摘要
目的 评价罗匹尼罗片剂治疗帕金森病患者的疗效和安全性.方法 随机、双盲、双模拟、罗匹尼罗和溴隐亭平行分组多中心临床试验.研究对象于2005年11月至2007年4月由北京、兰州、武汉等7所医院招募.221例帕金森病患者按随机数字表进行分组,分别随机接受罗匹尼罗（9 mg/d）或溴隐亭（15 mg/d）治疗,为期12周.疗效指标为统一帕金森病评定量表（UPDRS）各部分评分相对于基线的变化；对合用左旋多巴出现“剂末现象”的患者,基于患者日记记录的“关”期时间的变化及临床疗效的整体评价.安全性指标为不良反应、血压、脉搏、实验室检查值和心电图.计量资料采用t检验、配对t检验及协方差分析；计数资料采用x2检验.结果 意向性治疗人群中,治疗12周后与基线比较,罗匹尼罗组和溴隐亭组的UPDRSⅢ总评分均值分别下降（11±9）分和（11±10）分（t=0.685,P=0.932）；UPDRSⅡ总评分均值分别下降（4±4）分和（3±5）分（t=1.784,P=0.076）；罗匹尼罗非劣效于溴隐亭.罗匹尼罗组和溴隐亭组治疗12周后“关”期时间[（3.0±1.2）h,（3.8±1.6）h]与基线时[（4.2±2.0）h,（4.4±1.7）h]相比,关期小时数显著减少（t=10.772,t=5.746,P=0.000）.研究者对整体疗效评价显效率两组比较罗匹尼罗组优于溴隐亭组（q =7.241,P=0.007）.本次试验没有发生严重不良事件.罗匹尼罗组发生在5％以上的有关的不良反应有体位性低血压、恶心、头晕、上腹部不适、失眠、心悸,试验结束后多数不良事件已缓解或消失.不良反应发生频率罗匹尼罗组与溴隐亭组间差异无统计学意义.结论 罗匹尼罗用于治疗中国帕金森病患者是安全而有效的.
Objective To explore the efficacy and safety of ropinirole in the treatment of Parkinson disease.Methods From November 2005 to April 2007,a total of 221 subjects from 7 hospitals of Beijing,Lanzhou and Wuhan participated in a 12-week multi-center,randomized,bromocriptine-controlled,doubleblind,double-dummy and parallel-group trial.The efficacy of ropinirole was assessed with the unified Parkinson disease rating scale （UPDRS） score,＂off＂ time according to the patient＇s diary and the overall evolution of clinical efficacy.The safety was assessed on the basis of adverse events,blood pressure,pulse,laboratory measurement and electrocardiographic recordings.And the statistical analyses were performed with t,paired t,x2 and covariance tests.Results In the intent-to-treat population,the average UPDRSⅢ score decreased to （11 ±9） in ropinirole group and （11 ± 10） in bromocriptine group while the UPDRS Ⅱ score decreased to （4 ± 4） and （3 ± 5） respectively at Week 12 versus baseline.It showed that ropinirole was non-inferior to bromocriptine.The ＂off＂ time at Week 12 [（3.0 ± 1.2） h,（3.8 ± 1.6） h] versus baseline [（4.2±2.0）h,（4.4 ± 1.7）h] decreased （t =10.772,t =5.746,P =0.000）in ropinirole and bromocriptine groups.Ropinirole offered a better overall improvement rate （q =7.241,P =0.007）.The adverse events occurring at a ratio of over 5% caused by ropinirole included orthostatic hypotension,nausea,dizziness,upper abdominal discomfort,insomnia and palpitation.No significant difference existed in the frequency of adverse events between two groups.Conclusion Ropinirole is both effective and safe in the treatment of Chinese patients with Parkinson disease.
出处
《中华医学杂志》
CAS
CSCD
北大核心
2013年第25期1952-1957,共6页
National Medical Journal of China
关键词
帕金森病
溴隐亭
罗匹尼罗
随机对照试验
Parkinson disease
Bromocriptine
Ropinirole
Randomized, controlled clinicaltrials
