| Autor: |
Liu, X., Wang, L., Wen, A., Yang, J., Yan, Y., Song, Y., Ren, H., Wu, Y., Li, Z., Chen, W., Xu, Y., Li, L., Xia, J., Zhao, G. |
| Předmět: |
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| Zdroj: |
European Journal of Neurology; Jun2012, Vol. 19 Issue 6, p855-863, 9p, 1 Diagram, 3 Charts, 2 Graphs |
| Abstrakt: |
Background and purpose: Ginsenoside-Rd is a receptor-operated calcium channel antagonist and has shown promise as a neuroprotectant in our phase II study. As an extended work, we sought to confirm its efficacy and safety of Ginsenoside-Rd in patients with acute ischaemic stroke. Methods: We conducted a randomized, double-blind, placebo-controlled trial involving 390 patients with acute ischaemic stroke in a 3:1 ratio to receive a 14-day intravenous infusion of Ginsenoside-Rd or placebo within 72 h after the onset of stroke. Our primary end-point was the distribution of disability scores on the modified Rankin scale (mRs) at 90 days. Results: The efficacy analysis was based on 386 patients (Ginsenoside-Rd group: 290; placebo group: 96). Ginsenoside-Rd significantly improved the overall distribution of scores on the mRs, as compared with the placebo ( P = 0.02; odds ratios [OR], 1.74; 95% confidence interval [CI], 1.08-2.78). There were significant differences between the two groups when we categorized the scores into 0-1 vs. 2-5 ( P = 0.01; OR, 2.32; 95% CI, 1.23-4.38; 66.8% vs. 53.1%). It also improved the National Institutes of Health Stroke Scale (NIHSS) at 15 days [ P < 0.01; least squares mean (LSM), −0.77; 95% CI, −1.31 to −0.24]. Mortality and rates of adverse events were similar in the two groups. Conclusions: Ginsenoside-Rd improved the primary outcome of acute ischaemic stroke and had an acceptable adverse-event profile. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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