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1.
Licia Grazzi Cristina Tassorelli Marina de Tommaso Giulia Pierangeli Paolo Martelletti Innocenzo Rainero Pierangelo Geppetti Anna Ambrosini Paola Sarchielli Eric Liebler Piero Barbanti on Behalf of the PRESTO Study Group 《The journal of headache and pain》2018,19(1):98
Background
The PRESTO study of non-invasive vagus nerve stimulation (nVNS; gammaCore®) featured key primary and secondary end points recommended by the International Headache Society to provide Class I evidence that for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free 2 h post stimulation. Here, we examined additional data from PRESTO to provide further insights into the practical utility of nVNS by evaluating its ability to consistently deliver clinically meaningful improvements in pain intensity while reducing the need for rescue medication.Methods
Patients recorded pain intensity for treated migraine attacks on a 4-point scale. Data were examined to compare nVNS and sham with regard to the percentage of patients who benefited by at least 1 point in pain intensity. We also assessed the percentage of attacks that required rescue medication and pain-free rates stratified by pain intensity at treatment initiation.Results
A significantly higher percentage of patients who used acute nVNS treatment (n?=?120) vs sham (n?=?123) reported a?≥?1-point decrease in pain intensity at 30 min (nVNS, 32.2%; sham, 18.5%; P?=?0.020), 60 min (nVNS, 38.8%; sham, 24.0%; P?=?0.017), and 120 min (nVNS, 46.8%; sham, 26.2%; P?=?0.002) after the first attack. Similar significant results were seen when assessing the benefit in all attacks. The proportion of patients who did not require rescue medication was significantly higher with nVNS than with sham for the first attack (nVNS, 59.3%; sham, 41.9%; P?=?0.013) and all attacks (nVNS, 52.3%; sham, 37.3%; P?=?0.008). When initial pain intensity was mild, the percentage of patients with no pain after treatment was significantly higher with nVNS than with sham at 60 min (all attacks: nVNS, 37.0%; sham, 21.2%; P?=?0.025) and 120 min (first attack: nVNS, 50.0%; sham, 25.0%; P?=?0.018; all attacks: nVNS, 46.7%; sham, 30.1%; P?=?0.037).Conclusions
This post hoc analysis demonstrated that acute nVNS treatment quickly and consistently reduced pain intensity while decreasing rescue medication use. These clinical benefits provide guidance in the optimal use of nVNS in everyday practice, which can potentially reduce use of acute pharmacologic medications and their associated adverse events.Trial registration
ClinicalTrials.gov identifier: NCT02686034.2.
D. J. Klein D. Foster P. M. Walker S. M. Bagshaw H. Mekonnen M. Antonelli 《Intensive care medicine》2018,44(12):2205-2212
Purpose
The EUPHRATES trial examined the impact of polymyxin B hemoperfusion (PMX) on mortality in patients with septic shock and endotoxemia, defined as EAA?≥?0.60. No difference was found in 28-day all-cause mortality. However, the trial showed that in some patients with septic shock the burden of endotoxin activity was extreme (EAA?≥?0.9). In a post hoc analysis, we evaluated the impact of PMX use in patients with septic shock and endotoxin activity measured between 0.6–0.89.Methods
Post-hoc analysis of the EUPHRATES trial for the 194 patients with EAA?≥?0.6–0.89 who completed two treatments (PMX or sham). The primary end point was mortality at 28 days adjusted for APACHE II score and baseline mean arterial pressure (MAP). Additional end points included changes in MAP, cumulative vasopressor index (CVI), median EAA reduction, ventilator-free days (VFD), dialysis-free days (DFD) and hospital length of stay. Subpopulations analyzed were site and type of infection and those with norepinephrine dose > 0.1 mcg/kg/min at baseline.Results
At 28 days, 23 patients of 88 (26.1%) in the PMX group died versus 39 of 106 (36.8%) in the sham group [risk difference 10.7%, OR 0.52, 95% CI (0.27, 0.99), P?=?0.047]. When unadjusted for baseline variables, P?=?0.11. The 28-day survival time in the PMX group was longer than for the sham group [HR 0.56 (95% CI 0.33, 0.95) P?=?0.03]. PMX treatment compared with sham showed greater change in MAP [median (IQR) 8 mmHg (??0.5, 19.5) vs. 4 mmHg (??4.0, 11) P?=?0.04] and VFD [median (IQR) 20 days (0.5, 23.5) vs. 6 days (0, 20), P?=?0.004]. There were no significant differences in other end points. There was a significant difference in mortality in PMX-treated patients with no bacterial growth on culture [PMX, 6/30 (20%) vs. sham, 13/31 (41.9%), P?=?0.005]. The median EAA change in the population was ??12.9% (range: increase 49.2%–reduction 86.3%). The mortality in the above median EAA change group was PMX: 6/38 (15.7%) vs. sham 15/49 (30.6%), P?=?0.08.Conclusions
These hypothesis-generating results, based on an exploratory post hoc analysis of the EUPHRATES trial, suggest measurable responses in patients with septic shock and an EAA?≥?0.6 to 0.89 on changes in mean arterial pressure, ventilator-free days and mortality.Trial registration
Clinicaltrials.gov Identifier: NCT01046669. Funding Spectral Medical Incorporated.3.
