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在两项平行组研究中对盐酸他克林(安理申)进行评估。

Evaluation of tacrine hydrochloride (Cognex) in two parallel-group studies.

作者信息

Gracon S I

机构信息

CNS Clinical Development, Parke-Davis, Ann Arbor, MI 48106-1047, USA.

出版信息

Acta Neurol Scand Suppl. 1996;165:114-22. doi: 10.1111/j.1600-0404.1996.tb05881.x.

Abstract

The efficacy of tacrine hydrochloride (Cognex) for the treatment of Alzheimer's disease (AD) has been confirmed in two randomized, double-blind, placebo-controlled, parallel-group studies. More than 1100 patients with mild to moderate, probable AD were randomized to receive placebo or tacrine for 12 or 30 weeks. Outcome measures included objective assessments of cognitive function, qualitative assessments of treatment response from the caregiver and clinician perspective, and assessments of activities of daily living. Statistically significant treatment effects favoring tacrine were demonstrated in each domain. These results suggest several considerations for clinicians. Because response to treatment is dose related, patients should be titrated to their maximum tolerated dose. Response may be subtle and may range from improvement to stabilization or slowed decline. A minimum treatment period of 6 months is recommended to evaluate a response and treatment should be continued depending on patient tolerability.

摘要

盐酸他克林(Cognex)治疗阿尔茨海默病(AD)的疗效已在两项随机、双盲、安慰剂对照、平行组研究中得到证实。超过1100例轻度至中度、可能患有AD的患者被随机分配接受安慰剂或他克林治疗12周或30周。结果测量包括认知功能的客观评估、从照顾者和临床医生角度对治疗反应的定性评估以及日常生活活动的评估。在每个领域都显示出有利于他克林的具有统计学意义的治疗效果。这些结果为临床医生提供了几点考虑。由于对治疗的反应与剂量相关,患者应滴定至其最大耐受剂量。反应可能很细微,范围可能从改善到稳定或减缓衰退。建议至少治疗6个月以评估反应,并应根据患者的耐受性继续治疗。

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