中华医学杂志（英文版）2011，Vol.124Issue(20)：3269-3274,6.DOI:10.3760/cma.j.issn.0366-6999.2011.20.011
Prospective, naturalistic study of open-label OROS methylphenidate treatment in Chinese school-aged children with attention-deficit/hyperactivity disorder
Prospective, naturalistic study of open-label OROS methylphenidate treatment in Chinese school-aged children with attention-deficit/hyperactivity disorder
ZHENG Yi 1GONG Mei-en 2YIN Qing-yun 3MAI Jian-ning 4JING Jin 5LUO Xiang-yang 6MA Hong-wei 7LI Hai-bo 8XIE Ling 9LI Yan 10Kuang Gui-fang 11WANG Yu-feng 12YI Ming-ji 13WANG Feng 14ZHU Xiao-hua 15YAO Yah-bin 16QIN Jiong 17WANG Li-wen 18ZOU Li-ping 19JIN Xing-ming 20XU Tong 21WANG Yi 22QI Yuan-li23
作者信息
- 1. Department of Pediatrics, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China
- 2. Department of Psychology, Second Affiliated Hospital of Guangzhou Medical College, Guangzhou, Guangdong 510150, China
- 3. Department of Psychiatry,Guangzhou Brain Hospital of Guangzhou Medical College, Guangzhou, Guangdong 510510, China
- 4. Department of Neural Rehabilitation, Guangzhou Children's Hospital, Guangzhou, Guangdong 510120, China
- 5. Department of Pediatrics, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, China
- 6. Department of Pediatric Medicine, Second Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510130, China
- 7. Department of Child Health, Second Hospital of China Medical University, Shenyang, Liaoning 110022, China
- 8. Department of Pediatrics, First Hospital of Jilin University,Changchun, Jilin 130021, China
- 9. Department of Child Health, Nanjing Children's Hospital of Nanjing MedicalZniversity, Nanjing,Jiangsu 210008, China
- 10. Department of Neurology, Children's Hospital of Soochow University, Suzhou, Jiangsu 215003, China
- 11. Department of Pediatric Mental Health, Qingdao Women and Children Health Care Centers, Qingdao, Shandong 266011, China
- 12. Department of Pediatrics, Institute of Mental Health, Peking University, Beijing 100191, China
- 13. Department of Child Health, Affiliated Hospital of Qingdao University Medical School, Qingdao, Shandong 266003, China
- 14. Department of Neurology, Hubei Material and Child Health Hospital, Wuhan, Hubei 430070, China
- 15. Department of Psychiatry,Seventh People's Hospital of Hangzhou, Hangzhou, Zhejiang 310013, China
- 16. Department of Child Health, Tianjin Women's and Children's Health Center, Tianjin 300270, China
- 17. Department of Pediatric Neurology, Women's and Children's Department, Peking University First Hospital, Beijing 100034, China
- 18. Department of Pediatric Neurology, Capital Institute of Pediatrics, Beijing 100020, China
- 19. Department of Pediatric Medicine, Beijing Children's Hospital of Capital Medical University, Beijing 100045, China
- 20. Department of Pediatrics, Shanghai Children's Medical Center of Shanghai Jiaotong University,Shanghai 200127, China
- 21. Department of Pediatrics, Shanghai Changzheng Hospital of Second Military Medical University,Shanghai 200003, China
- 22. Department of Pediatrics, Pediatric Hospital of Fudan University, Shanghai 200032, China
- 23. Department of Psychiatry, Institute of Mental Health, Guangzhou, Guangdong 510080, China
- 折叠
摘要
Abstract
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.关键词
attention deficit hyperactivity disorder/methylphenidate/pharmacotherapyKey words
attention deficit hyperactivity disorder/methylphenidate/pharmacotherapy引用本文复制引用
ZHENG Yi,GONG Mei-en,YIN Qing-yun,MAI Jian-ning,JING Jin,LUO Xiang-yang,MA Hong-wei,LI Hai-bo,XIE Ling,LI Yan,Kuang Gui-fang,WANG Yu-feng,YI Ming-ji,WANG Feng,ZHU Xiao-hua,YAO Yah-bin,QIN Jiong,WANG Li-wen,ZOU Li-ping,JIN Xing-ming,XU Tong,WANG Yi,QI Yuan-li..Prospective, naturalistic study of open-label OROS methylphenidate treatment in Chinese school-aged children with attention-deficit/hyperactivity disorder[J].中华医学杂志（英文版）,2011,124(20):3269-3274,6.
