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SUSTAIN-2 (NCT02497287) was an open-label, phase III trial evaluating the safety of esketamine (ESK) nasal spray plus a newly initiated oral antidepressant (AD) for up to 1 year in adults with treatment-resistant depression (TRD). ESK is a schedule III drug that acts via glutamate receptor modulation. ESK is rapidly cleared from the plasma, and with intermittent dosing there is no accumulation. Thus, no withdrawal syndrome is expected. The current analysis assessed potential withdrawal symptoms in patients who discontinued ESK after long-term, intermittent use. In the absence of a glutamatergic-specific withdrawal scale, the Physicians Withdrawal Checklist1 (PWC-20) was used. The PWC-20 was designed to assess new or worsening benzodiazepine-like discontinuation symptoms after stopping non-SSRI anxiolytics.
ESK nasal spray was administered two times per week during a 4-week induction phase (IND). Responders entered the optimization/maintenance phase (O/M) where ESK nasal spray was dosed either weekly or every two weeks for up to 48 weeks. Patients entered a 4-week follow up period (F/U) after discontinuation from either phase, during which continuation of the AD was recommended. PWC-20 assessments were conducted at the last ESK dosing (endpoint of IND or O/M) and at weeks 1, 2 and 4 of F/U. Symptoms were rated using a 0-3-point scale (Not present = 0, Mild = 1, Moderate = 2, Severe = 3). To account for worsening of underlying depression, subset calculations were performed for depressive symptoms (PWC-DS: loss of appetite; anxiety or nervousness; irritability; dysphoric mood or depression; insomnia; fatigue, lethargy or lack of energy; restlessness or agitation; headaches; muscle aches or stiffness; weakness; difficulty concentrating or remembering; depersonalization-derealization) and withdrawal symptoms (PWC-WS: nausea and/or vomiting; diarrhea; poor coordination; diaphoresis; tremor or tremulousness; dizziness or light-headedness; increased acuity of sound, smell, or touch; paresthesias).
Data on 357 patients entering F/U were included in the analysis (91 completed treatment during the IND phase and 141 were treated during O/M). The mean (SD) PWC-20 total scores (range 0-60) at treatment endpoint, Week 1, 2 and 4 were 7.2 (6.8), 7.5(7.0), 7.4 (7.1) and 7.2 (6.9), respectively. At these same assessment times, mean PWC-WS scores (range 0-24) were 0.9 (1.7), 1.0 (1.7), 1.0 (1.8), and 0.9 (1.8). Mean PWC-DS scores (range 0-36) were 6.3 (5.6), 6.5 (5.7), 6.5 (5.8), and 6.3 (5.7), respectively. Complete analysis of data from the entire SUSTAIN-2 dataset will be presented.
No indication of drug-specific withdrawal symptoms was seen after stopping up to 1-year of intermittent treatment with ESK nasal spray for TRD.
To examine and quantify the potential dose–response relationship between green tea intake and the risk of gastric cancer.
We searched PubMed, EMBASE, Web of Science, CBM, CNKI and VIP up to December 2015 without language restrictions.
A systematic review and dose–response meta-analysis of observational studies.
Five cohort studies and eight case–control studies.
Compared with the lowest level of green tea intake, the pooled relative risk (95 % CI) of gastric cancer was 1·05 (0·90, 1·21, I2=20·3 %) for the cohort studies and the pooled OR (95 % CI) was 0·84 (0·74, 0·95, I2=48·3 %) for the case–control studies. The pooled relative risk of gastric cancer was 0·79 (0·63, 0·97, I2=63·8 %) for intake of 6 cups green tea/d, 0·59 (0·42, 0·82, I2=1·0 %) for 25 years of green tea intake and 7·60 (1·67, 34·60, I2=86·5 %) for drinking very hot green tea.
Drinking green tea has a certain preventive effect on reducing the risk of gastric cancer, particularly for long-term and high-dose consumption. Drinking too high-temperature green tea may increase the risk of gastric cancer, but it is still unclear whether high-temperature green tea is a risk factor for gastric cancer. Further studies should be performed to obtain more detailed results, including other gastric cancer risk factors such as smoking and alcohol consumption and the dose of the effective components in green tea, to provide more reliable evidence-based medical references for the relationship between green tea and gastric cancer.
Iron is an essential cofactor for many basic metabolic pathways in pathogenic microbes and their hosts. It is also dangerous as it can catalyse the production of reactive free radicals. This dual character makes the host can either limit iron availability to invading microbes or exploit iron to induce toxicity to pathogens. Successful pathogens, including Leishmania species, must possess mechanisms to circumvent host's iron limitation and iron-induced toxicity in order to survive. In this review, we discuss the regulation of iron metabolism in the setting of infection and delineate the iron acquisition strategies used by Leishmania parasites and their subversions to host iron metabolism to overcome host's iron-related defences.
In this work, pulsed electron deposition was used to prepare thin films of ITO on plastic substrates. These films were used as electrodes for organic photovoltaic devices to determine the feasibility of using PED deposited ITO as electrodes. ITO films deposited on plastic showed optical transmission values as high as 85% for films deposited at high pressures. Films deposited on plastic substrates were further used to prepare a test organic solar cell, with ITO as the bottom electrode. The device performance was seen to depend on the quality of the ITO electrode, and the ITO film deposited at the lowest oxygen pressure was found to be the best electrode for the organic photovoltaic device.
More than 40 gradual SEPs have been observed by GOES and SOHO from 2001 to 2003. During 12 SEPs of all these events, energetic electron flux enhancements with energies from 38 keV to 337 keV were observed by RAPID onboard Cluster spacecraft. During these 12 events the variation of the energetic electron flux measured by RAPID/Cluster was closely associated to the variation of the solar energetic proton flux. The observed energetic electron flux was independent on the location of Cluster in the magnetosphere and the background level of magnetospheric electrons (even when the Cluster spacecraft was crossing the magnetopause, the plasma sheet and the low latitude boundary layer). The similar variation of the enhancement of energetic electron flux has also been observed by POLAR and Geotail in some of these events. In some of these events, the electron measurement of RAPID/Cluster will not be contaminated by the SEP protons.To search for other articles by the author(s) go to: http://adsabs.harvard.edu/abstract_service.html
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