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1.
Purpose
Hepatitis C, a chronic disease with deadly consequences, is no longer predominantly a disease of older people.Methods
A limited search was conducted of the relevant literature on 2 topics: (1) the impact of hepatitis C on infants exposed by vertical transmission; and (2) the impact of hepatitis C infection on infected children and adolescents. The findings were supplemented by the first-hand experience of the authors.Findings
Young people, including women of childbearing age, infants, children, and adolescents, are being especially affected by hepatitis C infection secondary to the intravenous drug use and opioid epidemic. Unfortunately, estimates of disease in young populations are all misleading because universal screening has not been implemented.Implications
Lack of implementation of policies for screening and therapy on most affected populations will be responsible for perpetuation of this infection. In the era of highly effective therapy and a regimen that is approved by the US Food and Drug Administration for children, this outcome is unacceptable. 相似文献2.
Su-jin Rhee Howard Lee Li Young Ahn Kyoung Soo Lim Kyung-Sang Yu 《Clinical therapeutics》2018,40(10):1720-1728.e2
Purpose
Pregabalin and thioctic acid are likely to be used concomitantly for the treatment of painful diabetic neuropathy. In this study, the pharmacokinetic interaction between pregabalin and thioctic acid was investigated at steady state.Methods
A randomized, open-label, 6-sequence, 3-period, 3-treatment crossover study was conducted in 42 healthy male volunteers. The volunteers randomly received pregabalin 300 mg BID for 6 times, thioctic acid 600 mg once daily for 3 times, or the combination of pregabalin and thioctic acid. Serial blood samples were collected up to 24 hours after the last dosing in each period. Pharmacokinetic parameters were calculated by using noncompartmental analysis methods.Findings
The mean concentration–time curves were similar between each drug alone and in combination with the other drug. The 90% CIs of the geometric mean ratios with and without the co-administered drug for Cmax at steady state and AUC during the dosing interval were well within the conventional bioequivalence range of 0.8 to 1.25, except for Cmax at steady state for thioctic acid, which barely exceeded only the lower bound (0.78–1.15). Co-administered pregabalin and thioctic acid was well tolerated.Implications
Repeatedly administered pregabalin and thioctic acid do not interact pharmacokinetically. This study suggests that the combination of pregabalin and thioctic acid can safely be administered concomitantly without dose adjustment. ClinicalTrials.gov identifier: NCT01808300. 相似文献3.
Kwadwo A. Yeboah Amy Allspaw Akram Al-Makki Brian M. Shepler 《Clinical therapeutics》2018,40(9):1592-1595
Purpose
Several antihypertensive medications have been associated with various forms of sexual dysfunction. We present a case report of a premenopausal patient with hydralazine-associated amenorrhea.Methods
The Naranjo adverse drug reaction probability scale was used to assess causality. We also performed a literature search on PubMed to find publications that report hydralazine-associated amenorrhea.Results
The Naranjo scale generated a score of 6, suggesting a probable relationship between amenorrhea and hydralazine therapy. No publications associating hydralazine with amenorrhea were identified.Implications
A probable relationship exists between hydralazine and the development of amenorrhea. 相似文献4.
Background
Advanced Practice Registered Nurses (APRNs) provide access to cost-effective, high quality care. APRNs are underutilized in states that restrict their practice. Removing restrictions could expand access to quality health care, cost-effectively relieve the physician shortage, and contribute economically.Purpose
This study forecasts the health system and economic impacts of reducing practice restrictions for Florida APRNs.Methods
The analysis utilized a number of data sources and IMPLAN software and estimated changes in APRN supply given less restrictive practice laws, and consequential health system and economic benefits.Findings
Between 2013 and 2025 APRN full time equivalents could increase an additional 11% with less restrictive practice regulations. This could eliminate or reduce the shortage of different types of physicians. Health care cost-savings could be $50 to $493 per resident. There would be a number of general economic benefits.Discussion
A number of health system and economic benefits would ensue from less restrictive APRN regulation. 相似文献5.
