A Postmarketing Clinical Experience Study of Metadate® CD

Summary

Objective:The objective of the study was to investigate the effectiveness and safety of Metadate® CD (methylphenidate HCl, USP) Extended Release Capsules in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD), in actual clinical practice.

Method:This was a multicenter, open-label, postmarketing study. Eligible patients were aged 6-17 with a diagnosis of ADHD and receiving either no treatment or maintenance treatment with another approved methylphenidate (MPH) product. Metadate® CD was administered once daily for 3 weeks, titrated against reported and observed symptoms. Clinical Global Impression (CGI) scores at Week 3 were used for the primary efficacy evaluation. Patient treatment satisfaction was determined by questionnaire at the final evaluation visit. Safety was assessed through adverse event reporting, laboratory tests and vital sign measurements.

Results: Overall, of the 308 patients in the Intent-To-Treat population, the majority (65%) demonstrated a positive response to Metadate® CD (defined as CGI Global Improvement rating of very much or much improved). In addition, patients previously treated with immediate-release or extended-release tablet formulations of MPH were successfully converted to Metadate® CD at a comparable dose. Most patients (87%) were very satisfied or moderately satisfied with study treatment, and among previously treated patients, 71% rated Metadate® CD as much better or better than their previous MPH treatment. Adverse events were consistent with current FDA-approved product labeling for Metadate® CD.

Conclusions: Metadate® CD is effective and well-tolerated in actual clinical use for ADHD.     

An ensemble with the chinese pentatonic scale using electroencephalogram from both hemispheres

To listen to brain activity as a piece of music,we previously proposed scale-free brainwave music（SFBM）technology,which translated the scalp electroencephalogram（EEG）into musical notes according to the power law of both the EEG and music.In this study,the methodology was further extended to ensemble music on two channels from the two hemispheres.EEG data from two channels symmetrically located on the left and right hemispheres were translated into MIDI sequences by SFBM,and the EEG parameters modulated the pitch,duration and volume of each note.Then,the two sequences were filtered into an ensemble with two voices：the pentatonic scale（traditional Chinese music）or the heptatonic scale（standard Western music）.We demonstrated differences in harmony between the two scales generated at different sleep stages,with the pentatonic scale being more harmonious.The harmony intervals of this brain ensemble at various sleep stages followed the power law.Compared with the heptatonic scale,it was easier to distinguish the different stages using the pentatonic scale.These results suggested that the hemispheric ensemble can represent brain activity by variations in pitch,tempo and harmony.The ensemble with the pentatonic scale sounds more consonant,and partially reflects the relations of the two hemispheres.This can be used to distinguish the different states of brain activity and provide a new perspective on EEG analysis.     

Altered REM sleep architecture in patients with Myotonic dystrophy type 1: is related to sleep apnea?

ObjectiveTo determine the sleep architecture and sleep respiratory abnormalities and to correlate with sleep symptoms in patients with Myotonic dystrophy type 1 (DM1).MethodsWe recruited a cohort of genetically confirmed patients with DM1, who attended the Neuromuscular clinic between July 2016 and December 2019. Clinical, sleep and whole night polysomnography data were collected. The analysis of sleep architecture, sleep respiratory parameters and comparison with healthy controls (HC) was performed in our sleep laboratory.ResultsA total of 59 patients with DM1 underwent sleep evaluation. Hypersomnolence in 42 (77.8%), ESS>10 in 23 (39%), and PSQI>5 in 18 (30.5%) were found in patients with DM1. Thirty-one (68.89%) patients with DM1 and 22 (95.65%) HC had more than 4-h of total sleep time (TST). More than 4 h of TST was taken to compare respiratory and sleep architecture parameters. Patients with DM1 had reduced sleep efficiency, reduced N2 sleep, and increase in N1 sleep, wake index, stage shift index, nocturnal sleep-onset REM periods compared to HC. AHI>15 was found in 16 (51.61%) DM1 and in 3 HC (13.64%). AHI had positive correlation with BMI, but not with age, ESS or disease progression (MIRS). All DM1 with AHI>15; 8(80%) and 1(33.33%) in AHI5to15, and AHI<5 groups, respectively had hypersomnolence.ConclusionIn this first study on Indian cohort, daytime hypersomnolence, poor nocturnal sleep quality, sleep architecture irregularities are identified to be common in patients with DM1. These abnormalities may be explained by sleep-related breathing disorders that are highly prevalent in these patients.     

西北地区农村留守儿童心理健康状况

目的调查农村留守儿童心理健康状况及其特点,对农村中小学开展心理健康教育提供参考。方法采用王极盛编写的《中学生心理健康量表》对陕西省宝鸡市4个地区15所学校的618名农村留守儿童的心理健康水平进行测查。结果农村留守儿童的心理健康问题的检出率为52%(非留守儿童为41.13%);农村留守与非留守儿童在的强迫(t=2.22,P0.05)、偏执(t=4.27,P0.01)、敌对(t=2.96,P0.01)、人际关系(t=2.21,P0.05)、适应不良(t=3.50,P0.01)、心理不平衡(t=2.65,P0.05)等6个因子上存在显著性差异;留守儿童中,男性在偏执(t=2.44,P0.05)和情绪稳定性(t=2.70,P0.01)上明显不如女性;父母双双监护的儿童心理健康状况好于单亲监护,单亲监护的留守儿童心理健康状况好于双亲外出。结论农村留守儿童心理健康水平不容乐观,要重视农村留守儿童的心理健康教育。     

Evolving patterns in the diagnosis of reactive gastropathy: Data from a prospective Central European multicenter study with proposal of a new histologic scoring system

