Efficacy and safety of butylphthalide soft capsule in the treatment of vascular dementia: a meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

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

Neurology Centre/The Third Department of Brain Disorders, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, P.R.China;

Corresponding author：

TIAN Jinzhou, Email: jztian@hotmail.com

Keywords：

Vascular dementia; Butylphthalide soft capsule; Meta-analysis; Randomized controlled trial

DOI：

10.7507/1672-2531.201907060

Video：

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Objectives To systematically evaluate the efficacy and safety of butylphthalide soft capsule in the treatment of vascular dementia (VaD).Methods Databases including CNKI, WanFang Data, VIP, CBM, PubMed, EMbase, The Cochrane Library were electronically searched to collect randomized controlled trials of butylphthalide soft capsule in the treatment of vascular dementia published from September 2002 to July 2018. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.3 software.Results A total of 15 studies involving 1 149 patients were included. The butylphthalide soft capsule treatment group included 578 patients and the control group included 571 patients. The results of meta-analysis showed that compared with the control group (donepezil hydrochloride tablets or memantine hydrochloride tablets or EGb761 or negative control), the butylphthalide soft capsule treatment group improved the MMSE score of patients with VaD (MD=3.52, 95%CI 2.59 to 4.46, P<0.01), CDR score (MD=−0.72, 95%CI −0.80 to −0.65, P<0.01), and treatment efficiency (RR=1.31, 95%CI 1.20 to 1.43, P<0.01). However, there was no statistical difference in the number of adverse reactions between the treatment and control groups.Conclusions Butylphthalide soft capsule can be used in the treatment of patients with mild to moderate VaD. It can improve the cognitive function, raking of clinical dementia, and increase the effect rate of treatment. It can also work in conjunction with other drugs that improve cognitive function and no increase in adverse reactions has been found. However, due to the low quality of the included studies and small sample size, the actual efficacy strength is uncertain and the above conclusions are still required to be verified by more high-quality randomized controlled trials.

Citation： CAO Tianyu, TENG Yuou, YAO Xuan, SHI Jing, NI Jingnian, TIAN Jinzhou. Efficacy and safety of butylphthalide soft capsule in the treatment of vascular dementia: a meta-analysis. Chinese Journal of Evidence-Based Medicine, 2020, 20(4): 444-452. doi: 10.7507/1672-2531.201907060 Copy

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2.	Alzheimer’s Association. 2015 Alzheimer's disease facts and figures. Alzheimers Dement, 2015, 11(3): 332-384.
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4.	Chui H. Vascular dementia, a new beginning: shifting focus from clinical phenotype to ischemic brain injury. Neurol Clin, 2000, 18(4): 951-978.
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14.	潘蓉蓉, 周龙寿, 朱文宗, 等. 美金刚联合丁苯酞治疗血管性痴呆临床疗效观察. 温州医科大学学报, 2014, 44(10): 756-758.
15.	何秀贞, 陆奕彬. 老年血管性痴呆患者使用丁苯酞治疗的效果及药物对精神心理量表的影响. 海峡药学, 2016, 28(2): 181-183.
16.	韩征宇, 李光来. 丁苯酞对血管性认知障碍患者认知功能的改善作用. 临床医药实践, 2016, 25(2): 91-92.
17.	胡浩. 丁苯酞软胶囊对改善血管性痴呆患者认知功能的疗效及作用机制分析. 中国实用神经疾病杂志, 2017, 20(1): 98-99.
18.	王旭辉. 丁苯酞软胶囊联合多奈哌齐治疗血管性痴呆的临床观察. 中国药物与临床, 2014, 14(12): 1703-1704.
19.	龙翠英, 郑春玲, 王明科, 等. 丁苯酞软胶囊治疗轻中度血管性痴呆临床疗效观察. 中国实用神经疾病杂志, 2012, 15(17): 27-28.
20.	刘小丽. 丁苯酞软胶囊治疗轻中度血管性痴呆临床疗效观察. 吉林医学, 2015, 36(12): 2572-2573.
21.	阮世旺. 丁苯酞治疗老年血管性痴呆的临床疗效观察. 中国实用神经疾病杂志, 2017, 20(6): 111-113.
22.	宋红. 丁苯酞治疗老年血管性痴呆的临床疗效及对精神心理量表的影响. 中国医学创新, 2014, 11(35): 36-38.
23.	徐丰, 王爱华, 刘泽晶, 等. 丁苯酞治疗血管性痴呆的临床疗效观察. 中国现代药物应用, 2015, 9(5): 120-121.
24.	刘顺达, 高娟, 高阳, 等. 多奈派齐联合丁苯酞对提高血管性痴呆患者认知功能及生活能力的效果分析. 吉林医学, 2017, 38(9): 1670-1671.
25.	陈伟平, 徐书雯, 罗姝旖, 等. 恩必普对血管性痴呆治疗的评价. 广东省医师协会第三届神经内科医师大会, 2013.
26.	乔宇. 血管性痴呆患者应用丁苯酞治疗的临床效果及作用机制. 中国药物经济学, 2016, 11(11): 66-68.
27.	Back DB, Kwon KJ, Choi DH, et al. Chronic cerebral hypoperfusion induces post-stroke dementia following acute ischemic stroke in rats. J Neuroinflammation, 2017, 14(1): 216.
28.	Du SQ, Wang XR, Xiao LY, et al. Molecular mechanisms of vascular dementia: what can be learned from animal models of chronic cerebral hypoperfusion? Mol Neurobiol, 2017, 54(5): 3670-3682.

