Efficacy and safety of butylphthalide soft capsule in the treatment of Alzheimer’s disease: a meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

TENG Yuou , SHI Jing , CAO Tianyu , YAO Xuan , NI Jingnian ,  TIAN Jinzhou

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, P.R.China;

Corresponding?author：

TIAN Jinzhou, Email: jztian@hotmail.com

Keywords：

Alzheimer’s disease; Butylphthalide soft capsule; Meta-analysis; Randomized controlled trial

DOI：

10.7507/1672-2531.201904115

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Objectives To systematically review the efficacy and safety of butylphthalide soft capsule with routine treatment for Alzheimer’s disease (AD).Methods Databases including CNKI, WanFang Data, VIP, CBM, PubMed, EMbase, and The Cochrane Library were electronically searched from September 2002 to July 2018 to collect randomized controlled trials of butylphthalide soft capsule with routine treatment for Alzheimer’s disease. The trial was screened based on inclusion and exclusion criteria, and the methodological quality of the included trial was assessed. Meta-analysis was then performed by Revman 5.3 software.Results A total of 8 studies involving 576 patients were included. The butylphthalide soft capsule group included 283 patients and the control group included 293 patients. The result of meta-analysis showed that butylphthalide soft capsule with routine treatment (Donepezil hydrochloride or Memantine or EGb761) significantly improved the score of mini-mental state examination (MMSE) (MD=3.19, 95% CI 2.69 to 3.69, P<0.001) and clinical efficacy (RR=1.36, 95%CI 1.21 to 1.53, P<0.001). There was no significant difference in number of adverse events between the butylphthalide group and the control group (RR=1.13, 95%CI 0.77 to 1.67, P=0.52).Conclusions Based on the routine treatment, combining with butylphthalide soft capsule can further facilitate cognitive function of AD and improve clinical efficacy. At the same time, no increase in adverse reactions has been found. However, due to the low quality of the included studies, more high quality randomized controlled trials are required to verify the results.

Citation： TENG Yuou, SHI Jing, CAO Tianyu, YAO Xuan, NI Jingnian, TIAN Jinzhou. Efficacy and safety of butylphthalide soft capsule in the treatment of Alzheimer’s disease: a meta-analysis. Chinese Journal of Evidence-Based Medicine, 2019, 19(12): 1446-1452. doi: 10.7507/1672-2531.201904115 Copy

