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1.
Annie Penfield-Cyr Carmen Monthe-Dreze Marcela C. Smid Sarbattama Sen 《Clinical therapeutics》2018,40(10):1659-1667.e1
Purpose
Maternal body mass index (BMI) and systemic fatty acid (FA) concentrations affect inflammatory balance in pregnancy and play a key role in fetal growth and well-being. Little is known about how maternal BMI may affect the association between key FA concentrations and neonatal outcomes. The objective of this study was to examine the associations between the maternal omega (n)6:n3 FA ratio and neonatal outcomes according to maternal pre-pregnancy BMI category.Methods
This study is a secondary analysis of the Maternal-Fetal Medicine Units Network randomized controlled trial of omega-3 FA supplementation to prevent recurrent preterm birth. At consent (16–22 weeks of pregnancy), women were randomized to either the intervention arm (2g of n3 FAs) or the control arm (placebo). For the present analysis, the primary exposure was the ratio of proinflammatory to anti-inflammatory (n6:n3) FAs at 25 to 28 weeks of pregnancy. The primary outcome was fetal growth as measured by using birth-weight-for-gestational-age z score, birth-length-for-gestational-age z score, and head-circumference-for-gestational-age z score. BMI categories were defined as lean (18.5–24.9 kg/m²) and overweight/obese (OWOB) (≥25.0 kg/m²). Final analysis was stratified according to BMI and adjusted for education, race, parity, smoking status, total fish intake at the time of the blood draw, and number of days in the study at the time of delivery.Findings
A total of 440 participants were included in this analysis; 49% were lean, and 51% were OWOB. After adjustment for covariates, a higher maternal n6:n3 FA ratio was associated with impaired fetal growth (birth-weight-for-gestational-age z score, β?=?–0.04 per unit increase in n6:n3; 95% CI, –0.07 to –0.01), 1day shorter length of gestation (β?=?–0.14 week; 95% CI, –0.27 to –0.01), higher incidence of neonatal respiratory distress syndrome (odds ratio, 1.37; 95% CI, 1.04 to 1.80), and increased length of neonatal hospital stay (β?=?0.29 day; 95% CI, 0.003 to 0.58) in OWOB, but not lean, participants.Implications
Higher maternal inflammation during pregnancy, as measured by using the n6:n3 FA ratio, may be a marker of adverse perinatal and neonatal outcomes, particularly among OWOB women. 相似文献2.
Robert M. Rifkin Sundar Jagannath Brian G.M. Durie Mohit Narang Howard R. Terebelo Cristina J. Gasparetto Kathleen Toomey James W. Hardin Lynne Wagner Kejal Parikh Safiya Abouzaid Shankar Srinivasan Amani Kitali Faiza Zafar Rafat Abonour 《Clinical therapeutics》2018,40(7):1193-1202.e1
Purpose
Maintenance therapy after autologous stem cell transplantation (ASCT) improves clinical outcomes in multiple myeloma (MM), but the effect of continued treatment with lenalidomide-only maintenance, or any maintenance, on health care resource utilization (HCRU) is largely unknown.Methods
Here we present an analysis of HCRU and clinical outcomes in a cohort of patients from the Connect MM registry, the largest, ongoing, observational, prospective US registry of patients with symptomatic newly diagnosed MM. In this study, patients with newly diagnosed MM who completed induction and single ASCT without subsequent consolidation received lenalidomide-only maintenance (n?=?180), any maintenance (n?=?256), or no maintenance (n?=?165). HCRU (hospitalization, surgery/procedures, and concurrent medications [growth factors, bisphosphonates, or neuropathic pain medication]) was assessed starting from 100 days post-ASCT for up to 2 years.Findings
Although the rates of hospitalization per 100 person-years were similar across groups at the end of years 1 and 2, the median duration of hospitalization was numerically longer with no maintenance. The rates of use of growth factors, bisphosphonates, and neuropathic pain medication were generally similar in all 3 groups. The receipt of any maintenance was associated with significantly reduced use of neuropathic pain medications during year 1. Of note, lenalidomide-only maintenance was associated with significantly longer progression-free survival (54.5 vs 30.4 months; hazard ratio [HR]?=?0.58; 95% CI, 0.43–0.79; P?=?0.0005) and overall survival (OS) (median OS not reached in either group; HR?=?0.45; 95% CI, 0.28–0.73; P?=?0.001) compared with no maintenance. Likewise, the group treated with any maintenance had significantly longer median progression-free survival (44.7 vs 30.4 months; HR?=?0.62; 95% CI, 0.47–0.82; P?=?0.0008) and OS (median OS not reached in either group; HR?=?0.50; 95% CI, 0.33–0.76; P?=?0.001) than did the group that did not receive maintenance.Implications
These findings suggest that in this largely community-based study population, post-ASCT maintenance therapy, including lenalidomide-only maintenance, improves clinical outcomes without negatively affecting HCRU. ClinicalTrials.gov identifier: NCT01081028. 相似文献3.