Purpose
Respiratory syncytial virus (RSV) and influenza are important viral pathogens worldwide. Children, in particular, bear considerable burdens of morbidity and mortality associated with these viruses. There are limited therapeutic options for children infected with RSV or influenza. This review focuses on therapeutics for RSV and influenza that are currently under clinical investigation.Methods
This study used a systematic approach to identify prospective therapeutics in clinical trials and briefly reviewed those that are currently available for use in adults and children.Findings
Overall, we found 14 investigational drugs currently in clinical trials for RSV and 20 investigation drugs currently in clinical trials for influenza. These candidates range in development from Phase I to Phase III clinical trials.Implications
Both RSV and influenza are targets for active therapeutic research, and promising candidates for both viruses are currently in clinical development. 相似文献6.
Purpose
The objective of this review was to summarize the recent literature describing the current burden of disease due to herpesviruses in the antiviral and transplant era; describe mechanisms of action of antiviral agents and the development of resistance; summarize the literature of recent antiviral agents brought to market as well as agents under development; and to present literature on future strategies for herpesvirus therapeutics.Methods
An extensive search of the medical literature related to antiherpesviral therapy was conducted to compose this narrative review. Literature searches were performed via PubMed and ultimately 137 articles were included as most relevant to the scope of this article.Findings
Herpesviruses are a family of DNA viruses that are ubiquitous throughout human populations and share the feature of establishing lifelong infections in a latent phase with the potential of periodic reactivation. With the exception of herpes simplex virus, varicella zoster virus, and Epstein-Barr virus, which have a significant disease burden in individuals with normal immune function, the morbidity and mortality of the remaining viruses are primarily associated with the immunocompromised host. Over the last half-century, several agents have been tested in large randomized, placebo-controlled trials that have resulted in safe and effective antiviral agents for the treatment of many of these infections.Implications
With increasing use of antiherpesviral agents for extended periods, particularly in immunocompromised hosts, the emergence of resistant viruses has necessitated the development of newer agents with novel targets and better side-effect profiles. 相似文献7.
Xiaojiao Li Hong Chen Junqi Niu Guiling Chen Gong Shen Benedetta Massetto Diana M. Brainard Xiaoxue Zhu Hong Zhang Yanhua Ding 《Clinical therapeutics》2018,40(9):1556-1566
Purpose
The purpose of this study was to investigate the safety, tolerability, and pharmacokinetic profile of sofosbuvir and its metabolites after a single dose of sofosbuvir 400mg and once daily dosing of sofosbuvir 400mg for 7days in healthy Chinese subjects.Methods
This Phase I, open-label, single- and multiple-dose study enrolled 14 Chinese subjects aged 18 to 45years with an approximately even distribution of healthy male (n?=?9) and nonpregnant, nonlactating female subjects (n?=?5). Subjects received a single oral dose of sofosbuvir 400mg (one tablet) (morning, fasted conditions; single-dose treatment). After a 3-day washout, subjects received oral sofosbuvir 400mg (one tablet) (morning, fasted) for 7days (multiple dose treatment).Findings
No significant accumulation of sofosbuvir, GS-566500, or GS-331007 was observed. Steady state of the major metabolite GS-331007 was achieved after 4days of consecutive dosing with sofosbuvir 400mg once daily. Sofosbuvir was generally well tolerated.Implications
Overall, this study supports the further evaluation of sofosbuvir 400mg in the Chinese population. The pharmacokinetic properties of sofosbuvir, GS-556500, and GS-311007 were found to be broadly similar in healthy Chinese subjects compared with non-Chinese subjects in previous sofosbuvir studies. ChinaDrugTrials.org.cn identifier: CTR20150249. 相似文献8.
9.
Background
Pragmatic dissemination and implementation (D&I) research approaches can benefit patient care because they emphasize real-world settings and populations. Nurse scientists have an opportunity to reduce the gap between science and practice by using pragmatic D&I research and sustainability strategies.Purpose
This article discusses pragmatic models, methods, and measures used in D&I research and their relevance for nursing research and enhancing population health.Methods
Summary of pragmatic D&I models and related methods for designing a pragmatic studies. We discuss the RE-AIM framework and the PRECIS-2 planning aid and figure in detail. A case study is provided and application to nursing research is discussed.Discussion
Successful translation of pragmatic D&I research demands an approach that addresses external validity, and customization at multiple levels including the patient, clinician, and setting. Context is critically important, and it is never too early to design for dissemination.Conclusions
Pragmatic D&I approaches are needed to speed research translation, reduce avoidable waste of funding, improve clinical care, and enhance population health. Pragmatic D&I research is an area of tremendous opportunity for the nursing science community. 相似文献10.