Kajal Gokal Deborah Wallis Samreen Ahmed Ion Boiangiu Kiran Kancherla Fehmidah Munir 《Supportive care in cancer》2016,24(3):1139-1166
Purpose
This study evaluated the effectiveness of a self-managed home-based moderate intensity walking intervention on psychosocial health outcomes among breast cancer patients undergoing chemotherapy.Methods
The randomised controlled trial compared a self-managed, home-based walking intervention to usual care alone among breast cancer patients receiving chemotherapy. Outcome measures included changes in self-report measures of anxiety, depression, fatigue, self-esteem, mood and physical activity. Fifty participants were randomised to either the intervention group (n?=?25), who received 12 weeks of moderate intensity walking, or the control group (n?=?25) mid-way through chemotherapy. Participants in the intervention group were provided with a pedometer and were asked to set goals and keep weekly diaries outlining the duration, intensity and exertion of their walking. Levels of psychosocial functioning and physical activity were assessed pre- and post-intervention in both groups.Results
The intervention had positive effects on fatigue (F?=?5.77, p?=?0.02), self-esteem (F?=?8.93, p?≤?0.001), mood (F?=?4.73, p?=?0.03) and levels of physical activity (x 2?=?17.15, p?=?0.0011) but not anxiety (F?=?0.90, p?=?0.35) and depression (F?=?0.26, p?=?0.60) as assessed using the HADS. We found an 80 % adherence rate to completing the 12-week intervention and recording weekly logs.Conclusion
This self-managed, home-based intervention was beneficial for improving psychosocial well-being and levels of physical activity among breast cancer patients treated with chemotherapy.Trial registration
Current Controlled Trials ISRCTN50709297.4.
Gloria Roberti Luca Agnifili Francesca Berardo Ivano Riva Michele Figus Gianluca Manni Luciano Quaranta Francesco Oddone 《Advances in therapy》2018,35(5):686-696
Introduction
To compare the effects of a preservative-free (PF) ophthalmic solution containing hyaluronic acid (HA) 0.4% and taurine (TAU) 0.5% with those of a PF ophthalmic solution containing HA 0.2% on ocular surface signs, symptoms, and morphological parameters in glaucoma patients under multiple long-term topical hypotensive therapy.Methods
Eligible patients underwent evaluation of ocular surface parameters by ocular surface disease index (OSDI) and glaucoma symptom scale (GSS) questionnaires, breakup time test (BUT), Schirmer I test, corneal and conjunctival staining (Oxford scale), and conjunctival in vivo confocal microscopy (Heidelberg Retina Tomograph 3, Heidelberg Engineering GmbH, Heidelberg, Germany). After the baseline visit, patients were randomized to use a PF ophthalmic solution containing HA 0.4% and TAU 0.5%, QID, in both eyes (group 1) or to use a PF ophthalmic solution containing HA 0.2%, QID (group 2) in addition to the ongoing preserved hypotensive treatment. Follow-up visits were scheduled at 30 and 90 days.Results
Thirty-nine eyes of 39 glaucoma patients were included in the study. At baseline, results of study tests of both groups were similar. After 90 days in group 1 the BUT (p?=?0.01), the Oxford score (p?=?0.03), the conjunctival goblet cells (CGC) density (p?=?0.0005) ,and the two questionnaires score significantly improved (OSDI, p?=?0.003; GSS, p?=?0.003) compared to baseline values, while in group 2 all these parameters did not differ from baseline (BUT, p?=?0.39; Oxford score, p?=?0.54; CGC density, p?=?0.33, OSDI p?=?0.65, GSS, p?=?0.25). The BUT and the CGC density were statistically different between groups both at 30 and 90 days (p?=?0.04 and p?=?0.04, respectively). The Schirmer I test did not statistically change after 90 days in both groups.Conclusions
The PF ophthalmic solution with HA 0.4% and TAU 0.5% seems to improve CGC density and reduce signs and symptoms of dry eye in glaucoma patients under long-term multiple preserved hypotensive therapy.Trial registration
ClinicalTrials.gov identifier, NCT03480295.5.