4.
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
Purpose
The aim of this study was to evaluate the efficacy and safety of a fixed-dose combination of montelukast and levocetirizine in patients with perennial allergic rhinitis with mild to moderate asthma compared with the efficacy and safety of montelukast alone.Methods
This study was a 4-week, randomized, multicenter, double-blind, Phase III trial. After a 1-week placebo run-in period, the subjects were randomized to receive montelukast (10 mg/day, n?=?112) or montelukast (10 mg/day)/levocetirizine (5 mg/day) (n?=?116) treatment for 4 weeks. The primary efficacy end point was mean daytime nasal symptom score. Other efficacy end points included mean nighttime nasal symptom score, mean composite symptom score, overall assessment of allergic rhinitis by both subjects and physicians, forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC, asthma control test score, and the frequency of rescue medication used during the treatment period.Findings
Of 333 patients screened for this study, 228 eligible patients were randomized to treatment. The mean (SD) age of patients was 43.32 (15.02) years, and two thirds of subjects were female (66.67%). The demographic characteristics were similar between the treatment groups. Compared with the montelukast group, the montelukast/levocetirizine group reported significant reductions in mean daytime nasal symptom score (least squares mean [SE] of combination vs montelukast, –0.98 [0.06] vs –0.81 [0.06]; P?=?0.045). For all other allergic rhinitis efficacy end points, the montelukast/levocetirizine group showed greater improvement than the montelukast group. Similar results were observed in overall assessment scores and in FEV1, FVC, FEV1/FVC, and asthma control test score changes from baseline for the 2 treatment groups. Montelukast/levocetirizine was well tolerated, and the safety profile was similar to that observed in the montelukast group.Implications
The fixed-dose combination of montelukast and levocetirizine was effective and safe in treating perennial allergic rhinitis in patients with asthma compared with montelukast alone. ClinicalTrials.gov identifier: NCT02552667. 相似文献5.
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6.
Min Yang Yong Luo Tao Liu Xiaolong Zhong Jiao Yan Qi Huang Jie Tao Qingjuan He Mingyang Guo Yonghe Hu 《Clinical therapeutics》2018,40(10):1752-1764.e1
Purpose
Cardiovascular and diabetic complications are the main causes of death in patients with rheumatoid arthritis (RA). Puerarin has potential protective effects against subclinical atherosclerosis and insulin resistance, but the clinical evidence is still not sufficient to draw definitive conclusions. Therefore, we performed the clinical trial to assess the effect of puerarin on carotid intima-media thickness (CIMT) in RA.Methods
This is an open, controlled, randomized, and parallel-group comparison study of 119 patients with a definite diagnose of active RA. All 119 consecutive patients with RA receiving routine antirheumatic care were randomized to receive treatment with (n?=?60; 16 males and 44 females; mean age, 52.97 years; 95% CI, 49.78–56.15 years) or without (n?=?59; 17 males and 42 females; mean age, 54.05 years; 95% CI, 50.03–58.07 years) 400mg of puerarin. The effects of both interventions on CIMT, homeostasis model assessment of insulin resistance (HOMA-IR) value, and possible adverse events were assessed and compared at entry, 12 weeks, and 24 weeks. The collected data were processed and assessed using ANCOVA, paired t test, repeated-measure ANOVA, one-way ANOVA, Pearson's χ2 test, Fisher exact test, Kaplan-Meier survival analysis, Pearson correlation, and LOESS (locally weighted smoothing) regression analysis.Findings
No significant adverse effects occurred concerning the use of puerarin, and both interventions were generally well tolerated in all the patients. A tiny but significant decrease of CIMT was observed in puerarin-treated patients at 24 weeks (?0.003 mm; 95% CI, ?0.005 to ?0.001vs 0.019 mm; 95% CI, ?0.002 to 0.040; P < 0.001). At 24 weeks, insulin resistance was indicated with more pronounced improvement in the puerarin group versus the control group (homeostasis model assessment, ?0.40; 95% CI, ?0.47 to ?0.33vs ?0.05; 95% CI, ?0.08 to ?0.01; P < 0.001). Correlation analysis indicated an interaction between the parallel reductions in CIMT and insulin resistance in the puerarin group (r?=?0.878, P < 0.001) but not in the control group.Implications
In the study, 24 weeks of treatment with 400mg of puerarin exerted a significant effect against CIMT progression in patients with active RA, which may be associated with the improvement of insulin resistance. Puerarin holds promise as a drug candidate for the prevention and treatment of cardiometabolic comorbidities in patients with active RA. However, more strictly designed trials, such as double-blind and placebo-controlled trials, are still required. ClinicalTrials.gov identifier: NCT02254655. 相似文献7.
