Abstract：
:A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Carey JL,Nader N,Chai PR,Carreiro S,Griswold MK,Boyle KLdoi
10.1016/j.clinthera.2016.12.009subject
Has Abstractpub_date
2017-01-01 00:00:00pages
10-22issue
1eissn
0149-2918issn
1879-114Xpii
S0149-2918(16)30922-5journal_volume
39pub_type
杂志文章,评审abstract：PURPOSE:The Enhancing Quality of Prescribing Practices for Older Veterans Discharged From the Emergency Department (EQUIPPED) program is a quality improvement initiative that combines education, clinical decision support (ie, geriatric pharmacy order sets), and in-person academic detailing coupled with audit and feedba...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2020.02.013
更新日期：2020-04-01 00:00:00
abstract：BACKGROUND:Metastatic bone disease is a serious clinical problem in patients with advanced cancer. Bisphosphonates inhibit the activity of osteoclasts and are the treatment of choice for bone metastases. OBJECTIVE:This article reviews the efficacy and safety data from Phase III trials of ibandronate in metastatic bone...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2004.12.010
更新日期：2004-12-01 00:00:00
abstract：BACKGROUND:Mexican Americans, the fastest growing ethnic group in the United States, have a 2- to 3-fold higher prevalence of type 2 diabetes mellitus relative to the non-Hispanic white population. It is estimated that 10% of Mexican Americans >or=20 years of age have diabetes. OBJECTIVE:The goal of this study was to ...
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(03)90025-7
更新日期：2003-01-01 00:00:00
abstract：:A randomized, double-masked, parallel-group, multicenter clinical trial was conducted to compare the efficacy, tolerability, and effects on quality of life associated with treatment regimens including the angiotensin II receptor antagonist losartan, with hydrochlorothiazide (HCTZ) added as needed, with regimens includ...
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(96)80212-8
更新日期：1996-07-01 00:00:00
abstract：BACKGROUND:The real-world clinical effectiveness of exogenous insulin is limited by nonadherence. Various insulin delivery systems have been developed to help improve adherence, with prefilled pens gaining popularity among adult Singaporeans with diabetes. However, adherence to insulin in people with diabetes in Singap...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2014.05.009
更新日期：2014-07-01 00:00:00
abstract：:The placenta is vital to the health and development of the fetus, serving to deliver oxygen and nutrients, facilitate the removal of waste products, and provide a barrier to pathogens and other harmful substances present in the maternal circulation. When these processes fail to operate normally, they can lead to compl...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2020.11.002
更新日期：2020-11-24 00:00:00
abstract：BACKGROUND:Conflicting results using the combination of ezetimibe and statins to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS) have been reported. OBJECTIVE:The aim of this work was to assess the effectiveness of ezetimibe coadministered with statins in reducing cardiovascular...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2011.08.002
更新日期：2011-09-01 00:00:00
abstract：PURPOSE:We estimated the real-world costs of bleeding-related episodes (BREs) in adults with primary immune thrombocytopenia (ITP). METHODS:This retrospective cohort study used the MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits databases. We identified adult patients...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2017.01.023
更新日期：2017-03-01 00:00:00
abstract：:A national multicentre trial was organized in order to compare the efficacy and safety of leuprorelin acetate depot and danazol in the treatment of endometriosis. Sixty-seven patients with pelvic endometriosis of different severity at laparoscopy were included in the study and followed during the 24 weeks of treatment...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究
doi：
更新日期：1992-01-01 00:00:00
abstract：BACKGROUND:Valproic acid has been associated with a highly variable intersubject absorptive phase; therefore, magnesium salt (magnesium valproate [MgV]) was developed to diminish variation during enteric absorption. OBJECTIVES:The aims of this study were to assess the pharmacokinetics of single oral doses of MgV 500-m...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2009.09.016
更新日期：2009-09-01 00:00:00
abstract：:Basic research in the neurosciences has led to a theory of opiate withdrawal involving endogenous opioid peptides and hyperactive norepinephrine neurons. This theory predicts the efficacy of clonidine, a nonopiate agent, in the management of opiate withdrawal. Clonidine, which offers numerous advantages over methadone...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：
更新日期：1984-01-01 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：:A prospective, open-label, multicenter, Phase IV study of the efficacy and safety of intravenous (IV) ciprofloxacin (400 mg by 60-minute infusion every 12 hours) in the treatment of lower respiratory tract infections (LRTIs), urinary tract infections (UTIs), and skin/skin structure infections (SSSIs) in hospitalized p...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究
doi：10.1016/0149-2918(95)80101-4
更新日期：1995-05-01 00:00:00
abstract：BACKGROUND:Tetanus-diphtheria-acellular pertussis (Tdap) was licensed in the United States in 2005 to be given in place of tetanus-diphtheria (Td) for single use in adolescents. OBJECTIVES:This analysis was conducted to determine vaccination coverage with Td and Tdap among adolescents in the United States aged 13 to 1...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2010.07.016
更新日期：2010-08-01 00:00:00
abstract：OBJECTIVE:This study evaluated the efficacy and tolerability of glimepiride in patients with type 2 diabetes mellitus that was inadequately controlled with a combination of immediate- or extended-release metformin and a thiazolidinedione. METHODS:This was a multicenter, randomized, double-blind, placebo-controlled, pa...