Paula Scholz Philipp S. Müther Petra Schiller Moritz Felsch Sascha Fauser 《Advances in therapy》2018,35(12):2152-2166
Introduction
To compare the transconjunctival sutureless 23 gauge (G) pars plana vitrectomy (PPV) with 20 G PPV regarding inflammation, safety, visual outcome and patient comfort.Methods
We included 103 patients with symptomatic macular hole or macular pucker, scheduled for vitrectomy in this prospective, randomized, controlled, mono-center clinical trial. Patients were randomized 1:1 to either 20G PPV (n?=?51) or 23G PPV (n?=?52). All eyes underwent standard 20G or 23G PPV with membrane peeling. Primary outcome measure was change in aqueous humor flare 3 weeks after surgery compared with baseline. Secondary outcome measures were flare values 2 days and 26 weeks after surgery, subjective discomforts measured with a visual analog scale, best-corrected visual acuity, duration of surgery, intraocular pressure (IOP) and adverse events.Results
There was no significant difference in change of flare 3 weeks after PPV [? 1.7, 95% CI (? 6.3 to 2.9), p?=?0.466]. Both groups showed a significant increase in flare 2 days after surgery (20G: p?<?0.001, 23G: p?=?0.002), but only the 20G group after 3 weeks (p?=?0.011). The gain in visual acuity after 3 weeks was higher after 23G PPV (4.2 95% CI (0.4–8.0, p?=?0.029), but without a difference after 6 months. The duration of surgery was shorter in the 23G group (p?<?0.001). Patient comfort 3 weeks after surgery was greater after 23G PPV (foreign body sensation p?=?0.002; itching: p?=?0.021). However, the rate of complications did not differ between the groups.Conclusion
The primary aim, showing the superiority of the 23G group regarding the change of flare value from baseline to 3 weeks after surgery, was not met, but the level of inflammation decreased faster after 23G PPV. Clear advantages of the 23G PPV were a lower risk of postoperative IOP elevation, a shorter surgery time, faster visual recovery and greater patient comfort in the early postoperative phase.Clinical Trial Registration Number
ClinicalTrials.gov NCT01969929.6.
Anne-Marie H. Krebber Femke Jansen Pim Cuijpers C. René Leemans Irma M. Verdonck-de Leeuw 《Supportive care in cancer》2016,24(6):2541-2548
Purpose
The purpose of the study is to investigate screening in follow-up care to identify head and neck cancer (HNC) patients with untreated psychological distress.Methods
From November 2009 until December 2012, we investigated the use of OncoQuest (a touch screen computer system to monitor psychological distress (Hospital Anxiety and Depression Scale (HADS)) and quality of life (HRQOL; EORTC QLQ-C30 and H&N35 module) in routine follow-up care. Patients who screened positive for psychological distress (HADS-T >14, HADS-A >7, or HADS-D >7) were asked whether they received psychological or psychiatric treatment.Results
During the study period of 37 months, OncoQuest was used by 720 individual HNC patients, of whom 714 had complete HADS data. Psychological distress was present in 206 patients (29 %). Of those patients who fulfilled in- and exclusion criteria (n?=?137), 25 received psychological treatment (18 %). Receipt of psychological treatment was significantly related to a higher score on the HADS total scale (19.6 vs. 16.9; p?=?0.019), a lower (worse) score on the EORTC QLQ-C30 scale emotional functioning (46.0 vs. 58.6; p?=?0.023), a higher (worse) score on fatigue (58.2 vs. 46.4; p?=?0.032), problems with sexuality (44.1 vs. 34.4; p?=?0.043), oral pain (43.8 vs. 28.8; p?=?0.011) and speech problems (37.0 vs. 25.3; p?=?0.042).Conclusions
Screening for psychological distress via OncoQuest is beneficial because 82 % of HNC patients identified with an increased level of distress who do not yet receive mental treatment were identified. Patients who did receive treatment reported more distress and worse quality of life, which may be explained because patients with more severe problems maybe more inclined to seek help or might be detected easier by caregivers and referred to supportive care more often.7.
