普拉克索缓释片和速释片治疗帕金森病的疗效和安全性系统评价

System Evaluation of Efficacy and Safety of Pramipexole Extended-release and Immediate-release in the Treatment of Parkinson's Disease

目的系统评价普拉克索缓释片和速释片治疗帕金森病的疗效和安全性。方法计算机检索PubMed、中国知网、维普网、万方数据知识服务平台等,检索时限为建库至2016年3月。收集比较普拉克索缓释片与速释片治疗帕金森病的疗效和安全性的随机对照试验,对符合纳入标准的临床研究进行资料提取及质量评价,并采用Rev Man5. 2软件进行Meta分析。结果共纳入5个随机对照试验研究,共计1208例患者,Jadad评分均多6分。Meta分析结果显示:疗效方面,缓释片组和速释片组的临床疗效总评分[RR=0.94,95%CI(0.81,1.09)]、帕金森患者全面改善印象评分[RR=1.02,95%G(0.91,1.44)]、帕金森病综合评分量表Ⅱ+Ⅲ评分[RR=-0.13,95%CI(-1.04,0.77)]的结果相近,差异无统计学意义(P>0.05);安全性方面:两组总不良事件发生率[RR=1.02,95%CI(0.93,1.11)],眩晕(RR=1.06,95%CI(0.87,1.31)]、嗜睡(RR=0.86,95%CI(0.56,1.33)]、呕吐(RR=0.63,95%CI(0.26,1.49)]等常见不良反应发生率比较,差异无统计学意义(P>0.05)。结论现有证据表明,普拉克索缓释片和速释片治疗帕金森病的临床有效性和安全性相当。

Objective To systematically evaluate the efficacy and safety of pramipexole extended - release （ ER） and pramipexole immediate - release （IR） in the treatment of Parkinson＇s disease. Methods PubMed, CNKI, CQVIP, Wanfang Data and so on were searched by computer, and the retrieval time was from building up to March 2016. The randomized controlled trials about efficacy and safety of pramipexole ER and pramipexole IR in the treatment of Parkinson7 s disease were collected and compared. Data extraction and quality evaluation were carried out for clinical studies that met the inclusion criteria. And Meta - analysis was performed using Rev Man 5. 2 software. Results A total of 1 208 patients were included in the 5 RCTs with a Jadad score of ^6. Meta - analysis results were as follows： in the efficacy aspect, the difference between ER group and IR group was not statistically significant in the scores of Clinical Global Impression [ RR = 0. 94, 95% CI （0. 81, 1. 09） ] , Patient Global Impression Improvement [RR = 1. 02, 95% CI （0. 91, 1. 44） ] and UPDRS Ⅱ ＋ Ⅲ [RR = -0. 13 , 95% CI （ - 1. 04, 0.77）〕 （P 〉 0. 05 ） ; in the safety aspect, the difference between the two groups was not statistically significant in adverse drug event [RR = 1. 02, 95% CI （0. 93 , 1.11）], dizziness [ RR = 1. 06, 95% CI （0. 87 , 1.31）], somnolence [ RR = 0. 86 , 95% CI （0. 56 , 1. 33 ） ] and vomitting [ RR = 0. 63 , 95% CI （ 0. 26, 1. 49 ） ]. Conclusion The available evidence suggests that Pramipexole ER and IR demonstrate similar efficacy and safety in the treatment of Parkinson＇s disease.