Raskind M A, Sadowsky C H, Sigmund W R, Beitler P J, Auster S B
Veterans Affairs Puget Sound Health Care System, Seattle, USA.
Arch Neurol. 1997 Jul;54(7):836-40. doi: 10.1001/archneur.1997.00550190026010.
To examine the effects of tacrine hydrochloride in patients with Alzheimer disease (AD) and detectable baseline deficits in discrete cognitive and noncognitive parameters who are enrolled in a previously reported multicenter, double-blind, 30-week trial.
An exploratory analysis using last observation carried forward. The study population included a placebo group (n = 181) and all patients randomized to treatment within 160 mg/d of tacrine hydrochloride (n = 234), regardless of highest dose achieved or duration of tacrine therapy.
Male and female subjects, at least 50 years of age, with mild to moderate AD and detectable baseline deficits in discrete cognitive and noncognitive parameters.
Change from baseline to last observation carried forward in discrete subscale scores of the Alzheimer's Disease Assessment Scale (ADAS): cognitive (memory, language, praxis) and noncognitive (mood, behavior). Improvement was defined as a decrease of at least 1 point from baseline; stabilization was defined as no change or a decrease from baseline.
Compared with the placebo group, the percentage of patients receiving tacrine whose conditions improved or stabilized was significantly greater for 8 of 11 ADAS-cognitive items (word recall, word recognition, orientation, language production, comprehension, word finding, following commands, ideational praxis) and for the ADAS-noncognitive items: cooperation, delusions, and pacing.
Tacrine stabilizes or improves specific behavioral deficits and symptoms in AD. The previous demonstration of tacrine's effect on global cognitive function has been extended by suggesting an association between tacrine therapy and improvements in individual cognitive and noncognitive items of the ADAS. Effects of tacrine in clinical practice might be more accurately and efficiently assessed by measuring individual ADAS cognitive and noncognitive items relevant to individual patient pretreatment clinical status.
在一项先前报道的多中心、双盲、30周试验中，研究盐酸他克林对患有阿尔茨海默病（AD）且在离散认知和非认知参数方面有可检测基线缺陷的患者的影响。
采用末次观察结转的探索性分析。研究人群包括一个安慰剂组（n = 181）和所有随机接受每日160毫克盐酸他克林治疗的患者（n = 234），无论达到的最高剂量或他克林治疗持续时间如何。
年龄至少50岁的男性和女性受试者，患有轻度至中度AD，且在离散认知和非认知参数方面有可检测基线缺陷。
阿尔茨海默病评估量表（ADAS）离散子量表评分从基线到末次观察结转的变化：认知（记忆、语言、实践）和非认知（情绪、行为）。改善定义为比基线至少降低1分；稳定定义为无变化或比基线降低。
与安慰剂组相比，接受他克林治疗且病情改善或稳定的患者百分比在11项ADAS认知项目中的8项（单词回忆、单词识别、定向、语言表达、理解、找词、听从指令、观念性实践）以及ADAS非认知项目（合作、妄想、踱步）上显著更高。
他克林可稳定或改善AD患者的特定行为缺陷和症状。他克林对整体认知功能的影响先前已有证明，通过表明他克林治疗与ADAS个体认知和非认知项目的改善之间存在关联，这一影响得到了扩展。通过测量与个体患者治疗前临床状态相关的ADAS个体认知和非认知项目，可能更准确、有效地评估他克林在临床实践中的效果。
