Efficacy of danhong injection adjuvant therapy in patients with acute ischemic stroke: a real-world, multicenter, retrospective study

BackgroundPrevious clinical and experimental studies indicate that Danhong injection (DHI) confers protective effects against acute ischemic stroke (AIS). However, due to limited sample sizes, large-scale clinical studies are still needed to confirm its efficacy.MethodsThis real-world, multicenter r...

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Main Authors: Danping Pan, Haitong Wan, Yu He, Jiehong Yang, Yilei Guo, Li Yu, Feihu Zhang, Guoqing Zheng, Bin Xu, Yaohong Song, Mingjun Zhao, Xiangzhe Liu, Jianhe Liu, Gang Sun, Yaming Lin
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Language:English
Published: Frontiers Media S.A. 2025-06-01
Series:Frontiers in Pharmacology
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Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2025.1608719/full
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author Danping Pan
Haitong Wan
Haitong Wan
Yu He
Jiehong Yang
Yilei Guo
Li Yu
Feihu Zhang
Guoqing Zheng
Bin Xu
Yaohong Song
Mingjun Zhao
Xiangzhe Liu
Jianhe Liu
Gang Sun
Yaming Lin
author_facet Danping Pan
Haitong Wan
Haitong Wan
Yu He
Jiehong Yang
Yilei Guo
Li Yu
Feihu Zhang
Guoqing Zheng
Bin Xu
Yaohong Song
Mingjun Zhao
Xiangzhe Liu
Jianhe Liu
Gang Sun
Yaming Lin
author_sort Danping Pan
collection DOAJ
description BackgroundPrevious clinical and experimental studies indicate that Danhong injection (DHI) confers protective effects against acute ischemic stroke (AIS). However, due to limited sample sizes, large-scale clinical studies are still needed to confirm its efficacy.MethodsThis real-world, multicenter retrospective study used inpatient data from eight centers across Mainland China. AIS patients were divided into a DHI group or a Non-DHI group depending on whether they received DHI (7–14 consecutive days). Propensity score matching (PSM) was applied to balance baseline differences, and multiple analytical methods (crude analysis, multivariate regression, stabilized inverse probability of treatment weighting [sIPTW], and PSM combined with multivariate regression) were conducted. The primary outcome was the NIHSS score at discharge. Secondary outcomes included the proportions of patients with post-treatment NIHSS scores ≤4 or ≤1, the mRS score, the proportion of patients achieving mRS ≤1, and the incidence of in-hospital complications (IHC).ResultsA total of 3,560 patients were enrolled, including 1,425 in the DHI group, and 2,135 in the Non-DHI group, with 1,415 matched pairs identified via PSM. After treatment, the NIHSS score in the DHI group was 2.01 ± 3.10, compared with 2.50 ± 3.26 in the Non-DHI group, indicating significantly lower scores in the DHI group (adjusted RR = 0.81, 95% CI: 0.74–0.88, P < 0.001). These findings were consistent across multiple analytical methods (RR = 0.79–0.82). After treatment, the proportion of patients with NIHSS ≤4 and ≤1 was higher in the DHI group (adjusted RR = 1.02, 95% CI: 1.01–1.03, P = 0.005; adjusted RR = 1.07, 95% CI: 1.05–1.10, P < 0.001). The DHI group also had a lower mRS score (P < 0.001) and a higher proportion of patients achieving mRS ≤1 (adjusted RR = 1.12, 95% CI: 1.10–1.15, P < 0.001). No noteworthy difference was found between the two groups in the incidence of IHC (adjusted RR = 1.01, 95% CI: 0.99–1.03, P = 0.320).ConclusionDHI adjunctive therapy may improve neurological outcomes in patients with AIS. However, additional randomized controlled trials (RCTs) are needed to confirm its effectiveness in routine biomedicine-based clinical practice.Clinical Trial Registrationhttps://www.chictr.org.cn/bin/project/edit?pid=211769, identifier ChiCTR2400079391.