Background
Nurses are among the many U.S. health professionals engaged in international learning or service experiences and often travel to low-resource countries lacking guidance for ethical practice, respect for host partners, or collaborative work in different health systems.Purpose
The aim of this study is to develop evidence-based principles or guidelines for ethical global health nursing practice.Methods
A three-round Delphi study was conducted. Global health nurse experts participated in Round 1 focus group, followed by nurses with global health expertise ranking global health nursing statements in Rounds 2 and 3.Discussion
Findings led to 10 Ethical Principles for Global Health Nursing Practice and 30 statements for Ethical Guidelines in Global Health Nursing. These Ten principles address beneficence, nonmaleficence, dignity, respect, autonomy, social justice, and professional practice. The 30 guidelines offer more specific actions nurses must consider when working in global settings. 相似文献11.
Mami Uchida Hitoshi Kawazoe Shingo Takatori Hiroyuki Namba Ryuji Uozumi Akihiro Tanaka Hiromu Kawasaki Hiroaki Araki 《Clinical therapeutics》2018,40(7):1214-1222.e1
Purpose
Oxaliplatin-induced peripheral neuropathy has remained an unresolved issue in clinical practice. Our previous study hypothesized that inhibition of the renin-angiotensin system (RAS) may produce a preventive effect on oxaliplatin-induced neuropathy. The aim of this study was to clarify whether RAS inhibitors prevent oxaliplatin-induced peripheral neuropathy.Methods
This study retrospectively analyzed data from cancer patients who had received chemotherapy including oxaliplatin and were treated with or without RAS inhibitors. This retrospective observational study was conducted at Ehime University Hospital using electronic medical records from May 2009 to December 2016. The primary end point was the incidence of severe peripheral neuropathy during or after oxaliplatin treatment, according to the Common Terminology Criteria for Adverse Events, version 4.0. A multivariate Cox proportional hazards model analysis was used to identify risk factors.Findings
A total of 150 patients were included in the study. The estimated incidence of peripheral neuropathy was 36.9% and 91.7% in the RAS inhibitor group and the non–RAS inhibitor group, respectively. The multivariate analysis using a Cox proportional hazards model showed that the RAS inhibitor group was slightly associated with a decreased risk of neurotoxicity (adjusted hazard ratio, 0.42 [95% CI, 0.18–0.99]; P?=?0.048).Implications
The present findings suggest that RAS inhibitors have the ability to prevent oxaliplatin-induced peripheral neuropathy. 相似文献12.
Ignacio Conde-Carmona Sandra García-Medina Juan M. Jiménez-Vargas Alberto Martínez-Muñoz Sung-Hack Lee 《Clinical therapeutics》2018,40(10):1729-1740
Purpose
The aim of this study was to assess the pharmacokinetic interactions between a newly developed dipeptidyl peptidase (DPP)-4 inhibitor, gemigliptin, and metformin in healthy Mexican male volunteers, and the differences in the pharmacokinetic profile of gemigliptin between Korean and Mexican healthy volunteers.Methods
This was a multiple-dose, randomized, open-label, 3-way, 3-period crossover study. Subjects were randomized to 1 of 3 treatment sequences and received gemigliptin 50mg once a day, metformin1000mg BID, or both drugs during a 7-day treatment period, and underwent sampling for pharmacokinetic analysis and tolerability assessments. Point estimates and 90% CIs of Cmax,ss and AUCτ,ss least squares mean (LSM) ratios of the concurrent administration of gemigliptin?+?metformin to the administration of monotherapy with either drug were obtained, and the pharmacokinetic profile of gemigliptin observed was compared with that in healthy Korean volunteers studied during the initial development of gemigliptin.Findings
The coadministration of gemigliptin?+?metformin did not affect the pharmacokinetic characteristics of gemigliptin (LSM ratio [90% CI] for Cmax,ss and AUCτ,ss: 0.98 [0.87–1.10] and 0.94 [0.91–0.98], respectively) or metformin (LSM ratio [90% CI] for Cmax,ss and AUCτ,ss: 0.97 [0.88–1.08] and 1.02 [0.93–1.12], respectively) when administered as monotherapy and was well tolerated. In contrast with Korean healthy volunteers, Mexican subjects showed a modestly higher gemigliptin exposure (LSM ratio [90% CI] for AUCτ,ss: 1.22 [1.14–1.31]).Implications
The results of this study support, in ethnically different populations, the absence of drug–drug interactions between gemigliptin and metformin previously shown in Korean healthy volunteers. Considering the flat effect–concentration curve and wide therapeutic range of gemigliptin, the pharmacokinetic profile of gemigliptin observed in healthy Mexican and Korean subjects suggests that gemigliptin use in Mexican patients may be associated with outcomes, in terms of efficacy and tolerability, similar to those observed in the Korean population. ClinicalTrials.gov identifier: NCT03310749. 相似文献13.
