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Adverse drug events

L-B Zhao, G-D Zhen, Y Zhang, Y-Y Pan, G-H Du, S-Z Zhou, Z-F Li
OBJECTIVE: To observe the clinical efficacy of melatonin on acute organophosphorus pesticide poisoning (AOPP). PATIENTS AND METHODS: In this randomized control trial, a total of 59 AOPP patients with subsequent delirium were randomly divided into two groups, the melatonin group (n=29) and the placebo-controlled group (n=30). Patients in the melatonin group (n=29) underwent oral administration of melatonin in addition to the symptomatic treatment, while those in the placebo-controlled group took a placebo in addition to the symptomatic treatment...
March 2018: European Review for Medical and Pharmacological Sciences
Mosayeb Moradniani, Zohre Mirbeik-Sabzevari, Soleiman Jaferian, Shiva Shafiezadeh, Mohammad Javad Ehsani Ardakani, Mehrdad Mirzaee Roozbahany, Saleh Azadbakht, Hamidreza Sherkatolabbasieh
Aim: This study was aimed to evaluating the efficacy of levofloxacin based sequential therapy vs clarithromycin based sequential therapy in h.pylori (HP) eradication. Background: Several therapeutic regimen were investigated to treat HP infection. Sequential therapy is an alternative to classic triple therapy. Methods: In this randomized clinical trial, 200 HP infected patients randomly divided into two therapeutic groups .1-Levofloxacin based sequential regimen (group A); omeprazole and amoxicillin for 7days followed by omeprazole, amoxicillin and levofloxacin for 7days...
2018: Gastroenterology and Hepatology From Bed to Bench
Simona Lattanzi, Francesco Brigo, Claudia Cagnetti, Alberto Verrotti, Gaetano Zaccara, Mauro Silvestrini
Introduction: Up to 30% of the patients diagnosed with epilepsy will continue suffering from seizures despite treatment with antiepileptic drugs, either in monotherapy or polytherapy. Hence, there remains the need to develop new effective and well-tolerated therapies. Aim: The objective of this article was to review the evidence for the efficacy and safety of eslicarbazepine acetate (ESL) as adjunctive treatment in adult patients with focal onset seizures. Evidence review: ESL is the newest, third-generation, single enantiomer member of the dibenzazepine family...
2018: Core Evidence
Andrea Negro, Angela Koverech, Paolo Martelletti
Migraine is an important socioeconomic burden and is ranked the sixth cause of years of life lost because of disability in the general population and the third cause of years of life lost in people younger than 50 years. The cornerstone of pharmacological treatment is represented by the acute therapy. The serotonin (5-hydroxytryptamine [5-HT]) receptor subtype 1B /1D agonists, called triptans, are nowadays the first-line acute therapy for patients who experience moderate-to-severe migraine attacks. Unfortunately, a high percentage of patients are not satisfied with this acute treatment, either for lack of response or side effects...
2018: Journal of Pain Research
D H Palmer, Y T Ma, M Peck-Radosavljevic, P Ross, J Graham, L Fartoux, A Deptala, M Studeny, D Schnell, J Hocke, A-B Loembé, T Meyer
BACKGROUND: This multicentre, open-label, phase-I/randomised phase-II trial evaluated safety, pharmacokinetics, maximum-tolerated-dose (MTD) per dose-limiting toxicities (DLTs), and efficacy of nintedanib vs. sorafenib in European patients with unresectable advanced hepatocellular carcinoma (aHCC). METHODS: Phase I: Patients were stratified into two groups per baseline aminotransferase/alanine aminotransferase and Child-Pugh score; MTD was determined. Phase II: Patients were randomised 2:1 to nintedanib (MTD) or sorafenib (400-mg bid) in 28-day cycles until intolerance or disease progression...
March 22, 2018: British Journal of Cancer
Chenchen Wang, Christopher H Schmid, Roger A Fielding, William F Harvey, Kieran F Reid, Lori Lyn Price, Jeffrey B Driban, Robert Kalish, Ramel Rones, Timothy McAlindon
OBJECTIVES: To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. DESIGN: Prospective, randomized, 52 week, single blind comparative effectiveness trial. SETTING: Urban tertiary care academic hospital in the United States between March 2012 and September 2016...