Cédric Daubin Xavier Valette Fabrice Thiollière Jean-Paul Mira Pascal Hazera Djillali Annane Vincent Labbe Bernard Floccard François Fournel Nicolas Terzi Damien Du Cheyron Jean-Jacques Parienti for the BPCTrea Study Group 《Intensive care medicine》2018,44(4):428-437
Purpose
To compare the efficacy of an antibiotic protocol guided by serum procalcitonin (PCT) with that of standard antibiotic therapy in severe acute exacerbations of COPD (AECOPDs) admitted to the intensive care unit (ICU).Methods
We conducted a multicenter, randomized trial in France. Patients experiencing severe AECOPDs were assigned to groups whose antibiotic therapy was guided by (1) a 5-day PCT algorithm with predefined cutoff values for the initiation or stoppage of antibiotics (PCT group) or (2) standard guidelines (control group). The primary endpoint was 3-month mortality. The predefined noninferiority margin was 12%.Results
A total of 302 patients were randomized into the PCT (n?=?151) and control (n?=?151) groups. Thirty patients (20%) in the PCT group and 21 patients (14%) in the control group died within 3 months of admission (adjusted difference, 6.6%; 90% CI ??0.3 to 13.5%). Among patients without antibiotic therapy at baseline (n?=?119), the use of PCT significantly increased 3-month mortality [19/61 (31%) vs. 7/58 (12%), p?=?0.015]. The in-ICU and in-hospital antibiotic exposure durations, were similar between the PCT and control group (5.2?±?6.5 days in the PCT group vs. 5.4?±?4.4 days in the control group, p?=?0.85 and 7.9?±?8 days in the PCT group vs. 7.7?±?5.7 days in the control group, p?=?0.75, respectively).Conclusion
The PCT group failed to demonstrate non-inferiority with respect to 3-month mortality and failed to reduce in-ICU and in-hospital antibiotic exposure in AECOPDs admitted to the ICU.8.
Xiao-feng Xiong Li-li Fan Hong-xia Wu Min Zhu De-yun Cheng 《Advances in therapy》2018,35(12):2201-2213
Introduction
Tiotropium bromide has been widely used in clinical practice, while theophylline is another treatment option for chronic obstructive pulmonary disease (COPD). However, only a few relevant studies have investigated the long-term outcomes and efficacy of both in patients with COPD. We evaluated the effects of tiotropium and low-dose theophylline on stable COPD patients of groups B and D.Methods
Eligible participants (n?=?170) were randomized and received either tiotropium 18 µg once daily with theophylline 100 mg twice daily (Group I) or tiotropium 18 µg once daily (Group II) for 6 months. COPD assessment test (CAT), modified Medical Research Council (mMRC) dyspnea scores and pulmonary function tests were measured before randomization and during the treatment.Results
After 6 months of treatment, the CAT scores in both groups decreased significantly (11.41?±?3.56 and 11.08?±?3.05, p?<?0.0001). The changes of CAT (p?=?0.028) and mMRC scores (p?=?0.049) between the two groups differed after 1 month of treatment. In Group I, forced expiratory flow after 25% of the FVC% predicted (MEF25% pred) was significantly improved after 3 months (4.84?±?8.73%, p?<?0.0001) and 6 months (6.21?±?8.65%, p?<?0.0001). There was a significant difference in small airway function tests (MEF50% pred, MEF25% pred, and MMEF% pred) between the two groups after 6 month of treatment (p?=?0.003, p?<?0.0001, and p?=?0.021, respectively).Conclusions
Tiotropium combined with low-dose theophylline significantly improved the symptoms and general health of patients with stable COPD of groups B and D after 6 months of follow-up. Additionally, this therapy also improved the indicators of small airway function.Trial Registration
Chinese Clinical Trial Registry (Registry ID: ChiCTR1800019027).9.
