Objective To evaluate the adverse events following immunization (AEFI) of meningococcal vaccines, so as to provide references for the appraisal and treatment of AEFI. Methods The Chinese Bio-medicine Database (1978 to April, 2010), China Journal Full-text Database (1994 to April, 2010), VIP Database (1989 to April, 2010) and WangFang database (1988 to April, 2010) were fully searched, and the references listed in original studies were searched manually as well. Then two reviewers independently screened studies and abstracted relevant data.Results A total of 52 articles involving 61 cases were included. Among the AEFI cases, 72.13% were hypersensitive response, including henoch-schonlein purpura (accompanied with or without nephritis), anaphylactic shock, allergic eruption, angioedema, local allergic reaction and so on. Conclusion The results of this study show that meningococcal vaccines may result in AEFI. However, most AEFI are temporary and can be cured after treatment in time. In general, meningococcal vaccine is safe, but monitoring and treatment for AEFI are necessary.
Objective To evaluate tissue regeneration, body reaction, and biological safety of xenogeneous bladder acellular matrix (BAM) that can be used to repair rabbit bladder. Methods Porcine BAM was prepared through physical, chemical, and enzymatic methods, and the effects of acellularization and the structure were observed with HE staining and scanning electron microscope (SEM). Eighteen New Zealand white rabbits (weighing, 2.5-3.0 kg) undergoing partial cystectomy were randomly divided into 2 groups. After partial (about 30%) cystectomy, the porcine BAM was used to replace partial rabbit bladder in the experimental group (n=12), and the incision was directly sutured as control group (n=6). The survival condition of animals was observed after operation. At 15 days, 1, 2, 3, and 6 months after operation, the blood routine, renal function, and electrolyte were tested by collecting the blood samples. At 1, 2, 3, and 6 months after operation, maximum bladder capacity, bladder leak point pressure, and bladder compliance were measured through urodynamic studies. Then gross observation was performed for regeneration of bladder, and the specimens of the bladder were harvested for HE staining and immunohistochemical staining. The surrounding organs and local lymphoid tissues were harvested for gross observation and HE staining. Results Cell components were completely removed in the porcine BAM, showing three-dimensional porous structure under SEM. All the animals survived during the experiment. At 15 days after operation, white blood cell count increased, and then returned to normal level in 2 groups, showing no significant difference between 2 groups (P gt; 0.05). The tests of renal function and electrolyte suggested no significant difference between 2 groups (P gt; 0.05). The level of serum creatinine showed a tendency of increase, but it remained within normal range at 6 months after operation. The maximum bladder capacity and compliance in experimental group were significantly higher than those in control group at 3 and 6 months after operation (P lt; 0.05), but no significant difference in bladder leak point pressure at each time point between 2 groups (P gt; 0.05). The urothelial regeneration, smooth muscle regeneration, and blood vessel regeneration were seen by histological observation in 2 groups. In the 2 groups, chronic inflammatory cells infiltration could be observed at 1 month postoperatively, and then chronic inflammatory cells decreased significantly (P lt; 0.05), until complete disappearance. There was no significant difference in score of chronic inflammatory cell infiltration between 2 groups at 3 and 6 months after operation (P gt; 0.05). The α-smooth muscle actin expression was significantly increased with time passing in 2 groups (P lt; 0.05), and it was significantly higher in control group than in experimental group at each time point (P lt; 0.05). In addition, gross and HE staining observations showed no abnormalities in surrounding organs and local lymphoid tissues. Conclusion No immune rejection response occurs when porcine BAM is used for xenotransplantation. It is indicated that porcine BAM is relative safety for xenotransplantation.
After the May 12th Wenchuan earthquake, the Department of Architecture and Operation of West China Hospital took prompt action to examine the damage of the hospital buildings. And then experts were invited to perform a safety evaluation of all the hospital buildings. Meanwhile, a real-time monitoring system was initiated to identify any subsequent damage caused by after-shocks. In timely response to the clinical demand, potential dangers were removed so as to ensure the medical rescue work for the wounded.
Objective To systematically evaluate the safety profiles of anti-seizure medications (ASMs) regarding metabolic adverse events in the pediatric population, identify risk signals across different age stages, and provide evidence-based support for clinical individualized medication and pharmacovigilance. MethodsData from the Food and Drug Administration (FDA) adverse event reporting system (FAERS) spanning Q1 2013 to Q3 2024 were analyzed. Reports involving metabolic adverse events in patients aged 0~18 years after ASMs use were screened. Data mining methods, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN), were applied. Standardized classification was performed using the Medical Dictionary for Regulatory Activities (MedDRA) v26.1 to analyze adverse reaction signals across metabolic pathways, including glucose, lipids, proteins/amino acids, and bone/calcium/phosphorus/magnesium, as well as trace metals. Stratified safety evaluations were conducted across four age groups: infants (0~2 years), toddlers (2~6 years), children (6~2 years), and adolescents (12~18 years). ResultsA total of 2,356 metabolic adverse event reports were included. Significant signals were observed for protein and amino acid metabolism disorders (ROR=5.44), bone/calcium/magnesium/phosphorus metabolism disorders (ROR=1.59), and iron/trace metal metabolism disorders (ROR=1.83), with some signals being specific to the pediatric population. Several drugs, including valproate, topiramate, levetiracetam, and gabapentin, showed strong risk signals across multiple metabolic pathways, primarily manifesting as hyperammonemia, hypocalcemia, and hypomagnesemia. Risk profiles varied significantly by age group: lacosamide showed prominent signals for bone metabolism disorders in the 0~2 years group; perampanel showed significant signals for amino acid metabolism disorders in the 2~6 years group; and in the 12~18 years group, clonazepam and gabapentin showed extremely high ROR values (>48) for iron/trace metal metabolism disorders. The median onset time for metabolic adverse events associated with novel ASMs was significantly later than that of traditional ASMs (38 days vs. 8 days), suggesting a relatively delayed but prolonged metabolic toxicity for newer agents. ConclusionThe use of ASMs in minors can trigger multi-system metabolic disturbances, with significant differences in risk profiles across different drugs and age groups. We recommend strengthening the dynamic monitoring of metabolic parameters during treatment, with particular attention to the potential toxicity of high-risk drugs within specific age windows, thereby promoting the establishment of precision dosing and early intervention strategies.