摘要
目的系统评价普拉克索治疗不宁腿综合征（restless legs syndrome，RLS）的疗效与安全性。方法检索中国期刊全文数据库（CNKI）、美国国立医学生物信息中心PubMed数据库（PubMed）、荷兰医学文摘数据库（Embase）、Cochrane Library数据库关于普拉克索治疗RLS的随机、双盲、安慰剂对照研究。对符合条件的研究结果用RevMan5．0软件进行Meta分析。以普拉克索组和安慰剂组在国际不宁腿研究组评分量表（InternationalRLSStudyGroupratingscale，IRLS）评分变化方面的加权均数差（weighted mean difference，WMD）和普拉克索组相对于安慰剂组在临床疗效总评（clinical global impression—improvement，CGI—I）方面疗效显著率的相对危险度（relative risk，RR）为指标进行疗效评价，以其在不良事件方面的相对危险度为指标进行安全性评价。结果共纳入5项研究，1776例患者被随机分配，其中普拉克索组945例，安慰剂组831例。Meta分析结果显示，普拉克索组相对于安慰剂组在IRLS评分变化方面的WMD=-6．34（Z=12．76，P〈0．01），在CGI-I显著性评估方面的RR=1．65（Z=10．39，P〈0．01）；两组在不良事件方面的RR=1．14（Z=1．87，P=0．06）。结论普拉克索是治疗RLS的有效且安全的药物。
Objective To evaluate the efficacy and safety of pramipexole in treating restless legs syndrome （RLS）. Methods A search for randomized, double-blind, and placebo-controlled clinical trials of pramipexole in treating moderate to severe RLS using CNKI, PubMed, Embase and Coehrane Library database was carried out. A meta-analysis of included clinical trials was performed with RevMan 5.0 software. The 2 outcomes that the weighted mean difference（WMD） of change from baseline in International RLS Study Group rating scale（IRLS） score and the relative risk （RR） of response based on the Clinical Global Impression-Improvement （CGI-I） scale score were calculated for efficacy. Safety was assessed with RR of the adverse event （AE）. Results A total of 5 clinical trials were included in this meta-analysis, of which 1776 patients were randomly assigned （945 on pramipexole, 831 on placebo）. The records of patients were pooled. Overall WMD were - 6. 34 （ Z = 12. 76, P 〈 0. 01 ） for the change from baseline in IRLS score, and RR of response based on CGI-I were 1.65 （Z = 10.39, P 〈 0.01） .The overall RR of pramipexole versus placebo were 1.14 （ Z = 1.87, P = 0.06 ） for AE. Conclusion To treat RLS, pramipexole is an effective and safe drug.
出处
《中华神经科杂志》
CAS
CSCD
北大核心
2012年第3期182-187,共6页
Chinese Journal of Neurology
