BackgroundAlthough colitis has been reported in patients treated with immune checkpoint inhibitors (ICIs), associations between colitis and ICIs had not been thoroughly assessed in real-world studies. Here, we identified and characterized significant colitis-associated with ICIs.MethodsBased on the Food and Drug Administration Adverse Event Reporting System (FAERS) from January 2004 to December 2019, the disproportionality analysis and Bayesian analysis, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN) and the multi-item gamma Poisson shrinker (MGPS) algorithms were adopted to data mining of the suspected adverse events of colitis after ICIs administrating. Clinical characteristics of patients with ICIs-associated colitis and the time to onset of colitis following different ICI regimens were collected.ResultsA total of 3786 reports of colitis adverse events were identified with ICIs. Seven ICI monotherapies were associated with the reporting of colitis. Statistically significant ROR, PRR, information component (IC), and empirical Bayesian geometric mean (EBGM) emerged for all ICI monotherapies and combination therapies. ICIs-associated colitis affected mostly male (53.51%), with a wide mean age range (60.65 to 72 years). Colitis adverse events were commonly reported in patients with melanoma and lung cancer. Adverse outcomes of colitis concerning ICI were mainly outcomes of hospitalization-initiated or prolonged and other serious. Among colitis cases, 17.43% cases of colitis concerning ICI lead to death. The adverse event of colitis occurred earliest in ipilimumab monotherapy with a median time to onset of 64.21 days (IQR: 27–69 days) among all monotherapies.ConclusionsICI may lead to severe and disabling ICIs-associated colitis during therapy. Analysis of FAERS data identified signals for adverse events of colitis with ICI regimens. Practitioners should consider the factors that may increase the likelihood of colitis. The findings support a continued surveillance and risk factor identification studies. 相似文献
ObjectiveTo study two major molecular alterations in spontaneous abortions (SA) with unexplained etiology – fetal genomic anomalies and the endometrial expression of main angiogenic factors VEGFA/VEGFR2 and chemokines SDF-1/CXCR4.Materials and methodsWhole genome copy number analysis by arrayCGH or Next Generation Sequencing (NGS) was applied for detection of fetal genomic imbalances. The abortive decidua of SA without fetal aneuploidies was further investigated for expression levels of the abovementioned factors using real time PCR analysis. A total of 30 abortive materials were collected from spontaneous abortions after exclusion of known predisposing factors.ResultsIn 21 of 30 spontaneous abortions (70%), genomic anomalies were discovered by whole genome copy number analysis. Numerical anomalies were detected in 90% of aberrant cases, and in 10% - structural aberrations were revealed. An increased expression for essential factors of angiogenesis was identified in spontaneous abortions’ tissues - 3.44 times for VEGFA and 10.29 times for VEGFR2. We found an average of 14 times increase in the expression levels of SDF-1 and 3.21 times for its receptor CXCR4.ConclusionWe could suggest the occurrence of increased angiogenesis in SA without fetal aneuploidies, compared to the control tissues, which could lead to increased oxidative stress and fetal loss. 相似文献
Background: High-quality adverse drug reaction (ADR) reports are essential for conducting drug safety monitoring in pharmacovigilance. The study aim was to assess the current quality of ADR reports in western China, and to identify problems with ADR report quality.
Research design and methods: A sample of 1139 reports received by the Shaanxi ADR Monitoring Center from January 2015 to December 2017 was selected. ADR report quality was evaluated using an ADR report quality evaluation system.
Results: None of the reports were rated as excellent and 1.40% (n = 16) as good. Report quality was better for new and serious reports than for general reports. Medical institutions generated higher quality reports than pharmaceutical manufacturers. Nurses generated higher quality reports than doctors, pharmacists, and other professionals. Reporters of different occupations showed significant differences in the quality of the indicators Reporting time limit, Intervention ADR time, ADR termination time, ADR intervention measures, Original disease, and Cause of medication (P = 0.000).
