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1.
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2.
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3.
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4.
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5.
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6.
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7.
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8.
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9.
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10.
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11.
12.
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13.
Eric Lawitz Mohamed Bidair Thomas Marbury Christopher T. Jones Avantika Barve Baldur Magnusson David T. Barkan Ursula Bodendorf Kathryn Bracken Erica Canino Darlene Chen Kristina Dabovic Tycho Heimbach Marjorie Ison Catherine L. Jones Steven J. Kovacs Jay P. Lakshman Bin Li Richard A. Colvin 《Clinical therapeutics》2018,40(9):1567-1581.e4
Purpose
Infection with hepatitis C virus is the leading cause of infectious disease mortality in the United States. BZF961 is a novel small molecule inhibitor of the hepatitis C virus NS3-4A protease. Here we present the results of a randomized, double-blinded, placebo-controlled, multicentered study in treatment-naïve patients with chronic hepatitis C virus genotype-1 infection.Methods
Patients were enrolled sequentially in 2 parts and treated for 3days. BZF961 was administered as monotherapy (500mg BID for 3 days) or in combination with the cytochrome P450 3A4 inhibitor ritonavir to boost its exposure (BZF961 10, 20, or 50mg QD or BID).Findings
BZF961 was safe and well tolerated in the patients studied with no serious adverse events. There were no appreciable differences in adverse events among patients who received BZF961, BZF961 with ritonavir, or placebo. There was a significant, clinically meaningful reduction in viral load from baseline in patients treated either with BZF961 500mg every 12hours alone or BZF961 50mg every 12hours in combination with ritonavir. Activity against the hepatitis C virus of the lower-dose regimens was apparent but more modest. There were no relevant changes from baseline viral loads in placebo-treated patients.Implications
Coadministration of ritonavir with BZF961 boosted BZF961 exposure (including Cmin, which is the clinically relevant parameter associated with antiviral activity) in a therapeutic range with less variability compared with BZF961 alone. For strategic reasons, BZF961 is no longer under development. 相似文献14.
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15.
Background
Disclosure of prognosis-related information is an essential aspect of communication with pediatric patients with cancer and their families. The nurse is believed to play an important role in this process, but nurse perceptions and experiences have not been well-described.Purpose
Provide an exploration of pediatric oncology nurses’ experiences with prognosis-related communication (PRC).Method
Mixed-methods, multiphase design. This paper highlights the qualitative portion of the study.Findings
Three themes were identified: Importance of collaboration, impact of PRC, and delivery of prognostic information.Discussion
Collaboration is a critical element of PRC. Nurses are often not included in the disclosure process, which limits the ability of nurses to fully function in their roles, compromising patient, family, and nurse outcomes. A paradigm shift is required to empower nurses to be more active participants. More education of physicians and nurses is necessary to consistently engage nurses in PRC and prepare nurses for critical conversations. 相似文献16.
Tian-tian Zhang Sen Wang Ning Wan Li Zhang Zugui Zhang Jie Jiang 《Clinical therapeutics》2018,40(7):1122-1139
Purpose
The prominent efficacy of the addition of daratumumab to lenalidomide and dexamethasone (DRd) or the addition to bortezomib and dexamethasone (DVd) was proven previously for patients with relapsed or refractory multiple myeloma (RRMM). However, the cost-effectiveness of adding daratumumab to traditional doublet regimens versus doublet regimens alone (DRd vs Rd; DVd vs Vd) was unknown.Methods
We developed a semi-Markov model by using a US payer perspective and 10-year time horizon to estimate the cost and quality-adjusted life years (QALYs) for treatments. Clinical data were obtained from the POLLUX (Phase 3 Study Comparing DRd Versus Rd in Subjects with Relapsed or Refractory Multiple Myeloma [RRMM]) and CASTOR (Phase 3 Study Comparing DVd Versus Vd in Subjects with RRMM) trials. Deterministic and probabilistic sensitivity analyses were conducted to evaluate model uncertainty.Findings
The incremental cost-effectiveness ratio (ICER) for DVd compared with Vd was $284,180 per QALY; the ICER for DRd compared with Rd was $1,369,062 per QALY. Only when the price of daratumumab was reduced to 37% (US $702/vial) of the current price could the addition of daratumumab to Vd be cost-effective under the US willingness-to-pay (WTP) of $50,000/QALY. However, under no discount level of the daratumumab price is the addition of daratumumab to Rd acceptable. When the WTP increased to $300,000/QALY, the addition of DVd had a 56.7% probability of being cost-effective compared with the Vd regimen.Implications
Due to the high price of daratumumab, neither the addition of daratumumab to Rd nor Vd proved to be cost-effective under US WTP. However, if the daratumumab price fell to a certain discount level, the DVd regimen might be cost-effective. 相似文献17.