Natalie Bennett Lokho John Nishkarsh Likhar Rumjhum Agrawal Winfried M. Amoaku 《Advances in therapy》2018,35(5):591-603
Introduction
The aim of this systematic literature review was to evaluate the efficacy and safety of interventions for the treatment of choroidal neovascularization (CNV) secondary to etiologies other than age-related macular degeneration and pathologic myopia.Methods
Relevant randomized controlled trials (RCTs) and prospective observational studies were identified by searching MEDLINE, MEDLINE In-Process, EMBASE, and CENTRAL.Results
The search identified 5 RCTs; no relevant observational studies were identified. The studies differed in terms of underlying cause of CNV, patient numbers (n?=?9–178), follow-up time (2–36 months) and quality assessment. In the largest RCT (n?=?178 across a range of rare CNV etiologies), intravitreal ranibizumab showed superior efficacy versus sham from baseline to month 2 [mean best-corrected visual acuity (BCVA): +?9.5 vs. ??0.4 letters; p?<?0.001]; the gain was maintained up to month 12. In the treatment of CNV secondary to presumed ocular histoplasmosis syndrome (POHS), both intravitreal ranibizumab and photodynamic therapy (PDT) showed significant improvement from baseline BCVA over the 12-month period (n?=?9); however, all patients in the PDT group required rescue ranibizumab therapy. Unlicensed intravitreal bevacizumab was associated with a statistically significant improvement in BCVA compared to PDT at 12 months (p?<?0.001) in patients with CNV secondary to multifocal choroiditis (n?=?27). The use of steroids before PDT showed better BCVA outcomes than PDT alone (p?<?0.05) in patients with idiopathic CNV (n?=?20). Argon green laser therapy showed limited efficacy in patients with CNV secondary to OHS (n?=?134).Conclusion
There is evidence from a relatively large, good-quality study to support the use of intravitreal ranibizumab for the treatment of CNV secondary to rare diseases. However, the limited number of RCTs for this indication and differences in study characteristics between RCTs mean that there is uncertainty regarding comparative clinical effectiveness of interventions. RCTs with an active comparator are required to fully establish the comparative effectiveness of treatments for CNV secondary to rare diseases.Funding
Novartis Pharmaceuticals UK Ltd, Surrey, UK.10.
Johan Mårtensson Shailesh Bihari Jonathan Bannard-Smith Neil J. Glassford Patryck Lloyd-Donald Luca Cioccari Nora Luethi Aiko Tanaka Marco Crisman Nicolas Rey de Castro Marcus Ottochian Agnes Huang Maria Cronhjort Andrew D. Bersten Shivesh Prakash Michael Bailey Glenn M. Eastwood Rinaldo Bellomo 《Intensive care medicine》2018,44(11):1797-1806
Purpose
We set out to assess the resuscitation fluid requirements and physiological and clinical responses of intensive care unit (ICU) patients resuscitated with 20% albumin versus 4–5% albumin.Methods
We performed a randomised controlled trial in 321 adult patients requiring fluid resuscitation within 48 h of admission to three ICUs in Australia and the UK.Results
The cumulative volume of resuscitation fluid at 48 h (primary outcome) was lower in the 20% albumin group than in the 4–5% albumin group [median difference ??600 ml, 95% confidence interval (CI) ??800 to ??400; P?<?0.001]. The 20% albumin group had lower cumulative fluid balance at 48 h (mean difference ??576 ml, 95% CI ??1033 to ??119; P?=?0.01). Peak albumin levels were higher but sodium and chloride levels lower in the 20% albumin group. Median (interquartile range) duration of mechanical ventilation was 12.0 h (7.6, 33.1) in the 20% albumin group and 15.3 h (7.7, 58.1) in the 4–5% albumin group (P?=?0.13); the proportion of patients commenced on renal replacement therapy after randomization was 3.3% and 4.2% (P?=?0.67), respectively, and the proportion discharged alive from ICU was 97.4% and 91.1% (P?=?0.02).Conclusions
Resuscitation with 20% albumin decreased resuscitation fluid requirements, minimized positive early fluid balance and was not associated with any evidence of harm compared with 4–5% albumin. These findings support the safety of further exploration of resuscitation with 20% albumin in larger randomised trials.Trial registration
http://www.anzctr.org.au. Identifier ACTRN12615000349549.11.
Christopher G. Hughes Mayur B. Patel Nathan E. Brummel Jennifer L. Thompson J. Brennan McNeil Pratik P. Pandharipande James C. Jackson Rameela Chandrasekhar Lorraine B. Ware E. Wesley Ely Timothy D. Girard 《Intensive care medicine》2018,44(3):345-355
Purpose
Neurologic and endothelial injury biomarkers are associated with prolonged delirium during critical illness and may reflect injury pathways that lead to poor long-term outcomes. We hypothesized that blood–brain barrier (BBB), neuronal, and endothelial injury biomarkers measured during critical illness are associated with cognitive impairment and disability after discharge.Methods
We enrolled adults with respiratory failure and/or shock and measured plasma concentrations of BBB (S100B), neuronal (UCHL1, BDNF), and endothelial (E-selectin, PAI-1) injury markers within 72 h of ICU admission. At 3 and 12 months post-discharge, we assessed participants’ global cognition, executive function, and activities of daily living (ADL). We used multivariable regression to determine whether biomarkers were associated with outcomes after adjusting for relevant demographic and acute illness covariates.Results
Our study included 419 survivors of critical illness with median age 59 years and APACHE II score 25. Higher S100B was associated with worse global cognition at 3 and 12 months (P?=?0.008; P?=?0.01). UCHL1 was nonlinearly associated with global cognition at 3 months (P?=?0.02). Higher E-selectin was associated with worse global cognition (P?=?0.006 at 3 months; P?=?0.06 at 12 months). BDNF and PAI-1 were not associated with global cognition. No biomarkers were associated with executive function. Higher S100B (P?=?0.05) and E-selectin (P?=?0.02) were associated with increased disability in ADLs at 3 months.Conclusions
S100B, a marker of BBB and/or astrocyte injury, and E-selectin, an adhesion molecule and marker of endothelial injury, are associated with long-term cognitive impairment after critical illness, findings that may reflect mechanisms of critical illness brain injury.12.