1. Kim BJ, Oh MY, Jang MS, et al. Medial temporal atrophy and memory dysfunction in poststroke cognitive impairment-no dementia. J Clin Neurol, 2012, 8(1): 43-50.
2. Alzheimer’s Association. 2015 Alzheimer's disease facts and figures. Alzheimers Dement, 2015, 11(3): 332-384.
3. Leys D, Hénon H, Mackowiak-Cordoliani MA, et al. Poststroke dementia. Lancet Neurol, 2005, 4(11): 752-759.
4. Chui H. Vascular dementia, a new beginning: shifting focus from clinical phenotype to ischemic brain injury. Neurol Clin, 2000, 18(4): 951-978.
5. 郝振. 丁苯酞联合神经节苷酯对老年缺血性脑血管病患者PAL及NDS评分的影响. 中国老年学杂志, 2014, 34(8): 2057-2058.
6. Zhang L, Lü L, Chan WM, et al. Effects of DL-3-n-butylphthalide on vascular dementia and angiogenesis. Neurochem Res, 2012, 37(5): 911-919.
7. Zhao Q, Zhang C, Wang X, et al. (S)-ZJM-289, a nitric oxide-releasing derivative of 3-n-butylphthalide, protects against ischemic neuronal injury by attenuating mitochondrial dysfunction and associated cell death. Neurochem Int, 2012, 60(2): 134-144.
8. Li J, Li Y, Ogle M, et al. DL-3-n-butylphthalide prevents neuronal cell death after focal cerebral ischemia in mice via the JNK pathway. Brain Res, 2010, 1359: 216-226.
9. 翟锴华, 刘伯语, 卢宏. 丁基苯酞对血管性痴呆大鼠的保护作用. 中国现代医药杂志, 2010, 12(11): 9-11.
10. 廖艳彪. 丁基苯酞对血管性痴呆的认知功能的影响. 医学综述, 2014, 20(18): 3343-3345.
11. 田金洲. 中国痴呆诊疗指南. 北京: 人民卫生出版社, 2018.
12. 王彦阔, 孙丽萍, 张敏. 丁苯酞软胶囊联合多奈哌齐治疗血管性痴呆临床疗效观察. 脑与神经疾病杂志, 2010, 18(5): 387-390.
13. 高春燕. 恩必普联合金纳多治疗血管性痴呆疗效观察. 中国误诊学杂志, 2011, 11(29): 7117-7117.
14. 潘蓉蓉, 周龙寿, 朱文宗, 等. 美金刚联合丁苯酞治疗血管性痴呆临床疗效观察. 温州医科大学学报, 2014, 44(10): 756-758.
15. 何秀贞, 陆奕彬. 老年血管性痴呆患者使用丁苯酞治疗的效果及药物对精神心理量表的影响. 海峡药学, 2016, 28(2): 181-183.
16. 韩征宇, 李光来. 丁苯酞对血管性认知障碍患者认知功能的改善作用. 临床医药实践, 2016, 25(2): 91-92.
17. 胡浩. 丁苯酞软胶囊对改善血管性痴呆患者认知功能的疗效及作用机制分析. 中国实用神经疾病杂志, 2017, 20(1): 98-99.
18. 王旭辉. 丁苯酞软胶囊联合多奈哌齐治疗血管性痴呆的临床观察. 中国药物与临床, 2014, 14(12): 1703-1704.
19. 龙翠英, 郑春玲, 王明科, 等. 丁苯酞软胶囊治疗轻中度血管性痴呆临床疗效观察. 中国实用神经疾病杂志, 2012, 15(17): 27-28.
20. 刘小丽. 丁苯酞软胶囊治疗轻中度血管性痴呆临床疗效观察. 吉林医学, 2015, 36(12): 2572-2573.
21. 阮世旺. 丁苯酞治疗老年血管性痴呆的临床疗效观察. 中国实用神经疾病杂志, 2017, 20(6): 111-113.
22. 宋红. 丁苯酞治疗老年血管性痴呆的临床疗效及对精神心理量表的影响. 中国医学创新, 2014, 11(35): 36-38.
23. 徐丰, 王爱华, 刘泽晶, 等. 丁苯酞治疗血管性痴呆的临床疗效观察. 中国现代药物应用, 2015, 9(5): 120-121.
24. 刘顺达, 高娟, 高阳, 等. 多奈派齐联合丁苯酞对提高血管性痴呆患者认知功能及生活能力的效果分析. 吉林医学, 2017, 38(9): 1670-1671.
25. 陈伟平, 徐书雯, 罗姝旖, 等. 恩必普对血管性痴呆治疗的评价. 广东省医师协会第三届神经内科医师大会, 2013.
26. 乔宇. 血管性痴呆患者应用丁苯酞治疗的临床效果及作用机制. 中国药物经济学, 2016, 11(11): 66-68.
27. Back DB, Kwon KJ, Choi DH, et al. Chronic cerebral hypoperfusion induces post-stroke dementia following acute ischemic stroke in rats. J Neuroinflammation, 2017, 14(1): 216.
28. Du SQ, Wang XR, Xiao LY, et al. Molecular mechanisms of vascular dementia: what can be learned from animal models of chronic cerebral hypoperfusion? Mol Neurobiol, 2017, 54(5): 3670-3682.

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Efficacy and safety of butylphthalide soft capsule in the treatment of vascular dementia: a meta-analysis

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