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

Video：

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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. 中国痴呆诊疗指南 (2017 年版). 北京: 人民卫生出版社, 2018.
3. 熊杰, 冯亦璞. 丁基苯酞对局灶性脑缺血过程中线粒体损伤的保护作用. 药学学报, 2000, 35(6): 408-412.
4. 侯德仁, 薛俐, 陈坤, 等. 丁苯酞对阿尔茨海默病模型大鼠海马 GFAP 和 VEGF 的影响. 中南大学学报 (医学版), 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. 吴盛各, 李阳, 魏文峰, 等. 丁苯酞联合美金刚治疗阿尔茨海默病精神行为异常的临床研究. 西南国防医药, 2013, 23(6): 619-621.
7. 时婧, 左瑞菊, 王占强. 丁苯酞联合多奈哌齐对阿尔茨海默病患者认知功能及脑血管储备功能的影响. 临床误诊误治, 2018, 31(7): 98-102.
8. 林昭敏, 邱桂梅, 吴静, 等. 丁苯酞联合多奈哌齐治疗阿尔茨海默病的临床疗效. 临床合理用药杂志, 2017, 10(12): 28-30.
9. 李胜利, 李银银. 丁苯酞联合美金刚治疗阿尔茨海默病的疗效及对患者认知功能的影响. 现代诊断与治疗, 2018, 29(8): 1254-1256.
10. 陆守荣, 温浩, 宋惠珠, 等. 丁苯酞软胶囊联合多奈哌齐片治疗阿尔茨海默病的临床研究. 中国临床药理学杂志, 2016, 32(22): 2042-2045.
11. 齐凡星, 胡莹, 卢军栋, 等. 丁苯酞治疗阿尔茨海默病的临床观察. 中国药房, 2016, 27(17): 2412-2414.
12. 甄娜, 王红梅, 朱建国. 丁苯酞软胶囊联合银杏叶提取物治疗阿尔茨海默病的疗效研究. 医学临床研究, 2017, 34(4): 822-824.
13. 孙国兵, 付斌, 谭倩, 等. 丁苯酞联合多奈哌齐对阿尔茨海默病患者认知功能及脑血管储备功能的影响. 疑难病杂志, 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 病神经元凋亡的 Aβ 级联假说. 中原医刊, 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, 唐迪莹, 李欣欣, 等. β 淀粉样蛋白及 tau 蛋白相关机制在阿尔茨海默病中的研究进展. 中国老年学杂志, 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. 吕志迈, 徐运. 脑血管储备与阿尔茨海默病. 中国卒中杂志, 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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