Sunnie Kim James E. Signorovitch Hongbo Yang Oscar Patterson-Lomba Cheryl Q. Xiang Brian Ung Monika Parisi John L. Marshall 《Advances in therapy》2018,35(10):1564-1577
Introduction
nab-Paclitaxel plus gemcitabine (nab-P?+?G) and FOLFIRINOX (FFX) are among the most common first-line (1L) therapies for metastatic adenocarcinoma of the pancreas (MPAC), but real-world data on their comparative effectiveness are limited.Methods
This retrospective cohort study compared the efficacy and safety of 1L nab-P?+?G versus FFX, overall and under specific treatment sequences. Medical records were reviewed by 215 US physicians who provided information on MPAC patients who initiated 1L therapy with nab-P?+?G or FFX between April 1, 2015 and December 31, 2015. Study outcomes were overall survival (OS) and tolerability. OS was compared using Kaplan–Meier curves and adjusted Cox proportional hazards models.Results
In total, 654 medical records were reviewed, including those of 337 and 317 patients initiated on nab-P?+?G and FFX as 1L MPAC therapy, respectively. nab-P?+?G-initiated patients were older, less likely to have ECOG?≤?1, and had more comorbidities than FFX-initiated patients. Median OS (mOS) was 12.1 and 13.8 months for nab-P?+?G- and FFX-initiated patients, respectively (HR?=?0.99, P?=?0.96). Among patients with ECOG?≤?1, mOS was 14.1 and 13.7 months, respectively (HR?=?1.00, P?=?0.99). Among patients with 1L nab-P?+?G and FFX, 36.1% and 41.3% received 2L therapy and experienced mOS of 16.3 and 16.6 months, respectively (HR?=?1.04, P?=?0.76). The rates of diarrhea, fatigue, mucositis, and nausea and vomiting were significantly higher in the FFX than nab-P?+?G cohort.Conclusion
The real-world survival was similar between patients receiving 1L nab-P?+?G or FFX both overall and among patients who received active 2L treatments. In addition, nab-P?+?G was associated with significantly lower rates of common AEs compared with FFX.Funding
Celgene.13.
Rainbow T. H. Ho Ted C. T. Fong Phyllis H. Y. Lo Samuel M. Y. Ho Peter W. H. Lee Pamela P. Y. Leung David Spiegel Cecilia L. W. Chan 《Supportive care in cancer》2016,24(12):4929-4937
Purpose
This study aimed to evaluate the efficacy of supportive-expressive group (SEG) therapy and body-mind-spirit (BMS) intervention on emotional suppression and psychological distress in Chinese breast cancer patients.Methods
This three-arm randomized controlled trial assigned 157 non-metastatic breast cancer patients to BMS, SEG, or social support control group. SEG focused on emotional expression and group support, whereas BMS emphasized relaxation and self-care. All groups received 2-h weekly sessions for 8 weeks. The participants completed measurements on emotional suppression, perceived stress, anxiety, and depression at baseline and three follow-up assessments in 1 year.Results
Using latent growth modeling, overall group difference was found for emotional suppression (χ 2(2)?=?8.88, p?=?0.012), marginally for perceived stress (χ 2(2)?=?5.70, p?=?0.058), but not for anxiety and depression (χ 2(2)?=?0.19–0.94, p?>?0.05). Post-hoc analyses revealed a significant and moderate reduction (Cohen d?=?0.55, p?=?0.007) in emotional suppression in SEG compared to control group, whereas BMS resulted in a marginally significant and moderate fall (d?=?0.46, p?=?0.024) in perceived stress. Neither SEG nor BMS significantly improved anxiety and depression (d?<?0.20, p?>?0.05).Conclusions
The present results did not demonstrate overall effectiveness for either BMS or SEG therapy in the present sample of Chinese non-metastatic breast cancer patients. The participants appear to derive only modest benefits in terms of their psychological well-being from either intervention.14.
