Analysis and suggestion on adverse events of active medical devices in Shandong province / 中华医院管理杂志

Objective:To analyze the characteristics of adverse events of active medical devices in Shandong province, as well as the impact of device use duration on the risk rate of adverse events, for reference in improving the monitoring system of active medical device adverse events in China and the level of hospital medical quality management.Methods:The data came from the adverse event reporting data of active medical devices collected by Shandong Adverse Drug Reaction Monitoring Center from January 2019 to October 2021. The R software was used to analyze the distribution, cause and severity of adverse events, and a linear regression model of adverse event risk rate(Y) and adverse event time point(X) was established.Results:A total of 35 254 adverse events of active devices were included, of which 3 059 were serious injuries. The province/municipality with the largest number of reported adverse events was Shanghai(8 006 cases), and the least was Hainan province(4 cases); The majority of adverse events were reported by hospitals, with 34 056(96.60%). The medical devices reporting a higher number of adverse events were ventilators(688 cases), monitors(4 623 cases), infusion pumps(1 079 cases), syringe infusion pumps(1 995 cases), medical electron accelerators(529 cases)and infant incubators(513 cases). In the linear regression model, the risk rate of adverse events increased with the useduration of the device when 0.00%≤ X<14.14%; the risk rate of adverse events decreased with the increase of service time when 14.14%≤ X<100.00%. Conclusions:The number of adverse events reported in each province is different, and hospitals are the main reporting units.The causes of adverse events of different medical devices indicate different correlation strengths with the product itself. The use duration of medical devices poses a great impact on the risk rate of adverse events.

Lipids, Anthropometric Measures, Smoking and Physical Activity Mediate the Causal Pathway From Education to Breast Cancer in Women: A Mendelian Randomization Study / 한국유방암학회지

Purpose@#We aimed to investigate whether obtaining a higher level of education was causally associated with lower breast cancer risk and to identify the causal mechanism linking them. @*Methods@#The main data analysis used publicly available summary-level data from 2 large genome-wide association study consortia. Mendelian randomization (MR) analysis used 65 genetic variants derived from the Social Science Genetic Association Consortium as instrumental variables for years of schooling. The outcomes from the Breast Cancer Association Consortium (BCAC) were the overall breast cancer risk (122,977 cases/105,974 controls in women) and the two subtypes: estrogen receptor (ER)-positive breast cancer and ER-negative breast cancer. Fixed and random effects inverse variance weighted methods were used to estimate the causal effects, along with other additional MR methods for sensitivity analyses. @*Results@#Results showed that each additional standard deviation of 4.2 years of education was causally associated with a 27% lower risk of ER-negative breast cancer (odds ratio, 0.73; 95% confidence interval, 0.64–0.84; p-value 10 minutes explain a small part of the causal effect of education on the risk of developing breast cancer, and their mediation proportion is approximately 1%. @*Conclusion@#A low level of education is a causal risk factor in the development of breast cancer as it is associated with poor lipid profile, obesity, smoking, and types of physical activity.

Determination of 8 Kinds of Cephalosporins in Aquatic Products by Multi-walled Carbon Nanotubes Solid Phase Extraction-Ultra High Performance Liquid Chromatography-Mass Spectrometry / 分析化学

An ultra-high performance liquid chromatography-mass spectrometry ( UPLC-MS/MS) method was developed for the determination of 8 kinds of cephalosporins, cefoperazone, cefquinome, cefalonium, cefazolin, cefapirin, Ceftiofur, cefpirome and cefalexin, in edible parts of aquatic products. The samples were extracted with acetonitrile-water and cleaned up by multi-walled carbon nanotubes ( MwCNTs) SPE cartridge. All the target compounds were separated on an Acquity Xselect CSH C18 column with gradient elution by using acetonitrile and 0. 1% formic acid aqueous as eluent, and detected by UPLC-MS/MS under ESI+ ionization and MRM mode. Under optimized conditions, this method had a good linearity (R2≥0. 995) and the limits of quantification were in the range of 2-10 μg/kg ( S/N=10 ) . The recoveries of the method for the target compounds spiked at three different levels were 67. 3%-94. 2% with the relative standard deviations (RSDs) of 3. 3%-14%. The method had the characteristics of low cost, high accuracy and good precision, and could meet the requirements of cephalosporins determination.