Effect of DL-3-n-Butylphthalide on Cerebral Hypoperfusion Due to Atherosclerotic Stenosis: A Multicenter, Double-Blind, Randomized Controlled, Preliminary Trial.
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| Title: | Effect of DL-3-n-Butylphthalide on Cerebral Hypoperfusion Due to Atherosclerotic Stenosis: A Multicenter, Double-Blind, Randomized Controlled, Preliminary Trial. |
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| Authors: | Chen, Dawei (AUTHOR), Chang, Xinxin (AUTHOR), Pan, Bei (AUTHOR), Li, Yumeng (AUTHOR), Qiu, Feng (AUTHOR), Tang, Yonghong (AUTHOR), Gao, Xiaoping (AUTHOR), Yin, Yanwei (AUTHOR), Yang, Fen (AUTHOR), Wang, Yu (AUTHOR), Zhang, Jiang (AUTHOR), Wang, Minghua (AUTHOR), Zhu, Zhengyu (AUTHOR), Guo, Yanping (AUTHOR), Sun, Degang (AUTHOR), Tian, Wensheng (AUTHOR), Yu, Hui (AUTHOR), Wei, Yafen (AUTHOR), Yu, Yadong (AUTHOR), Zhao, Yi (AUTHOR) |
| Source: | CNS Drugs. Jul2026, Vol. 40 Issue 7, p997-1009. 13p. |
| Subjects: | Cerebral circulation, Internal carotid artery, Atherosclerotic plaque, Drugs, Collateral circulation, Randomized controlled trials, Cerebral ischemia |
| Abstract: | Background: Augmentation of collateral circulation is an alternative method to improve cerebral hypoperfusion when revascularization is not suitable. DL-3-n-butylphthalide (NBP) has been shown to enhance cerebral collateral circulation and improve cerebral blood flow (CBF) in previous studies. The objective of this study was to explore the effect of NBP on cerebral hemodynamic impairment due to atherosclerotic stenosis in internal carotid system. Methods: This was a double-blind, placebo-controlled, randomized clinical trial conducted in 38 Chinese hospitals between 14 January 2022, and 11 April 2024. Eligible participants were aged 35–85 years with ≥ 70% stenosis in unilateral internal carotid artery or middle cerebral artery, accompanied by cerebral hypoperfusion and no recent cerebral ischemic events. The patients were randomly assigned in a 1:1 ratio to a treatment group receiving 600 mg NBP daily or a placebo group receiving an ineffective dose of NBP daily for 4 weeks. The cerebral perfusion was assessed by computed tomography perfusion. The grades of cerebral perfusion change from baseline to 12 weeks were classified into amelioration, stabilization, and deterioration. The primary efficacy outcome was the percentage of patients achieving CBF amelioration. Results: Of 485 enrolled patients (median age 63 years, 66.6% men), 244 were assigned to the NBP group and 241 to the placebo group. At the end of follow-up, 204 in the NBP group and 212 in the placebo group completed second cerebral perfusion. NBP group had 113 (55.4%) patients with CBF amelioration in stenotic territory and placebo group had 93 (43.9%) comparable patients at 12 weeks (risk ratio 1.32; 95% confidence interval 1.08–1.61; p = 0.006). Conclusions: For cerebral hypoperfusion from atherosclerotic stenosis in internal carotid system, NBP treatment resulted in a higher proportion of patients achieving CBF amelioration than placebo. Trial Registration: chictr.org.cn: ChiCTR2100053112. [ABSTRACT FROM AUTHOR] |
| Copyright of CNS Drugs is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
| FullText | Text: Availability: 0 |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 194868132 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Effect of DL-3-n-Butylphthalide on Cerebral Hypoperfusion Due to Atherosclerotic Stenosis: A Multicenter, Double-Blind, Randomized Controlled, Preliminary Trial. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Chen%2C+Dawei%22">Chen, Dawei</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Chang%2C+Xinxin%22">Chang, Xinxin</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pan%2C+Bei%22">Pan, Bei</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Li%2C+Yumeng%22">Li, Yumeng</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Qiu%2C+Feng%22">Qiu, Feng</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Tang%2C+Yonghong%22">Tang, Yonghong</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gao%2C+Xiaoping%22">Gao, Xiaoping</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Yin%2C+Yanwei%22">Yin, Yanwei</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Yang%2C+Fen%22">Yang, Fen</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wang%2C+Yu%22">Wang, Yu</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Zhang%2C+Jiang%22">Zhang, Jiang</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wang%2C+Minghua%22">Wang, Minghua</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Zhu%2C+Zhengyu%22">Zhu, Zhengyu</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Guo%2C+Yanping%22">Guo, Yanping</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Sun%2C+Degang%22">Sun, Degang</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Tian%2C+Wensheng%22">Tian, Wensheng</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Yu%2C+Hui%22">Yu, Hui</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wei%2C+Yafen%22">Wei, Yafen</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Yu%2C+Yadong%22">Yu, Yadong</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Zhao%2C+Yi%22">Zhao, Yi</searchLink> (AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22CNS+Drugs%22">CNS Drugs</searchLink>. Jul2026, Vol. 40 Issue 7, p997-1009. 