普拉克索治疗帕金森病的多中心、随机、双盲、溴隐亭对照临床疗效和安全性研究

Efficacy of pramipexole in the treatment of Parkinson's disease:a multi-center,randomized,double-blind,bromocriptine-control trial

目的评价普拉克索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、普拉克索和溴隐亭平行分组多中心临床试验。208例帕金森病患者随机接受普拉克索(4.5mg/d)或溴隐亭(22.5mg/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;左旋多巴每日剂量相对基线的变化;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"开"和"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。结果意向性治疗人群中,治疗12周后与基线比较,普拉克索组和溴隐亭组的 UPDRSⅢ总评分均值分别下降11.60分和10.01分;UPDRSⅡ总评分均值分别下降4.19分和3.27分;普拉克索非劣效于溴隐亭,两组之间也无优效关系。在 UPDRSⅡ～Ⅳ总评分变化≥130%的受试者比例、研究者整体临床评价和药物的起效时间等方面,普拉克索均优于溴隐亭(P<0.05)。普拉克索发生在5%以上的有关的不良反应有头晕、嗜睡、恶心、便秘、厌食、视觉异常、上腹部不适、体位性低血压等。普拉克索的不良反应发生频率与溴隐亭组间差异无统计学意义。结论普拉克索用于治疗中国帕金森病患者是安全而有效的。

Objective To investigate the efficacy and safety of pramipexole in the treatment of Parkinson＇ s disease. Methods A total of 208 Parkinson＇s patients with wearing off participated in a multicenter, 12-weeks randomized, bromocriptine-controlled, double blind, double-dummy and parallel-group trial. The efficacy of pramipexole was assessed according to the patient＇ s diary card and using the Unified Parkinson＇ s Disease Rating Scale （UPDRS） score, the daily levodopa dosage and the overall evolution of clinical efficacy. The safety was assessed on the basis of adverse events, blood pressure, pulse, laboratory measurements and ECG recordings. Results In 208 cases of the intent-to-treat population, the averaged UPDRS m score had decreased to 11.60 in pramipexole （4. 5 mg/d ） and 10. 01 in bromocriptine group （22. 5 mg/d）, the averaged UPDRS H score had decreased to 4. 19 and 3. 27, respectively, as compared with 12-weeks and base-line, which showed that pramipexole was neither inferior nor superiorit to bromocriptine. Pramipexole was superior to bromocriptine considering that it had more than 30% of patients had changes of UPDRS H -IV scores before and after treatment, a better overall clinic impression evaluated by the researchers and a short time beginning to be effective. The adverse events in a ratio over 5% caused by pramipexole were dizziness, somnolence, nausea, constipation, anorexia, blurred vision, upperabdominal malaise; orthostatic hypotension. No significant difference in terms of the frequencies of adverse events between pramipexole and bromocfiptine group. Conclusion Pramipexole should be regarded as an effective and safe treatment for Chinese patients with Parkinson＇ s disease.