Kristina S. Boye Reema Mody Jianmin Wu Maureen J. Lage Fady T. Botros Brad Woodward 《Clinical therapeutics》2018,40(8):1396-1407
Purpose
The aims of this study were to use real-world treatment results to compare changes in estimated glomerular filtration rate (eGFR) and glycosylated hemoglobin (HbA1c) among patients with type 2 diabetes who initiated treatment with dulaglutide or insulin glargine and to determine the proportions of patients with renal impairment who initiate each treatment.Methods
The study used data from the Practice Fusion electronic health records database from October 2013 through June 2017. Adults with type 2 diabetes who initiated dulaglutide or insulin glargine therapy and had multiple recorded serum creatinine and/or HbA1c laboratory test results were included in the study. The dulaglutide cohort (n?=?1222) was matched to the insulin glargine cohort (n?=?13,869) using Mahalanobis distance matching with propensity score calipers. Multivariable analyses of the matched cohorts of individuals with serum creatinine results (n?=?1183 dulaglutide and 1183 insulin glargine) examined the association between intent-to-treat therapy and changes in eGFR. In addition, multivariable analyses were also conducted on a subset of these patients who also had recorded HbA1c tests (n?=?1088 dulaglutide and 1088 insulin glargine) to examine the association between changes in HbA1c during the 1 year postperiod.Findings
Among patients who initiated dulaglutide therapy, only 0.9% of patients had an index eGFR <30 and ≥15 mL/min/1.73 m2 and 0.1% had an index eGFR <15 mL/min/1.73 m2. In contrast, 4.1% of insulin glargine–treated patients had an index eGFR <30 and ≥15 mL/min/1.73 m2 and 1.2% had an index eGFR <15 mL/min/1.73 m2. Compared with patients who initiated therapy with insulin glargine, initiation of dulaglutide therapy was associated with a significantly smaller decrease in eGFR (?0.4 vs ?0.9 mL/min/1.73 m2; P?=?0.0024), a significantly smaller likelihood of having a 30% or greater reduction in eGFR (3.3% vs 4.1%; P < 0.0001), and a significantly larger reduction in HbA1c (?0.5% vs ?0.2%; P < 0.0001).Implications
In clinical practice, the use of dulaglutide was relatively more limited in patients with a higher degree of renal impairment compared with use of insulin glargine. However, initiation of dulaglutide therapy, compared with insulin glargine therapy, was associated with a significantly smaller decrease in eGFR and a larger reduction in HbA1c during the 1 year postperiod. 相似文献8.