Heringlake M Handke U Hanke T Eberhardt F Schumacher J Gehring H Heinze H 《Intensive care medicine》2007,33(12):2168-2172
Objective
The modified algorithm for the non-invasive determination of cardiac output (CO) by electrical bioimpedance—electrical velocimetry (EV®)—has been reported to give reliable results in comparison with echocardiography and pulmonary arterial thermodilution (PA-TD) in patients either before or after cardiac surgery. The present study was designed to determine whether EV®-CO measurements reflect intraindividual changes in CO during cardiac surgery.Design
Prospective, observational study.Setting
Operating room (OR) and intensive care unit (ICU) of a university hospital.Patients
Twenty-nine patients undergoing elective cardiac surgery.Interventions
None.Measurements
CO was determined simultaneously by PA-TD and EV® after induction of anesthesia (t1) and 4.9?±?3.5?h after ICU admission (t2).Results
TD-CO was 3.9?±?1.4 and 5.4?±?1.1 l/min at t1 and t2 (?p?0.0001). EV®-CO was 4.3?±?1.1 and 4.9?±?1.5 l/min at t1 and t2 (?p?=?0.013). Bland–Altman analysis showed a bias of ?0.4 l/min and 0.4 l/min and a precision of 3.2 and 3.6 l/min (34.3% and 67.4%) at t1 and t2, respectively. Analysis of the individual pre- to postoperative changes in CO with both methods revealed bidirectional changes in n?=?12 patients and unidirectional changes with a difference greater than 50% and less than 50% in n?=?9 and n?=?8 patients, respectively.Conclusions
The disagreement between PA-TD and EV®-CO measurements after anesthesia induction and after ICU admission, as well as the fact that thoracic bioimpedance did not adequately reflect pre- to postoperative changes in CO, questions the reliability of EV®-CO measurements in cardiac surgery patients and contrasts sharply with previous studies.15.
Mina Nicola Ahmed Elberry Ossama Sayed Raghda Hussein Haitham Saeed Mohamed Abdelrahim 《Advances in therapy》2018,35(7):1049-1058
Introduction
We have investigated the effect of adding a pressurized metered dose inhaler (pMDI) training device to verbal counselling on pulmonary function and inhalation technique.Methods
A total of 304 adult asthmatic subjects (>?18 years old) were enrolled in a 3-month study of assessment and education. They were divided into an investigation group (Trainhaler plus Flo-Tone and verbal counselling, n?=?261, mean age 49.2 years) and a control group (verbal counselling only, n?=?43, mean age 48.7 years). Pulmonary function and inhalation technique were evaluated, mistakes noted, and the correct technique advised at three consecutive monthly visits. Visits also included verbal pMDI counselling (both groups) and training device coaching (investigation group).Results
By visit 2, the mean number of technique errors decreased significantly (p?<?0.05) in both groups (investigation group p?<?0.001). The investigation group demonstrated a marked decrease in the frequency of the critical error of maintaining a slow inhalation rate until the lungs are full—a technique difficult to learn via verbal counselling alone. The improvement in pulmonary function was significant from the second clinic visit in the investigation group (p?<?0.05) and from the third visit in both groups (p?<?0.001).Conclusions
Use of a training device combined with verbal counselling improved inhalation technique. An earlier, significant improvement was also noted in pulmonary function.16.
17.
Henrik Svedsater Helen A. Doll Jake Macey Gail Miles Lisa Bradshaw Magdalena Vanya 《Advances in therapy》2018,35(9):1378-1399
Introduction
This study evaluated patients’ experiences with fluticasone furoate/vilanterol (FF/VI) combination therapy in UK patients with asthma or chronic obstructive pulmonary disease (COPD).Methods
Participants aged ≥?18 years, with self-reported, physician-diagnosed asthma or COPD (≥?1 year) who had been receiving FF/VI (≥?3 months) were recruited from UK primary care. This two-phase, mixed-methods study consisted of a semi-structured, telephone-interview phase (qualitative) and a self-completed online/paper-survey phase (quantitative).Results
The telephone-interview phase included 50 individuals [asthma, n?=?25; COPD, n?=?25; mean age (SD) 56.7 years (13.3); 50% female]. Of these, 21 with asthma reported that their condition was stable/well controlled and 13 with COPD felt their condition was manageable. Most participants found FF/VI easy to use (asthma, 25; COPD, 23), easy to integrate into their daily routine (asthma, 25; COPD, 24), and able to control symptoms for ≥?24 h (asthma, 14; COPD, 16). During the survey phase, 199 individuals were recruited [asthma, n?=?100; COPD, n?=?99; mean age (SD) 63.6 years (15.1); 59.3% female]. Most participants were satisfied/very satisfied with the efficacy of FF/VI in terms of all-day symptom relief (asthma, 84%; COPD, 75%) and found FF/VI easy/very easy to fit into their daily routine (asthma, 99%; COPD, 96%), easy/very easy to use (asthma, 97%; COPD, 92%), and convenient/very convenient to take as instructed (asthma, 95%; COPD, 93%). Significantly more individuals with asthma (87% versus 46%, P?<?0.001) and numerically more individuals with COPD (84% versus 76%, P?=?0.055) were satisfied/very satisfied with FF/VI compared with their most recent previous maintenance medication.Conclusion
The majority of individuals in this study had confidence in FF/VI and were satisfied or very satisfied with various key attributes of the treatment.Trial Registration
GSK study HO-15-15503/204888.Funding
GSK.18.
