Abstract：
:The field of rheumatology has made major contributions to medicine through the identification of cellular and molecular targets and with the development of therapies for the treatment of an impressive range of immune-mediated rheumatic diseases. In recent years new milestones have been achieved. These include the recognition of an "at risk" state, defined by distinct clusters of characteristics, including disease-specific autoantibodies in serum and symptom complexes that include inflammatory joint pain. Studies seeking to prevent high-risk individuals from progressing to a state of clinically apparent arthritis have been initiated. Here, exploiting the current evidence base, an experimental framework to inform trial design is described, taking into consideration study patient phenotypes and highlighting the impact of risk stratification and the options available for therapeutic intervention according to the different phases of the preclinical syndrome. Pragmatic primary end points and suggestions for a set of risk-focused trial outcome measures are proposed, including both clinical assessments and patient-reported outcome measures. Rheumatoid arthritis prevention studies provide an important experimental framework for generating deeper insights into risk stratification and for refining trial design in the future. To this end, a research agenda is suggested, together with some considerations for imaging and for biological sampling. This commentary concludes with some of the operational issues that arise from such studies and addresses some of the challenges associated with recruitment and retention of the at-risk trial participant.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Cope APdoi
10.1016/j.clinthera.2019.04.014subject
Has Abstractpub_date
2019-07-01 00:00:00pages
1299-1311issue
7eissn
0149-2918issn
1879-114Xpii
S0149-2918(19)30178-Xjournal_volume
41pub_type
杂志文章abstract：:Community-acquired pneumonia (CAP) is responsible for an average of 4.5 million visits annually to physicians' offices, emergency departments, and outpatient clinics. However, there have been few studies using national data on the costs of treating CAP. Without such data, it is difficult to assess whether new therapie...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/s0149-2918(98)80144-6
更新日期：1998-07-01 00:00:00
abstract：BACKGROUND:Emergence agitation (EA) after emergence from sevoflurane anesthesia is a common phenomenon in children. The efficacy of prophylactic midazolam or clonidine in preventing EA is controversial. OBJECTIVE:We performed a meta-analysis of clinical trials of the 2 drugs to evaluate their ability to prevent EA in ...
journal_title：Clinical therapeutics
pub_type： 杂志文章,meta分析,评审
doi：10.1016/j.clinthera.2013.08.016
更新日期：2013-10-01 00:00:00
abstract：BACKGROUND:Rates of patient adherence (compliance) to pharmacotherapy range from <5% to >90%. Negative determinants include multiple daily dosing (MDD), chronic duration, and asymptomatic disease. Reports suggest that once-daily (QD) dosing may improve adherence, but their findings are inconclusive. OBJECTIVE:The purp...
journal_title：Clinical therapeutics
pub_type： 杂志文章,meta分析
doi：10.1016/s0149-2918(02)85026-3
更新日期：2002-02-01 00:00:00
abstract：PURPOSE:Selection and prompt initiation of the appropriate empiric antimicrobial therapy are critical to decrease morbidity and mortality and shorten the length of hospitalization among patients with hospital-associated intra-abdominal infections (HA-IAIs). Therapeutic choices for the treatment of patients with HA-IAI ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2016.04.035
更新日期：2016-06-01 00:00:00
abstract：PURPOSE:Polycystic ovary syndrome (PCOS) is a metabolic and endocrinal disorder affecting a number of women of reproductive age. We aimed to reveal the correlation between the endocannabinoid system and PCOS, which may provide a new therapeutic target for PCOS treatment. METHODS:Serum levels of anandamide and 2-arachi...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2017.02.007
更新日期：2017-04-01 00:00:00
abstract：:Twenty-four patients with pulmonary infections (7 pneumoniae, 17 exacerbations of chronic bronchitis) were treated with a combination of 250 mg of amoxicillin and 125 mg of clavulanic acid supplemented by 500 mg of amoxicillin every eight hours. All patients showed good clinical, roentgenological, and bacteriological ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1982-01-01 00:00:00
abstract：:Hypoglycemia in people with insulin-treated type 2 diabetes can be a limiting factor for management and a barrier to optimizing glycemic control. Even mild episodes of hypoglycemia can affect an individual's quality of life, and fear of hypoglycemia can lead to underinsulinization. This article explores the prevalence...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2016.09.020
更新日期：2017-08-01 00:00:00
abstract：BACKGROUND:Belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulating protein, was the first biologic agent approved for, and the first drug approved in 55 years for, the treatment of systemic lupus erythematosus (SLE) by the US Food and Drug Administration (FDA). OBJECTIVE:This article reviews the curren...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2012.02.028
更新日期：2012-05-01 00:00:00
abstract：:In a double-blind study, 59 patients with chronic erosive gastritis received 50 mg of pirenzepine twice daily and 55 patients received 400 mg of cimetidine twice daily for six weeks. In both groups, days of pain, of heartburn, and of nausea per week were significantly reduced during treatment (P less than 0.01). After...
