摘要
目的:系统评价普拉克索添加治疗帕金森病(PD)的疗效与安全性。方法:计算机检索PubMed、EMbase、Cochrane图书馆、中国生物医学文献数据库、中国期刊全文数据库、维普数据库和万方数据库,收集普拉克索添加治疗PD的随机对照试验(RCT),采用Rev Man 5.1统计软件对纳入研究的相关数据进行Meta分析。结果:共纳入14项RCT,合计1 852例患者。Meta分析结果显示,普拉克索联合左旋多巴与多巴脱羧酶抑制药治疗PD可以显著提高患者总有效率[OR=3.45,95%CI(2.46,4.85),P<0.01],提高患者日常生活活动能力总评分(UPDRSⅡ)[MD=-1.38,95%CI(-2.05,-0.71),P<0.01]和运动检查总评分(UPDRSⅢ)[MD=-5.71,95%CI(-9.25,-2.17),P<0.01],减少患者每日服用左旋多巴的剂量[MD=-167.42,95%CI(-207.94,-126.90),P<0.01],与对照组比较,差异均有统计学意义。此外,普拉克索不增加患者恶心、呕吐、体位性低血压、眩晕和嗜睡的发生率,但可能增加异动症[OR=2.21,95%CI(1.66,2.95),P<0.01]、幻觉[OR=3.22,95%CI(2.04,5.09),P<0.01]和失眠[OR=1.52,95%CI(1.00,2.32),P=0.05]的发生率。结论:普拉克索添加治疗PD疗效显著,但部分不良反应发生率亦会增加。由于纳入研究的质量不统一,该结论需谨慎对待,尚需高质量、大样本的RCT进一步加以验证。
OBJECTIVE： To evaluate therapeutic efficacy and safety of pramipexole as adjunctive therapy for Parkinson＇s disease （PD）. METHODS： Retrived from PubMed, Cochrane Library, EMbase, CBM, CNKI, VIP and Wanfang database, RCTs about pramipexole as adjuctive therapy in the treatment of PD were collected. Rev Man 5.1 software was applied for data analysis. RESULTS： A total of 14 RCTs were included, involving 1 852 patients. Meta-analysis of all studies showed that parmipexole combined with levodopa and Dopa decarboxylase inhibitor could improve total effective rate [OR：3.45, 95% CI（2.46, 4.85）, P〈 0.01], improve the scores of daily living ability [MD=-1.38, 95%CI（-2.05,--0.71）, P〈0.01] and the score of motor function [MD=-5.71,95%CI（-9.25,-2.17）, P〈0.01] as well as reduce daily dose of levodopa [MD=- 167.42, 95%CI（-207.94, -126.90）, P〈0.01]. There was no statistical significance difference between it and levodopa and Dopa decarboxylase inhibitor alone. The incidence of nausea, vomiting, hypotension postural, dizziness and somnolence had no change after parmipexole therapy, but pramipexole might increase the incidence of dyskinesia [OR=2.21, 95%CI（1.66, 2.95）, P〈0.01], hallucination [OR= 3.22, 95%CI（2.04,5.09）, P〈0.01] and insomnia [OR=1.52, 95%CI（1.00,2.32）, P=0.05]. CONCLUSIONS： Clinical efficacy of promipexole as adjunctive therapy is markedly better than levodopa alone in the treatment of PD, but some adverse events induced by pramipexole is higher than control group. However, the results of this systematic review should be considered carefully for the limitation of included studies. High quality large-scale RCTs are required for further validation.
出处
《中国药房》
CAS
CSCD
2013年第44期4163-4167,共5页
China Pharmacy
关键词
普拉克索
左旋多巴
帕金森病
随机对照试验
系统评价
Pramipexole
Levodopa
Parkinson＇ s disease
Randomized control trial
Systematic review
作者简介
药师，硕士研究生。研究方向：临床药学。电话：010．88325989。E-mail：sixia2012@126．com
通信作者：主任药师。研究方向：医院药学、临床药学。电话：010—88325750。E—mail：fengwanyu2000@yahoo．com．cn