David J. W. Knight Dale Gardiner Amanda Banks Susan E. Snape Vivienne C. Weston Stig Bengmark Keith J. Girling 《Intensive care medicine》2009,35(5):854-861
Objective
To investigate the effect of enteral Synbiotic 2000 FORTE® (a mixture of lactic acid bacteria and fibre) on the incidence of ventilator associated pneumonia (VAP) in critically ill patients.Design
Prospective, randomised, double blind, placebo controlled trial.Setting
Tertiary referral centre, general Adult Intensive Care Unit (ICU).Patients and participants
259 enterally fed patients requiring mechanical ventilation for 48 h or more were enrolled.Intervention
All patients were enterally fed as per a standard protocol and randomly assigned to receive either synbiotic 2000 FORTE® (twice a day) or a cellulose-based placebo for a maximum of 28 days.Measurements and results
Treatment group (n = 130) was well matched with placebo group (n = 129) for age (mean 49.5 and 50 years, respectively) and APACHE II score (median 17 for both). Oropharyngeal microbial flora and colonisation rates were unaffected by synbiotics. The overall incidence of VAP was lower than anticipated (11.2%) and no statistical difference was demonstrated between groups receiving synbiotic and placebo in the incidence of VAP (9 and 13%, P = 0.42), VAP rate per 1,000 ventilator days (13 and 14.6, P = 0.91) or hospital mortality (27 and 33%, P = 0.39), respectively.Conclusions
Enteral administration of Synbiotic 2000 FORTE® has no statistically significant impact on the incidence of VAP in critically ill patients.19.
Philippe Vignon François Dalmay Vanessa Jean-Michel Simon Bocher Erwan L’her Jérôme Cros Gwenaël Prat EchoSimu Group 《Intensive care medicine》2018,44(7):1097-1105
Purpose
To assess the impact of computerized transthoracic echocardiography (TTE) simulation on the learning curve to achieve competency in basic critical care echocardiography (CCE).Methods
In this prospective bicenter study, noncardiologist residents novice in ultrasound followed either a previously validated training program with adjunctive computerized simulation on a mannequin (two 3 h-sessions; Vimedix simulator, CAE Healthcare) (interventional group; n?=?12) or solely the same training program (control group; n?=?12). All trainees from the same institution were assigned to the same study group to avoid confusion bias. Each trainee was evaluated after 1 (M1), 3 (M3) and 6 (M6) months of training using our previously validated scoring system. Competency was defined by a score?≥?90% of the maximal value.Results
The 24 trainees performed 965 TTE in patients with cardiopulmonary compromise during their 6-month rotation. Skills assessments relied on 156 TTE performed in 106 patients (mean age 53?±?14 years; mean Simplified Acute Physiologic Score 2: 55?±?19; 79% ventilated). When compared to the control group, trainees of the interventional group obtained a significantly higher mean skills assessment score at M1 (41.5?±?4.9 vs. 32.3?±?3.7: P?=?0.0004) and M3 (45.8?±?2.8 vs. 42.3?±?3.7: P?=?0.0223), but not at M6 (49.7?±?1.2 vs. 50.0?±?2.7: P?=?0.6410), due to higher practical and technical skills scores. Trainees of the control group required significantly more supervised TTE to obtain competency than their counterparts (36?±?7 vs. 30?±?9: p?=?0.0145).Conclusions
Adjunctive computerized simulation accelerates the learning curve of basic CCE in improving practical and technical skills and reduces the number of TTE examinations required to reach competency.20.
Kelly Thompson Colman Taylor Stephen Jan Qiang Li Naomi Hammond Manoj Saxena Balasubramanian Venkatesh Simon Finfer 《Intensive care medicine》2018,44(8):1249-1257