Conclusions: The ADR data quality was poor in western China, and of lower quality than reported data from previous research in other regions. Improvements in the quality and availability of ADR reports are urgently needed. 相似文献
PurposeThe provision of neonatal intensive care to infants born at 23 or 24 weeks' gestation poses medical, surgical and ethical challenges. Gastrointestinal perforation is a well-recognized complication of preterm birth, occurring most often as a result of necrotizing enterocolitis (NEC) or spontaneous intestinal perforation (SIP). Given the risk of morbidity and mortality in these ‘periviable’ infants, this complication may prompt transition from active management to palliative care. In our institution, the surgical care of periviable infants with gut perforation has not been dictated by gestational age. This study reports our outcomes.MethodsA retrospective cohort analysis of integrated neonatal medical and surgical care of all infants born between 23+ 0 and 24+ 6 weeks' gestation admitted to a tertiary level neonatal intensive care unit (NICU) during a 16 year period (2002–2017).ResultsA total of 198 periviable neonates (73 born at 23 weeks' gestation and 125 born at 24 weeks) were admitted during the 16-year period; most were inborn with only 26 retrieved from regional centers. Twenty-six of these infants developed gut perforation: 14 SIP, 8 NEC, 3 esophageal perforation and one after reduction of an incarcerated inguinal hernia. Twelve (46%) periviable infants with gut perforation survived to discharge home, seven of whom had no/mild disability at 2–3 years corrected gestational age. Of the 198 periviable infants admitted to NICU, 116 (58%) were alive at a corrected gestational age of 2–3 years and 29 of the 56 (51%) assessed had mild or no disability.ConclusionsIn the setting of combined medical and surgical care in a tertiary level NICU almost half of all periviable infants with a gut perforation survived, many with no/mild disability at 2–3 years corrected gestational age. Rigid protocols that rely on gestational age alone to guide treatment are not appropriate. These results support the contention that, when possible, extremely preterm infants should be born and cared for in units with combined medical and surgical expertise.Level of evidenceLevel III cohort study. 相似文献
Although an inverse relationship between body mass index (BMI) and baroreflex sensitivity (BRS) was found, the effect of waist circumference (WC) on BRS is still inconclusive. The contradictory results of previous studies may be related to the heterogeneity and relatively small sample size of the subjects examined. The aim of this population-based study was to investigate whether the influence of increased WC is more detrimental to BRS than BMI. A total of 760 community dwellers were recruited and they were classified into Q1 (n = 189), Q2 (n = 183), Q3 (n = 192) and Q4 (n = 196) groups, based on WC quartiles. Spontaneous BRS was determined by spectral α coefficient method. Valsalva ratio was the longest RR interval after release of Valsalva maneuver divided by the shortest RR interval during maneuver. Cardiac autonomic function was calculated by power spectrum of heart rate in low and high frequency (LF, 0.04–0.15 Hz; HF, 0.15–0.40 Hz), and LF/HF ratio in supine position for five minutes. There were significant differences in spontaneous BRS and Valsalva ratio among different WC groups. In multivariate analysis, obesity was inversely associated with spontaneous BRS and Valsalva ratio. However, these inverse relationships became insignificant after further adjustment for WC quartiles. In contrast, Q4 vs. Q1, Q3 vs. Q1 and Q2 vs. Q1 of WC were inversely related to spontaneous BRS. Q4 vs. Q1 and Q3 vs. Q1 of WC were negatively associated with the Valsalva ratio. In conclusion, increased and even high-normal WC had a stronger adverse effect on BRS than BMI, independent of cardio-metabolic risk factors. 相似文献
ObjectiveBrain arteriovenous malformation (BAVM) is defined as abnormal communication between cerebral of arteries and veins, without capillaries. Clinically, it may involve intracranial hemorrhage or seizures. Complete spontaneous resolution, known as BAVM disappearance, has been reported in rare cases.MethodsWe retrospectively collated all cases of BAVM in Lille University Hospital, from 2005 to 2018, and identified all cases of spontaneous BAVM disappearance on angiography (nidus and early venous drainage).ResultsThere were 4 cases of spontaneous BAVM disappearance, in 3573 patients: i.e., prevalence of 0.1%. Sex ratio was 2:2; ages ranged from 14 to 46 years; nidus size was generally small (< 20 mm); 3 of the 4 patients had superficial venous drainage. Revelation of BAVM was by hemorrhage in 3 cases and by seizure in 1. There were no cases of recanalization at 1 year's follow-up.ConclusionSpontaneous BAVM disappearance is rare. Associated factors may include small nidus, superficial venous drainage and hemorrhage. 相似文献