March 21, 2018: BMJ: British Medical Journal
Cyrille Patrice Launay, Hélène Rivière, Julia Chabot, Olivier Beauchet
BACKGROUND: The 6-item Brief Geriatric Assessment (BGA) is a screening tool to identify frail inpatients who are at risk of adverse health events. Its predictive value for in-hospital mortality has not been examined yet. OBJECTIVE: This study examined whether the BGA is able to predict in-hospital mortality in older patients. METHODS: A total of 1082 participants were included in this observational prospective cohort study. At their admission to the medical wards of Angers University Hospital (France), all inpatients aged ≥65 years were screened with the BGA...
April 2018: Maturitas
Guan Sen Kew, Brian See
INTRODUCTION: Zolpidem is a short-acting nonbenzodiazepine hypnotic that has been approved by the Republic of Singapore Air Force (RSAF) for aircrew sleep management since 2005. Prior to consuming zolpidem for operational reasons, each RSAF aircrew member is required to undergo a ground test to exclude operationally relevant adverse drug effects. This study describes the RSAF's zolpidem ground testing outcomes over a 12.5-yr period. METHODS: This is a retrospective case series of 578 RSAF aircrew members who underwent zolpidem test dosing from 1 January 2005 to 30 June 2017...
April 1, 2018: Aerospace Medicine and Human Performance
Illce B Lázaro-Pacheco, Alfredo I Servín-Caamaño, José L Pérez-Hernández, Gabriela Rojas-Loureiro, Luis Servín-Abad, Fátima Higuera-DE LA Tijera
BACKGROUND: Acid suppression has been associated with adverse events; such as, enteric infections. Proton pump inhibitors (PPI) are frequently prescribed in patients with cirrhosis, but is unclear if PPI are associated with the development of bacterial infections in these patients. OBJECTIVE: To assess the impact of PPI intake on the development of bacterial, viral and fungal infections in patients with cirrhosis. METHODS: An observational, retrospective, historic cohort study...
January 2018: Arquivos de Gastroenterologia
Xianhua Liu, Ruiheng Yang, Bo Dai, Honghao Zhang, Jinxue Wang, Ning Ma
BACKGROUND: Studies indicate that nicotinic acid and related compounds may decrease phosphorus concentrations effectively by reducing the absorption in the gastrointestinal tract. However, the efficacy and safety of oral niacin treatments have only been investigated in a limited number of small-scale studies. METHODS: We performed this meta-analysis by pooling 12 qualified relevant preclinical and clinical trials to evaluate the association of nicotinic acid (and its related compounds) treatment and hyperphosphatemia among dialysis patients...
March 2018: Medicine (Baltimore)
Raquel González, Clara Pons-Duran, Mireia Piqueras, John J Aponte, Feiko O Ter Kuile, Clara Menéndez
BACKGROUND: The World Health Organization recommends intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine for malaria for all women who live in moderate to high malaria transmission areas in Africa. However, parasite resistance to sulfadoxine-pyrimethamine has been increasing steadily in some areas of the region. Moreover, HIV-infected women on cotrimoxazole prophylaxis cannot receive sulfadoxine-pyrimethamine because of potential drug interactions. Thus, there is an urgent need to identify alternative drugs for prevention of malaria in pregnancy...
March 21, 2018: Cochrane Database of Systematic Reviews
Li Xu, Jia Liu, Qilong Zhang, Min Li, Jingchi Liao, Weifeng Kuang, Cansheng Zhu, Huan Yi, Fuhua Peng
Objectives Amphotericin B plus flucytosine is the most widely used induction therapy regimen for non-HIV-infected and non-transplant patients; however, the therapeutic outcomes are unsatisfactory, especially when two antifungal drugs are at sub-therapeutic doses. Methods In this study of induction therapy, all non-HIV-infected, non-transplant patients with a first episode of cryptococcal meningitis were divided into two groups. In group I, the patients received amphotericin B plus 5-flucytosine. In group II, in addition to amphotericin B and 5-flucytosine, the patients also received fluconazole...
March 21, 2018: Neurological Research
Pol Specenier
The prognosis of recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (HNSCC) after failure of first line chemotherapy is dismal. Until the publication of the results of CheckMate 141, not a single agent provided any survival benefit as a second line treatment for R/M HNSCC. Areas covered: A comprehensive review of the literature was conducted on the role of nivolumab in HNSCC. Expert commentary: Nivolumab is approved by the Food and Drug Administration for the treatment of patients based on the results of CheckMate 141 showing an overall survival benefit as compared to standard care (single agent docetaxel, methotrexate, or cetuximab)...
