Efficacy and safety comparison of DL-3-n-butylphthalide and Cerebrolysin: Effects on neurological and behavioral outcomes in acute ischemic stroke

  • Authors:
    • Li‑Xia Xue
    • Ting Zhang
    • Yu‑Wu Zhao
    • Zhi Geng
    • Jing‑Jiong Chen
    • Hao Chen
  • View Affiliations

  • Published online on: March 10, 2016     https://doi.org/10.3892/etm.2016.3139
  • Pages: 2015-2020
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Abstract

Cerebrolysin and DL-3-n-butylphthalide (NBP) have each shown neuroprotective efficacy in preclinical models of acute ischemic stroke (AIS) and passed clinical trials as therapeutic drugs for AIS. The present study was a clinical trial to assess and compare the efficacy and safety of NBP and Cerebrolysin in the reduction of neurological and behavioral disability following AIS. A randomized, double‑blind trial was conducted with enrolment of 60 patients within 12 h of AIS. In addition to routine treatment, patients were randomly assigned to receive a 10‑day intravenous administration of NBP, Cerebrolysin or placebo. National Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) scores were used to evaluate the efficacy of the treatment in the patients with AIS at 11 and 21 days after the initiation of therapy. Adverse events were also analyzed among the three groups. After 10 days of treatment with NBP or Cerebrolysin, the NIHSS and BI scores at day 21 showed statistical differences compared with those in the placebo group (P<0.05). The improvements of NIHSS and BI scores in the NBP and Cerebrolysin groups were higher than those in the placebo group at days 11 and 21 (P<0.05). A statistically significant difference in the improvement of 21‑day NIHSS scores was observed between the two treatment groups (P<0.05). No significant difference was found among the three groups with regard to the rate of adverse events. Favorable outcomes and good safety were observed in the patients with moderate AIS treated with NBP or Cerebrolysin. The results indicate that NBP may be more effective than Cerebrolysin in improving short‑term outcomes following AIS. This trial is registered at ClinicalTrials.gov with clinical trial identifier number NCT02149875.
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May-2016
Volume 11 Issue 5

Print ISSN: 1792-0981
Online ISSN:1792-1015

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Spandidos Publications style
Xue LX, Zhang T, Zhao YW, Geng Z, Chen JJ and Chen H: Efficacy and safety comparison of DL-3-n-butylphthalide and Cerebrolysin: Effects on neurological and behavioral outcomes in acute ischemic stroke. Exp Ther Med 11: 2015-2020, 2016
APA
Xue, L., Zhang, T., Zhao, Y., Geng, Z., Chen, J., & Chen, H. (2016). Efficacy and safety comparison of DL-3-n-butylphthalide and Cerebrolysin: Effects on neurological and behavioral outcomes in acute ischemic stroke. Experimental and Therapeutic Medicine, 11, 2015-2020. https://doi.org/10.3892/etm.2016.3139
MLA
Xue, L., Zhang, T., Zhao, Y., Geng, Z., Chen, J., Chen, H."Efficacy and safety comparison of DL-3-n-butylphthalide and Cerebrolysin: Effects on neurological and behavioral outcomes in acute ischemic stroke". Experimental and Therapeutic Medicine 11.5 (2016): 2015-2020.
Chicago
Xue, L., Zhang, T., Zhao, Y., Geng, Z., Chen, J., Chen, H."Efficacy and safety comparison of DL-3-n-butylphthalide and Cerebrolysin: Effects on neurological and behavioral outcomes in acute ischemic stroke". Experimental and Therapeutic Medicine 11, no. 5 (2016): 2015-2020. https://doi.org/10.3892/etm.2016.3139