估，完成试验的接受ERT和他克林治疗的女性比随机分配接受他克林或安慰剂治疗但未接受ERT的女性改善更明显。采用意向性分析，她们在ADASc上有显著改善（p=0.01）。
先前及持续的ERT可能会增强AD女性对他克林的反应。需要进行随机试验。