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：1989-11-01 00:00:00
abstract：BACKGROUND:Numerous studies have explored dietary-management strategies for decreasing leukotriene synthesis by inflammatory cells through supplementation with polyunsaturated fatty acids such as gamma-linolenic acid (GLA) and eicosapentaenoic acid (EPA). OBJECTIVES:This study sought to determine the optimal daily int...
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(03)80116-9
更新日期：2003-03-01 00:00:00
abstract：:Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) of the propionic acid family with demonstrated efficacy in the treatment of rheumatoid arthritis and osteoarthritis; a distinguished safety profile; and good tolerability. This report describes a new extended-release formulation that maintains therapeutic pla...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：
更新日期：1994-03-01 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：:Pediatric patients experience unique differences from the adult population in pharmacokinetic parameters and, consequently, require individualized dosing. Medications useful in pediatric medicine often lack a therapeutic indication and dosing guideline for this population. In addition, the absence of an available pedi...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：
更新日期：1991-09-01 00:00:00
abstract：BACKGROUND:Approved by the US Food and Drug Administration in 2007, ambrisentan is the second oral endothelin A-receptor antagonist available for the management of pulmonary arterial hypertension (PAH) in patients with World Health Organization class II or III symptoms. OBJECTIVE:This article examines the clinical pha...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2008.05.005
更新日期：2008-05-01 00:00:00
abstract：PURPOSE:Few studies have investigated restless legs syndrome (RLS) treatment effects on individual International RLS Study Group Rating Scale (IRLS) items. We assessed the effects of gabapentin enacarbil (GEn) on individual IRLS items and their correlation with sleep disturbances in adults with moderate-to-severe prima...
journal_title：Clinical therapeutics
pub_type： 杂志文章,meta分析
doi：10.1016/j.clinthera.2016.05.008
更新日期：2016-07-01 00:00:00
abstract：BACKGROUND:Rufinamide is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients aged ≥4 years. OBJECTIVES:The primary purpose of this study was to compare the relative bioavailability and other pharmacokinetics of rufinamide administered as a 400-mg tablet formulation (r...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2011.01.016
更新日期：2011-01-01 00:00:00
abstract：:In its clinical assessment of the respiratory syncytial virus (RSV)-specific monoclonal antibody palivizumab, the IMpact-RSV Study Group demonstrated a reduction in hospitalizations for RSV-related lower respiratory tract infection in infants who received prophylaxis compared with infants who did not receive prophylax...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/S0149-2918(00)88326-5
更新日期：1999-04-01 00:00:00
abstract：BACKGROUND:Antimicrobial prophylaxis in select neutropenic patients has reduced fever, infection rates, hospital length of stay, and hospitalization rates. Guidelines from the Infectious Diseases Society of America recommend the consideration of prophylaxis with a fluoroquinolone in patients at high risk for infection ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2014.04.013
更新日期：2014-06-01 00:00:00
abstract：BACKGROUND:Despite increasing investigation in the area of cardiovascular instability in preterm infants, huge gaps in knowledge remain. None of the current treatments for hypotension, including the use of inotropic agents, have been well studied in the preterm population, and data regarding safety and efficacy are lac...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2006.09.006
更新日期：2006-09-01 00:00:00
abstract：PURPOSE:Despite significant advances in optimizing drug therapy, heart failure-related mortality and morbidity remain high. There has been great progression with regard to device therapy in heart failure, and device use continues to increase. The aims of this review were to critically re-examine the evidence base and t...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2015.08.012
