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刊物信息
期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
编辑部主任:粟晓黎
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237

 

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FDA approves Requip for Restless Legs Syndrome

 
 

ROCKVILLE, MD., May 5, 2005 -- The FDA has approved Requip (ropinirole) to treat moderate to severe Restless Legs Syndrome (RLS). The GlaxoSmithKline drug was first approved for Parkinson’s disease in 1997.

Restless Legs Syndrome is a condition that affects about ten percent of the population. The disorder is characterized by an urge to move the legs, usually accompanied by or caused by uncomfortable leg sensations. For most people with the condition, symptoms begin or worsen during periods of rest or inactivity and are partially or totally relieved by movement. Symptoms typically worsen or occur only in the evening or at night, and can disturb sleep.

Requip was found to be effective for RLS in three randomized, double-blind placebo controlled studies in adults diagnosed with moderate to severe RLS. The studies measured effectiveness of the drug using the International Restless Leg Syndrome Scale, a patient rated scale that measures different aspects of RLS including severity of muscle movement and discomfort, sleep disturbance, mood and overall effect on quality of life.

The Clinical Global Impression-Global Improvement scale was also used. This is an investigator rated scoring of improvement following treatment. All three studies demonstrated a statistically significant difference between the treatment group receiving Requip and the group receiving placebo.

Common side effects of Requip reported in clinical trials include nausea, headache, and vomiting. The label for the drug will also include a caution that Requip has been associated with sedating effects, including somnolence (sleepiness), and the possibility of falling asleep while engaged in activities of daily living, including operation of a motor vehicle. Syncope (fainting) or symptomatic hypotension (low blood pressure) may occur, particularly during initial treatment or dosing.

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