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1.
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2.
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3.
Vaishali Sahasrabudhe Steven G. Terra Anne Hickman Didier Saur Sangeeta Raje Haihong Shi Kyle Matschke Susan Zhou David L. Cutler 《Clinical therapeutics》2018,40(10):1701-1710
Purpose
Ertugliflozin, an oral, highly selective inhibitor of the sodium-glucose cotransporter 2, is approved in the United States and the European Union for the treatment of adults with type 2 diabetes mellitus. Hepatic impairment may affect, to varying degrees, the absorption, metabolism, and excretion of drugs and may be associated with a lower plasma protein binding compared with that in healthy individuals. This study was conducted to assess the effect of hepatic impairment on the pharmacokinetic (PK), safety, and tolerability profiles of ertugliflozin after administration of a single, 15-mg oral dose.Methods
This was a Phase I, open-label, single-dose study in healthy individuals (n?=?8) and those with moderate hepatic impairment (n?=?8). Eligible participants were men or women aged 18 to 75years with a body mass index of 18.0 to 40.5 kg/m2. Healthy individuals had normal hepatic function; patients with hepatic impairment had a Child-Pugh score of 7 to 9 points (moderate hepatic impairment). Blood samples were collected before dosing and during 96hours after dosing for evaluation of PK parameters. Adverse events were monitored throughout the study.Findings
The adjusted least squares geometric meanratios for total ertugliflozin AUC0–∞ and Cmax inpatients with moderate hepatic impairment comparedwith healthy individuals were 87.4% (90% CI, 68.1%–112.2%) and 78.7% (90% CI, 65.7%–94.2%), respectively. The AUC0–∞ and Cmax for unbound ertugliflozin were also similar between patients with moderate hepatic impairment and healthy individuals. Mean half-life estimates for ertugliflozin were similar (14.6vs 13.8 hours) in patients with moderate hepatic impairment and healthy individuals. The number of participants with all-causality treatment-emergent adverse events was similar for both groups (2 of 8 patients with moderate hepatic impairment and 3 of 8 healthy individuals).Implications
Moderate hepatic impairment had no clinically relevant effect on the PK and safety profiles of ertugliflozin. The results of this study support a recommendation for no dose adjustment of ertugliflozin in patients with mild or moderate hepatic impairment. Ertugliflozin was well tolerated when administered tohealthy individuals and patients with moderate hepatic impairment. ClinicalTrials.gov identifier: NCT02115347. 相似文献4.
Peter Ong Anastasios Athanasiadis Andrea Perne Heiko Mahrholdt Tim Schäufele Stephan Hill Udo Sechtem 《Clinical research in cardiology》2014,103(1):11-19
Background
Coronary angiography is often performed in patients with recurrent or ongoing angina after successful percutaneous coronary intervention (PCI) in search of an in-stent restenosis (ISR). However, in many of these patients, no significant ISR can be detected. We speculate that enhanced coronary vasoconstriction represents an alternative explanation for angina in these patients.Methods
From 1,285 patients with angiographically unobstructed coronaries (no stenosis ≥50 %) who underwent intracoronary acetylcholine provocation testing (ACH-test) between 2008 and 2011, we consecutively recruited 104 patients (42 female (40 %), mean age 64 ± 11 years) who fulfilled the following inclusion criteria: previous stent implantation due to obstructive coronary artery disease (CAD), ongoing/recurrent exertional angina, no significant (<50 %) ISR.Results
In fifty-one patients with previous PCI (49 %), the ACH-test elicited enhanced epicardial vasoconstriction (≥75 % diameter reduction with reproduction of the patient’s symptoms) and microvascular vasoconstriction (reproduction of symptoms, ischemic ECG-changes and no epicardial vasoconstriction) was seen in 18 additional patients (17 %). The ACH-test was uneventful in the remaining 35 patients (34 %). Epicardial vasoconstriction in patients with previous PCI was most often distal and diffuse (31/51, 61 %, p < 0.01).Conclusion
Enhanced epicardial and microvascular coronary vasoconstrictions are frequently found in patients with stable angina after successful PCI but without significant ISR. Intracoronary acetylcholine provocation testing may be useful in these patients to determine the cause of angina and initiate appropriate medical treatment. 相似文献5.
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6.
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.
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9.
