| Objective To evaluate the effects of agkistrodon hemocoagulase on its hemostatic and hemoagglutinant function and safety on the patients with thoracic and abdominal operations.Methods It is a randomized, double-blind, parallel controlled study.Total 80 patients including 20 thoracic cases and 60 abdominal cases accepted operations were enrolled into the study, and then assigned to study group (60 cases, haernocoagulase acutus 2U i.v.) and control group (20 cases, haemocoagulase atutus placebo 2U i.v.) by the ratio 3 to 1.The drugs were injected in order 30 minutes before operation. The operational wound,hemostatic time,amount of bleeding,amount of bleeding per square unit were observed in the process of operation . Moreover,the body coagulation parameters and safety indexes would be observed at the time of perioperation,the body coagulation parameters would be monitored before operation,ten minutes after operation beginning,one day after operation and three days after operation.The safety indexes would be monitored before operation and three days after operation.And we keep an eye on the adverse drug reactions.The adverse drug reaction (ADR) of trial-drug was monitored in the whole experiment.Results The average length,average depth and the average area of the wound in the study group were similar with the results in the control group(P>0.05).The average length of the wound between the two groups was (8.89±0.85),( 8.57±1.00)cm respectively. The average depth was (0.91±0.34) , (0.77±0.22)cm in two groups, and the average area was (16.33±6.39),( 13.45±4.72) cm2. The average hemostatic time,average hemorrhagic volumes and the average hemorrhagic volume per square unit of the wound were significantly lower in the study groups than the ones in the control group (P<0.05).The average hemostatic time of study group and control group was (128.49±71.04) , (177.19±77.31)s respectively. The hemorrhagic volumes was (2.70±1.94) , (4.35±2.10)g in the two groups, the hemorrhagic volume per square unit were (0.19±0.17) , (0.35±0.17)g/cm2. In the abdominal operation,the hemostatic time was(113.87±62.82)s VS. (172.69±78.62)s ,hemorrhagic volumes was (2.28±1.27)g VS. (4.19±2.29)g ,and hemorrhagic volume per square unit was (0.15±0.09)g/cm2 VS. (0.34±0.19)g/cm2 in study group and control group respectively. The indexes in study group were less than control group significantly (P<0.05)。In the thoracic operation,the hemostatic time was (173.33±78.03)s VS. (191.60±79.79)s,hemorrhagic volumes was (4.00±2.93)g VS. (4.84±1.41)g and hemorrhagic volume per square unit was (0.34±0.24)g/cm2 VS. (0.38±0.08)g/cm2 in study group and control group respectively. The indexes in study group were similar with control group ( P > 0.05) .The parameters of body coagulation( including PT,APTT,TT,Fib,PLT) and safety indexes (ineluding vitalsign,electroeardiogram,liver and renal function,blood routine,urine routine) were observed in the time of perioperation. The results of hemoagglutination function and blood viscosity were similar in two groups. No adverse event was reported.Conclusion Haemocoagulase Acutus is ineffectual to the wound of the thoracic operation ,while it plays a better hemostatic role on the wound of abdominal operation,it can obviously shorten the wound bleeding time and decrease the blood lose of the wound,and showed little influence to body coagulation.It is a safe and dependable blood clotting drug.
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