Maral DerSarkissian Patrick Lefebvre Kruti Joshi Brianne Brown Marie-Hélène Lafeuille Rachel H. Bhak Michael Hellstern Priyanka Bobbili Brian Shiner Antoine C. El Khoury Yinong Young-Xu 《Clinical therapeutics》2018,40(9):1496-1508
Purpose
The aim of this article was to describe and compare treatment patterns, health care resource utilization (HRU), and health care costs before and after transition in veterans with schizophrenia who were transitioned from paliperidone palmitate given once monthly (PP1M) to paliperidone palmitate given every 3 months (PP3M) according to prescribing-information guidelines.Methods
This retrospective, longitudinal study was conducted using electronic health records data from the Veterans Health Administration (VHA). Veterans were eligible for inclusion if they were aged 18years or older, had ≥1 dispensation of PP3M, were enrolled with VHA benefits for ≥24 months prior to transition to PP3M, had ≥1 schizophrenia diagnosis, were transitioned to PP3M according to prescribing-information guidelines (operationalized as no gap in PP1M treatment of >45days during the 4 months prior to PP3M transition, with the same dosage in the last 2 PP1M dispensations), and had appropriate dose conversion. Treatment patterns, HRU, and costs 6 months pre and post PP3M transition were described and compared using the McNemar test and the Wilcoxon signed rank test.Findings
Of the 277 veterans identified, the majority were men (92.8%); the median age was 56.5years. Among 197 veterans who had at least 6 months of follow-up pre and post PP3M transition, oral antipsychotic use was significantly decreased (from 49.7% to 43.1%; P?=?0.0326). Additionally, the mean number of days spent in an inpatient setting (41.4vs 21.6; P?=?0.0164), the mean number of outpatient visits per patient (31.0vs 25.6; P < 0.0001), and the mean total health care costs ($27,745vs $23,772; P?=?0.0050) were significantly decreased.Implications
After transitioning to PP3M treatment, veterans had significantly reduced use of oral antipsychotics, HRU, and costs. Although generalizability may be limited due to the veteran population and to those who transitioned according to PP3M prescribing guidelines, future studies in other patient populations may be used to extend these conclusions. 相似文献9.
Bai-Li Song Meng Wan Dan Tang Chao Sun Yu-Bing Zhu Nyame Linda Hong-Wei Fan Jian-Jun Zou 《Clinical therapeutics》2018,40(7):1170-1178
Purpose
Some studies in the white population have shown that carriers of at least 1 loss-of-function allele in the gene that encodes the cytochrome P-450 2C19 isozyme (CYP2C19) have lower levels of the clopidogrel active metabolite (CAM) and a reduced antiplatelet effect of clopidogrel. However, data are limited regarding the association between CYP2C19 genetic variants and exposure to CAM and on the pharmacodynamic properties of CAM in the Chinese population. Data from the white population cannot be extrapolated to the Chinese population because of the marked interethnic differences in CYP2C19 variants. This study was aimed to investigate the influence of CYP2C19 genetic polymorphisms on the pharmacokinetic properties of CAM and the antiplatelet effect of clopidogrel in healthy Chinese volunteers, and to provide evidence for the role of a CYP2C19 genotyping test in predicting the antiplatelet effect of clopidogrel in the Chinese population.Methods
Twenty healthy subjects received a single 300-mg dose of clopidogrel and were assigned to 1 of 3 groups according to CYP2C19 genotype: CYP2C19 *1/*1 (normal metabolizers [NM]; n?=?8), CYP2C19 *1/*2 or *3 (intermediate metabolizers [IM]; n?=?10) and CYP2C19 *2/*2 or *3 and *3/*3 (poor metabolizers [PM]; n?=?2). Blood samples were collected at baseline and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after administration. The plasma concentrations of clopidogrel and CAM were analyzed by LC-MS/MS, and adenosine diphosphate–induced platelet aggregation was measured by light-transmittance aggregometry.Findings
There were no significant differences in Cmax and AUC0–t of clopidogrel prodrug in the NM group compared with the IM and PM groups. The mean CAM Cmax value was significantly higher in the NM group than in IM and PM groups (45.39 [12.57] vs 29.15 [7.92] ng/mL [P?=?0.003] and 19.55 [2.19] ng/mL [P?=?0.004], respectively). The mean CAM AUC0–t value was significantly higher in the NM group than in the IM and PM groups (61.05 [21.63] vs 37.67 [11.01] ng · h/mL [P?=?0.007] and 27.08 [2.72] ng · h/mL [P?=?0.016]). The NM group exhibited a significantly higher percentage of inhibition of platelet aggregation than did the IM or PM group (P?=?0.001). The correlations between the pharmacokinetic properties (Cmax, AUC0–t) of CAM and the pharmacodynamic data (maximal and inhibition of platelet aggregation) were significant (both, Pearson r > 0.5 and P < 0.01).Implication
In these healthy Chinese subjects, carriers of CYP2C19 loss-of-function allele(s) had significantly reduced exposure of CAM and decreased levels of inhibition of platelet aggregation with clopidogrel; these genotypes therefore might be a determinant for the formation of CAM and its antiplatelet effects. Study identifier: ChiCTR-OCH-14004382. 相似文献10.
