Abstract：
:The history of drug safety monitoring, or pharmacovigilance, has been an interesting one. Despite many and ongoing changes, it has typically been characterized by a rather slow-moving and reactive progression. Pharmacovigilance has always lagged behind other fields and industries and has been slow to adapt to new approaches. The main aspect holding it back has been a focus on the administrative and adherence side of creating individual case safety reports (ICSRs) and distributing these reports to the various stakeholders per strict regulatory requirements. Now, in 2018, we are more behind the curve than ever, and the field seems to be at a breaking point, calling for urgent and drastic changes. The question at hand is whether in this era of an abundance of electronically available data and technological advancements, which allow the application of automation, this process still makes sense. Is there still a place for creating and redistributing ICSRs from marketed use in a current, state-of-the-art safety system? Artificial intelligence, deep machine learning, and related technologies are already in place in many other industries. Swift and rigorous change is necessary for the discipline of pharmacovigilance to keep up with what is happening in the world at large.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Streefland MBdoi
10.1016/j.clinthera.2018.10.012subject
Has Abstractpub_date
2018-12-01 00:00:00pages
1973-1980issue
12eissn
0149-2918issn
1879-114Xpii
S0149-2918(18)30507-1journal_volume
40pub_type
杂志文章abstract：PURPOSE:Phenylephrine is a commonly used vasopressor for the treatment of spinal-induced hypotension in obstetric patients, but it is associated with reflex bradycardia and a corresponding decrease in cardiac output. This study aims to assess the effectiveness of continuous epinephrine versus phenylephrine infusion in ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2020.08.004
更新日期：2020-10-01 00:00:00
abstract：BACKGROUND:Panitumumab, formerly known as ABX-EGF, was the first recombinant human immunoglobulin G2 monoclonal antibody approved by the US Food and Drug Administration for the treatment of patients with epidermal growth factor receptor-expressing metastatic colorectal cancer (mCRC) refractory to fluoropyrimidine-, oxa...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2008.01.014
更新日期：2008-01-01 00:00:00
abstract：BACKGROUND:Few studies have examined the relative efficacy and tolerability of antihypertensive drug classes in Chinese populations. OBJECTIVE:This study compared the efficacy, tolerability, and duration of antihypertensive effect of amlodipine besylate and enalapril in Chinese patients with hypertension, including el...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1016/s0149-2918(04)80145-0
更新日期：2004-08-01 00:00:00
abstract：:Hyaluronic acid is the most abundant mucopolysaccharide in connective tissue. Because of its high viscous elasticity, it lubricates joints and can hold cells together in the intercellular spaces in connective tissue. The administration of exogenous hyaluronic acid can increase the repair potential of damaged tissue. A...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1989-11-01 00:00:00
abstract：BACKGROUND:Type 2 diabetes mellitus is twice as prevalent in African Americans and Hispanic Americans as in non-Hispanic whites. However, the effectiveness and safety profile of rosiglitazone maleate used as combination therapy with sulfonylureas in the management of diabetes and its effect on cardiovascular disease (C...