Hailan Wu Shengxin Xie Jicheng Yu Yuancheng Chen Jufang Wu Beining Guo Zhenghai Zhu Ying Zhou Zhiqiang Wang Jing Zhang 《Clinical therapeutics》2018,40(9):1548-1555
Purpose
The pharmacokinetic (PK) and pharmacodynamic characteristics of levornidazole were studied in patients with intra-abdominal anaerobic infection to provide the rationale of new clinical dosing regimen of levornidazole.Methods
A single-center, open, multidose trial was conducted in 16 patients with intra-abdominal anaerobic infection. Patients received levornidazole at 500mg q12h by intravenous infusion for 3 to 7days. The plasma samples collected before and after the last dose were analyzed by the LC-MS/MS method to determine the concentration of levornidazole. The PK parameters of levornidazole were calculated, and the PK profiles of levornidazole after the dosing regimen of 750mg q24h for 7days were simulated based on the linear PK profile of levornidazole. Monte Carlo simulation was used for estimating the cumulative fraction of response and probability of target attainment (PTA) of both dosing regimens at steady-state against Bacteroides fragilis.Findings
After administration of the last dose of 500mg of levornidazole, the mean (SD) Cmax_ss, AUC0-12, and t1/2 of levornidazole were 24.0 (5.37) μg/mL, 176.59 (29.22) μg·h/mL, and 11.03 (1.34) hours, respectively. The mean (SD) CLss and Vss of levornidazole were 2.90 (0.47) L/h and 45.90 (7.44) L, respectively. The mean (SD) distribution volume of central compartment (V1) and distribution volume of peripheral compartment (V2) were 26.71 (8.51) L and 19.21 (10.86) L, respectively. On the basis of simulation, the accumulation ratio of levornidazole in the 750mg q24h dosing regimen was 30.2% lower than the value in the 500mg q12h dosing regimen. Forthe 2 dosing regimens, the Cmax_ss, AUC0–τ, AUC0–∞, CLss, and Vss did not produce a significant difference between patients and healthy volunteers (P > 0.05). The cumulative fraction of response of levornidazole against B fragilis was >90%, and the probability of target attainment after both dosing regimens was >90%, when the MIC was ≤1 μg/mL.Implications
No significant differences were found in the PK profiles of levornidazole at steady state between the patients with intra-abdominal anaerobic infection and healthy volunteers. The clinical conventional 750mg q24h regimen can achieve similar clinical and microbiological efficacies against anaerobic in the patients after the 500mg q12h regimen. 相似文献10.
Yong Kyun Kim Dong-Hwan Lee Jaehyun Jeon Hang-Jea Jang Hyeon-Kuk Kim Kyubok Jin Sung-Nam Lim Sung Sook Lee Bong Soo Park Yang Wook Kim Jae-Gook Shin Sungmin Kiem 《Clinical therapeutics》2018,40(8):1384-1395
Purpose
The aim of this study was to investigate the population pharmacokinetic (PK) profile of meropenem in Korean patients with acute infections.Methods
The study included 37 patients with a creatinine clearance ≤50 or >50 mL/min who received a 500- or 1000-mg dose of meropenem, respectively, infused intravenously over 1 hour every 8 hours. Blood samples were collected before and at 1, 1.5, and 5 hours after the start of the fourth infusion. The population PK analysis was conducted by using nonlinear mixed effect modeling software (NONMEM). Monte-Carlo simulations were performed to identify optimal dosing regimens.Findings
Thirty-seven subjects completed the study. Meropenem PK variables were well described by using a one-compartment model. The typical values (relative SE) for weight-normalized clearance (CL) and Vd were 0.266 L/h/kg (12.29%) and 0.489 L/kg (11.01%), respectively. Meropenem CL was significantly influenced by the serum creatinine level, which explained 11% of the interindividual CK variability. The proposed equation to estimate meropenem CL in Korean patients was as follows: CL (L/h)?=?0.266?×?weight?×?[serum creatinine/0.74]–1.017. The simulation results indicate that the current meropenem dosing regimen may be suboptimal in patients infected with normal or augmented renal function.Implications
Prolonged infusions of meropenem over at least 2 hours should be considered, especially in patients with augmented renal function and those infected with pathogens for which the minimum inhibitory meropenem concentration is >1 μg/mL. Our results suggest an individualized meropenem dosing regimen for patients with abnormal renal function and those infected with pathogens with decreased in vitro susceptibility. 相似文献11.
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12.
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13.
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14.
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15.
Mohammed A. Al-Hijji Rajiv Gulati Ryan J. Lennon Malcolm Bell Abdallah El Sabbagh Jae Yoon Park Joshua Slusser Gurpreet S. Sandhu Guy S. Reeder Charanjit S. Rihal Mandeep Singh 《Mayo Clinic proceedings. Mayo Clinic》2018,93(10):1448-1461
Objective
To study the influence of anemia on long-term outcomes of patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI).Patients and Methods
The study included 5668 consecutive unique patients with acute coronary syndrome who underwent PCI at Mayo Clinic from January 1, 2004, through December 31, 2014. The patients were stratified on the basis of the presence (hemoglobin [Hgb] level, <13 g/dL in men and <12 g/dL in women) and severity (moderate to severe Hgb level, <11 g/dL in men and women) of pre-PCI anemia and compared with patients without anemia. The primary outcomes were in-hospital and long-term all-cause mortality after balancing baseline comorbidities using the inverse propensity weighting method.Results
Unadjusted all-cause in-hospital mortality (4.6% [84 of 1831] vs 2.0% [75 of 3837]) and 5-year follow-up mortality (44.4% [509] vs 15.4% [323]) were higher in patients with anemia than in those without anemia (P<.001 for both). After applying inverse propensity weighting analysis, the all-cause in-hospital mortality (2.0% [37] vs 2.0% [75]; P=.85) and 5-year mortality (17.8% [203] vs 15.4% [323]; P=.05) were not significantly different between patients with and without anemia; however, there were higher rates of all-cause 5-year mortality in patients with moderate to severe anemia (22.3% [113] vs 15.4% [323]; P<.001) compared with patients without anemia. The trend in 5-year mortality was driven by increased noncardiac mortality in patients with anemia (10.2% [91] vs 7.1% [148]; P=.04) and moderate to severe anemia (10.4% [52] vs 7.1% [148]; P=.006) when compared with nonanemic patients.Conclusion
After accounting for differences in risk profiles of anemic and nonanemic patients, anemia appeared to be an independent risk factor for increased long-term all-cause and noncardiac mortality. 相似文献16.
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17.
18.
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19.
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20.