更新日期：2015-10-01 00:00:00
abstract：:A phase II study of weekly low-dose doxorubicin (6 to 12 mg/m2) showed it to be an effective, well-tolerated therapy in advanced breast cancer. Although most of the 34 patients studied had been clinically resistant to previous endocrine measures and/or other kinds of chemotherapy, had a median score of 60 on Karnofsky...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1982-01-01 00:00:00
abstract：BACKGROUND:Oral bisphosphonates are well established for the treatment and prevention of postmenopausal osteoporosis; however, they are poorly absorbed from the gastrointestinal (GI) tract and have been associated with GI adverse events. Thus, current dosing guidelines recommend that the patient not eat or lie down for...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/s0149-2918(03)90005-1
更新日期：2003-01-01 00:00:00
abstract：BACKGROUND:Desvenlafaxine succinate, a serotonin-norepinephrine reuptake inhibitor (SNRI), was approved by the US Food and Drug Administration (FDA) in February 2008 for the treatment of adult patients with major depressive disorder (MDD). Desvenlafaxine is the third SNRI approved by the FDA for this indication. OBJEC...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2009.07.012
更新日期：2009-06-01 00:00:00
abstract：PURPOSE:Samidorphan (3-carboxamido-4-hydroxy naltrexone) is a novel opioid receptor antagonist that is currently in clinical development. The oral dose pharmacokinetics, safety, and tolerability of samidorphan were evaluated in 2 double-blind, placebo-controlled, randomized studies in healthy adults. METHODS:The first...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2014.10.001
更新日期：2015-02-01 00:00:00
abstract：PURPOSE:In China, dabigatran and rivaroxaban are the only approved non-vitamin K antagonist oral anticoagulants for the treatment of atrial fibrillation (AF). The goal of this article was to assess the cost-effectiveness of dabigatran versus rivaroxaban for the prevention of stroke and systemic embolism in Chinese pati...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2019.11.011
更新日期：2020-01-01 00:00:00
abstract：BACKGROUND:Several studies have reported increased health care resource use among hypertensive patients with uncontrolled blood pressure (BP). OBJECTIVE:The purpose of this study was to investigate the relationship between BP control and health care resource use. METHODS:Data were obtained from the Caring for Hyperte...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：10.1016/s0149-2918(01)80143-0
更新日期：2001-10-01 00:00:00
abstract：:The increasing worldwide recognition of the deleterious sequelae of Chlamydia trachomatis urogenital tract infections makes rapid, inexpensive diagnostic tests a high priority. Cell culture, still the standard for all other methods, is only 90% sensitive. Direct fluorescent antibody (FA) tests use highly specific mono...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1986-01-01 00:00:00
abstract：BACKGROUND:Mycophenolate mofetil (MMF) is an immunosuppressant indicated for prophylaxis of acute organ transplant rejection. Generic MMF is less costly than the branded product, but European regulatory authorities require bioequivalence studies for the marketing of generics. OBJECTIVES:The aims of the 2 studies repor...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2011.04.003
更新日期：2011-03-01 00:00:00
abstract：PURPOSE:The purpose of this study was to compare the bioavailability between 2 milk thistle-containing dietary supplements, Product B and IsaGenesis, in healthy volunteers. METHODS:Bioavailability between Product B, originally formulated as a powdered capsule, and IsaGenesis, reformulated as a soft gel, were compared ...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2017.11.013
更新日期：2018-01-01 00:00:00
abstract：:The objective of this 12-week, double-masked, randomized, multicenter study was to compare the elastoviscous properties of a high-molecular-weight viscosupplement, hylan G-F 20 (polymer concentration, 0.8%), with those of a lower-molecular-weight hyaluronan (LMW HA) product (polymer concentration, 1%) and to determine...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：10.1016/s0149-2918(00)80010-7
更新日期：1999-09-01 00:00:00