journal_title：Clinical therapeutics
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.clinthera.2007.09.011
更新日期：2007-09-01 00:00:00
abstract：BACKGROUND:Respiratory syncytial virus (RSV) lower respiratory tract infection (LRI) in early life has been associated with sustained airway hyperreactivity during childhood; however, corresponding data in premature infants are sparse. OBJECTIVE:The objective of this study was to determine whether RSV-LRI during early...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2011.01.007
更新日期：2010-12-01 00:00:00
abstract：BACKGROUND:Patients undergoing general anesthesia for laparoscopic cholecystectomy are at high risk for postoperative emetic symptoms (nausea, vomiting, and retching). Antihistamines, butyrophenones, dopamine receptor antagonists, and selective serotonin receptor antagonists (SSRAs) have been investigated for the preve...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验,收录出版
doi：10.1016/s0149-2918(04)90177-4
更新日期：2004-07-01 00:00:00
abstract：BACKGROUND:Empagliflozin is a sodium glucose cotransporter 2 inhibitor in clinical development as a treatment for type 2 diabetes mellitus. OBJECTIVE:The goal of this study was to investigate potential drug-drug interactions between empagliflozin and verapamil, ramipril, and digoxin in healthy volunteers. METHODS:The...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2013.02.015
更新日期：2013-03-01 00:00:00
abstract：PURPOSE:Long-acting insulin analogues were developed to facilitate consistent glycemic control without excessive hypoglycemia. However, structural modifications of the insulin molecule can alter biological responses and binding characteristics with specific receptors. The aim of this study was to estimate the risk of s...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2014.06.031
更新日期：2014-09-01 00:00:00
abstract：BACKGROUND:Pharmacokinetic/pharmacodynamic (PK/PD) optimization of antibiotic therapy has been shown to improve outcomes in several antibiotic classes. Despite the frequent use of beta-lactams, clinical data in humans remain limited. OBJECTIVE:This study evaluated the relationship between serum pharmacokinetics, pharm...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：10.1016/s0149-2918(01)80103-x
更新日期：2001-08-01 00:00:00
abstract：:A total of 804 pediatric patients (572 neonates and 232 infants and children) with suspected or documented serious infections were enrolled in a multicenter open study of netilmicin, a new semisynthetic aminoglycoside. All patients were evaluable for safety; 161 (20%) had bacteriologically documented infections and we...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：
更新日期：1983-01-01 00:00:00
abstract：BACKGROUND:The effectiveness of a drug is significantly influenced by a patient's adherence to the required regimen. OBJECTIVE:The goal of this retrospective database analysis was to determine the factors affecting adherence over a 12-month follow-up period in adults with type 2 diabetes mellitus (DM) initiating once-...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2013.03.021
更新日期：2013-06-01 00:00:00
abstract：BACKGROUND:Three inhibitors of phosphodiesterase 5 (PDE5) are now available for the treatment of erectile dysfunction (ED): sildenafil citrate, vardenafil, and tadalafil. Pharmacologic differences between these compounds may result in patient preferences for one over another and may influence treatment decisions made b...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究
doi：10.1016/s0149-2918(03)80329-6
更新日期：2003-11-01 00:00:00
abstract：PURPOSE:The goal of this study was to review recent clinical studies of azilsartan medoxomil (AZL-M) and chlorthalidone (CLD), a combined angiotensin receptor blocker and thiazide-like diuretic, and its role in recently published guidelines. This review explores the role of AZL-M/CLD in treating patients with hypertens...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2020.05.015
更新日期：2020-07-01 00:00:00
abstract：:A recent report of two isolates of Streptococcus bovis resistant to killing by low levels of penicillin G prompted this study of the in vitro susceptibility of 100 clinical isolates of S bovis to six antibiotics. Using a microdilution method, we found the minimum bactericidal concentrations for 99% of the isolates to ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1984-01-01 00:00:00
abstract：PURPOSE:This study was designed to evaluate the safety and pharmacokinetic profiles of MRX-I tablet, an oxazolidinone antibacterial agent, in healthy Chinese subjects. METHODS:The study was composed of 3 sequential periods. Period 1 was a randomized, double-blind, placebo-controlled, sequential ascending dose (50 to 1...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2017.12.017
更新日期：2018-02-01 00:00:00
abstract：:Lipid metabolism, platelet function, and blood coagulability were evaluated in 20 patients with diabetes mellitus and stable fasting blood sugar levels before, during, and after treatment with the pancreatic enzyme elastase for 16 weeks. Serum high-density lipoprotein cholesterol levels increased from 46.9 mg/dl befor...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1989-11-01 00:00:00
