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学科主题: 临床医学
题名:
Evaluation of open-label topiramate ad primary or adjunctive therapy in infantile spasms
作者: Zou, Li-Ping1; Lin, Qing2; Qin, Jiong2; Cai, Fang-Cheng3; Liu, Zhi-Sheng4; Mix, Eilhard; Topiramate Study Grp5
关键词: topiraniate ; infantile spasms ; epilepsy
刊名: CLINICAL NEUROPHARMACOLOGY
发表日期: 2008-03-01
DOI: 10.1097/WNF.0b013c3180986d43
卷: 31, 期:2, 页:86-92
收录类别: SCI
文章类型: Review
WOS标题词: Science & Technology
类目[WOS]: Clinical Neurology ; Pharmacology & Pharmacy
研究领域[WOS]: Neurosciences & Neurology ; Pharmacology & Pharmacy
关键词[WOS]: METABOLIC-ACIDOSIS ; WEST-SYNDROME ; VIGABATRIN ; SEIZURES ; CHILDREN
英文摘要:

Objeictivc: A multicenter open-label clinical trial was conducted to evaluate the clinical usefulness of topiramate (TPM) as primary or adjunctive therapy for infantile spasms in the postmarketing period in China.

Methods: Thirty-four centers participated in the trial. Patients included in the study had 1 or more seizures per day before treatment. One hundred twenty (22.1%) very young patients with an age younger than 6 month and 64.2% of patients were younger than 1 year at start of treatment. All patients received a starting dose of 0.5 to 1 mg kg(-1) d(-1) TPM twice daily. The dosage was increased by 0.5 to 1 mg kg(-1) d(-1) every 5 to 7 days up to 3 to 5 mg kg(-1) d(-1). The resulting range of the total TPM dosage was 25 to 200 mgd(-1) (3-57-20 mg kg(-1) d(-1)), with a median value of 73.9 mg d(-1). Seizure outcomes were measured by intention-to-treat analysis. Patients were seen by a neurologist, and their data were evaluated at the day of inclusion and after 4, 8, 12, 16, and 20 weeks (from visit 1 to visit 5) of treatment.

Results: Five hundred forty-four patients entered the study. After 20 weeks of TPM treatment, 239 patients (43.9%) were seizure-free. A higher proportion of patients in the monotherapy group than in the add-on therapy group showed a seizure rate reduction. An increase in seizure frequency was observed in 8 patients (1.5%) during the 20-week treatment period. Nineteen patients were withdrawn before completing the study, and in 46 cases, some data of the structured data files and questionnaires were missing. No efficacy of TPM treatment was recorded in these cases. Adverse effects occurred in 211 patients (38.8%). Most frequent side effects were anorexia and somnolence.

Conclusions: Topiramate proved to be an effective and safe monotherapy and add-on therapy in patients with infantile spasms younger than 1 year.

语种: 英语
WOS记录号: WOS:000254698200004
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/59294
Appears in Collections:北京大学第一临床医学院_儿科_期刊论文

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作者单位: 1.Wuhan Childrens Hosp, Dept Neurol, Wuhan, Peoples R China
2.Univ Rostock, Dept Neurol, Rostock, Germany
3.Capital Univ Med Sci, Beijing Childrens Hosp, Dept Neurol, Beijing 100045, Peoples R China
4.Peking Univ, Hosp 1, Dept Pediat, Beijing 100871, Peoples R China
5.Chongqing Univ Med Sci, Chongqing Childrens Hosp, Dept Neurol, Chongqing, Peoples R China

Recommended Citation:
Zou, Li-Ping,Lin, Qing,Qin, Jiong,et al. Evaluation of open-label topiramate ad primary or adjunctive therapy in infantile spasms[J]. CLINICAL NEUROPHARMACOLOGY,2008,31(2):86-92.
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