检索结果-南通市图书馆

Effectiveness and safety of opicapone in Parkinson’s disease patients with motor fluctuations: the OPTIPARK open-label study

引用

Translational Neurodegeneration 2020年第1期9卷 96-104页

作者： Heinz Reichmann Andrew Lees José-Francisco Rocha Diogo Magalhaes Patrício Soares-da-Silva the OPTIPARK investigators Department of Neurology University of DresdenDresdenGermany University College London Reta Lila Weston InstituteLondonUK Global Parkinson’s Disease Department BIAL–Portela&CA S.ACoronadoPortugal Research and Development Department BIAL–Portela&CA S.Ada Siderurgia Nacional4745-457 S Mamede do CoronadoPortugal Department of Pharmacology and Therapeutics Faculty of MedicineUniversity PortoPortoPortugal MedInUP Center for Drug Discovery and Innovative MedicinesUniversity PortoPortoPortugal 不详

Background:The efficacy and safety of opicapone,a once-daily catechol-O-methyltransferase inhibitor,have been established in two large randomized,placebo-controlled,multinational pivotal ***,clinical evidence from routine practice is needed to complement the data from the pivotal ***:OPTIPARK(NCT02847442)was a prospective,open-label,single-arm trial conducted in Germany and the UK under clinical practice *** with Parkinson’s disease and motor fluctuations were treated with opicapone 50 mg for 3(Germany)or 6(UK)months in addition to their current levodopa and other antiparkinsonian *** primary endpoint was the Clinician’s Global Impression of Change(CGI-C)after 3 *** assessments included Patient Global Impressions of Change(PGI-C),the Unified Parkinson’s Disease Rating Scale(UPDRS),Parkinson’s Disease Questionnaire(PDQ-8),and the Non-Motor Symptoms Scale(NMSS).Safety assessments included evaluation of treatment-emergent adverse events(TEAEs)and serious adverse events(SAEs).Results:Of the 506 patients enrolled,495(97.8%)took at least one dose of *** these,393(79.4%)patients completed 3 months of ***,71.3 and 76.9%of patients experienced any improvement on CGI-C and PGI-C after 3 months,respectively(full analysis set).At 6 months,for UK subgroup only(n=95),85.3%of patients were judged by investigators as improved since commencing *** scores at 3 months showed statistically significant improvements in activities of daily living during OFF(mean±SD change from baseline:?3.0±4.6,p<0.0001)and motor scores during ON(?4.6±8.1,p<0.0001).The mean±SD improvements of?3.4±12.8 points for PDQ-8 and-6.8±19.7 points for NMSS were statistically significant versus baseline(both p<0.0001).Most of TEAEs(94.8%of events)were of mild or moderate *** considered to be at least possibly related to opicapone were reported for 45.1%of patients,with dyskinesia(11.5%)and dry mouth(6.5%)being

关键词： Levodopa Motor fluctuations open-label Opicapone Parkinson’s disease

来源：

维普期刊数据库评论

在线全文

维普期刊数据库

学校读者我要写书评

暂无评论

An open-label trial of divalproex sodium extended release for pediatric bipolar spectrum disorder in children age 6 - 12 years

引用

open Journal of Psychiatry 2012年第2期2卷 123-128页

作者： Janet Wozniak Paul Hammerness Robert Doyle Gagan Joshi K. Yvonne Woodworth Joseph Biederman Pediatric Psychopharmacology Research Unit Massachusetts General Hospital Boston USA

Objective: To estimate the rate of response to divalproex sodium extended release in pediatric bipolar spectrum disorder in young children age 6 - 12. Methods: This was an 8-week, open-label treatment of youth with DSM-IV bipolar disorder with divalproex sodium extended release (ER) monotherapy. Severity of mania was assessed weekly with the Young Mania Rating Scale (YMRS). Results: The sample was 8.9 ± 2.0 years of age and predominantly male (83%). At study entry the mean YMRS score was 26.3 ± 4.5. Of the 18 subjects enrolled, 7 (39%) completed the 8 week course. We failed to find a clinically or statistically significant improvement with divalproex sodium ER. Pre-post comparisons at endpoint (LOCF) indicated an average response reduction of 6.1 ± 2.6 in the YMRS to a mean of 20.3 ± 8.1. Weight increased by 1.36 ± 0.7 kg (p = 0.08) from baseline to endpoint. Conclusion. Divalproex sodium ER monotherapy was associated with poor tolerability, was associated with clinically concerning weight gain but had modest therapeutic benefits in the management of symptoms of mania and depression in children with pediatric bipolar disorder.

