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

Abstract

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 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).

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.

Clinical trial registration: https://www.chictr.org.cn/bin/project/edit?pid=211769, identifier ChiCTR2400079391.

Keywords: acute ischemic stroke; clinical efficacy; danhong injection; real-world multicenter retrospective study; traditional Chinese medicine.