ABSTRACT
Objective Long-chain triacylglycerol (LCT) by three producers,each mixed with the same medium-chain triacylglycerol (MCT),were compared with the brand MCT/LCT in causing focal necrosis of hepatocytes in beagle dogs (a bioequivalence evaluation).Methods 21 beagle dogs (male,0.7-1.5 years old,10-15 kg) were used in this study.According to the sources of the LCT,the animals were divided into Group A (LCT made in China),Group B (LCT made in Japan),Group C (LCT made in Germany),and the control group (the brand 10％ MCT/LCT).Central venous port was placed via the lumber vein of the animals under general anesthesia.After 2 weeks of rehabilitation,MCT/LCT was administered through this port for 28 days at 9 g/ (kg · d) [while the routine dose used clinically was 1 g/ (kg · d)].The laboratory indexes and the pathomorphism of the liver and kidney were studied single blindly.Results Laboratory tests,including liver and kidney function,blood coagulation function and lipid metabolism,did not identify differences among emulsions with different sources of LCT.Liver biopsy at day 28 showed no focal necrosis in Group C and the control group;there was minor damage in Group B;and Group A had obvious liver necrosis.and the pathological findings of other organs are similar.No significant difference was observed in biopsies of other organs.Conclusions Emulsions with different sources of LCT varied in their damage to the liver.Generics with LCT of higher quality were equivalent to the brand MCT/LCT in terms of safety.
ABSTRACT
<p><b>OBJECTIVE</b>To evaluate the hemostatic role of hemocoagulase in abdominal operation and its effects on coagulation.</p><p><b>METHODS</b>180 patients receiving abdominal operation were studied prospectively by randomized, double-blind controlled and multicenter design. They were divided into Hemocoagulase group (60 patients), lizhixue group (60), and manitol hexanitrate group (60). The groups were, observed in terms of the effects on hemostatic time, hemorrhagic volume, hemorrhagic volume per square unit, and body coagulation (BT, CT, PT, APTT and PLT) parameters.</p><p><b>RESULTS</b>The groups received different drugs. The average hemostatic time in the hemocoagulase group was 121.6 s, hemorrhagic volume was 9.6 g, and hemorrhagic volume per square unit was 0.2 g. The similar results were observed in the lizhixue group (P > 0.05), but they were significantly different (P < 0.05) from those of the manitol hexanitrate group (159.2 s, 12.49 g, 0.3 g). In the hemocoagulase and lizhixue groups hemorrhagic and hemoagglution time decreased 30 minutes and 1 day after operation. This finding was significantly differenct from that in the manitol hexanitrate group (P < 0.05).</p><p><b>CONCLUSION</b>Hemocoagulase plays a good hemostatic role in the hemorrhagic capillary at abdominal incision.</p>
Subject(s)
Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Abdomen , Batroxobin , Pharmacology , Therapeutic Uses , Blood Coagulation , Double-Blind Method , Hemostasis, Surgical , Methods , Hemostatics , Therapeutic Uses , Prospective StudiesABSTRACT
ObjectiveTo evaluate the hemostatic effect of human thrombin in surgery.Methods A prospective, randomized, controlled and multicenter study was designed to evaluate the hemostatic effect of human thrombin on abdominal operation incision (96 cases) and liver wound (40 cases). Human thrombin was insufflated topically in study group, with 0 9% NS as control. Results The average hemostatic time of abdominal incision in study group was (104?70) s, hemorrhagic volume per square unit was (0 4?0 3)g/cm 2, in liver wound the average hemostatic time was (106?78) s, the hemorrhagic volume per square unit was (1 0?0 7) g/cm 2, the difference was all statistically significant ( P