March 21, 2018: Expert Review of Anticancer Therapy
Roxanne Saucier, Daniel Wolfe, Nabarun Dasgupta
INTRODUCTION: An extended-release injectable naltrexone suspension (Vivitrol® ) was approved in USA in 2010 for the prevention of relapse to opioid dependence. Concerns, raised at the time of approval, about rebound overdose risk following the last dose, have not been adequately studied. We sought to determine the time period of concern for fatal overdose associated with Vivitrol. METHODS: We performed a retrospective case review of Vivitrol spontaneous reports (October 2010-March 2016) in the US Food and Drug Administration Adverse Event Reporting System via the Freedom of Information Act...
March 20, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Saber Jan, Braveen Ragunanthan, Sandra R DiBrito, Omolabake Alabi, Maria Gutierrez
Background: Cefepime is a fourth-generation cephalosporin antibiotic used to treat a variety of infections. The US Food and Drug Administration approved its use in certain types of infections among pediatric patients, and yet there have been mixed data about its efficacy and safety in this population. Objective: The objective of this review is to compare efficacy and all-cause mortality of cefepime to other clinically indicated antibiotics among children. Methods: We conducted a systematic search of MEDLINE, EMBASE, CENTRAL, LILACS, and clinicaltrials...
2018: Frontiers in Pediatrics
Yohei Kubota, Toh Yoon Ezekiel Wong
When elderly patients are prescribed many different medications, the risk for developing serious adverse events should be kept in mind. One of these adverse events is agranulocytosis, which, although rare, can be life-threatening if left untreated. The majority of agranulocytosis cases are caused by drugs, including antibiotics. Here, we report a case of severe agranulocytosis in a 96-year-old woman following antibiotic therapy which was successfully managed using recombinant human granulocyte colony-stimulating factor (rhG-CSF) and the appropriate choice of antibiotics to treat her concomitant infection...
2018: Case Reports in Medicine
Lucas Morin, Kristina Johnell, Marie-Laure Laroche, Johan Fastbom, Jonas W Wastesson
Objective: Polypharmacy is the concomitant use of several drugs by a single person, and it increases the risk of adverse drug-related events in older adults. Little is known about the epidemiology of polypharmacy at the population level. We aimed to measure the prevalence and incidence of polypharmacy and to investigate the associated factors. Methods: A prospective cohort study was conducted using register data with national coverage in Sweden. A total of 1,742,336 individuals aged ≥65 years at baseline (November 1, 2010) were included and followed until death or the end of the study (December 20, 2013)...
2018: Clinical Epidemiology
Lanlan Zhang, Chengzhong Wang, Wei Li
Objective: To evaluate clinical efficacy, safety, and tolerability of levetiracetam as mono- or adjunctive therapy in the treatment of children and adolescents with epilepsy. Materials and methods: We performed a meta-analysis of randomized controlled trials published from January 2007 to December 2016 in the databases Web of Science, Medline, Embase, Cochrane Library, and PubMed, Bing, Baidu, Google Scholar, Chinese National Knowledge Infrastructure (CNKI), and Wanfang Data...
2018: Neuropsychiatric Disease and Treatment
Deyu Zhou, Lei Miao, Yulan He
OBJECTIVE: A drug-drug interaction (DDI) is a situation in which a drug affects the activity of another drug synergistically or antagonistically when being administered together. The information of DDIs is crucial for healthcare professionals to prevent adverse drug events. Although some known DDIs can be found in purposely-built databases such as DrugBank, most information is still buried in scientific publications. Therefore, automatically extracting DDIs from biomedical texts is sorely needed...
March 17, 2018: Artificial Intelligence in Medicine
Han-Yun Tseng, Shu-Han Yu, Chun-Yi Lee, Wen-Hao Huang, Seng-Loong Huang, Chi-Shin Wu, Yen-Feng Chiu, Chao A Hsiung
BACKGROUND: Sedative-hypnotic medication use has been related to severe adverse events and risks. This study investigated the prevalence of and characteristics associated with the use of sedatives and hypnotics among community-dwelling elderly persons aged 65 years and over in Taiwan. METHODS: A representative sample of community-dwelling adults was recruited. Clinical and sociodemographic data were collected for assessing physical, mental, and cognitive functioning and disorders...
March 21, 2018: International Psychogeriatrics
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