关键词： Bipolar Disorders Pediatric Psychopharmacology open-label

来源：

维普期刊数据库评论

在线全文

维普期刊数据库

学校读者我要写书评

暂无评论

Irinotecan plus S-1 versus S-1 in patients with previously treated recurrent or metastatic esophageal cancer(ESWN 01):a prospective randomized,multicenter,open-labeled phase 3 trial

引用

Cancer Communications 2019年第1期39卷 151-160页

作者： Jing Huang Binghe Xu Ying Liu Junxing Huang Ping Lu Yi Ba Lin Wu Yuxian Bai Shu Zhang Jifeng Feng Ying Cheng Jie Li Lu Wen Xianglin Yuan Changwu Ma Chunhong Hu Qingxia Fan Xi Wang Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeNo 17 Panjiayuan NanliChaoyang DistrictBeijing 100021P.R.China Department of Medical Oncology Henan Cancer HospitalZhengzhou 450008HenanP.R.China Department of Medical Oncology Taizhou People’s HospitalTaizhou 225300JiangsuP.R.China Department of Medical Oncology First Affiliated Hospital of Xinxiang Medical UniversityXinxiang 453100HenanP.R.China Department of Medical Oncology Tianjin Cancer HospitalTianjin 300060P.R.China Department of Medical Oncology Hunan Cancer HospitalChangsha 410006HunanP.R.China Department of Medical Oncology Harbin Medical University Cancer HospitalHarbin 150040HeilongjiangP.R.China Department of Medical Oncology Shandong Cancer HospitalJinan 250117ShandongP.R.China Department of Medical Oncology Jiangsu Cancer HospitalNanjing 210009JiangsuP.R.China Department of Medical Oncology Jilin Cancer HospitalChangchun 130012JilinP.R.China Department of Radiotherapy Shanxi Cancer HospitalTaiyuan 030013ShanxiP.R.China Department of Medical Oncology Shanxi Cancer HospitalTaiyuan 030013ShanxiP.R.China Department of Medical Oncology Tongji HospitalWuhan 430030HubeiP.R.China Department of Medical Oncology Chifeng Municipal HospitalChifeng 024000Inner MongoliaP.R.China Department of Oncology The Second Xiangya Hospital of Central South UniversityChangsha 410011HunanP.R.China Department of Oncology The First Affiliated Hospital of Zhengzhou UniversityZhengzhou 450052HenanP.R.China

Background:The benefit of systemic treatments in esophageal squamous cell carcinoma(ESCC)which has pro-gressed after chemotherapy is still uncertain and optimal regimens based on randomized trials have not yet been *** aimed to compare the efficacy of irinotecan plus S-1 with S-1 monotherapy in recurrent or metastatic ESCC patients who had resistance to platinum-or taxane-based ***:We conducted a prospective randomized,multicenter,open-label,phase 3 trial in 15 centers across *** patients were adults with histologically confirmed recurrent or metastatic ESCC,and were randomly assigned(ratio,1:1)to receive either irinotecan plus S-1(intravenous infusion of irinotecan[160 mg/m2]on day 1 and oral S-1[80-120 mg]on days 1-10,repeated every 14 days)or oral S-1 monotherapy(80-120 mg/day on days 1-14,repeated every 21 days)using a central computerized minimization *** primary endpoint was progression-free survival(PFS).Results:Between December 23,2014 and July 25,2016,we screened 148 patients and randomly assigned 123 patients to receive either irinotecan plus S-1 regimen(n=61)or S-1 monotherapy(n=62).After a median follow-up of 29.2 months(95%confidence interval[CI]17.5-40.9 months),the median PFS was significantly longer in the irinotecan plus S-1 group than in the S-1 monotherapy group(3.8 months[95%CI 2.9-4.3 months]vs.1.7 months[95%CI 1.4-2.7 months],hazard ratio=0.58,95%CI 0.38-0.86,P=0.006).The objective response rates were 24.6%in the irinotecan plus S-1 group and 9.7%in the S-1 monotherapy group(P=0.002).The patients in the irinotecan plus S-1 group presented with increased rates of grade 3-4 leukopenia(16.4%vs.0%),neutropenia(14.8%vs.1.6%),and nausea(4.9%vs.0%).No significant difference in grade 3-4 diarrhea and no treatment-related deaths were observed in both ***: The combination of irinotecan with S-1 was similarly tolerable but significantly prolonged PFS compared to S-1 monotherapy as a second- o

关键词： Esophageal squamous cell carcinoma Recurrent Metastasis Multicenter open-label randomized trial Irinotecan S-1 Overall survival Progression-free survival Objective response rate Disease control rate

来源：

维普期刊数据库评论

在线全文

维普期刊数据库

学校读者我要写书评

暂无评论

欢迎您,

建议与咨询留下您的常用邮箱和电话号码，以便我们向您反馈解决方案和替代方法

时间限定

文献类型

馆藏选择

核心期刊

语言

文献类型

帮助

文字说明：

检索规则说明：

检索范例：

分类表

所选分类

限定检索结果

文献类型

馆藏范围

日期分布

学科分类号

主题

机构

作者

语言

在线全文

在线全文

在线全文

请选择保存的检索档案：

请选择收藏分类：

通借通还

欢迎您,

建议与咨询 留下您的常用邮箱和电话号码，以便我们向您反馈解决方案和替代方法

时间限定

文献类型

馆藏选择

核心期刊

语言

文献类型

帮助

文字说明：

检索规则说明：

检索范例：

分类表

所选分类

限定检索结果

文献类型

馆藏范围

日期分布

学科分类号

主题

机构

作者

语言

在线全文

在线全文

在线全文

请选择保存的检索档案： 新增检索档案 确定 取消

请选择收藏分类： 新增自定义分类 确定 取消

通借通还

建议与咨询留下您的常用邮箱和电话号码，以便我们向您反馈解决方案和替代方法

请选择保存的检索档案：

请选择收藏分类：