| Objective To evaluate the hemostatic role of Haemocoagulase Acutus onto wound ofthoracic and abdominal operation and its influence and safety on body coagulation, offerthe experiment basis for its clinical usage.Methods A total of forty eight patients including eighteen thoracic cases and thirty sixabdominal cases accepted operation were studied by randomized, double-blind anddummy-controlled designing. They were divided into study group (twenty four cases,accepted Haemocoagulase Acutus) and control group(twenty four cases, acceptedHaemocoagulase Acutus placebo). Meanwhile, the two groups have the equal casesaccepted thoracic or abdominal operation, each must include nine subjects that wereaccepted thoracic operation and fifteen subjects that were accepted abdominaloperation.According to the requirement of study-center, respectively generatedunpredictable sequences from seventy nine to ninty six for thoracic operation and sixtyseven to ninty six for abdominal operation based on a random procedure, then array thecurrent numbers to corresponding treatment assignment. According to the experimentcenter, it was assigned the treatment continuously in sequence. In the experiment, the studygroup was accepted 2 ampoul Haemocoagulase Acutus and the control group was accepted2 ampoul Haemocoagulase Acutus placebo. The drugs were injected in order 30 minutesbefore operation, when the injection rate was not limited, but need slowly, generally it maybe accomplished in one minute. In the process of operation, the results of the length anddepth of wound were observed and the area of the wound were calculated, at the same timethe bleeding time, blood lose and blood lose per square unit were record too. Moreover, thebody coagulation parameters and safety indexes would be observed at the time ofperioperation, the body coagulation parameters would be monitored the time beforeoperation, ten minutes after operation beginning, one day after operation and three daysafter operation. The safety indexes would be monitored the time before operation and threedays after operation. The trial-drug relative adverse events after using HaemocoagulaseAcutus were monitored all the time in the experiment.Results The groups received different operations and accepted different drugs, theresults of the average length ,average depth and the average area of the wound were similar after comparing (P＞0.05), the wound of the study group had the average length of12.16±1.67 cm, the average depth of 0.97±0.56 cm, and the average area of 23.42±11.89cm~2, and the control group had the average length of 12.50±1.76 cm, the average depth of0.92±0.42 cm, and the average area of 23.15±12.74 cm~2. And the results were gotten afterinjected the drugs, the average bleeding time in the study group was 125.75±42.15 s, theaverage blood lose was 4.10±2.87 g, and the average blood lose per square unit was0.18±0.13 g/cm~2, these were significantly different (P＜0.05) from those of the controlgroup, which had the average bleeding time was 190.41±54.38 s, the average blood losewas 7.33±3.40g, and the average blood lose per square unit was 0.29±0.15 g/cm~2. But aftercomparing the average bleeding time, the average blood lose and the average blood lose persquare unit, it was observed that the results were similar between the groups, which wereaccepted operation and all accepted Haemocoagulase Acutus 2 ampoul. The averagebleeding time of the thoracic operation group injected Hemocoagulase Acutus 2 ampoulwas 132.73±45.2 s, the average blood lose was 4.17±3.28 g, and the average blood loseper square unit was 0.12±0.08 g/cm~2; then the average bleeding time of the abdominaloperation group injected Hemocoagulase Acutus 2 ampoul was 114.11±35.7 s, the averageblood lose was 3.97±2.20 g, and the average blood lose per square unit was 0.27±0.16g/cm~2. The parameters of body coagulation including PT, APTT, TT, Fib and PLG andsafety indexes including vital sign, electrocardiogram, liver and renal function, bloodroutine, urine routine were observed in the time of perioperation. According to the resultsbefore and after operation, it were similar after comparing between the two groups (P＞0.05). There were no trial-drug relative adverse events occurred after injectingHaemocoagulase Acutus or its placebo all the time in the experiment.Conclusion Haemocoagulase Acutus plays a better hemostatic role onto the wound ofthoracic or abdominal operation, it can obviously shorten the wound bleeding time anddecrease the blood lose of the wound ,and showed little influence to body coagulation. Itwas proved that a safe and dependable blood clotting drug.
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