Hemorrhage induced by antithrombotic agents: new insights from a real-world pharmacovigilance study.

BACKGROUND: Hemorrhage represents the most common and serious side effect of antithrombotic agents. Many studies have compared the risk of bleeding between different antithrombotic agents, but analysis of time-to-onset for hemorrhage induced by these drugs is yet sparse. METHODS: We conducted a retrospective study based on the adverse drug reaction reports on antithrombotic agents collected by the Henan Adverse Drug Reaction Monitoring Center. We assessed the reporting odds ratio to determine the disproportionate reporting signals for bleeding and the Weibull shape parameter was used to evaluate the time-to-onset data. RESULTS: In the signal detection, crude low molecular weight heparin-hemorrhage was found as a positive signal. The hemorrhage for most antithrombotic agents was random failure profiles. In particular, the hazard of hemorrhage decreased over time for warfarin and clopidogrel and increased for alteplase, nadroparin, and dipyridamole. CONCLUSION: We found that the risk of bleeding in patients taking Crude low molecular weight heparins was significantly higher compared to other antithrombotic agents, but with a small magnificence, which may be attributed to the severely irrational use of this medication under improper management. Statistics in days, results showed that the risk of bleeding decreased over time for warfarin and clopidogrel and increased for alteplase, nadroparin, and dipyridamole.

Safety of Using Traditional Chinese Medicine Injections in Primary Medical Institutions: Based on the Spontaneous Reporting System 2016-2020 in Henan Province, China.

Objective: Traditional Chinese medicine (TCM) injection is widely used, but its adverse drug reaction (ADR) may be a serious public health concern in primary medical institutions. This research will explore the safety of TCM injections and provide clinical recommendations at the primary medical institutions. Method: ADR data were collected by the Henan Adverse Drug Reaction Monitoring Center from 2016 to 2020 were analized Descriptive statistics, chi-square analysis, binary logistic regression, and Mantel-haenszel hierarchical analysis were used to identify the risk factors associated with the rational use of TCM injections in primary medical institutions. Results: A total of 30,839 cases were collected in this study, 4905 cases (15.90%) were SADRs. Patients using TCM injections in primary medical institutions were more likely to cause SADRs (OR = 1.149, 95% CI: 1.061-1.245). Aged over 60 years (OR = 1.105, 95% CI: 1.007-1.212), non-essential drugs (OR = 1.292, 95% CI: 1.173-1.424), autumn (OR = 1.194, 95% CI: 1.075-1.326) and TCM injections with safflower (OR = 1.402, 95% CI: 1.152-1.706), danshen (OR = 1.456, 95% CI: 1.068-1.984) and medication reasons with chemotherapy (OR = 2.523, 95% CI: 1.182-5.386) and hypertension (OR = 1.495, 95% CI: 1.001-2.233) were more likely to suffer SADR in primary medical institutions. Conclusion: In general, the number of reported cases of TCM injection was declining over time, but the proportion of SADRs in primary medical institutions increased. In the future, it is necessary to continue to restrict TCM injections at the macro policy level, and vigorously promote the varieties in the essential drug list. At the micro level, it is necessary to intervene in specific populations, specific diseases and specific drugs, first start with them, step by step, and effectively prevent SADR occurrences in primary medical institutions.

Corrigendum: Suspected Adverse Drug Reactions in Pediatric Cancer Patients in China: An Analysis of Henan Province Spontaneous Reporting System Database.

[This corrects the article DOI: 10.3389/fonc.2021.807171.].

The severity of adverse drug reactions and their influencing factors based on the ADR monitoring center of Henan Province.

Adverse drug reactions (ADRs) may be a serious public health problem and have received widespread attention in recent years. This study has analyzed the factors leading to the occurrence of serious ADRs (SADRs), determined the factors affecting the prognosis of patients with severe adverse reactions at different levels of medical institutions, and finally made corresponding recommendations for the monitoring, prevention, and treatment of SADRs. We used descriptive analysis and chi-square test to analyze the year, age, gender, proportion of SADRs, and the results of the ADRs in the report. Use the logistic regression to analyze the factors affecting the prognosis of SADRs in different levels of medical institutions. A total of 387 642 people's 394 037 ADRs were collected from the Henan Provincial Adverse Drug Reaction Monitoring Center from 2016 to 2020. Among them 35 742 cases of serious ADRs (9.1%), 96.1% were eventually relieved or cured, but 39 cases of SADRs caused death. The main causes of death included hemorrhages, organ failure, and allergies. Age, number of medication and illnesses, level of medical institution, history of adverse reactions, and type and method of medication were all factors that affected the severity of ADR. The prognosis of SADRs is worse than normal ADRs. The ADRs in autumn and winter and new adverse reactions are unique risk factors found in this study. The elderly and patients with multiple diseases or taking multiple drugs should pay attention to their adverse reactions. They should be closely observed within a week after taking the medicine. The supervision of patients with a history of allergies and new adverse reactions should be strengthened by primary medical institutions, and in nonprimary medical institutions should paid attention with past medical histories, and use imported drugs and biological agents with caution to ensure the safety and health of patients.

