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学科主题: 精神卫生
题名:
Prospective, naturalistic study of open-label OROS methylphenidate treatment in Chinese school-aged children with attention-deficit/hyperactivity disorder
作者: Zheng Yi1; Wang Yu-feng2; Qin Jiong3; Wang Li-wen4; Zou Li-ping5; Jin Xing-ming6; Xu Tong7; Wang Yi8; Qi Yuan-li9; Gong Mei-en10; Yin Qing-yun11; Mai Jian-ning12; Jing Jin13; Luo Xiang-yang14; Ma Hong-wei15; Li Hai-bo16; Xie Ling17; Li Yan18; Kuang Gui-fang19,20; Yi Ming-ji21; Wang Feng22; Zhu Xiao-hua23; Yao Yan-bin24
关键词: attention deficit hyperactivity disorder ; methylphenidate ; pharmacotherapy
刊名: CHINESE MEDICAL JOURNAL
发表日期: 2011-10-20
DOI: 10.3760/cma.j.issn.0366-6999.2011.20.011
卷: 124, 期:20, 页:3269-3274
收录类别: SCI ; SSCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Medicine, General & Internal
研究领域[WOS]: General & Internal Medicine
关键词[WOS]: DEFICIT HYPERACTIVITY DISORDER ; ORAL SYSTEM-METHYLPHENIDATE ; ONCE-A-DAY ; IMMEDIATE-RELEASE ; CONTROLLED TRIAL ; DOUBLE-BLIND ; ADHD ; EFFICACY ; ADOLESCENTS ; ADULTS
英文摘要:

Background Attention deficit hyperactivity disorder (ADHD) is one of the most common mental disorders during childhood, characterized by the core symptoms of hyperactivity, impulsivity and inattention and puts great burden on children themselves, their families and the society. Osmotic release oral system methylphenidate (OROS-MPH) is a once-daily controlled-release formulation developed to overcome some of the limitations associated with immediate-release methylphenidate (IR-MPH). It has been marketed in China since 2005 but still lacks data from large-sample clinical trials on efficacy and safety profiles. The aim of this study was to evaluate the effectiveness and safety of OROS-MPH in children aged 6 to 16 years with ADHD under naturalistic clinical setting.

Methods This 6-week, multi-center, prospective, open-label study enrolled 1447 ADHD children to once-daily OROS-MPH (18 mg, 36 mg or 54 mg) treatment. The effectiveness measures were parent-rated Inattention and Overactivity With Aggression (IOWA) Conners I/O and O/D subscales, physician-rated CGI-I and parent-rated global efficacy assessment scale. Blood pressure, pulse rate measurement, adverse events (AEs) and concomitant medications and treatment review were conducted by the investigator and were served as safety measures.

Results A total of 1447 children with ADHD (mean age (9.52 +/- 2.36) years) were enrolled in this trial. Totally 96.8% children received an OROS-MPH modal dose of 18 mg, 3.1% with 36 mg and 0.1% with 54 mg at the endpoint of study. The parent IOWA Conners I/O score at the end of week 2 showed statistically significant (P <0.001) improvement with OROS-MPH (mean: 6.95 +/- 2.71) versus the score at baseline (10.45 +/- 2.72). The change in the parent IOWA Conners O/D subscale, CGI-I and parent-rated global efficacy assessment scale also supported the superior efficacy for OROS-MPH treatment. Fewer than half of 1447 patients (511(35.3%)) reported AEs, and the majority of the events reported were mild (68.2%). No serious adverse events were reported during the study.

Conclusion This open-label, naturalistic study provides further evidence of effectiveness and safety of OROS-MPH in school-aged children under routine practice. Chin Med J 2011;124(20):3269-3274

语种: 英语
项目资助者: Xi&prime ; an Jassen Pharmmaceutical Ltd, China
WOS记录号: WOS:000296307700011
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/51203
Appears in Collections:北京大学精神卫生研究所_儿童心理卫生中心_期刊论文

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作者单位: 1.Capital Med Univ, Dept Pediat, Beijing Anding Hosp, Beijing 100088, Peoples R China
2.Peking Univ, Dept Pediat, Inst Mental Hlth, Beijing 100191, Peoples R China
3.Peking Univ, Hosp 1, Dept Pediat Neurol, Womens & Childrens Dept, Beijing 100034, Peoples R China
4.Capital Inst Pediat, Dept Pediat Neurol, Beijing 100020, Peoples R China
5.Capital Med Univ, Dept Pediat Med, Beijing Childrens Hosp, Beijing 100045, Peoples R China
6.Shanghai Jiao Tong Univ, Dept Pediat, Shanghai Childrens Med Ctr, Shanghai 200127, Peoples R China
7.Second Mil Med Univ, Dept Pediat, Shanghai Changzheng Hosp, Shanghai 200003, Peoples R China
8.Fudan Univ, Dept Pediat, Pediat Hosp, Shanghai 200032, Peoples R China
9.Inst Mental Hlth, Dept Psychiat, Guangzhou 510080, Guangdong, Peoples R China
10.Guangzhou Med Univ, Dept Psychol, Affiliated Hosp 2, Guangzhou 510150, Guangdong, Peoples R China
11.Guangzhou Med Univ, Guangzhou Brain Hosp, Dept Psychiat, Guangzhou 510510, Guangdong, Peoples R China
12.Guangzhou Childrens Hosp, Dept Neural Rehabil, Guangzhou 510120, Guangdong, Peoples R China
13.Sun Yat Sen Univ, Dept Pediat, Affiliated Hosp 3, Guangzhou 510130, Guangdong, Peoples R China
14.Sun Yat Sen Univ, Dept Pediat Med, Affiliated Hosp 2, Guangzhou 510130, Guangdong, Peoples R China
15.China Med Univ, Dept Child Hlth, Hosp 2, Shenyang 110022, Liaoning, Peoples R China
16.Jilin Univ, Dept Pediat, Hosp 1, Changchun 130021, Jilin, Peoples R China
17.Nanjing Univ, Dept Child Hlth, Nanjing Childrens Hosp, Nanjing 210008, Jiangsu, Peoples R China
18.Soochow Univ, Dept Neurol, Childrens Hosp, Suzhou 215003, Jiangsu, Peoples R China
19.Qingdao Women Hlth Care Ctr, Dept Pediat Mental Hlth, Qingdao 266011, Shandong, Peoples R China
20.Qingdao Children Hlth Care Ctr, Dept Pediat Mental Hlth, Qingdao 266011, Shandong, Peoples R China
21.Qingdao Univ, Sch Med, Dept Child Hlth, Affiliated Hosp, Qingdao 266003, Shandong, Peoples R China
22.Hubei Mat & Child Hlth Hosp, Dept Neurol, Wuhan 430070, Hubei, Peoples R China
23.Seventh Peoples Hosp Hangzhou, Dept Psychiat, Hangzhou 310013, Zhejiang, Peoples R China
24.Tianjin Womens & Childrens Hlth Ctr, Dept Child Hlth, Tianjin 300270, Peoples R China

Recommended Citation:
Zheng Yi,Wang Yu-feng,Qin Jiong,et al. Prospective, naturalistic study of open-label OROS methylphenidate treatment in Chinese school-aged children with attention-deficit/hyperactivity disorder[J]. CHINESE MEDICAL JOURNAL,2011,124(20):3269-3274.
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