Ivermectin administration is associated with lower gastrointestinal complications and greater ventilator-free days in ventilated patients with COVID-19: A propensity score analysis

IntroductionCOVID-19 patients have been reported to have digestive symptoms with poor outcome. Ivermectin, an antiparasitic drug, has been used in COVID-19 patients. The objective of this study was to evaluate whether ivermectin has effects on gastrointestinal complications and ventilator-free days in ventilated patients with COVID-19.MethodsCOVID-19 patients who were mechanically ventilated in the ICU were included in this study. The ventilated patients who received ivermectin within 3 days after admission were assigned to the Ivermectin group, and the others were assigned to the Control group. Patients in the Ivermectin group received ivermectin 200 μg/kg via nasal tube. The incidence of gastrointestinal complications and ventilator-free days within 4 weeks from admission were evaluated as clinical outcomes using a propensity score with the inverse probability weighting method.ResultsWe included 88 patients in this study, of whom 39 patients were classified into the Ivermectin group, and 49 patients were classified into the Control group. The hazard ratio for gastrointestinal complications in the Ivermectin group as compared with the Control group was 0.221 (95% confidence interval [CI], 0.057 to 0.855; p = 0.029) in a Cox proportional-hazard regression model. The odds ratio for ventilator-free days as compared with the Control group was 1.920 (95% CI, 1.076 to 3.425; p = 0.027) in a proportional odds logistic regression model.ConclusionsIvermectin improved gastrointestinal complications and the number of ventilator-free days in severe COVID-19 patients undergoing mechanical ventilation. Prevention of gastrointestinal symptoms by SARS-Cov-2 might be associated with COVID-19 outcome.     

Current state of biologic pharmacovigilance in the European Union: improvements are needed

Introduction: Pharmacovigilance is essential to monitoring the safety profiles of authorized medicines. Compared with small-molecule drugs, biological drugs are more complex, more susceptible to structural variability due to manufacturing processes, and have the potential to induce immune-related reactions, underscoring the importance of safety monitoring for these products. Although highly similar to reference products, biosimilars are not expected to be structurally identical. For these reasons, proper reporting of potential adverse drug reactions (ADRs) using distinguishable names and batch numbers is essential for accurate tracing of all biological drugs. To address the need for robust pharmacovigilance, the European Parliament and Council of the European Union provided legislation regarding pharmacovigilance of biologics in 2010.

Areas covered: This narrative review examines the current state of pharmacovigilance for biologics in the European Union (EU) and discusses relevant information on pharmacovigilance of biosimilars, the current EU pharmacovigilance system, and areas that could be improved.

Expert opinion: Although steps have been taken to improve pharmacovigilance of biologics in the EU, several enhancements can still be made, including additional training for healthcare professionals on ADR reporting, the use of 2D barcodes that enhance traceability, and an open discussion of potentially missed opportunities in the pharmacovigilance of biosimilars.     

益气养精法对老年肺癌患者肿瘤标志物、生存期影响研究

目的探究益气养精法对老年肺癌患者肿瘤标志物、生存期影响。方法研究纳入60例老年肺癌患者,均由本院2016年1月-2017年1月收治,采取随机数字表法将患者分为两组,对照组患者(30例)常规化疗治疗,观察组患者(30例)在化疗基础上联合益气养精法治疗,比较两组患者治疗效果、治疗前后癌胚抗原(carcino-embryonic antigen,CEA)及血清癌抗原125(serum oncoantigen 125,CA 125)肿瘤标志物水平、不良反应情况及患者2年生存率。结果观察组患治疗有效率高于对照组,P<0.05;治疗前,两组患者CEA及CA 125水平相当,P>0.05,治疗后均改善,观察组优于对照组,P<0.05;观察组患者不良反应与对照组相当,均较低,P>0.05;观察组患者2年生存率高于对照组,P<0.05。结论益气养精法治疗老年肺癌患者效果患者,患者症状改善,不良反应少,安全可靠,且患者2年生存率较高。     

Endoscopy-Related Bleeding and Thromboembolic Events in Patients on Direct Oral Anticoagulants or Vitamin K Antagonists

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补肾纳气法治疗小儿支气管哮喘的临床分析

目的：探讨分析补肾纳气法治疗小儿支气管哮喘的临床效果。方法方便选取该院儿科于2013年3月—2014年11月收治的小儿支气管哮喘患者67例，根据随机数字法分为对照组33例和观察组34例，对照组患者予以氨茶碱片治疗，观察组患者实施补肾纳气法治疗，观察两组患者的治疗效果，进行临床对照性分析。结果对照组患者不良反应发生率24.2%，观察组患者不良反应发生率5.8%，观察组不良反应发生率明显低于对照组(P﹤0.05)；对照组患者总有效率60.6%，观察组患者总有效率85.3%。观察组患者治疗后总有效率明显高于对照组(P﹤0.05)。结论补肾纳气法治疗小儿支气管哮喘的临床效果好，应用价值高，值得在临床实践中推广应用。     

Prevalence and pathophysiology of early dumping in patients after primary Roux-en-Y gastric bypass during a mixed-meal tolerance test

Background

Early dumping is a poorly defined and incompletely understood complication after Roux-en-Y gastric (RYGB).