| Objective: The efficacy and safety of Citicoline in treatment of acute cerebral infarction and acute cerebral hemorrhage, which happened in internal carotid artery system, was evaluated. The efficacy and safety between the new drug Citicoline Sodium Tablets and Citicoline Sodium Capsules was compared.Methods: A randomized, double-blind, placebo-controlled, multicenter clinical trail was conducted. Citicoline Sodium Capsules was used as positive-control drug. A total of 134 patients entered the study for 21 days, 67 in new drug group, and 67 in the placebo group. During the treatment, NIHSS and the Barthel index were evaluated. Before and after the treatment, blood routine test(including RBC, Hb, PLT and WBC), fasting blood glucose test, urine routine test, feces routine test, blood biochemistry test (including BUN, Cr, ALT, AST, TC and TG), and ECG were observed.Results: In 134 patients, 4 dropped off, 6 inconsistent with enrolling requirement were excluded. Altogether in 130 patients, 65 in the new drug group, and 65 in the placebo group, the efficacy and safety were analysed. After treatment, in the new drug group, the Barthel index integrate rised from 51.58±24.68 to 77.58±18.28 (p<0.0001) and the NIHSS score decreased from 12.38±4.15 to 4.45±2.85 (p<0.0001); in the placebo group, the Barthel index integrate rised from 42.73±21.89 to 73.13±19.10(P<0.0001) and the NIHSS score decreased from 12.50±4.18 to 4.45±2.22 (P<0.0001). But there was no statistical significant difference between the new drug group and the placebo group. During the clinical trail, there was no adverse event happened, so these two drug were well safely.Conclusion: Citicoline is an effective and safe agent for the treatment of acute cerebral infarction and acute cerebral hemorrhage. Thus Citicoline has neuroprotective effect. The efficacy and safety of the new drug Citicoline Sodium Tablets is similar to Citicoline Sodium Capsules.
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