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spelling doaj-art-e11df09ee5a5469fbbcbe1e7c74ed7642025-08-20T02:33:00ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-06-011610.3389/fphar.2025.16087191608719Efficacy of danhong injection adjuvant therapy in patients with acute ischemic stroke: a real-world, multicenter, retrospective studyDanping Pan0Haitong Wan1Haitong Wan2Yu He3Jiehong Yang4Yilei Guo5Li Yu6Feihu Zhang7Guoqing Zheng8Bin Xu9Yaohong Song10Mingjun Zhao11Xiangzhe Liu12Jianhe Liu13Gang Sun14Yaming Lin15School of Basic Mecicine Sciences, Zhejiang Chinese Medical University, Hangzhou, ChinaSchool of Basic Mecicine Sciences, Zhejiang Chinese Medical University, Hangzhou, ChinaAcademy of Chinese Medical Sciences, Henan University of Chinese Medicine, Zhengzhou, ChinaSchool of Pharmaceutical Sciences, Zhejiang Chinese Medical University, Hangzhou, ChinaSchool of Basic Mecicine Sciences, Zhejiang Chinese Medical University, Hangzhou, ChinaSchool of Basic Mecicine Sciences, Zhejiang Chinese Medical University, Hangzhou, ChinaSchool of Basic Mecicine Sciences, Zhejiang Chinese Medical University, Hangzhou, ChinaSchool of Basic Mecicine Sciences, Zhejiang Chinese Medical University, Hangzhou, ChinaDepartment of Neurology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, ChinaDepartment of Neurology, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, ChinaDepartment of Cardiology, Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing, ChinaDepartment of Cardiology, Affliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, ChinaDepartment of Encephalology, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, ChinaDepartment of Cardiology, The First Hospital of Hunan University of Chinese Medicine, Changsha, China0Department of Cardiology, The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, China1Department of Neurology, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, ChinaBackgroundPrevious clinical and experimental studies indicate that Danhong injection (DHI) confers protective effects against acute ischemic stroke (AIS). However, due to limited sample sizes, large-scale clinical studies are still needed to confirm its efficacy.MethodsThis real-world, multicenter retrospective study used inpatient data from eight centers across Mainland China. AIS patients were divided into a DHI group or a Non-DHI group depending on whether they received DHI (7–14 consecutive days). Propensity score matching (PSM) was applied to balance baseline differences, and multiple analytical methods (crude analysis, multivariate regression, stabilized inverse probability of treatment weighting [sIPTW], and PSM combined with multivariate regression) were conducted. The primary outcome was the NIHSS score at discharge. Secondary outcomes included the proportions of patients with post-treatment NIHSS scores ≤4 or ≤1, the mRS score, the proportion of patients achieving mRS ≤1, and the incidence of in-hospital complications (IHC).ResultsA total of 3,560 patients were enrolled, including 1,425 in the DHI group, and 2,135 in the Non-DHI group, with 1,415 matched pairs identified via PSM. After treatment, the NIHSS score in the DHI group was 2.01 ± 3.10, compared with 2.50 ± 3.26 in the Non-DHI group, indicating significantly lower scores in the DHI group (adjusted RR = 0.81, 95% CI: 0.74–0.88, P < 0.001). These findings were consistent across multiple analytical methods (RR = 0.79–0.82). After treatment, the proportion of patients with NIHSS ≤4 and ≤1 was higher in the DHI group (adjusted RR = 1.02, 95% CI: 1.01–1.03, P = 0.005; adjusted RR = 1.07, 95% CI: 1.05–1.10, P < 0.001). The DHI group also had a lower mRS score (P < 0.001) and a higher proportion of patients achieving mRS ≤1 (adjusted RR = 1.12, 95% CI: 1.10–1.15, P < 0.001). No noteworthy difference was found between the two groups in the incidence of IHC (adjusted RR = 1.01, 95% CI: 0.99–1.03, P = 0.320).ConclusionDHI adjunctive therapy may improve neurological outcomes in patients with AIS. However, additional randomized controlled trials (RCTs) are needed to confirm its effectiveness in routine biomedicine-based clinical practice.Clinical Trial Registrationhttps://www.chictr.org.cn/bin/project/edit?pid=211769, identifier ChiCTR2400079391.https://www.frontiersin.org/articles/10.3389/fphar.2025.1608719/fulldanhong injectionacute ischemic strokeclinical efficacyreal-world multicenter retrospective studytraditional Chinese medicine
spellingShingle Danping Pan
Haitong Wan
Haitong Wan
Yu He
Jiehong Yang
Yilei Guo
Li Yu
Feihu Zhang
Guoqing Zheng
Bin Xu
Yaohong Song
Mingjun Zhao
Xiangzhe Liu
Jianhe Liu
Gang Sun
Yaming Lin
Efficacy of danhong injection adjuvant therapy in patients with acute ischemic stroke: a real-world, multicenter, retrospective study
Frontiers in Pharmacology
danhong injection
acute ischemic stroke
clinical efficacy
real-world multicenter retrospective study
traditional Chinese medicine
title Efficacy of danhong injection adjuvant therapy in patients with acute ischemic stroke: a real-world, multicenter, retrospective study
title_full Efficacy of danhong injection adjuvant therapy in patients with acute ischemic stroke: a real-world, multicenter, retrospective study
title_fullStr Efficacy of danhong injection adjuvant therapy in patients with acute ischemic stroke: a real-world, multicenter, retrospective study
title_full_unstemmed Efficacy of danhong injection adjuvant therapy in patients with acute ischemic stroke: a real-world, multicenter, retrospective study
title_short Efficacy of danhong injection adjuvant therapy in patients with acute ischemic stroke: a real-world, multicenter, retrospective study
title_sort efficacy of danhong injection adjuvant therapy in patients with acute ischemic stroke a real world multicenter retrospective study
topic danhong injection
acute ischemic stroke
clinical efficacy
real-world multicenter retrospective study
traditional Chinese medicine
url https://www.frontiersin.org/articles/10.3389/fphar.2025.1608719/full
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