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11.
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12.
Gillian A. Beauchamp Jennifer L. Carey Tyler Adams Amy Wier Manuel F. Colón Matthew Cook Robert Cannon Kenneth D. Katz Marna Rayl Greenberg 《Clinical therapeutics》2018,40(8):1366-1374.e8
Purpose
Adults aged >65 years are susceptible to intentional and unintentional poisoning, with contributing factors that include polypharmacy, comorbidity, susceptibility to medication error, and gaps in research. Although toxicologists are often tasked with managing and preventing poisoning among older adults, little is known about sex differences in these poisonings. The aim of this study was to review sex differences in poisonings among older adults managed at the bedside by medical toxicologists.Methods
All case subjects aged >65 years in the Toxicology Investigators Consortium (ToxIC) registry between January 2010 and December 2016 were reviewed. Data included reasons for exposure and consultation, exposure agents and routes, presenting clinical findings, and treatment provided. Cases missing age, sex, or primary reason for toxicology consultation data were excluded. We used χ2 tests to assess differences in distribution of study variables according to participant sex.Findings
Among 51,441 total registry cases, 542 (1.05%) were excluded because of missing data. Among the remaining 50,899 cases, 2930 (5.8%) were included for age >65 years; 52.3% of older adults were female. Race was missing or unknown for 49.2% of cases. Adverse drug reactions were more commonly encountered in female subjects than in their male counterparts (9.6% vs 6.4%; P?=?0.001). No statistically significant sex differences were observed for total numbers of intentional, unintentional pharmaceutical, and nonpharmaceutical exposures. The most common medications involved were cardiovascular (16.8%) and analgesics/opioids (14.8%). Female subjects were more likely than male subjects to be evaluated by a toxicologist for cardiovascular medications (18.7% vs 14.7%; P?=?0.004) and analgesics/opioids (17.6% vs 11.8%; P < 0.001). Male subjects were more likely than female subjects to be evaluated for ethanol toxicity (7.4% vs 1%; P < 0.001) and for envenomations (4.2% vs 1.8%; P < 0.001). The most common route of exposure was oral ingestion (81.3%). Signs/symptoms were noted in 54.8% of cases, with the most common abnormal vital sign being bradycardia (17.2%). Pharmacologic support was the most common intervention and was more common in male subjects than in female subjects (17.7% vs 12.3%; P < 0.001). Deaths were reported in 38 female subjects (2.45%) and 46 male subjects (3.34%); there was no statistically significant difference in death rate according to sex (P?=?0.148).Implications
Older female adults were more commonly evaluated by a medical toxicologist for an adverse drug reaction than older male adults. Female patients were more likely than male patients to be evaluated for poisoning related to analgesic/opioids and cardiovascular medications, and older male patients more frequently received pharmacologic support than older female patients. No significant sex differences were observed in numbers of toxicology consultations for intentional, unintentional pharmaceutical, and nonpharmaceutical exposures. 相似文献13.
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14.
