司来吉兰治疗帕金森病的有效性与安全性的系统评价

Effectiveness and safety of selegiline in the treatment of Parkinson's disease:A systematic review

目的:采用Meta分析的方法系统评价司来吉兰治疗帕金森病(Parkinson’s disease,PD)的有效性与安全性。方法:计算机检索英文数据库:MEDLINE、EMbase、CENTRAL和中文数据库:WanFang,CNKI、VIP,查找司来吉兰治疗PD的随机对照试验,检索时限截至2013年2月。由2位研究者根据纳入与排除标准独立筛选文献、提取资料并评价质量后,采用RevMan5.2.0软件进行Meta分析。结果:最终纳入20个RCT,其中英文文献17篇,中文文献3篇。结果显示司来吉兰在治疗PD后的死亡率与对照组相比虽然降低,但差异没有统计学意义[RR=1.06,95%CI(0.80,1.41),P=0.70].单用司来吉兰治疗PD[SMD=-0.46,95%CI(-0.74,-0.18),P=0.001]或者作为辅助治疗合用司来吉兰治疗PD[SMD=-2.72,95%CI(-7.29,1.85),P=0.24]与对照组相比都能改善患者的UPDRS总评分,且差异都有统计学意义。单用[SMD=-0.18,95%CI(-0.46,0.11),P=0.22]或者作为辅助治疗合用司来吉兰[SMD=-0.24,95%CI(-0.43,-0.05),P=0.01]与对照组相比都能改善UPDRS日常生活能力评分,作为辅助治疗合用较单用好.单用[SMD=-0.29,95%CI(-0.74,0.15),P=0.20]或者作为辅助治疗合用司来吉兰[SMD=-0.34,95%CI(-0.52,-0.17),P=0.000 1]与对照组相比都能改善UPDRS运动评分和运动功能,且作为辅助治疗合用优于单用,差异有统计学意义。司来吉兰的不良反应发生率低,主要集中在神经系统、消化系统、循环系统、内分泌系统等。结论:司来吉兰治疗PD时,应个体化给药,大多数患者对司来吉兰的耐受较好,但仍有少数患者出现不良反应,司来吉兰与对照组相比不能延长PD患者的长期生存率,但可以改善PD患者的UPDRS评分,应根据患者的病情状况等实施个体化给药以有效控制PD。

OBJECTIVE To evaluate the effectiveness and safety of selegiline in the treatment of Parkinson＇s disease （PD）. METHODS Random controlled trails of selegiline for PD were gathered from MEDLINE, EMbase, CENTRAL, CNKI, VIP and WanFang. We screened the retrieved studies according to the inclusion and exclusion criteria, evaluated the quality of ineluded studies, then performed Meta-analyses with The Cochrane Collaboration＇s Revman 5.2. 0 software. RESULTS Twenty randomized controlled trials of selegiline in the treatment of PD were included. Eight studies reported the mortality between selegiline and placebo, according to the Meta-analysis results： the mortality was no significant difference between the two groups（P = 0. 7）. The symptom control was significant difference, the mean change in UPDRS motor score and the development of motor fluctuations was also significant difference between the two groups. Selegiline as adjunct （P = 0. 0001） was better than selegiline as monotherapy （P = 0. 2） therapy in PD. CONCLUSION In the treatment of PD, selegiline is effective. Therefore, an individualized regimen should be applied according to patients＇ tolerance and economic status.