Abstract: OBJECTIVE: To compare the effects of Danhong injection(DHI) with different doses on ischemic stroke.METHODS: Chinese hospital registered DHI study is a perspective observational study, in which a total of 1292 patients with ischemic stroke were treated with DHI. Two different doses of DHI were used in the present study. The patients were matched by acute phase of ischemic stroke(within 2 weeks after onset), partial anterior circulation infraction, sex, age, and National Institute of Health Stroke Scale(NIHSS) score. Finally 148 patients were grouped into the 20 or 40 mL DHI group with 74 in each. The primary endpoint was the improvement of NIHSS score at 14-day after treatment.RESULTS: Of the 148 patients with ischemic stroke,the 74 in the 40 mL DHI group had clinically important improvements in the NIHSS score. The baseline and 14-day NIHSS score for the 40 mL DHI group were 6.6 ± 4.3 and 2.4 ± 2.5 respectively, versus 6.3± 5.7 and 3.6 ± 4.2, for the 20 mL DHI group(change from baseline in the 40 mL DHI group vs change from baseline in the 20 mL DHI group,-1.49points; P = 0.029). Improvements were maintained after the baseline characteristics and other drugs were controlled(P = 0.012). No adverse events were observed.CONCLUSION: Effects of DHI on partial anterior circulation infarction in patients with acute phase of ischemic stroke is dose-dependent; however, further studies with larger sample sizes are needed to validate our findings(Chinese Clinical Trial Register,Number: ChiCTR-ONC-13003230).

Key words: Stroke, Endothelin-1, Danhong injec tion, Clinical trial