[Effect of recombinant human thrombin for hemostasis in liver resection: a randomized controlled phase â ¢ clinical trial].

Objective: To evaluate the hemostatic efficacy, safety and immunogenicity of recombinant human thrombin in the treatment of liver wounds that still ooze after conventional surgical hemostasis. Methods: A multicenter, stratified randomized, double-blind, placebo-controlled phase Ⅲ trial with a planned enrollment of 510 subjects at 33 centers, with a 2∶1 randomization to the thrombin group versus the placebo group. An interim analysis will be conducted after approximately 70% of the subjects have completed the observation period. The primary efficacy endpoint was the rate of hemostasis within 6 minutes at the point of bleeding that could be evaluated. Safety analysis was performed one month after surgery, and the positive rates of anti-drug antibody (ADA) and neutralizing antibody were evaluated. Results: At the interim analysis, a total of 348 subjects had been randomized and received the study drug (215 were male and 133 were female). They were aged 19-69 (52.9±10.9)years. Among them, 232 were in the thrombin group and 116 were in the placebo group, with balanced and comparable demographics and baseline characteristics between the two groups. The hemostasis rate at 6 minutes was 71.6% (95%CI:65.75%-77.36%) in the thrombin group and 44.0% (95%CI: 34.93%-53.00%) in the placebo group, respectively (P<0.001). No grade≥3 drug-related adverse events and no drug-related deaths were reported from the study.No recombinant human thrombin-induced immunologically-enhanced ADA or immunologically-induced ADA was detected after topical use in subjects. Conclusion: Recombinant human thrombin has shown significant hemostatic efficacy and good safety in controlling bleeding during liver resection surgery, while also demonstrating low immunogenicity characteristics.

[The analysis of structural magnetic resonance imaging manifestation of hippocampus based on voxel and spherical harmonic surface morphometry in mesial temporal lobe epilepsy].

Objective: To compare the hippocampal volume and local surface morphology changes in patients with mesial temporal lobe (mTLE) using the voxel-based morphometry and spherical harmonic methods respectively. Methods: A total of 66 patients (31 males and 35 females, age range from 17 to 48 (28±8) years) with mTLE and 80 age-and gender-matched controls (38 males and 42 females, age range from 19 to 46 (27±7) years) were retrospectively collected from July 2009 to February 2019 at Jinling hospital.. High resolution structural MRI of the whole brain, three-dimensional T1-weighted data(3DT1) were acquired from each subject. The changes of hippocampal volume and surface morphology were evaluated between mTLE groups and controls for observing the hippocampal atrophy pattern by using voxel-based morphometry and spherical harmonic shape descriptions point distribution model respectively. Pearson correlation analysis was conducted for observing the relationship between the morphological changes of hippocampus and disease duration. Results: Compared with the controls, hippocampal volume on the affected side in patients with mTLE was significantly reduced (Z-score:-1.55±0.57 vs 0.38±0.58, P<0.001) and negatively correlated with disease duration (r=-0.297, P=0.016). Furthermore, surface morphology analysis subtly showed that the atrophy of the affected hippocampus in patients with mTLE mainly located in the head, mesial lateral part and posterior tail of the hippocampus. Their displacement values were negatively correlated with disease duration (r=-0.336, P=0.006) and positively associated with the hippocampal grey matter volume (r=0.336, P=0.006). Conclusions: Voxel-based morphometry analysis reveals a global reduction in hippocampal volume, while the morphological measurement method based on surface shape can describe the local morphological changes of hippocampal atrophy.

[Magnetic resonance imaging morphological study of the effects of juvenile febrile convulsions on the brain structure of medial temporal lobe epilepsy].

Objective: To investigate the effect of febrile convulsions on gray matter volume (GMV) in medial temporal lobe epilepsy (mTLE) and its correlation with disease duration. Methods: A retrospective study was conducted to collect 41 mTLE patients with a history of febrile convulsions (mTLE-FC), 42 mTLE patients with no initial precipitating injury (mTLE-noIPI), and 42 normal and age and sex matched normal controls. High-resolution T1-weighted (T(1)WI) whole brain MR scans were performed on all subjects. Voxel-based morphometry were used to obtain GMV brain maps, and the GMV differences between the three groups of subjects were compared (P<0.01, GRF corrected). Finally, Spearmen rank correlation analysis was used to explore the correlation between GMV changes and the course of disease. Results: Compared with the normal control subjects, each mTLE group showed extensive GMV reduction, mainly in the affected hippocampus, thalamus, temporal lobe, and bilateral cerebellum. Further analysis found that mTLE-FC group had more significant reductions in GMV than the mTLE-noIPI group in the affected hippocampus, amygdala, inferior temporal gyrus, contralateral hippocampus, para hippocampus, and inner cingulate gyrus. At the same time, the affected amygdala and hippocampal GMV in the mTLE-FC group was significantly negatively related to the course of disease (r=-0.381, P=0.014), while the mTLE-noIPI group had no downward trend (r=0.081, P=0.611). The atrophic trend of the affected amygdala and hippocampus in patients with mTLE-FC was significantly greater than that in patients with mTLE-noIPI (P=0.029, permutation test). Conclusions: There is extensive damage to the gray matter structure of bilateral cerebral hemispheres, mainly in the hippocampus, in mTLE patients. The brain damage of mTLE patients with a history of juvenile fever convulsions is more extensive and serious, and the trend of progressive exacerbation with the course of the disease is more obvious, suggesting mTLE associated with juvenile fever convulsions may have different pathophysiological mechanisms.

Neonatal alloimmune thrombocytopenia due to HLA-A2 antibody.

A male, full-term baby with thrombocytopenia was born by a G3P2A1 mother who was not associated with autoimmune disease. Platelet antibody screening was positive by using lymphocytotoxicity test, platelet suspension immunofluorescence test and solid-phase red cell adherence test. The identified HLA antibody was of A2 specificity. It was confirmed by testing the mother's and the baby's sera against the lymphocytes and platelets of 10 HLA-A2-positive donors. The possibility of platelet-specific antibody as the cause of neonatal alloimmune thrombocytopenia was ruled out by testing against platelets of 10 HLA-A2-negative donors and the known platelet-specific antigens utilizing immobilized, purified platelet glycoprotein as targets. The mother's serum reacted strongly with both the father's and the baby's platelets and lymphocytes. This neonatal thrombocytopenia was most likely due to the maternal HLA antibody, which was induced by her antecedent gestations.