Phase IIa clinical trail of hemocoagulase acutus for injection / 南方医科大学学报

ABSTRACT

<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of hemocoagulase acutus for injection and determine its curative dose.</p><p><b>METHODS</b>Forty-five patients on abdominal surgeries were randomly allocated into 2 study groups and 1 control group. Thirty minutes before the operation, the patients in the study groups received intravenous hemocoagulase acutus at 1 U and 2 U, respectively, and control group had no treatment. The hemostatic time, hemorrhagic volume, and hemoagglutination were observed in all the groups.</p><p><b>RESULTS</b>The average hemorrhagic volume and hemorrhagic volume per square were significantly lower in the two study groups than in the control group (P<0.05), and the average hemorrhagic volume per square were significantly lower in study group 2 U than in the 1 U group (P<0.05). No significant differences were found in adverse effects between the 3 groups.</p><p><b>CONCLUSION</b>Hemocoagulase acutus for injection has good hemostatic effect for controlling capillary hemorrhage at the abdominal incisions and can be safely used in the surgical patients.</p>