罗替戈汀透皮贴剂治疗帕金森病疗效及安全性系统评价

Efficacy and safety of rotigotine transdermal patch for Parkinson’s disease：a systematic review

摘要:

目的：运用Meta分析的方法，系统评价罗替戈汀透皮贴剂在帕金森病（Parkinson’s disease，PD）中的有效性、耐受性和安全性。方法：系统地检索PubMed，Cochrane图书馆，EMBASE和Web of Knowledge等数据库有关罗替戈汀透皮贴剂治疗PD的随机对照试验，采用Rev Man 5.1软件对数据进行分析。结果：（1）共纳入7个随机对照研究，1 969例患者。（2）Meta分析结果显示：①有效性：罗替戈汀透皮贴剂在减少统一帕金森病评估量表Ⅱ部分评分（WMD=-1.69，95%CI=-2.18 to -1.19，P=0.000）和Ⅲ部分评分（WMD=-3.86，95%CI=-4.86 to -2.86，P=0.000）上均优于安慰剂。②耐受性：罗替戈汀透皮贴剂较安慰剂不增加患者总的退出风险（RR=0.88，95%CI=0.64～1.21，P=0.44），但增加患者因为不良事件退出的风险（RR=1.82，95%CI=1.29~2.59，P=0.000）。③安全性：罗替戈汀透皮贴剂较安慰剂增加局部皮肤反应（RR=2.77，95%CI=2.23~3.43，P=0.000）、呕吐（RR=6.15，95%CI=2.88～13.13，P=0.000）及异动症（RR=2.52，95%CI=1.47～4.32，P=0.000）的发生风险。结论：罗替戈汀透皮贴剂能有效的控制PD患者的症状，但也增加了局部皮肤反应等不良事件的发生风险。

Abstract:

Objective：To evaluate the efficacy，tolerability，and safety of rotigotine transdermal patch in Parkinson’s disease. Methods：The PubMed，Cochrane Library databases，EMBASE，and Web of Knowledge were searched for the randomized clinical trial（RCT） of rotigotine transdermal patch in Parkinson’s disease. RevMan 5.1 software was used to analyze the data. Results：（1） Seven large-scale RCTs，involving 1 969 patients were included in this meta-analysis. （2）The results showed：①Efficacy：compared with placebo，the use of rotigotine resulted in greater improvement in UPDRS Ⅱ score（WMD=-1.69，95%CI=-2.18 to -1.19，P=0.000） and Ⅲ score（WMD=-3.86，95%CI=-4.86 to -2.86，P=0.000）. ②Tolerability：no difference was found in overall withdrawals（RR=0.88，95%CI=0.64 to 1.21，P=0.44），but rotigotine was associated with a significantly higher rate of withdrawals due to adverse events（RR=1.82，95%CI=1.29 to 2.59，P=0.000）. ③Safety：rotigotine was associated with a significantly higher rate of application site reactions（RR=2.77，95%CI=2.23 to 3.43，P=0.000），vomiting（RR=6.15，95%CI=2.88 to 13.13，P=0.000），and dyskinesia（RR=2.52，95%CI=1.47 to 4.32，P=0.000） compared with placebo. Conclusion：The use of rotigotine can reduce the symptoms of PD. However，rotigotine is also associated with a higher incidence of adverse events，especially application site reactions.