National comprehensive cancer network recommendations for drugs without US food and drug administration approval in metastatic breast cancer: A cross-sectional study

BackgroundNational Comprehensive Cancer Network (NCCN) guidelines can include recommendations for off-label use of anti-cancer drugs. Here, we evaluate NCCN recommendations not supported by US Food and Drug Administration (FDA) approval and explore associations with such recommendations.MethodsAll NCCN recommendations for MBC and their supporting data were identified. Drug labels were reviewed to determine whether recommendations are FDA approved. Logistic regression was used to compare FDA approved and off-label recommendations for pre-specified categories, including drug type, tumor subtype, level of recommendation and line of therapy.ResultsOf 124 recommendations identified, 68 (55%) were off-label. Chemotherapy and human epidermal growth factor receptor 2 (HER2) targeted drugs were associated with lower odds of FDA approval (OR = 0.28, p = 0.001 and OR = 0.29, 95% p = 0.005, respectively). Recommendations for endocrine therapy (OR = 3.44, p = 0.009) and non-HER2 targeted treatment (OR = 10.0, p < 0.001) were more commonly FDA approved indications. Compared to combination therapies, monotherapies were more likely to be FDA approved (OR = 3.45, p = 0.001) as were category 1 (OR = 7.63, p = 0.001) and preferred NCCN recommendations (OR = 4.07, p < 0.001). Compared to off-label recommendations, NCCN recommendations of approved drugs were based on significantly higher sample size (mean 477 vs. 342 patients, p = 0.02) and were non-significantly associated with availability of randomized data (OR = 2.0, 95% CI 0.89–4.49, p = 0.09).ConclusionMore than half of all NCCN recommendations for MBC are off-label, mostly involving chemotherapy containing regimes for HER2 negative disease and combinations which include HER2-targeted drugs. Improved transparency of NCCN guidelines may result from reporting of the strength of the evidence supporting recommendations for MBC.     

心房颤动射频消融术后心脏损伤后综合征1例治疗心得及文献复习

对我院心脏中心2018年5月诊断的1例心房颤动射频消融术后心脏损伤后综合征的临床资料进行回顾性分析,并对国内外相关文献进行复习。患者RFCA术后早期出现胸腔积液、炎性标志物升高,拟诊断为RFCA术所致心脏损伤后综合征(postcardiac injury syndrome,PCIS),应用皮质类固醇激素后胸腔积液吸收。PCIS患者一般情况下预后良好。有明显发热、胸痛症状的患者,可予非甾体类消炎镇痛药物(如吲哚美辛)等对症处理。早期应用皮质类固醇激素对有心包积液和胸腔积液的患者有良好的治疗效果。     

Pathogenesis of chronic lymphocytic leukemia and the development of novel therapeutic strategies

Chronic lymphocytic leukemia (CLL) is the most common adult leukemia in Western countries and is characterized by the clonal expansion of mature CD5⁺ B cells. There have been substantial advances in the field of CLL research in the last decade, including the identification of recurrent mutations, and clarification of clonal architectures, signaling molecules, and the multistep leukemogenic process, providing a comprehensive understanding of CLL pathogenesis. Furthermore, the development of therapeutic approaches, especially that of molecular target therapies against CLL, has markedly improved the standard of care for CLL. This review focuses on the recent insights made in CLL leukemogenesis and the development of novel therapeutic strategies.     

经支气管镜介入治疗气管支气管结核的效果

目的 探讨对气管支气管结核患者选择经支气管镜介入+抗结核药物治疗后获得的临床效果.方法 选择医院2017年3月—2019年4月收治的78例气管支气管结核患者作为试验对象;数字奇偶法分组后探究每组治疗方法;比照组(39例):选择抗结核药物展开疾病治疗;试验组(39例):选择经支气管镜介入+抗结核药物展开疾病治疗;最终就组间气管支气管结核组间治疗结果 差异展开对比.结果 试验组气管支气管结核患者治疗总有效率(97.44%)高于比照组(74.36%)明显(P<0.05).结论 气管支气管结核患者于临床接受经支气管镜介入+抗结核药物治疗后,利于结核疗效提升,可促进气管支气管结核患者康复进程缩短.     

Impact of pharmaceutical price controls on the cost of cardiovascular drugs: does essentiality matter?

ABSTRACT

Background

With the goal of improving the affordability of medicines, governments across the globe have instituted various forms of price controls. Since 2013, India has been regulating the prices of drugs included in its national list of essential medicines (NLEM). Here we evaluate the cost variations among available cardiovascular drugs and perform cost-analysis comparing essential and non-essential drugs.     

A pilot study of levonorgestrel concentrations and bleeding patterns in women with epilepsy using a levonorgestrel IUD and treated with antiepileptic drugs

Objectives

We explored levonorgestrel (LNG) concentrations, bleeding patterns and endometrial thickness in women with epilepsy (WWE) initiating an LNG-intrauterine device (IUD) co-administered with antiepileptic drugs (AEDs).

MRI characteristics of MOG-Ab associated disease in adults: An update

Our knowledge of the radiological spectrum of myelin oligodendrocyte glycoprotein antibody associated disease (MOGAD) is growing rapidly. An update on the radiological features of the disease, and its evolution is thus necessary. Magnetic resonance imaging (MRI) has an increasingly important role in the differential diagnosis of MOGAD particularly from aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder (AQP4-NMOSD), and multiple sclerosis (MS). Differentiating these conditions is of prime importance because the management is different between the three inflammatory diseases, and thus could prevent further attack-related disability. Therefore, identifying the MRI features suggestive of MOGAD has diagnostic and prognostic implications. We herein review optic nerve, spinal cord and the brain MRI findings from MOGAD adult patients, and compare them to AQP4-NMOSD and MS.