Predictive value of the coronary artery calcium score and advanced plaque characteristics: Post hoc analysis of the PREDICT registry

BackgroundWhether coronary plaque characteristics assessed in coronary computed tomography angiography (CCTA) in association with the coronary artery calcium score (CACS) have predictive value for coronary events is unclear. We aimed to examine the predictive value of the CACS and plaque characteristics for the occurrence of coronary events.MethodsAmong 2802 patients who were analyzed in the PREDICT registry, 2083 with suspected coronary artery disease (CAD) were studied using post hoc analysis. High-risk plaques were defined as having ≥2 adverse characteristics, such as low computed tomographic attenuation, positive remodeling, spotty calcification, and napkin-ring sign. An adjudicative composite of coronary events (cardiac death, nonfatal acute coronary syndrome, and coronary revascularization ≥3 months after indexed CCTA) were analyzed.ResultsSeventy-three (3.5%) patients had coronary events and 313 (15.0%) had high-risk plaques. Multivariate Cox proportional hazard analysis showed that high-risk plaques remained an independent predictor of coronary events (adjusted hazard ratio [HR] 1.95, 95% confidence interval [CI] 1.13–3.34, P ?= ?0.0154), as well as the log-transformed CACS (adjusted HR 1.24, 95% CI 1.11–1.39, P ?= ?0.0002) and the presence of obstructive stenosis (adjusted HR 5.63, 95% CI 3.22–10.12, P 0.0001). In subgroup analyses, high-risk plaques were independently predictive only in the low CACS class (<100).ConclusionThis study shows that assessment of adverse features by coronary plaque imaging independently predicts coronary events in patients with suspected CAD and a low CACS. Our findings suggest that the clinical value of high-risk plaques to CACS and stenosis assessment appears marginal.     

纤维支气管镜灌洗联合常规药物治疗变应性支气管肺曲霉病患者的效果

目的:观察纤维支气管镜灌洗联合常规药物治疗变应性支气管肺曲霉病(ABPA)患者的效果。方法:选取94例ABPA患者作为研究对象,按照随机数字表法分为观察组和对照组各47例。对照组采取常规药物治疗,观察组在对照组的基础上联合纤维支气管镜灌洗治疗。比较两组临床疗效和不良反应发生率。结果:观察组治疗总有效率为89.36%(42/47),明显高于对照组的72.34%(34/47),差异有统计学意义(P<0.05);两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:纤维支气管镜灌洗联合常规药物治疗ABPA患者的效果优于单纯常规药物治疗,且安全性好。     

Immune Checkpoint Inhibitor Toxicities

Immune checkpoint inhibitors are molecules that increase the endogenous immune response against tumors. They have revolutionized the field of oncology. Since their initial approval for the treatment of advanced melanoma, their use has expanded to the treatment of several other advanced cancers. Unfortunately, immune checkpoint inhibitors have also been associated with the emergence of a new subset of autoimmune-like toxicities, known as immune-related adverse events. These toxicities differ depending on the agent, malignancy, and individual susceptibilities. Although the skin and colon are most commonly involved, any organ may be affected, including the liver, lungs, kidneys, and heart. Most of these toxicities are diagnosed by excluding other secondary infectious or inflammatory causes. Corticosteroids are commonly used for treatment of moderate and severe immune-related adverse events, although additional immunosuppressive therapy may occasionally be required. The occurrence of immune-related toxicities may require discontinuation of immunotherapy, depending on the specific toxicity and its severity. In this article, we provide a focused review to familiarize practicing clinicians with this important topic given that the use of immune checkpoint inhibitors continues to increase.     

丁苯酞对急性缺血性脑卒中患者淋巴细胞亚群的影响研究

目的 探讨丁苯酞对急性缺血性脑卒中患者淋巴细胞亚群变化情况的影响。方法 选取2017年1月～2018年12月期间在本院就诊的99例急性缺血性脑卒中患者,分为对照组(n=48)和研究组(n=51),对照组接受常规治疗,研究组在常规治疗基础上联合使用丁苯酞软胶囊。于治疗前后测定淋巴细胞亚群变化情况,同时对脑梗死面积、Barthel指数、美国国立卫生研究院脑卒中量表(NIHSS)评分进行比较,计算不良反应发生率。结果治疗后两组CD3+、CD4+、CD4+/CD8+水平较治疗前明显上升(P0.05),且治疗后研究组CD3+、CD4+、CD4+/CD8+水平明显高于对照组(P0.05);治疗后两组脑梗死面积较治疗前均明显变小(P0.05),Barthel指数评分较治疗前均明显增大(P0.05),NIHSS评分较治疗前均明显减小(P0.05),且治疗后研究组脑梗死面积小于对照组(P0.05),Barthel指数评分大于对照组(P0.05),NIHSS评分小于对照组(P0.05);研究组不良反应发生率(1.96%)与对照组不良反应发生率(4.17%)比较,差异无统计学意义(P0.05)。结论 急性缺血性脑卒中使用丁苯酞,则CD3+、CD4+、CD8+水平改善程度更加明显,细胞免疫功能恢复良好,缩小脑梗死面积,改善神经功能缺损,恢复日常生活能力,安全性好。     

Adverse drug reaction reporting in institutions across six Chinese provinces: a cross-sectional study

Background: Although China’s adverse drug reaction (ADR) reporting and monitoring has developed rapidly, many challenges remain. This study assessed ADR monitoring and reporting in China and identified monitoring problems.

Research design and methods: A cross-sectional survey was conducted of ADR reporting institutions in six Chinese provinces in April–December 2014. Questionnaires assessed ADR systems, basic resources, and pharmacovigilance activity.

Results: Of 720 questionnaires distributed, the response rate was 81.8%. About 93% (n = 371) of pharmaceutical companies and medical institutions had established ADR monitoring departments/units. Few institutions (26%, n = 104) allocated an ADR budget; 7% (n = 30) had received ADR monitoring funding in the last year (2013). Almost all institutions (99%, n = 555) had computers and 47% (n = 263) had a network database. Many institutions conducted public education about drug safety (49%, n = 283), medicine utilization reviews/quality surveys (28%, n = 158), and medicine consultation services (88%, n = 511). Institutions in eastern, central, and western China differed significantly on implementation of existing regulations and pharmacovigilance activities.

Conclusions: The institutions surveyed have established ADR monitoring systems. However, these systems have flaws. Urgent improvements are needed in funding, basic resources, reporting processes, and other pharmacovigilance activities.     

Colitis following the use of immune checkpoint inhibitors: A real-world analysis of spontaneous reports submitted to the FDA adverse event reporting system

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.     

Management of hip fracture in COVID-19 infected patients

Given that the global population of elderly individuals is expanding and the difficulty of recovery, hip fractures will be a huge challenge and a critical health issue for all of humanity. Although people have spent more time at home during the coronavirus disease 2019 (COVID-19) pandemic, hip fractures show no sign of abating. Extensive studies have shown that patients with hip fracture and COVID-19 have a multifold increase in mortality compared to those uninfected and a more complex clinical condition. At present, no detailed research has systematically analyzed the relationship between these two conditions and proposed a comprehensive solution. This article aims to systematically review the impact of COVID-19 on hip fracture and provide practical suggestions. We found that hip fracture patients with COVID-19 have higher mortality rates and more complicated clinical outcomes. Indirectly, COVID-19 prevents hip fracture patients from receiving regular medical treatment. With regard to the problems we encounter, we provide clinical recommendations based on existing research evidence and a clinical flowchart for the management of hip fracture patients who are COVID-19 positive. Our study will help clinicians adequately prepare in advance when dealing with such patients and optimize treatment decisions.