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<p>This study hypothesized that Cerebrolysin, a multimodal neuroprotective agent, enhances the efficacy and safety of mechanical thrombectomy (MT) in both acute ischemic stroke (AIS) and recovery stroke phases in selected patients with good collateral status (CTA-CS 2–3) and effective recanalization (mTICI 2b-3). A single-center, prospective, open-label, single-arm study with blinded outcome assessment of 50 consecutive patients with moderate-to-severe AIS treated with MT ≤ 6&#xa0;h of stroke onset followed by Cerebrolysin (30&#xa0;ml iv within 8&#xa0;h of onset and continued to day 21, first cycle) and in a recovery phase (between 69–90&#xa0;days, second cycle) compared to 50 historical controls matched by propensity scores. Key outcomes included functional independence (mRS 0–2 at 90&#xa0;days), safety endpoints, and neurological recovery (NIHSS at 24&#xa0;h and 7&#xa0;day post MT). Patients receiving Cerebrolysin achieved higher rates of mRS 0–2 at 90&#xa0;days (68% vs. 44%, <i>p</i> = 0.016, OR 2.7, 95% CI 1.2–6.1; NNT: 4.2), had reduced risk of secondary ICH (14% vs. 40%, <i>p</i> = 0.02; RR 0.37, 95% CI 0.14–0.95), and had lower NIHSS on day 7 (median [IQR]: 3 [4] vs. 6 [9], <i>p</i> = 0.01). There was a significant difference in Barthel Index scores between the Cerebrolysin group and the control group at 30&#xa0;days (median [IQR]: 77 [32] vs. 63 [50], <i>p</i> = 0.03) and at 3&#xa0;months (86 [22] vs. 75 [29], <i>p</i> = 0.01) primarily driven by the increase in the mobility and transfer components. Multivariate analysis identified Cerebrolysin as an independent predictor of favorable outcomes at 3&#xa0;months (OR 7.5, 95% CI 1.8–30.9), particularly in patients with diabetes (interaction OR 9.6, 95% CI 1.01–92). The overall mortality rates at 30 and 90&#xa0;days were similar in both groups (2% vs 6% and 8% vs 12%, <i>p</i> &gt; 0.1). Cerebrolysin improved functional outcomes at 90&#xa0;days, accelerated neurological recovery, and reduced complications post-MT in patients with small ischemic core, good collateral circulation, and effective recanalization at baseline. These findings warrant further randomized trials to validate its efficacy and explore its long-term benefits.</p><p>Registration: URL: <a href="https://www.clinicaltrials.gov">https://www.clinicaltrials.gov</a>; unique identifier: NCT04904341.</p>

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Efficacy of Cerebrolysin Treatment as an Add-On Therapy to Mechanical Thrombectomy in Patients with Acute Ischemic Stroke Due to Large Vessel Occlusion in Anterior Circulation: Results of a 3-Month Follow-up of a Prospective, Open Label, Single-Center Study

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  • 发表日期：

    2025年5月6日

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  • Jacek Staszewski,
  • Aleksander Dębiec,
  • Stefan Strilciuc,
  • Katarzyna Gniadek-Olejniczak,
  • Renata Piusinska-Macoch,
  • David Balo,
  • George Harston,
  • Adam Stępień,
  • Krzysztof Brzozowski,
  • Piotr Zięcina,
  • Jerzy Narloch,
  • Marek Wierzbicki,
  • Piotr Piasecki

摘要

This study hypothesized that Cerebrolysin, a multimodal neuroprotective agent, enhances the efficacy and safety of mechanical thrombectomy (MT) in both acute ischemic stroke (AIS) and recovery stroke phases in selected patients with good collateral status (CTA-CS 2–3) and effective recanalization (mTICI 2b-3). A single-center, prospective, open-label, single-arm study with blinded outcome assessment of 50 consecutive patients with moderate-to-severe AIS treated with MT ≤ 6 h of stroke onset followed by Cerebrolysin (30 ml iv within 8 h of onset and continued to day 21, first cycle) and in a recovery phase (between 69–90 days, second cycle) compared to 50 historical controls matched by propensity scores. Key outcomes included functional independence (mRS 0–2 at 90 days), safety endpoints, and neurological recovery (NIHSS at 24 h and 7 day post MT). Patients receiving Cerebrolysin achieved higher rates of mRS 0–2 at 90 days (68% vs. 44%, p = 0.016, OR 2.7, 95% CI 1.2–6.1; NNT: 4.2), had reduced risk of secondary ICH (14% vs. 40%, p = 0.02; RR 0.37, 95% CI 0.14–0.95), and had lower NIHSS on day 7 (median [IQR]: 3 [4] vs. 6 [9], p = 0.01). There was a significant difference in Barthel Index scores between the Cerebrolysin group and the control group at 30 days (median [IQR]: 77 [32] vs. 63 [50], p = 0.03) and at 3 months (86 [22] vs. 75 [29], p = 0.01) primarily driven by the increase in the mobility and transfer components. Multivariate analysis identified Cerebrolysin as an independent predictor of favorable outcomes at 3 months (OR 7.5, 95% CI 1.8–30.9), particularly in patients with diabetes (interaction OR 9.6, 95% CI 1.01–92). The overall mortality rates at 30 and 90 days were similar in both groups (2% vs 6% and 8% vs 12%, p > 0.1). Cerebrolysin improved functional outcomes at 90 days, accelerated neurological recovery, and reduced complications post-MT in patients with small ischemic core, good collateral circulation, and effective recanalization at baseline. These findings warrant further randomized trials to validate its efficacy and explore its long-term benefits.

Registration: URL: https://www.clinicaltrials.gov; unique identifier: NCT04904341.