abstract：BACKGROUND:A link between the use of alendronate and atypical diaphyseal femoral fracture has been suggested. OBJECTIVE:The goal of this study was to evaluate the benefits of alendronate in preventing rehospitalization due to hip fractures and whether its use increases risk of hospitalization for atypical diaphyseal f...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2011.09.006
更新日期：2011-11-01 00:00:00
abstract：BACKGROUND:The Lescol Intervention Prevention Study (LIPS) was a multinational randomized controlled trial that showed a 47% reduction in the relative risk of cardiac death and a 22% reduction in major adverse cardiac events (MACEs) from the routine use of fluvastatin, compared with controls, in patients undergoing per...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2005.09.012
更新日期：2005-09-01 00:00:00
abstract：:Absorption of the antiarrhythmic agent mexiletine from conventional capsules (200 mg) and two sustained-release formulations (360 and 432 mg) was studied in four healthy volunteer subjects, and use of the 360-mg preparation was studied in nine patients who had been using conventional capsules. In the four volunteers, ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1983-01-01 00:00:00
abstract：BACKGROUND:NXN-188 is a dual-action oral therapeutic being developed for the treatment of acute migraine. The mechanism of action of NXN-188 involves inhibition of both the neuronal nitric oxide synthase enzyme isoform and affinity for serotonin (5-hydroxytryptamine1B/D) receptors. OBJECTIVES:The aims of the initial P...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2010.01.006
更新日期：2010-01-01 00:00:00
abstract：:This paper briefly reviews the extent of current drug coverage for Medicare beneficiaries and describes the most important issues faced by aged beneficiaries who receive or seek drug coverage through a Medicare managed care plan. Changes in payment rates to these plans as a result of the Balanced Budget Act of 1997 ma...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/s0149-2918(98)80123-9
更新日期：1998-11-01 00:00:00
abstract：:In a previous report of a multicenter study (Kannel et al, 1990), the results of 6 months' treatment with lovastatin in 489 adults with primary hypercholesterolemia were presented. The present report contains the results from the 236 women patients. The intial dose of lovastatin was 20 mg daily and could be increased ...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究
doi：
更新日期：1992-05-01 00:00:00
abstract：BACKGROUND:Anemia is a common complication of chronic kidney disease (CKD). The approved dosing interval for currently available erythropoiesis-stimulating agents (ESAs) is 2 to 3 times weekly for epoetin alfa (EPO) and every 1 to 2 weeks for darbepoetin alfa (DARB). However, clinicians sometimes use less frequent dosi...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2007.09.012
更新日期：2007-09-01 00:00:00
abstract：BACKGROUND:Imprudent prescribing of antibiotics for patients with colds, upper respiratory tract infections (URIs), and bronchitis may contribute to antibiotic resistance and waste economic resources. OBJECTIVE:The purpose of this study was to determine the antibiotic prescribing rate for adults diagnosed with colds, ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/s0149-2918(02)85013-5
更新日期：2002-01-01 00:00:00
abstract：:In this open-label, randomized, cross-over study, 12 healthy subjects received four doses of a new sustained-release formulation of diltiazem hydrochloride for six consecutive days. Blood samples were drawn on days 5 and 6 for determination of plasma diltiazem and desacetyldiltiazem levels. The peak concentrations aft...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验
doi：
更新日期：1992-03-01 00:00:00
abstract：PURPOSE:Allergic rhinitis (AR) is a highly prevalent disease, affecting the quality of life of millions of Americans. Intranasal corticosteroids (INCs) are widely recommended as first-line therapy for moderate to severe AR. Although these drugs exhibit similar safety and efficacy, a potentially differentiating factor w...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2019.05.017
更新日期：2019-08-01 00:00:00
abstract：:The in vitro activity of Ro 09-1428, a new parenteral cephalosporin, was compared with that of other beta-lactams and aminoglycosides in 1230 clinical isolates from 1028 consecutive patients. Using an agar dilution method, the drugs were tested against 625 isolates of Enterobacteriaceae, 68 Pseudomonas aeruginosa, 36 ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1992-07-01 00:00:00
abstract：:Patients with diabetes are responsible for the vast majority of management requirements of their condition. However, their ability and motivation to engage in required self-management behaviors may be mitigated by multiple intrinsic and extrinsic factors. Intrinsic barriers include attitudes and health beliefs, limite...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2013.01.002
更新日期：2013-02-01 00:00:00
abstract：BACKGROUND:Chronic obstructive pulmonary disease (COPD) is associated with substantial morbidity and mortality. Published practice guidelines and treatment algorithms for COPD are designed to increase awareness of the problem and improve patient care; however, <40% of subjects diagnosed with COPD are receiving appropri...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2007.10.006
更新日期：2007-10-01 00:00:00
