恩他卡朋治疗帕金森病的多中心_随机_双盲_安慰剂对照临床研究

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1、·406·中华神经科杂志2003年12月第36卷第6期ChinJNeurol,December2003,Vol36,No.6·论著·恩他卡朋治疗帕金森病的多中心、随机、双盲、安慰剂对照临床研究张振馨李辉罗毅蒋雨平陈生弟陈海波孙斌温洪波王坚翁中方王新德【摘要】目的研究恩他卡朋作为左旋多巴的辅助药物治疗帕金森病患者剂末现象的疗效和安全性。方法帕金森病伴剂末现象患者209例的12周、多中心、随机、双盲、安慰剂、平行分组对照临床试验。根据患者日记记录的“开”和“关”期时间、统一帕金森病评定量表(UPDRS)各部分评分、研究者总体评估变化量表和左旋多巴每日剂量评定疗效。结果恩他卡朋治疗12周时

2、意向性治疗(ITT)人群“开”的时间自基线的(714±118)h/d延长至(911±215)h/d“;关”的时间自基线的(618±212)h/d缩短至(512±218)h/d;UPDRS2Ⅲ平均得分自基线的3617±1113减少至3010±1414;左旋多巴每日剂量(mg/d)自基线的58912±26413减少至4周的56115±24811;总体评估变化量表检查显示6919%的医生主观感觉到病情好转。与安慰剂组相比差异均有显著意义。常见的不良事件是多巴胺能反应,但是与安慰剂组相比差异均无显著意义。结论恩他卡朋是有效而安全的治疗帕金森病伴剂末现象的辅助药物。【关键词】帕金森病;儿茶酚类

3、;临床试验Arandomized,placebo2controlled,double2blind,parallel2grouptrialofentacaponeinpatientswith3fluctuatingParkinson’sdiseaseZHANGZhen2xin,LIHui,LUOYi,JIANGYu2ping,CHENSheng2di,CHENHai2bo,SUNBin,WENHong2bo,WANGJian,WENGZhong2fang,WANGXin2de13DepartmentofNeurologyandDepartmentofClinicalEpidemiolo

4、gy,PekingUnionMedicalCollegeHospital,ChineseAcademyofMedicalScience,Beijing100730,China【Abstract】ObjectiveTostudytheefficacyandsafetyofentacaponeasanadjuncttolevodopatreatmentinpakinsonianpatientswithwearing2offmotorfluctuations1MethodsAtotal209pakinsonianpatientswithend2of2dosedeteriorationpar

5、ticipatedinamulti2center,122weeksrandomized,placebo2controlled,doubleblind,parallel2grouptrial1Theefficacyofentacaponewasassessedusingthepatient’sdiarycard,theUnifiedParkinson’sDiseaseRatingScale(UODRS)score,thedailylevodopadosage,andtheglobalassessmentofchanges1Results9612%oftheentacaponeand92

6、14%oftheplacebo2treatedpatientscompletedthestudy1In209casesoftheITTpopulation,incomparisontotheplacebo2treatedpatients,entacaponehadincreasedthemean“on”time(h/d)from714±118inbase2lineto911±215inweek12,decreasedthe“fof”time(from618±212inbase2lineto512±218inweek12),improvedthemotorscores(from3617

7、±1113inbase2lineto3010±1414inweek12),andreducedthelevodopadose(from58912±26413inbase2lineto56115±24811inweek4)1Theimprovementwasalsoevidentonimpressionofsuccessfultreatmentfor6919%ofneurologiststhroughglobalchangeassessment1Therew