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.2005.10.017
更新日期：2005-10-01 00:00:00
abstract：:One hundred children with peritonitis resulting from a perforated appendix were treated with ceftazidime or netilmicin. Metronidazole was added to both groups to treat the anaerobic organisms commonly associated with the infecting aerobic organisms in peritonitis. Escherichia coli was the most common aerobe found in p...
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：1990-01-01 00:00:00
abstract：:Thirty children with serious gram-negative infections were treated with either netilmicin, 2 mg/kg, or tobramycin, 1 mg/kg, every eight hours for a minimum of 72 hours. Because of the administration of different doses, a "blind" investigator evaluated treatment response while another investigator adjusted the doses on...
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：PURPOSE:Public discourse regarding the hepatitis C virus (HCV) drug Sovaldi® (sofosbuvir) has become inflamed, generating much heat but little light concerning the clinical, health economic, and quality-of-life merits of Sovaldi®. The purpose of this article is to provide a factual basis for evaluating the claims regar...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2015.02.009
更新日期：2015-05-01 00:00:00
abstract：BACKGROUND:Spinal muscular atrophy (SMA) is an autosomal recessive motor neuron disease caused by mutations in the survival motor neuron gene (SMN1) and the leading genetic cause of infant mortality. Currently, there is no effective treatment other than supportive care. OBJECTIVE:This article provides a general overvi...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2013.11.006
更新日期：2014-01-01 00:00:00
abstract：PURPOSE:This observational study of oncologic clinical practices was designed to describe real-world patterns of use of emerging therapies (abiraterone acetate, cabazitaxel, enzalutamide, radium-223, sipuleucel-T) in patients with castration-resistant prostate cancer and to characterize their concomitant use with denos...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2017.12.015
更新日期：2018-04-01 00:00:00
abstract：:The effects of long-term aprindine administration on cardiac function were clinically investigated in seven patients with supraventricular or ventricular arrhythmias associated with organic heart disease. Three patients had normal cardiac function and four had various degrees of cardiac dysfunction before treatment wi...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1984-01-01 00:00:00
abstract：BACKGROUND:Cefprozil and erythromycin are acceptable alternatives to penicillin in the treatment of pharyngitis/tonsillitis due to group A beta-hemolytic streptococcus (GABHS). OBJECTIVE:The purpose of this trial was to determine the relative efficacy and tolerability of cefprozil and erythromycin in the treatment of ...
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)89084-0
更新日期：2001-11-01 00:00:00
abstract：PURPOSE:The purpose of this study was to evaluate the bioavailability of hydroxyprogesterone caproate (HPC) administered as a subcutaneous injection in the back of the upper arm using a prefilled autoinjector syringe with a 27-gauge needle compared with standard intramuscular injection in the gluteus maximus using a 21...
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.2017.10.020
更新日期：2017-12-01 00:00:00
abstract：BACKGROUND:Postherpetic neuralgia (PHN), which affects up to 70% of elderly persons with herpes zoster, can have debilitating effects, including physical and social disability and significant psychological distress. A variety of agents have been used, either singly or in combination, to control PHN, including topical a...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/s0149-2918(03)80320-x
更新日期：2003-10-01 00:00:00
abstract：PURPOSE:Levodopa (LD) is the most effective oral pharmacotherapy for the management of motor symptoms in Parkinson's disease. However, LD use is complicated by a progressive shortening of the duration of efficacy of a dose, resulting in episodes of inadequate responsiveness, or OFF periods. OFF periods may also occur u...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2020.04.004
更新日期：2020-06-01 00:00:00
abstract：PURPOSE:Megestrol acetate oral suspension is an appetite stimulant indicated for cachexia. It is available in a conventional formulation and as a nanocrystal dispersion. The aim of this study was to compare the tolerability and pharmacokinetics of these formulations under fed conditions in healthy Korean volunteers. M...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2014.09.022
更新日期：2015-02-01 00:00:00
abstract：PURPOSE:This study examined the utility of therapeutic drug monitoring (TDM) of imatinib, nilotinib, and dasatinib in adult patients with chronic-phase chronic myeloid leukemia (CML). TDM in CML entails the measurement of plasma tyrosine kinase inhibitor (TKI) concentration to predict efficacy and tolerability outcomes...
journal_title：Clinical therapeutics
pub_type： 杂志文章,meta分析
doi：10.1016/j.clinthera.2019.10.009
更新日期：2019-12-01 00:00:00
abstract：:Nonadherence to recommended pneumococcal conjugate vaccine (PCV) schedules may have implications for protection against pneumococcal disease. In this commentary, we have assessed adherence to the recommended dosing schedules (the completion of the primary PCV and booster series) in different European countries. We fou...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2014.03.001
更新日期：2014-05-01 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
abstract：:Of 250 patients undergoing transurethral prostatectomy, 34 had significant bacteriuria after surgery. In 20 patients, including some without significant colonies of bacteria, the same organisms were found before surgery. Closed surgical systems and aseptic techniques can prevent infection from outside the patient, but...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1988-01-01 00:00:00