Alan R. Cherney Amy B. Smith Charles C. Worrilow Kevin R. Weaver Dawn Yenser Jennifer E. Macfarlan Glenn A. Burket Andrew L. Koons Raymond J. Melder Marna R. Greenberg Bryan G. Kane 《Clinical therapeutics》2018,40(8):1375-1383
Purpose
The quality of clinical teaching in the emergency department from the students' perspective has not been previously described in the literature. Our goals were to assess senior residents' teaching ability from the resident/teacher and student/learner viewpoints for any correlation, and to explore any gender association. The secondary goal was to evaluate the possible impact of gender on the resident/student dyad, an interaction that has previously been studied only in the faculty/student pairing.Methods
After approval by an institutional review board, a 1-year, grant-funded, single-site, prospective study was implemented at a regional medical campus that sponsors a 4-year dually approved emergency medicine residency. The residency hosts both medical school students (MSs) and physician's assistant students (PAs). Each student and senior resident working concurrently completed a previously validated ER Scale, which measured residents' teaching performance in 4 categories: Didactic, Clinical, Approachable, and Helpful. Students evaluated residents' teaching, while residents self-assessed their performance. The participants' demographic characteristics gathered included prior knowledge of or exposure to clinical teaching models. Gender was self-reported by participants. The analysis accounted for multiple observations by comparing participants' mean scores.Findings
Ninety-nine subjects were enrolled; none withdrew consent. Thirty-seven residents (11 women) and 62 students (39 women) from 25 MSs and 6 PA schools were enrolled, completing 517 teaching assessments. Students evaluated residents more favorably in all ER Scale categories than did residents on self-assessments (P < 0.0001). This difference was significant in all subgroup comparisons (types of school versus postgraduate years [PGYs]). Residents' evaluations by type of student (MS vs PA) did not show a significant difference. PGY 3 residents assessed themselves higher in all categories than did PGY 4 residents, with Approachability reaching significance (P?=?0.0105). Male residents self-assessed their teaching consistently higher than did female residents, significantly so on Clinical (P?=?0.0300). Students' evaluations of the residents' teaching skills by residents' gender did not reveal gender differences.Implications
MS and PA students evaluated teaching by EM senior residents statistically significantly higher than did EM residents on self-evaluation when using the ER Scale. Students did not evaluate residents' teaching with any difference by gender, although male residents routinely self-assessed their teaching abilities more positively than did female residents. These findings suggest that, if residency programs utilize resident self-evaluation for programmatic evaluation, the gender of the resident may impact self-scoring. This cohort may inform future study of resident teaching in the emergency department, such as the design of future resident-as-teacher curricula. 相似文献15.
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16.
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17.
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18.
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19.
Li Li Yuchun Wei Yong Huang Qingxi Yu Wenju Liu Shuqiang Zhao Jinsong Zheng Hong Lu Jinming Yu Shuanghu Yuan 《Molecular imaging and biology》2018,20(6):1061-1067
Purpose
To explore a representative hypoxic parameter to predict the treatment response and prognosis for [18F]fluoromisonidazole ([18F]FMISO) positron emission tomography (PET)/X-ray computed tomography (CT) in patients with non-small cell lung cancer (NSCLC).Procedures
Twenty-nine patients with NSCLC underwent FMISO-PET scans before chemoradiotherapy (CRT). The maximum standard uptake values (SUVmax) in the tumor, normal lung, aortic arch, and vertical ridge muscle were measured, and the tumor-to-lung (T/L) ratios, tumor-to-blood (T/B) ratios, ands tumor-to-muscle (T/M) ratios were calculated and analyzed. Fractional hypoxic volume (FHV) was expressed as percentage of hypoxic volume.Results
SUVmax, T/L ratio, T/B ratio, and FHV were all significantly different between the responders and the non-responders (SUVmax, 2.07?±?0.53 vs. 2.61?±?0.69, P?=?0.026; T/L ratio, 3.16?±?0.85 vs. 4.09?±?1.46, P?=?0.047; T/B ratio, 1.27?±?0.20 vs. 1.48?±?0.32, P?=?0.042; 38.92?±?18.47 vs. 52.91?±?11.29 %, P?=?0.020). However, the T/M ratio was not significantly different between the two populations (1.46?±?0.31 vs. 1.67?±?0.33, P?=?0.098). The correlation ratio between hypoxic parameters and treatment responses ranged from high to low as FHV (r?=?0.412); SUVmax (r?=?0.400); T/L ratio (r?=?0.379), P?<?0.05; and T/B ratio (r?=?0.355), P?=?0.059. According to the area under curve (AUC) to predict response, the hypoxic parameters were arranged as FHV (AUC?=?0.748), SUVmax (AUC?=?0.731), T/L ratio (AUC?=?0.719), and T/B ratio (AUC?=?0.705). Binary logistic regression analyses showed that FHV was the only independent predictor for treatment response with the P value of 0.038. In the progression-free survival (PFS) prediction, both FHV and SUVmax reached statistical significance by Kaplan–Meier plots (FHV, 46.99 %, P?=?0.010; SUVmax, 1.99, P?=?0.046) while only FHV was the independent prognostic factor in multivariate analysis by Cox proportional hazard model (P?=?0.037).Conclusion
FHV may be a representative hypoxic parameter to predict the CRT response and PFS in patients with NSCLC.20.