Purpose
This review article focuses on preventing vertical transmission of hepatitis B virus (HBV) among pregnant women living in sub-Saharan Africa (SSA), where disease is endemic and the estimated maternal HBV seroprevalence is >8%. Available interventions that have been studied in low- and middle-income countries are compared in terms of efficacy and effectiveness in clinical practice. Global disease-elimination targets, barriers to HBV-prevention efforts, and critical research gaps are discussed.Methods
A PubMed literature search in February 2018 identified relevant studies of interventions to reduce or prevent the transmission of HBV during pregnancy or in the peripartum period. Studies that focused on interventions that are currently available or could be made available in SSA were included. Trials conducted in SSA and other low-income countries were prioritized, although studies of interventions in middle- and high-income countries were included.Findings
Among 127 studies and reports included in the review, 60 included data from SSA. The most cost-effective intervention to reduce HBV infection rates in SSA is timely birth-dose vaccination followed by completion of the 3-dose infant-vaccination series. The identification and treatment of pregnant women with elevated HBV viral load to further reduce the risk for vertical transmission in SSA show promise, but efficacy and tolerability trials in Africa are lacking.Implications
Scale-up of currently available tools is required to reach HBV disease-elimination goals in SSA. Many countries in SSA are in the process of rolling out national birth-dose vaccination campaigns; this roll out provides an opportunity to evaluate and improve processes in order to expand coverage. Early antenatal care, promotion of facility deliveries, and increased awareness of HBV prevention are also key components of prevention success. Future studies in SSA should identity an HBV-prevention package that is effective, well tolerated, and feasible and can be administered in the antenatal clinic and tailored to vertical-transmission risk. 相似文献14.
Jean Ferrières Katherine Gorcyca Şerban R. Iorga David Ansell Dylan L. Steen 《Clinical therapeutics》2018,40(9):1484-1495.e22
Purpose
The goal of this study was to summarize patterns of lipid-lowering therapy (LLT) usage and achievement of guideline-identified lipid goals in a 2015 general practice cohort of French patients with atherosclerotic cardiovascular disease (ASCVD) and/or diabetes mellitus (DM).Methods
From the IMS Health Real-World Data database, patients aged ≥18years were classified hierarchically into mutually exclusive categories of ASCVD subgroups and DM. LLT use and lipid goal achievement were assessed on the date of lipid measurement. The data were compared with previously published results of LLT use and lipid goal achievement in a 2014 UK population.Findings
Of 32,924 patients meeting the inclusion criteria, only 47.5% were prescribed a statin as of the index date. Hierarchically, the highest rates of use of any statin (73.3%) and high-intensity statins (43.3%) were among patients with recent acute coronary syndrome; rates in DM without ASCVD were 38.7% and 2.3%, respectively. Overall, achievement of LDL-C levels <1.8 mmol/L (<70 mg/dL) was only 13.9% for patients with ASCVD and 10.7% with DM. Relative to a 2014 UK population, the 2015 French cohort (data reanalyzed according to the UK statin categorization) were prescribed “high-dose statins” less frequently (31.4% vs 20.9%, and 18.7% vs 7.2%, for ASCVD and DM). Similarly, the proportion of patients with high-dose statins achieving LDL-C levels <1.8mmol/L was higher in the 2014 UK population than in the 2015 French population (37.3% vs 22.2%, and 36.8% vs 20.3%, for ASCVD and DM).Implications
In a large cohort of French patients with ASCVD and/or DM, LLT usage and LDL-C goal achievement were suboptimal, relative to current guidelines. 相似文献15.