Screening Tools Based on Nomogram for Diabetic Kidney Diseases in Chinese Type 2 Diabetes Mellitus Patients.

BACKGROUND: The influencing factors of diabetic kidney disease (DKD) in Chinese patients with type 2 diabetes mellitus (T2DM) were explored to develop and validate a DKD diagnostic tool based on nomogram approach for patients with T2DM. METHODS: A total of 2,163 in-hospital patients with diabetes diagnosed from March 2015 to March 2017 were enrolled. Specified logistic regression models were used to screen the factors and establish four different diagnostic tools based on nomogram according to the final included variables. Discrimination and calibration were used to assess the performance of screening tools. RESULTS: Among the 2,163 participants with diabetes (1,227 men and 949 women), 313 patients (194 men and 120 women) were diagnosed with DKD. Four different screening equations (full model, laboratory-based model 1 [LBM1], laboratory-based model 2 [LBM2], and simplified model) showed good discriminations and calibrations. The C-indexes were 0.8450 (95% confidence interval [CI], 0.8202 to 0.8690) for full model, 0.8149 (95% CI, 0.7892 to 0.8405) for LBM1, 0.8171 (95% CI, 0.7912 to 0.8430) for LBM2, and 0.8083 (95% CI, 0.7824 to 0.8342) for simplified model. According to Hosmer-Lemeshow goodness-of-fit test, good agreement between the predicted and observed DKD events in patients with diabetes was observed for full model (χ2=3.2756, P=0.9159), LBM1 (χ2=7.749, P=0.4584), LBM2 (χ2=10.023, P=0.2634), and simplified model (χ2=12.294, P=0.1387). CONCLUSION: LBM1, LBM2, and simplified model exhibited excellent predictive performance and availability and could be recommended for screening DKD cases among Chinese patients with diabetes.

Suspected Adverse Drug Reactions in Pediatric Cancer Patients in China: An Analysis of Henan Province Spontaneous Reporting System Database.

INTRODUCTION: Adverse drug reactions (ADRs) in pediatric cancer patients have not yet received due attention in the world. Antineoplastic drugs are frequently related to ADRs. Few studies focus on the ADR and the intervention measures in pediatric cancer patients. METHODS: ADR reports submitted to Henan Adverse Drug Reaction Monitoring Center from 2016 to 2020 for individuals aged from birth to 17 years (including 17 years) were included. Data were analyzed with respect to gender, age, disease types, past history of ADR, occurrence time of ADR, polypharmacy, route of administration, off-label drug use, name of suspected drugs per ADR report, and severity of ADR reports. RESULTS: A total of 431 ADR reports related to antineoplastic drugs in pediatric patients were collected, 31.55% were serious ADRs (SADRs). The median age of patients was six years (inter quartile range, IQR: 3-11), the age groups with higher reporting rates were concentrated in 1-3-year-olds (130). Past history of ADR, occurrence time of ADR and polypharmacy were statistically associated with SADR. Myelosuppression was the most frequent ADR (15.55%), cytarabine was the most frequent drug (26.22%). The signal mining method produced 14 signals, three signals were off-label ADRs. CONCLUSIONS: This study described the characteristics of ADRs in pediatric cancer patients. By conducting signal mining method, three off-label ADRs need further study. We should pay more attention to these ADRs and develop relative management strategies. More researches are needed to achieve a better understanding of the characteristics of ADRs in pediatric cancer patients of China.

Safety Profile of Monoclonal Antibody Compared With Traditional Anticancer Drugs: An Analysis of Henan Province Spontaneous Reporting System Database.

