[Phase IIa clinical trail of hemocoagulase acutus for injection].
OBJECTIVE
To evaluate the efficacy and safety of hemocoagulase acutus for injection and determine its curative dose.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Zhou
Jun-jie
JJ
Department of General Surgery, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China. tiandansun@21cn.com
Huang
Zong-hai
ZH
Yu
Jin-long
JL
Li
Zhou
Z
Zhou
Guang-jun
GJ
D000005:Abdomen / Q000601:surgery*; D000293:Adolescent; D000328:Adult; D000368:Aged; D017836:Agkistrodon / Q000378:metabolism; D000818:Animals; D012103:Batroxobin / Q000008:administration & dosage / Q000627:therapeutic use*; D001777:Blood Coagulation / Q000187:drug effects*; D016063:Blood Loss, Surgical / Q000517:prevention & control; D006488:Hemostasis, Surgical / Q000379:methods*; D006490:Hemostatics / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
D006490:Hemostatics; D012103:Batroxobin