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

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. 丁苯酞聯合神經節苷酯對老年缺血性腦血管病患者PAL及NDS評分的影響. 中國老年學雜志, 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.	翟鍇華, 劉伯語, 盧宏. 丁基苯酞對血管性癡呆大鼠的保護作用. 中國現代醫藥雜志, 2010, 12(11): 9-11.
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11.	田金洲. 中國癡呆診療指南. 北京: 人民衛生出版社, 2018.
12.	王彥闊, 孫麗萍, 張敏. 丁苯酞軟膠囊聯合多奈哌齊治療血管性癡呆臨床療效觀察. 腦與神經疾病雜志, 2010, 18(5): 387-390.
13.	高春燕. 恩必普聯合金納多治療血管性癡呆療效觀察. 中國誤診學雜志, 2011, 11(29): 7117-7117.
14.	潘蓉蓉, 周龍壽, 朱文宗, 等. 美金剛聯合丁苯酞治療血管性癡呆臨床療效觀察. 溫州醫科大學學報, 2014, 44(10): 756-758.
15.	何秀貞, 陸奕彬. 老年血管性癡呆患者使用丁苯酞治療的效果及藥物對精神心理量表的影響. 海峽藥學, 2016, 28(2): 181-183.
16.	韓征宇, 李光來. 丁苯酞對血管性認知障礙患者認知功能的改善作用. 臨床醫藥實踐, 2016, 25(2): 91-92.
17.	胡浩. 丁苯酞軟膠囊對改善血管性癡呆患者認知功能的療效及作用機制分析. 中國實用神經疾病雜志, 2017, 20(1): 98-99.
18.	王旭輝. 丁苯酞軟膠囊聯合多奈哌齊治療血管性癡呆的臨床觀察. 中國藥物與臨床, 2014, 14(12): 1703-1704.
19.	龍翠英, 鄭春玲, 王明科, 等. 丁苯酞軟膠囊治療輕中度血管性癡呆臨床療效觀察. 中國實用神經疾病雜志, 2012, 15(17): 27-28.
20.	劉小麗. 丁苯酞軟膠囊治療輕中度血管性癡呆臨床療效觀察. 吉林醫學, 2015, 36(12): 2572-2573.
21.	阮世旺. 丁苯酞治療老年血管性癡呆的臨床療效觀察. 中國實用神經疾病雜志, 2017, 20(6): 111-113.
22.	宋紅. 丁苯酞治療老年血管性癡呆的臨床療效及對精神心理量表的影響. 中國醫學創新, 2014, 11(35): 36-38.
23.	徐豐, 王愛華, 劉澤晶, 等. 丁苯酞治療血管性癡呆的臨床療效觀察. 中國現代藥物應用, 2015, 9(5): 120-121.
24.	劉順達, 高娟, 高陽, 等. 多奈派齊聯合丁苯酞對提高血管性癡呆患者認知功能及生活能力的效果分析. 吉林醫學, 2017, 38(9): 1670-1671.
25.	陳偉平, 徐書雯, 羅姝旖, 等. 恩必普對血管性癡呆治療的評價. 廣東省醫師協會第三屆神經內科醫師大會, 2013.
26.	喬宇. 血管性癡呆患者應用丁苯酞治療的臨床效果及作用機制. 中國藥物經濟學, 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. 丁苯酞聯合神經節苷酯對老年缺血性腦血管病患者PAL及NDS評分的影響. 中國老年學雜志, 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. 翟鍇華, 劉伯語, 盧宏. 丁基苯酞對血管性癡呆大鼠的保護作用. 中國現代醫藥雜志, 2010, 12(11): 9-11.
10. 廖艷彪. 丁基苯酞對血管性癡呆的認知功能的影響. 醫學綜述, 2014, 20(18): 3343-3345.
11. 田金洲. 中國癡呆診療指南. 北京: 人民衛生出版社, 2018.
12. 王彥闊, 孫麗萍, 張敏. 丁苯酞軟膠囊聯合多奈哌齊治療血管性癡呆臨床療效觀察. 腦與神經疾病雜志, 2010, 18(5): 387-390.
13. 高春燕. 恩必普聯合金納多治療血管性癡呆療效觀察. 中國誤診學雜志, 2011, 11(29): 7117-7117.
14. 潘蓉蓉, 周龍壽, 朱文宗, 等. 美金剛聯合丁苯酞治療血管性癡呆臨床療效觀察. 溫州醫科大學學報, 2014, 44(10): 756-758.
15. 何秀貞, 陸奕彬. 老年血管性癡呆患者使用丁苯酞治療的效果及藥物對精神心理量表的影響. 海峽藥學, 2016, 28(2): 181-183.
16. 韓征宇, 李光來. 丁苯酞對血管性認知障礙患者認知功能的改善作用. 臨床醫藥實踐, 2016, 25(2): 91-92.
17. 胡浩. 丁苯酞軟膠囊對改善血管性癡呆患者認知功能的療效及作用機制分析. 中國實用神經疾病雜志, 2017, 20(1): 98-99.
18. 王旭輝. 丁苯酞軟膠囊聯合多奈哌齊治療血管性癡呆的臨床觀察. 中國藥物與臨床, 2014, 14(12): 1703-1704.
19. 龍翠英, 鄭春玲, 王明科, 等. 丁苯酞軟膠囊治療輕中度血管性癡呆臨床療效觀察. 中國實用神經疾病雜志, 2012, 15(17): 27-28.
20. 劉小麗. 丁苯酞軟膠囊治療輕中度血管性癡呆臨床療效觀察. 吉林醫學, 2015, 36(12): 2572-2573.
21. 阮世旺. 丁苯酞治療老年血管性癡呆的臨床療效觀察. 中國實用神經疾病雜志, 2017, 20(6): 111-113.
22. 宋紅. 丁苯酞治療老年血管性癡呆的臨床療效及對精神心理量表的影響. 中國醫學創新, 2014, 11(35): 36-38.
23. 徐豐, 王愛華, 劉澤晶, 等. 丁苯酞治療血管性癡呆的臨床療效觀察. 中國現代藥物應用, 2015, 9(5): 120-121.
24. 劉順達, 高娟, 高陽, 等. 多奈派齊聯合丁苯酞對提高血管性癡呆患者認知功能及生活能力的效果分析. 吉林醫學, 2017, 38(9): 1670-1671.
25. 陳偉平, 徐書雯, 羅姝旖, 等. 恩必普對血管性癡呆治療的評價. 廣東省醫師協會第三屆神經內科醫師大會, 2013.
26. 喬宇. 血管性癡呆患者應用丁苯酞治療的臨床效果及作用機制. 中國藥物經濟學, 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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