Introduction: Monoclonal antibody (mAb) is an important treatment option for cancer patients and has received widespread attention in recent years. In this context, a comparative safety evaluation of mAbs and traditional anticancer drugs in real-world is warranted. Methods: ADR reports submitted to Henan Adverse Drug Reaction Monitoring Center from 2016 to 2020 for individuals taking antineoplastic drugs were included. Data were analyzed with respect to demographic characteristics, disease types, polypharmacy, past history of ADRs, system organ class, name of suspected drugs per ADR report, severity, result, impact on the primary disease, and biosimilars. Results: A total of 15,910 ADR reports related to antineoplastic drugs were collected, 575 (3.61%) cases were related to mAbs. Female had more reports of ADRs than male. The ADRs of non-mAbs mainly occurred in 1-3 days after injection (4,929, 32.15%), whereas those of mAbs mainly occurred on the same day (297, 51.65%). Serious ADRs accounted for 30.26% (n = 174) of mAb-related reports and 34.46% (n = 5,285; four death cases) of non-mAb-related reports, respectively. A total of 495 (86.08%) reports were related to the branded drugs of mAbs. In general, our findings indicate that the female, the population aged 60-79 years, people with a single disease, people who have no ADRs in the past and people who have received treatment regimens were less likely to be affected by the primary disease after receiving mAbs therapy. The signal mining method produced 14 signals, only Sintilimab-Hepatic failure was off-label ADR. Conclusion: This study partly confirmed the safety profile of mAbs. It is unlikely to affect groups such as the female, the population aged 60-79 years, people with a single disease, people who have no ADRs in the past and people who have received treatment regimens. Combined drugs have little effect on the primary disease. By conducting signal mining method, 14 signals were produced, and only one of them was off-label ADR.

Perceived psychosocial health and its sociodemographic correlates in times of the COVID-19 pandemic: a community-based online study in China.

BACKGROUND: Coronavirus disease 2019 (COVID-19) pandemic has been affecting people's psychosocial health and well-being through various complex pathways. The present study aims to investigate the perceived psychosocial health and its sociodemographic correlates among Chinese community-dwelling residents. METHODS: This cross-sectional survey was carried out online and using a structured questionnaire during April 2020. In total, 4788 men and women with the age range of 11-98 years from eight provinces in eastern, central and western China were included in the analysis. We adopted a tactical approach to capture three key domains of perceived psychosocial health that are more likely to occur during a pandemic including hopelessness, loneliness, and depression. Multiple regression method, binary logistic regression model and variance inflation factor (VIF) were used to conduct data analysis. RESULTS: Respectively 34.8%, 32.5% and 44.8% of the participants expressed feeling more hopeless, lonely, and depressed during the pandemic. The percentage of all three indicators was comparatively higher among women than among men: hopelessness (50.7% vs 49.3%), loneliness (52.4% vs 47.6%), and depression (56.2% vs 43.8%). Being married was associated with lower odds of loneliness among men (odds ratio [OR] = 0.63, 95% CI: 0.45-0.90). Loneliness was negatively associated with smoking (OR = 0.67, 95% CI: 0.45-0.99) and positively associated with drinking (OR = 1.45, 95% CI: 1.04-2.02). Compared with those in the lowest income bracket (< CNY 10 000), men (OR = 0.34, 95% CI: 0.21-0.55) and women (OR = 0.36, 95% CI: 0.23-0.56) in the highest level of annually housed income (> CNY 40 000) had the lowest odds of reporting perceived hopelessness (OR = 0.35, 95% CI: 0.25-0.48). Smoking also showed negative association with depression only among men (OR = 0.63, 95% CI: 0.43-0.91). CONCLUSIONS: More than one-third of the participants reported worsening in the experience of hopelessness and loneliness, with more than two-fifth of worsening depression during the pandemic compared with before the outbreak. Several socioeconomic and lifestyle factors were found to be associated with the outcome variables, most notably participants' marital status, household income, smoking, alcohol drinking, existing chronic conditions. These findings may be of significance to treat patients and help them recover from the pandemic.

Additional common loci associated with stroke and obesity identified using pleiotropic analytical approach.

Stroke is a complex disease with multiple etiologies. Numerous studies suggest an established association between obesity and stroke, which may partly arise from the shared genetic components between the two phenotypes. Despite genome-wide association studies (GWASs) have identified some loci associated with stroke and obesity individually, the estimated genetic variability explained by these loci is limited (especially for stroke) and the pleiotropic loci between them are largely unknown. In this study, we jointly applied the pleiotropy-informed conditional false discovery rate (cFDR) method and the genetic analysis incorporating pleiotropy and annotation (GPA) method on summary statistics of two large GWASs to detect the genetic overlap between stroke (n = 446,696) and obesity (n = 681,275). Stratified Q-Q and fold-enrichment plots showed strong pleiotropic enrichment between the two phenotypes. With cFDR < 0.05 and fdr.GPA < 0.2, we identified 24 (16 novel) stroke-associated SNPs and 12 (10 novel) of them to be potentially pleiotropic SNPs for both phenotypes. The corresponding genes were enriched in trait-associated gene ontology (GO) terms "brain development" and "negative regulation of transport". In conclusion, our study demonstrated the feasibility and effectivity of the two pleiotropic methods which successfully improved the genetic discovery by incorporating related GWAS datasets and validated the genetic intercommunity between stroke and obesity. The identification of pleiotropic loci may provide us any new insights into potential genetic and etiology mechanism between them for the further studies.