Karen E. Wickersham Molly Crothers Danielle Puth Miriam N. Weiss Kendall Powell Barbara Resnick 《Geriatric nursing (New York, N.Y.)》2019,40(1):63-66
Purpose
Assess patient- and clinical-related variables associated with targeted cancer treatments (TTs) for adults ≥85 years of age.Rationale
TTs have pathway-specific side effects that negatively affect QoL and medication adherence, which may reduce TT efficacy. Research has not focused on patients aged ≥85 years; therefore, the scope of TT use in this age group is not understood.Methods
We conducted an electronic medical record review to identify individuals ≥85 years treated with TT.Results
The sample (N?=?295) was 53.5% male, 41% married/partnered, and 73.7% Caucasian.Common cancer types included breast (26.3%), prostate (31.3%), and leukemia (14.1%). Only one-third (n?=?98) of the sample had TT side effects noted in their patient chart.Conclusions
Patients aged ≥85 years took similar TTs and experienced similar side effects as reported by research of younger patients; however, symptom experience was not well-reported. 相似文献16.
Purpose
This commentary discusses the therapeutic and economic potentials of regenerative medicine (RM) by addressing how the reprioritization of resources in drug development may alleviate unmet medical need across many diseases, but especially cardiovascular diseases (CVDs) and musculoskeletal diseases (MSDs), the leading causes of mortality and morbidity, respectively, in the United States.Methods
Data and perspectives represented in this commentary were obtained through an online literature search, public press releases from federal agencies and companies, online opinion pieces, published journal articles, and consulting agency reports; however, there were limitations to the available data because of the breadth and novelty of the therapeutic modalities involved.Findings
Currently, the misallocation of resources within the therapeutic areas of CVDs and MSDs are possibly contributing to low approval rates, high cost of drug treatments, and consequently, disease burden. With a 2025 global market estimate of US $50.5 billion, RM is expected to become a major player in the pharmaceutical industry, with a potential to change the treatment paradigm and lessen disease burden across multiple disease areas, most notably in CVDs and MSDs.Implications
While the public sector appears to be doing its fair share by funding basic research and revamping regulatory regimes to address the vagaries of RM as a rapidly emerging novel technology, the support framework necessary for transforming the field from a promising concept to available therapy requires levels of resource allocation and marketing support that only the private sector can provide. 相似文献17.
Peter Ong Giancarlo Pirozzolo Anastasios Athanasiadis Udo Sechtem 《Clinical therapeutics》2018,40(9):1584-1590
Purpose
Coronary spasm is frequently found in patients with angina and unobstructed coronaries. The pathophysiology is incompletely understood, although sex differences have been described. Often a positive family history (PFH) is encountered. We assessed the relationship between sex, coronary spasm, and a PFH for cardiovascular disease.Methods
This single-center observational study recruited 415 stable angina patients with unobstructed coronaries (no stenosis >50%) between 2008 and 2011 (mean [SD] age, 62 [10] years; 38% men). Patients were referred for angiography because of signs and symptoms of myocardial ischemia. Intracoronary acetylcholine (ACh) testing was performed in all patients according to a standardized protocol. Risk factor assessment included hypertension, hypercholesterolemia, diabetes, smoking, and a PFH. The latter was defined as a first-degree relative with myocardial infarction or stroke. Statistical analysis involved comparison of categorical and continuous variables. Multivariable analysis aimed at identifying predictors for a pathologic ACh testing, microvascular spasm, and a PFH.Findings
Epicardial spasm was found in 33% of patients and microvascular spasm in 30% of patients. A pathologic ACh test was more frequent in women than in men (72% vs 49%; P < 0.0005). A PFH was found in 55% of patients with significantly more women than men (61% vs 45%; P?=?0.001). Among patients with epicardial spasm, women had a PFH significantly more often than men (66% vs 43%; P?=?0.006). The latter difference was not found when comparing women and men with microvascular spasm.Implications
There is a female preponderance among patients with angina and unobstructed coronaries. ACh testing enables detection of coronary spasm. Epicardial spasm in women is associated with a PFH. 相似文献18.
