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胞二磷胆碱用于治疗老年人慢性脑部疾病相关的认知和行为障碍。

Cytidinediphosphocholine (CDP choline) for cognitive and behavioural disturbances associated with chronic cerebral disorders in the elderly.

作者信息

Fioravanti M, Yanagi M

机构信息

Department of Psychiatric Science and Psychological Medicine, University of Rome "La Sapienza", P.le A. Moro, 5, Rome, Italy.

出版信息

Cochrane Database Syst Rev. 2000(4):CD000269. doi: 10.1002/14651858.CD000269.

Abstract

BACKGROUND

CDP-choline has a widespread, but not exclusive use in the treatment of disorders of a cerebrovascular nature. The many years of its use have caused an evolution in dosage, method of administration, and selection of patients to which the treatment was given. Design of the clinical studies, including length of observation, severity of disease, and methodology of evaluation of the results have also varied. In spite of uncertainties about its efficacy, CDP-choline is frequently prescribed for cognitive impairment in several continental European countries, especially when the clinical picture is predominantly one of cerebrovascular disease.

OBJECTIVES

The objective is to assess the efficacy of CDP-choline (cytidinediphosphocholine) in the treatment of cognitive, emotional, and behavioural deficits associated with chronic cerebral disorders of older people.

SEARCH STRATEGY

The CDCIG register of trials and other databases were searched in July 2000 for all relevant, non-animal randomized controlled trials using the terms CDP-choline/CDP, Citicoline, Cytidine Diphosphate choline and Diphosphocholine. The Psychlit (1974-1996), Psychiatry (1980-1996) and MEDLINE electronic databases have been searched independently by the reviewers. The reviewers have also contacted manufacturers of CDP-choline.

SELECTION CRITERIA

All relevant, non-animal, unconfounded, double-blind, placebo-controlled, randomized trials of CDP-choline for patients with cognitive impairment due to chronic cerebral disorders are considered for inclusion in the review.

DATA COLLECTION AND ANALYSIS

Two reviewers independently reviewed the included studies, extracted the data, and pooled when appropriate and possible. The pooled odd ratios (95% CI) or the average differences (95% CI) were estimated. No intention-to-treat data were available from the studies included.

MAIN RESULTS

Seven of the included studies observed the subjects for a period between 20 to 30 days, one study was of 6 weeks duration, 3 studies used cycles extending over 2 and 3 months and one study observed continuous administration over 3 months. The studies differed in dose, inclusion criteria for subjects, and outcome measures. Results are reported for the domains of attention, memory testing, behavioural rating scales, global clinical impression and tolerability. There is no significant evidence of a beneficial effect of CDP-choline on attention. There are modest, but statistically significant, beneficial effects of CDP-choline on memory function and behaviour. For the outcome of clinical global impression, the odds ratio for improvement in the subjects treated with CDP-choline as opposed to the subjects treated with placebo is 8.89 [5.19 to 15.22]. The drug is well tolerated.

REVIEWER'S CONCLUSIONS: There is some evidence that CDP-choline has a positive effect on memory and behaviour in at least the short term. The evidence of benefit from global impression is stronger, but is still limited by the duration of the studies. There is evidence that the effect of treatment is more homogeneous for patients with cognitive impairment secondary to cerebrovascular disorder. Further studies with a more appropriate length of treatment are recommended owing to the chronic and irreversible nature of the disorders for which this treatment is indicated.

摘要

背景

胞磷胆碱在治疗脑血管性疾病方面有广泛应用,但并非仅此用途。多年来其使用在剂量、给药方法以及接受治疗的患者选择方面都有所演变。临床研究的设计,包括观察时长、疾病严重程度以及结果评估方法也各不相同。尽管其疗效存在不确定性,但在欧洲大陆的几个国家,胞磷胆碱常用于治疗认知障碍,尤其是当临床表现主要为脑血管疾病时。

目的

评估胞磷胆碱(胞苷二磷酸胆碱)治疗老年人慢性脑部疾病相关的认知、情感和行为缺陷的疗效。

检索策略

2000年7月,在疾病控制和信息小组(CDCIG)试验注册库及其他数据库中检索所有相关的非动物随机对照试验,检索词为胞磷胆碱/CDP、西地胆碱、胞苷二磷酸胆碱和二磷酸胆碱。综述作者独立检索了心理文摘数据库(1974 - 1996年)、精神病学数据库(1980 - 1996年)和医学索引数据库(MEDLINE)。综述作者还联系了胞磷胆碱的制造商。

入选标准

所有关于胞磷胆碱治疗慢性脑部疾病所致认知障碍患者的相关、非动物、无混杂因素、双盲、安慰剂对照、随机试验均考虑纳入本综述。

数据收集与分析

两位综述作者独立审查纳入的研究,提取数据,并在适当且可能的情况下进行汇总。估计汇总的比值比(95%置信区间)或平均差异(95%置信区间)。纳入的研究均未提供意向性治疗数据。

主要结果

纳入的7项研究对受试者观察了20至30天,1项研究为期6周,3项研究采用了持续2至3个月的周期,1项研究观察了3个月的持续给药情况。这些研究在剂量、受试者纳入标准和结局测量方面存在差异。报告了注意力、记忆测试、行为评定量表、整体临床印象和耐受性等方面的结果。没有显著证据表明胞磷胆碱对注意力有有益作用。胞磷胆碱对记忆功能和行为有适度但具有统计学意义的有益作用。对于临床整体印象的结果,接受胞磷胆碱治疗的受试者与接受安慰剂治疗的受试者相比,改善的比值比为8.89[5.19至15.22]。该药物耐受性良好。

综述作者结论

有一些证据表明胞磷胆碱至少在短期内对记忆和行为有积极作用。来自整体印象的获益证据更强,但仍受研究时长的限制。有证据表明,对于脑血管疾病继发认知障碍的患者,治疗效果更具同质性。鉴于该治疗所针对疾病的慢性和不可逆性质,建议进行治疗时长更合适的进一步研究。

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