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用于治疗阿尔茨海默病的中药:随机对照试验的荟萃分析

Chinese Medicine for Alzheimer's Disease: A Meta-Analysis of Randomized Controlled Trials.

作者信息

Ma Hang-Kun, Liu Yue, Li Bo, Zhang Ying, Sun Lin-Juan, Xu Feng-Qin

机构信息

Geriatric Institution, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.

Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.

出版信息

Chin J Integr Med. 2018 Dec;24(12):938-943. doi: 10.1007/s11655-018-2567-4. Epub 2018 Sep 22.

Abstract

OBJECTIVE

To evaluate the effificacy of oral Chinese medicine (CM) in comparison with donepezil, a cholinesterase inhibitor (ChEI), for the treatment of Alzheimer's disease (AD).

METHODS

Randomized controlled trials (RCTs) have been searched, and the effect of CM compared with donepezil in AD has been investigated. An electronic search of MEDLINE, Excerpta Medica Database (EMBASE), Cochrane Library, Chinese Biological Medicine Database (CBMdisc), and China National Knowledge Infrastructure (CNKI) to identify articles in English and Chinese from the inception of the database until October 18, 2015. A modifified Jadad score (7-points) to judge the methodological quality of studies, comprehensive meta-analysis was performed with Cochrane Collaboration Revman 5.3. Dichotomous data were analyzed by relative risk (RR) with a 95% confifidence interval (CI), while continuous variables were analyzed by using mean differences (MD) with 95% CI for effect size.

RESULTS

Six studies involving 596 AD patients through Jadad assessment with low bias were included in the meta-analysis. No signifificant difference was observed in cognitive improvement and daily abilities of patients using the Mini Mental State Examination (MMSE) (MD: 0.69, 95% CI:-0.17 to 1.56) and Activities of Daily Living (ADL) scale (MD: 0.94, 95% CI:-1.54 to 3.43). There were no signifificant differences in status of illness or MD for mild-moderate AD patients at 24 weeks (MD: 0.62, 95% CI:-2.99 to 4.23) and 48 weeks (MD:-0.73, 95% CI:-5.02 to 3.56). Severe AD patients were also assessed at 24 weeks (MD: 3.13, 95% CI:-6.92 to 13.18) and 48 weeks (MD: 4.23, 95% CI:-6.38 to 14.84). Furthermore, compared with donepezil, Xin (Heart)-regulating CM and Shen (Kidney)-tonifying groups were observed (MD:-1.50, 95% CI:-3.08 to 0.08; MD:-1.92, 95% CI:-3.50 to-0.33; respectively). CM had fewer side effects in AD patients.

CONCLUSION

Compared with donepezil, oral CM showed no signifificant difference in effectiveness in AD patients, and more evidence is needed to verify the fifindings.

摘要

目的

评估口服中药与胆碱酯酶抑制剂多奈哌齐相比治疗阿尔茨海默病(AD)的疗效。

方法

检索随机对照试验(RCT),研究中药与多奈哌齐治疗AD的效果。通过电子检索MEDLINE、医学文摘数据库(EMBASE)、考克兰图书馆、中国生物医学数据库(CBMdisc)和中国知网(CNKI),以识别从各数据库建库至2015年10月18日期间的中英文文章。采用改良的Jadad评分(7分)判断研究的方法学质量,使用考克兰协作网的Revman 5.3软件进行综合荟萃分析。二分数据采用相对危险度(RR)及95%置信区间(CI)进行分析,连续变量采用效应量的均数差(MD)及95%CI进行分析。

结果

六项研究纳入荟萃分析,共596例AD患者,经Jadad评估偏倚较低。使用简易精神状态检查表(MMSE)(MD:0.69,95%CI:-0.17至1.56)和日常生活活动能力(ADL)量表(MD:0.94,95%CI:-1.54至3.43)评估,患者的认知改善和日常能力方面未观察到显著差异。轻度至中度AD患者在24周(MD:0.62,95%CI:-2.99至4.23)和48周(MD:-0.73,95%CI:-5.02至3.56)时的病情状态或MD无显著差异。重度AD患者在24周(MD:3.13,95%CI:-6.92至13.18)和48周(MD:4.23,95%CI:-6.38至14.84)时也进行了评估。此外,与多奈哌齐相比,观察到调心类中药组和补肾类中药组(分别为MD:-1.50,95%CI:-3.08至0.08;MD:-1.92,95%CI:-3.50至-0.33)。中药治疗AD患者的副作用较少。

结论

与多奈哌齐相比,口服中药在AD患者中的疗效无显著差异,需要更多证据来验证该结果。

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