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1. Alzheimer’s Disease International. World Alzheimer Report 2015. Available at: http://www.worldalzreport2015.org.
2. 田金洲. 中國癡呆診療指南 (2017 年版). 北京: 人民衛生出版社, 2018.
3. 熊杰, 馮亦璞. 丁基苯酞對局灶性腦缺血過程中線粒體損傷的保護作用. 藥學學報, 2000, 35(6): 408-412.
4. 侯德仁, 薛俐, 陳坤, 等. 丁苯酞對阿爾茨海默病模型大鼠海馬 GFAP 和 VEGF 的影響. 中南大學學報 (醫學版), 2010, 35(2): 111-115.
5. Peng Y, Xing C, Lemere CA, et al. l-3-n-Butylphthalide ameliorates beta-amyloid-induced neuronal toxicity in cultured neuronal cells. Neurosci Lett, 2008, 434(2): 224-229.
6. 吳盛各, 李陽, 魏文峰, 等. 丁苯酞聯合美金剛治療阿爾茨海默病精神行為異常的臨床研究. 西南國防醫藥, 2013, 23(6): 619-621.
7. 時婧, 左瑞菊, 王占強. 丁苯酞聯合多奈哌齊對阿爾茨海默病患者認知功能及腦血管儲備功能的影響. 臨床誤診誤治, 2018, 31(7): 98-102.
8. 林昭敏, 邱桂梅, 吳靜, 等. 丁苯酞聯合多奈哌齊治療阿爾茨海默病的臨床療效. 臨床合理用藥雜志, 2017, 10(12): 28-30.
9. 李勝利, 李銀銀. 丁苯酞聯合美金剛治療阿爾茨海默病的療效及對患者認知功能的影響. 現代診斷與治療, 2018, 29(8): 1254-1256.
10. 陸守榮, 溫浩, 宋惠珠, 等. 丁苯酞軟膠囊聯合多奈哌齊片治療阿爾茨海默病的臨床研究. 中國臨床藥理學雜志, 2016, 32(22): 2042-2045.
11. 齊凡星, 胡瑩, 盧軍棟, 等. 丁苯酞治療阿爾茨海默病的臨床觀察. 中國藥房, 2016, 27(17): 2412-2414.
12. 甄娜, 王紅梅, 朱建國. 丁苯酞軟膠囊聯合銀杏葉提取物治療阿爾茨海默病的療效研究. 醫學臨床研究, 2017, 34(4): 822-824.
13. 孫國兵, 付斌, 譚倩, 等. 丁苯酞聯合多奈哌齊對阿爾茨海默病患者認知功能及腦血管儲備功能的影響. 疑難病雜志, 2018, 17(8): 781-785.
14. Busciglio J, Lorenzo A, Yeh J, et al. Beta-amyloid fibrils induce tau phosphorylation and loss of microtubule binding. Neuron, 1995, 14(4): 879-888.
15. Li H, Jia J, Yang Z. Mini-mental state examination in elderly Chinese: a population-based normative study. J Alzheimers Dis, 2016, 53(2): 487-96.
16. Jana A, Pahan K. Fibrillar amyloid-beta peptides kill human primary neurons via NADPH oxidase-mediated activation of neutral sphingomyelinase. Implications for Alzheimer’s disease. J Biol Chem, 2004, 279(49): 51451-51459.
17. 宋秋杰, 李林. Alzheimer 病神經元凋亡的 Aβ 級聯假說. 中原醫刊, 2005, 32(7): 26-28.
18. Golde TE, Petrucelli L, Lewis J. Targeting Abeta and tau in Alzheimer’s disease, an early interim report. Exp Neurol, 2010, 223(2): 252-266.
19. 王蒙, 唐迪瑩, 李欣欣, 等. β 淀粉樣蛋白及 tau 蛋白相關機制在阿爾茨海默病中的研究進展. 中國老年學雜志, 2017, 37(12): 3101-3103.
20. Coyle JT, Price DL, DeLong MR. Alzheimer’s disease: a disorder of cortical cholinergic innervation. Science, 1983, 219(4589): 1184-1190.
21. Birks JS. Cholinestrerase inhibitors for Alzheimer’s disease. Cochrane Datebase Syst Rev, 2006, (1): CD005593.
22. Ohta Y, Darwish M, Hishikawa N, et al. Therapeutic effects of drug switching between acetylcholinesterase inhibitors in patients with Alzheimer’s disease. Geriatr Gerontol Int, 2017, 17(11): 1843-1848.
23. 呂志邁, 徐運. 腦血管儲備與阿爾茨海默病. 中國卒中雜志, 2007, 2(8): 679-683.
24. Li J, Li Y, Ogle M, et al. DL3-n-butylphthalide prevents neuronal cell death after focal cerebral ischemia in mice via the JNK pathway. Brain Res, 2010, 1359: 216-226.
25. Hong LS, Scott WA, Ilya L, et al. A novel approach to delayed-start analyses for demonstrating disease-modifying effects in Alzheimer’s disease. PLoS One, 2015, 10(3): e0119632.
26. Howard R, Phillips P, Johnson T, et al. Determining the minimum clinically important differences for outcomes in the DOMINO trial. Int J Geriatr Psychiatry, 2011, 26(8): 812-817.

Chinese Journal of Evidence-Based Medicine

Efficacy and safety of butylphthalide soft capsule in the treatment of Alzheimer’s disease: a meta-analysis

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