Histologic examination of gastric biopsies is crucial for determining the cause of gastritis. This prospective multicenter study was undertaken to investigate different histologic parameters arguing in favor or against the diagnosis of reactive gastropathy and to correlate findings with patient's symptoms and endoscopic findings. A total of 1123 individuals aged 15–93 years participated in a prospective multicenter study (histoGERD trial). Diagnosis of Helicobacter gastritis was made following the Updated Sydney System. Diagnosis of reactive gastropathy was based upon Dixon's parameters of foveolar hyperplasia, smooth muscle fibers in the lamina propria and vasodilatation and congestion of mucosal capillaries. Including paucity of acute and chronic inflammatory cells in analysis, a new score with visual analog scales for the diagnosis of reactive gastropathy was developed. All three histologic parameters in favor of the diagnosis of reactive gastropathy were positively associated with the endoscopic diagnosis of gastritis (p < 0.001), yet negatively with Helicobacter infection (p < 0.001). In contrast, presence of acute and chronic inflammatory cells in lamina propria was positively associated with Helicobacter infection (p < 0.001), yet not with the endoscopic diagnosis of gastritis. Our score demonstrated strong association between histologic and endoscopic diagnoses (p < 0.001), yet not with patient's symptoms. In conclusion, our data prove foveolar hyperplasia, smooth muscle fibers and vasodilatation and congestion as key histologic parameters for the diagnosis of reactive gastropathy. The proposed score may enhance the diagnostic accuracy. It should be validated in future studies.     

A Procedure to Measure the in-Situ Hygrothermal Behavior of Earth Walls

Rammed earth is a sustainable material with low embodied energy. However, its development as a building material requires a better evaluation of its moisture-thermal buffering abilities and its mechanical behavior. Both of these properties are known to strongly depend on the amount of water contained in wall pores and its evolution. Thus the aim of this paper is to present a procedure to measure this key parameter in rammed earth or cob walls by using two types of probes operating on the Time Domain Reflectometry (TDR) principle. A calibration procedure for the probes requiring solely four parameters is described. This calibration procedure is then used to monitor the hygrothermal behavior of a rammed earth wall (1.5 m × 1 m × 0.5 m), instrumented by six probes during its manufacture, and submitted to insulated, natural convection and forced convection conditions. These measurements underline the robustness of the calibration procedure over a large range of water content, even if the wall is submitted to quite important temperature variations. They also emphasize the importance of gravity on water content heterogeneity when the saturation is high, as well as the role of liquid-to-vapor phase change on the thermal behavior.     

Evaluation of depression in patients with alzheimer's disease according to the location of medical care

The objective of the study was to assess the severity of depression and to assess the level of self-sufficiency of patients with Alzheimer's disease, with particular emphasis on the place of residence and level of education. The study covered 90 people diagnosed with Alzheimer's disease. All respondents were persons over 65?years of age and residents of cities with a population over one-hundred thousand. The research method based on this work is the author's own questionnaire, the Zung Self-Rating Depression Scale (ZSDS) about depression and the Karnofsky Performance Scale Index (KPSI) for assessment of a patient's self-sufficiency. Regardless of residence, patients with Alzheimer's disease displayed signs of mild or moderate depression (100% in social welfare homes and hospital patients and 60% in those with caregivers at home). Patients with Alzheimer's disease have an unsatisfactory salary in social-economic terms. In those with Alzheimer's disease, quality of life is best for those in family homes under the care of their immediate family. People with a vocational education were the largest group of people diagnosed with Alzheimer's. Patients at home and in the hospital had a higher level of physical activity, but most patients in the hospital needed regular medical care, as did patients in social welfare homes.     

Long-term study of ropinirole patch in Parkinson's disease patients with/without basal l-dopa

IntroductionA dopamine agonist patch could be an important treatment option for Parkinson's disease. This study evaluated the long-term efficacy and safety of the ropinirole hydrochloride patch. The steady state plasma ropinirole concentration was also assessed.MethodsIn a multicenter, open-label, uncontrolled study, Parkinson's disease patients with/without basal levodopa and with/without prior dopamine agonist therapy (any of these four regimens) received application of a ropinirole patch once daily for up to 52 weeks with unforced titration from 8 to 64 mg. For patients with prior dopamine agonist therapy, the initial dose of ropinirole patch was determined from the prior dopamine agonist dose by using a conversion table.ResultsMost adverse events were mild or moderate. All application site adverse events were mild, except for moderate application site erythema in one patient. In patients with prior dopamine agonist therapy, switching to ropinirole patch did not lead to a significant early increase of adverse events. A change from baseline in the UPDRS Part III total score, the primary efficacy endpoint, showed improvement until Week 16 compared with baseline, followed by little subsequent change until Week 52, indicating maintenance of efficacy. The plasma ropinirole concentration was at steady state throughout the study period and showed a dose-proportional increase.ConclusionOnce-daily application of ropinirole patch showed long-term efficacy and safety (52 weeks) for Parkinson's disease. Switching from other dopamine agonists to ropinirole patch was effective and safe. The plasma ropinirole concentration was at steady state throughout the study period and showed a dose-proportional increase.     

On the Dimensionalities of the Dissociative Experiences Scale (DES) and the Dissociation Questionnaire (DIS-Q)

Abstract

The dimensionalities of the Dissociative Experiences Scale (DES) and the Dissociation Questionnaire (DIS-Q) have been explored by factor analysis by a number of investigators. The general claim is that both scales are multidimensional. However, we argue that, in both cases, this ap parent multidimensionality is a form of range restriction that arises because some symptoms are more common than other symptoms. As a result, the resulting subscales derived from the multifactor solutions are so highly intercorrelated as to be incapable of meaningful discriminant validity. The current findings support a more parsimonious single factor solution for both scales.