Purpose
Morphine ARER is a novel oral, abuse-deterrent, extended-release (ER) formulation of morphine sulfate with physical and chemical properties that deter misuse and abuse by nonoral routes of administration. Here we evaluate the relative bioavailability of morphine ARER and extended-release morphine.Methods
This single-dose, 2-treatment, 2-period, 2-sequence, randomized crossover study in healthy adult subjects compared the relative bioavailability of morphine ARER 100 mg to that of ER morphine 100 mg in the fasted condition. At 12 and 1.5 hours before dosing and 12 hours after dosing, all subjects received a 50-mg oral naltrexone tablet to minimize opioid-related side effects. Pharmacokinetic parameters including the AUC0–t, AUC0–∞, and Cmax of morphine and its metabolite morphine-6-glucuronide (M6G) were determined at various times up to 48 hours postdose. The bioequivalence of morphine ARER and ER morphine was determined using an ANOVA of the least-squares mean values of morphine and M6G bioavailability.Findings
Forty-nine subjects completed the study. Both morphine ARER and ER morphine exhibited peak plasma morphine and M6G concentrations of ～30 ng/mL and ～200 ng/mL, respectively, at 3 hours postdose. The 90% CIs of the ln-transformed values of morphine AUC0–t, AUC0–∞, and Cmax were within the 80% to 125% range for bioequivalence. M6G values also indicated bioequivalence of morphine ARER and ER morphine. The most common adverse events were nausea and somnolence.Implications
These data show that, in these subjects, morphine ARER was bioequivalent to ER morphine, a treatment for pain with well-established efficacy and safety profiles. 相似文献19.
Joanne E.Brady Marni Stott-Miller George Mu Sue Perera 《Clinical therapeutics》2018,40(9):1509-1521.e5
Purpose
Treatment options for patients with ulcerative colitis (UC) or Crohn disease (CD) have increased considerably in recent years with the advent of new biologics, but little is known about treatment pathways in clinical practice. We aimed to characterize treatment patterns and sequences in patients with UC or CD newly initiated on a biologic or an immunosuppressant (IMS).Methods
This retrospective cohort study used US health insurance claims data dated from January 1, 2009, to December 31, 2013, from patients with UC or CD newly initiated on a biologic or an IMS. Treatment patterns and sequences were described during a 24-month follow-up period.Findings
Among 5543 patients with UC and 7561 patients with CD, 2403 and 4677 patients, respectively, were initiated on a biologic; 3140 and 2884 patients were initiated on an IMS. In patients initiated on a biologic, monotherapy was chosen in 71% for UC (primarily infliximab [68%]) and in 79% for CD (primarily adalimumab [52%]). Approximately one third of patients remained on the first-line biologic during the follow-up period; 69% (UC) and 70% (CD) of patients were initiated on a second-line therapy, among whom 25% (UC) and 39% (CD) received a different biologic monotherapy, suggesting intolerance, inadequate response, or loss of response to first-line therapy. In patients initiated on an IMS, 58% (UC) and 66% (CD) were initiated on monotherapy; combination therapy with a corticosteroid was prescribed in 41% (UC) and 30% (CD) of patients; and second-line therapy was initiated in 72% (UC) and 75% (CD) of patients.Implications
While current treatment options seem effective in a proportion of patients with UC and CD, others require multiple lines of therapy, suggesting anunmet need for alternative treatments in UC and CD to achieve disease control. 相似文献20.
Mi-Kyeong Kim Sook Young Lee Hae-Sim Park Ho Joo Yoon Sang-Ha Kim Young Joo Cho Kwang-Ha Yoo Soo-Keol Lee Hee-Kyoo Kim Jung-Won Park Heung-Woo Park Jin-Hong Chung Byoung Whui Choi Byung-Jae Lee Yoon-Seok Chang Eun-Jung Jo Sang-Yeub Lee You Sook Cho Choon-Sik Park 《Clinical therapeutics》2018,40(7):1096-1107.e1