13p. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Cerebral+circulation%22">Cerebral circulation</searchLink><br /><searchLink fieldCode="DE" term="%22Internal+carotid+artery%22">Internal carotid artery</searchLink><br /><searchLink fieldCode="DE" term="%22Atherosclerotic+plaque%22">Atherosclerotic plaque</searchLink><br /><searchLink fieldCode="DE" term="%22Drugs%22">Drugs</searchLink><br /><searchLink fieldCode="DE" term="%22Collateral+circulation%22">Collateral circulation</searchLink><br /><searchLink fieldCode="DE" term="%22Randomized+controlled+trials%22">Randomized controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22Cerebral+ischemia%22">Cerebral ischemia</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Background: Augmentation of collateral circulation is an alternative method to improve cerebral hypoperfusion when revascularization is not suitable. DL-3-n-butylphthalide (NBP) has been shown to enhance cerebral collateral circulation and improve cerebral blood flow (CBF) in previous studies. The objective of this study was to explore the effect of NBP on cerebral hemodynamic impairment due to atherosclerotic stenosis in internal carotid system. Methods: This was a double-blind, placebo-controlled, randomized clinical trial conducted in 38 Chinese hospitals between 14 January 2022, and 11 April 2024. Eligible participants were aged 35–85 years with ≥ 70% stenosis in unilateral internal carotid artery or middle cerebral artery, accompanied by cerebral hypoperfusion and no recent cerebral ischemic events. The patients were randomly assigned in a 1:1 ratio to a treatment group receiving 600 mg NBP daily or a placebo group receiving an ineffective dose of NBP daily for 4 weeks. The cerebral perfusion was assessed by computed tomography perfusion. The grades of cerebral perfusion change from baseline to 12 weeks were classified into amelioration, stabilization, and deterioration. The primary efficacy outcome was the percentage of patients achieving CBF amelioration. Results: Of 485 enrolled patients (median age 63 years, 66.6% men), 244 were assigned to the NBP group and 241 to the placebo group. At the end of follow-up, 204 in the NBP group and 212 in the placebo group completed second cerebral perfusion. NBP group had 113 (55.4%) patients with CBF amelioration in stenotic territory and placebo group had 93 (43.9%) comparable patients at 12 weeks (risk ratio 1.32; 95% confidence interval 1.08–1.61; p = 0.006). Conclusions: For cerebral hypoperfusion from atherosclerotic stenosis in internal carotid system, NBP treatment resulted in a higher proportion of patients achieving CBF amelioration than placebo. Trial Registration: chictr.org.cn: ChiCTR2100053112. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of CNS Drugs is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1007/s40263-026-01293-w Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 13 StartPage: 997 Subjects: – SubjectFull: Cerebral circulation Type: general – SubjectFull: Internal carotid artery Type: general – SubjectFull: Atherosclerotic plaque Type: general – SubjectFull: Drugs Type: general – SubjectFull: Collateral circulation Type: general – SubjectFull: Randomized controlled trials Type: general – SubjectFull: Cerebral ischemia Type: general Titles: – TitleFull: Effect of DL-3-n-Butylphthalide on Cerebral Hypoperfusion Due to Atherosclerotic Stenosis: A Multicenter, Double-Blind, Randomized Controlled, Preliminary Trial. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Chen, Dawei – PersonEntity: Name: NameFull: Chang, Xinxin – PersonEntity: Name: NameFull: Pan, Bei – PersonEntity: Name: NameFull: Li, Yumeng – PersonEntity: Name: NameFull: Qiu, Feng – PersonEntity: Name: NameFull: Tang, Yonghong – PersonEntity: Name: NameFull: Gao, Xiaoping – PersonEntity: Name: NameFull: Yin, Yanwei – PersonEntity: Name: NameFull: Yang, Fen – PersonEntity: Name: NameFull: Wang, Yu – PersonEntity: Name: NameFull: Zhang, Jiang – PersonEntity: Name: NameFull: Wang, Minghua – PersonEntity: Name: NameFull: Zhu, Zhengyu – PersonEntity: Name: NameFull: Guo, Yanping – PersonEntity: Name: NameFull: Sun, Degang – PersonEntity: Name: NameFull: Tian, Wensheng – PersonEntity: Name: NameFull: Yu, Hui – PersonEntity: Name: NameFull: Wei, Yafen – PersonEntity: Name: NameFull: Yu, Yadong – PersonEntity: Name: NameFull: Zhao, Yi IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 07 Text: Jul2026 Type: published Y: 2026 Identifiers: – Type: issn-print Value: 11727047 Numbering: – Type: volume Value: 40 – Type: issue Value: 7 Titles: – TitleFull: CNS Drugs Type: main |
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