Pan Danping, Wan Haitong, He Yu, Yang Jiehong, Guo Yilei, Yu Li, Zhang Feihu, Zheng Guoqing, Xu Bin, Song Yaohong, Zhao Mingjun, Liu Xiangzhe, Liu Jianhe, Sun Gang, Lin Yaming
School of Basic Mecicine Sciences, Zhejiang Chinese Medical University, Hangzhou, China.
Academy of Chinese Medical Sciences, Henan University of Chinese Medicine, Zhengzhou, China.
Front Pharmacol. 2025 Jun 12;16:1608719. doi: 10.3389/fphar.2025.1608719. eCollection 2025.
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.
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).
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, < 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, = 0.005; adjusted RR = 1.07, 95% CI: 1.05-1.10, < 0.001). The DHI group also had a lower mRS score ( < 0.001) and a higher proportion of patients achieving mRS ≤1 (adjusted RR = 1.12, 95% CI: 1.10-1.15, < 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, = 0.320).
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.
https://www.chictr.org.cn/bin/project/edit?pid=211769, identifier ChiCTR2400079391.
先前的临床和实验研究表明，丹红注射液（DHI）对急性缺血性卒中（AIS）具有保护作用。然而，由于样本量有限，仍需要大规模临床研究来证实其疗效。
这项真实世界的多中心回顾性研究使用了中国大陆8个中心的住院患者数据。根据AIS患者是否接受DHI治疗（连续7 - 14天），将其分为DHI组或非DHI组。采用倾向得分匹配（PSM）来平衡基线差异，并进行了多种分析方法（粗分析、多变量回归、稳定的治疗权重逆概率法[sIPTW]以及PSM结合多变量回归）。主要结局是出院时的美国国立卫生研究院卒中量表（NIHSS）评分。次要结局包括治疗后NIHSS评分≤4或≤1的患者比例、改良Rankin量表（mRS）评分、mRS≤1的患者比例以及住院并发症（IHC）的发生率。
共纳入3560例患者，其中DHI组1425例，非DHI组2135例，通过PSM确定了1415对匹配对。治疗后，DHI组的NIHSS评分为2.01±3.10，而非DHI组为2.50±3.26，表明DHI组评分显著更低（调整后的风险比[RR]=0.81，95%置信区间[CI]：0.74 - 0.88，P<0.001）。这些结果在多种分析方法中一致（RR = 0.79 - 0.82）。治疗后，DHI组NIHSS≤4和≤1的患者比例更高（调整后的RR = 1.02，95%CI：1.01 - 1.03，P = 0.005；调整后的RR = 1.07，95%CI：1.05 - 1.10，P<0.001）。DHI组的mRS评分也更低（P<0.001），且mRS≤1的患者比例更高（调整后的RR = 1.12，95%CI：1.10 - 1.15，P<0.001）。两组在IHC发生率方面未发现显著差异（调整后的RR = 1.01，95%CI：0.99 - 1.03，P = 0.320）。
DHI辅助治疗可能改善AIS患者的神经功能结局。然而，需要额外的随机对照试验（RCT）来证实其在基于常规生物医学的临床实践中的有效性。
https://www.chictr.org.cn/bin/project/edit?pid=211769，标识符ChiCTR2400079391