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18.
Stephen E. Daniels Hartley C. Atkinson Ioana Stanescu Chris Frampton 《Clinical therapeutics》2018,40(10):1765-1776.e5
Purpose
Acute pain is a significant burden to the individual and to society. There is a clear need for a pain medication that provides improved analgesia over common analgesics, without compromising tolerability. The goal of this study was to determine the efficacy of a new fixed-dose combination of acetaminophen 975 mg and ibuprofen 292.5 mg (FDC 975/292.5) relative to acetaminophen or ibuprofen monotherapy, or placebo.Methods
This prospective, multicenter, randomized, double-blind, placebo-controlled, Phase III trial included 408 adult volunteers aged 18 to 60 years experiencing moderate to severe pain after surgical removal of at least 2 impacted third molars. Subjects were randomized in a 3:3:3:2 ratio to the following interventions: FDC 975/292.5, acetaminophen 975 mg, ibuprofen 292.5 mg, and placebo. Self-reported pain intensity scores were recorded over a 48-hour double-blind treatment period using a 100-mm visual analog scale. In addition, time to perceptible and meaningful pain relief was assessed by using the two-stopwatch method; use of rescue medication (oxycodone) was recorded; and patients rated their pain relief on a 5-point categorical scale. All adverse events during the 30-day study period were assessed.Findings
The majority of participants were female (67.4%) and white (90.0%), with a mean age of 24.8 years. Demographic and baseline characteristics were balanced across treatment groups, with a mean baseline pain score of 56.4 mm. The primary end point was the time-adjusted sum of pain intensity differences over 48 hours, which was found to be significantly greater for FDC 975/292.5 than for both monotherapies and placebo (all, P < 0.001). The robustness of the procedures used in the calculation of the primary end point was confirmed in a series of sensitivity analyses. Statistical superiority of the combination was evident in all secondary end points (time to meaningful pain relief, maximum pain score, response rate, participants using supplementary analgesia, time to rescue, oxycodone consumption, and categorical pain relief score) with the exception of time to perceptible pain relief versus monotherapies and the time to peak response versus ibuprofen. The percentage of patients reporting adverse events was 37.3% in the FDC 975/292.5 group, with no significant differences between treatment groups. Nausea was the most common adverse event across all groups.Implications
Overall, the fixed-dose combination of acetaminophen and ibuprofen provided greater and more rapid analgesia than comparable doses of either agent alone or placebo in adults after removal of impacted third molars. ClinicalTrials.gov identifier: NCT01420653. 相似文献19.
Xuehua Ke Abhishek Kavati Debra Wertz Qing Huang Liya Wang Vincent J. Willey Judith J. Stephenson Benjamin Ortiz Reynold A. Panettieri Jonathan Corren 《Clinical therapeutics》2018,40(7):1140-1158.e4
Purpose
The objective of this study was to examine patient characteristics, treatment patterns, and exacerbations among patients with asthma newly treated with omalizumab.Methods
Data for this study were obtained from administrative claims and medical records. The index date was the date of the first claim for omalizumab. All patients had ≥12 months of continuous health plan eligibility before and after the index date. Demographic and clinical characteristics were obtained 12 months before the index date. Treatment patterns of asthma medications, including omalizumab, and asthma exacerbations were evaluated in the preindex and postindex periods.Findings
The study included 1564 patients. Asthma-related medication use decreased from the preindex to the postindex periods (oral corticosteroids, 83.3%–66.4%, P < 0.001; inhaled corticosteroids [ICSs], 33.1%–26.8%, P < 0.001; long-acting β2-adrenergic agonists [LABAs], 6.6%–5.2%, P?=?0.009; ICS-LABA combination, 69.3%–64.3%, P < 0.001; leukotriene modifiers, 67.8%–59.7%, P < 0.001). The proportion of patients with any asthma exacerbations decreased by 33.6% (66.6%–44.2%, P < 0.001). Notably, the relative decreases in hospitalization and emergency department exacerbations were 79.3% and 72.2%, respectively. A total of 930 patients (59.5%) discontinued omalizumab treatment during the entire postindex period (maximum, 3400 days [approximately 9 years]), with 353 (38.0%) restarting omalizumab treatment.Implications
In this real-world analysis, patients newly initiating omalizumab therapy for allergic asthma used fewer concomitant asthma medications, while experiencing significant reductions in asthma exacerbations, especially hospitalization- and emergency department–specific exacerbations, from pre– to post–omalizumab treatment initiation periods. 相似文献20.