Efficacy of Danhong Injection Adjuvant Therapy in Patients With Acute Ischemic Stroke: A Real-World, Multicenter, Retrospective Study

Danping Pan¹Haitong Wan^1,2*Yu He¹Jiehong Yang¹Yilei Guo¹Li Yu¹Feihu Zhang¹Guoqing Zheng³Bin Xu⁴Yaohong Song⁵Mingjun Zhao⁶Xiangzhe Liu⁷Jianhe Liu⁸Gang Sun⁹Yaming Lin¹⁰

• ¹Zhejiang Chinese Medical University, Hangzhou, China
• ²Henan University of Chinese Medicine, Zhengzhou, Henan Province, China
• ³First Affiliated Hospital, Zhejiang Chinese Medical University, Hangzhou, Zhejiang Province, China
• ⁴Second Affiliated Hospital, Zhejiang Chinese Medical University, Hangzhou, Zhejiang Province, China
• ⁵Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing, Jiangsu Province, China
• ⁶Affiliated Hospital of Shaanxi Institute of Traditional Chinese Medicine, Xi'an, China
• ⁷First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, Henan Province, China
• ⁸The First Hospital of Hunan University of Chinese Medicine, Changsha, Hunan, China
• ⁹The First Affiliated Hospital, Guizhou University of Traditional Chinese Medicine, Guiyang, Guizhou Province, China
• ¹⁰Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, Yunnan Province, China

Background: Previous 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.Methods: This 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).Results: A total of 3560 patients were enrolled, including 1425 in the DHI group, and 2135 in the Non-DHI group, with 1415 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).Conclusion: DHI 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.