中华神经科杂志
中華神經科雜誌
중화신경과잡지
Chinese Journal of Neurology
2015年
10期
887-892
,共6页
王磊%刘金玲%韩国胜%钟池
王磊%劉金玲%韓國勝%鐘池
왕뢰%류금령%한국성%종지
不宁腿综合征%苯并噻唑类%结果可重复性%Meta分析
不寧腿綜閤徵%苯併噻唑類%結果可重複性%Meta分析
불저퇴종합정%분병새서류%결과가중복성%Meta분석
Restless legs syndrome%Benzothiazoles%Reproducibility of results%Meta-analysis
目的 系统评价普拉克索治疗不宁腿综合征(RLS)在不同人种中的有效性与安全性.方法 检索Pubmed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RevMan 5.2软件进行荟萃分析.以普拉克索组与安慰剂组在国际RLS研究组评分量表(IRLS)评分变化方面的加权均数差(WMD)和两组在临床疗效总评(CGI-I)方面疗效显著率的相对危险度(RR)为指标进行有效性评价,以其在不良事件方面的RR为指标进行安全性评价;针对每项指标再按照白色人种和黄色人种进行亚组分析.结果 共纳入6个研究.荟萃分析结果显示,普拉克索组相对于安慰剂组在IRLS评分变化方面的WMD为-4.72(Z =6.57,P<0.01);亚组分析显示白色人种亚组(WMD-4.33,Z=3.90,P<0.01)和黄色人种亚组(WMD-4.52,Z=42.28,P<0.01)在IRLS评分改善方面都明显优于安慰剂组.普拉克索组相对于安慰剂组在CGI-I显著性方面的RR =1.64(Z=10.39,P<0.叭);亚组分析显示白色人种亚组(RR=1.60,Z=4.66,P<0.01)和黄色人种亚组(RR=1.51,Z=4.42,P<0.01)在CGI-I显著性方面也都明显优于安慰剂组.普拉克索组相对于安慰剂组在不良事件方面的RR值为1.26(Z =5.11,P<0.01);亚组分析显示白色人种亚组(RR=1.26,Z=2.27,P=0.02)和黄色人种亚组(RR=1.36,Z=2.98,P=0.003)不良事件发生率较安慰剂组差异均有统计学意义.结论 普拉克索是治疗RLS有效而安全的药物,且在白色人种和黄色人种中的结论都与此相似.
目的 繫統評價普拉剋索治療不寧腿綜閤徵(RLS)在不同人種中的有效性與安全性.方法 檢索Pubmed數據庫關于普拉剋索治療RLS的隨機雙盲安慰劑對照研究.對符閤條件的研究結果用RevMan 5.2軟件進行薈萃分析.以普拉剋索組與安慰劑組在國際RLS研究組評分量錶(IRLS)評分變化方麵的加權均數差(WMD)和兩組在臨床療效總評(CGI-I)方麵療效顯著率的相對危險度(RR)為指標進行有效性評價,以其在不良事件方麵的RR為指標進行安全性評價;針對每項指標再按照白色人種和黃色人種進行亞組分析.結果 共納入6箇研究.薈萃分析結果顯示,普拉剋索組相對于安慰劑組在IRLS評分變化方麵的WMD為-4.72(Z =6.57,P<0.01);亞組分析顯示白色人種亞組(WMD-4.33,Z=3.90,P<0.01)和黃色人種亞組(WMD-4.52,Z=42.28,P<0.01)在IRLS評分改善方麵都明顯優于安慰劑組.普拉剋索組相對于安慰劑組在CGI-I顯著性方麵的RR =1.64(Z=10.39,P<0.叭);亞組分析顯示白色人種亞組(RR=1.60,Z=4.66,P<0.01)和黃色人種亞組(RR=1.51,Z=4.42,P<0.01)在CGI-I顯著性方麵也都明顯優于安慰劑組.普拉剋索組相對于安慰劑組在不良事件方麵的RR值為1.26(Z =5.11,P<0.01);亞組分析顯示白色人種亞組(RR=1.26,Z=2.27,P=0.02)和黃色人種亞組(RR=1.36,Z=2.98,P=0.003)不良事件髮生率較安慰劑組差異均有統計學意義.結論 普拉剋索是治療RLS有效而安全的藥物,且在白色人種和黃色人種中的結論都與此相似.
목적 계통평개보랍극색치료불저퇴종합정(RLS)재불동인충중적유효성여안전성.방법 검색Pubmed수거고관우보랍극색치료RLS적수궤쌍맹안위제대조연구.대부합조건적연구결과용RevMan 5.2연건진행회췌분석.이보랍극색조여안위제조재국제RLS연구조평분량표(IRLS)평분변화방면적가권균수차(WMD)화량조재림상료효총평(CGI-I)방면료효현저솔적상대위험도(RR)위지표진행유효성평개,이기재불량사건방면적RR위지표진행안전성평개;침대매항지표재안조백색인충화황색인충진행아조분석.결과 공납입6개연구.회췌분석결과현시,보랍극색조상대우안위제조재IRLS평분변화방면적WMD위-4.72(Z =6.57,P<0.01);아조분석현시백색인충아조(WMD-4.33,Z=3.90,P<0.01)화황색인충아조(WMD-4.52,Z=42.28,P<0.01)재IRLS평분개선방면도명현우우안위제조.보랍극색조상대우안위제조재CGI-I현저성방면적RR =1.64(Z=10.39,P<0.팔);아조분석현시백색인충아조(RR=1.60,Z=4.66,P<0.01)화황색인충아조(RR=1.51,Z=4.42,P<0.01)재CGI-I현저성방면야도명현우우안위제조.보랍극색조상대우안위제조재불량사건방면적RR치위1.26(Z =5.11,P<0.01);아조분석현시백색인충아조(RR=1.26,Z=2.27,P=0.02)화황색인충아조(RR=1.36,Z=2.98,P=0.003)불량사건발생솔교안위제조차이균유통계학의의.결론 보랍극색시치료RLS유효이안전적약물,차재백색인충화황색인충중적결론도여차상사.
Objective To analyze the efficacy and safety of pramipexole in treating restless legs syndrome (RLS) to different races.Methods A search for randomized,double-blind,and placebocontrolled clinical trials of pramipexole in treating RLS using Pubmed was carried out.A meta-analysis of included clinical trials was performed with Revman 5.2.The efficacy was calculated based on the change of the weighted mean difference (WMD) with International Restless Legs Syndrome Study Group rating scale (IRLS) and the relative risk (RR) of response with Clinical Global Impression-Improvement (CGI-I) scale.Safety was assessed with RR of the adverse event (AE).Subgroup analysis was conducted in the white race subgroup and the yellow race subgroup,separately.Results A total of 6 clinical trials were included in this meta-analysis.The records of patients were pooled.Overall,WMD of the change in IRLS score was-4.72 (Z =6.57,P < 0.01),which was-4.33 in white race subgroup (Z =3.90,P < 0.01) and-4.52 (Z =42.28,P <0.01) in yellow race subgroup.Overall RR of response based on CGI-I was 1.64 (Z =10.39,P <0.01),which was 1.60 (Z =4.66,P <0.01) in white race subgroup,and 1.51 (Z =4.42,P < 0.01) in yellow race subgroup.Overall RR for AE was 1.26 (Z =5.11,P < 0.01),which was 1.26 (Z =2.27,P =0.02) in white race subgroup and 1.36 (Z =2.98,P =0.003) in yellow race subgroup.Conclusion To treat RLS,pramipexole is an effective and safe drug.The results are similar for both the white race and the yellow race.