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中华临床医师杂志(电子版) ›› 2020, Vol. 14 ›› Issue (01) : 52 -61. doi: 10.3877/cma.j.issn.1674-0785.2020.01.012

所属专题: 文献

循证医学

长效与标准非麦角类多巴胺受体激动剂治疗帕金森病的Meta分析
周长青1,(), 高唱1, 彭国光2   
  1. 1. 402760 重庆市璧山区人民医院神经内科
    2. 400016 重庆医科大学附属第一医院神经内科
  • 收稿日期:2019-02-03 出版日期:2020-01-15
  • 通信作者: 周长青

Long-acting versus standard non-ergot dopamine agonists in treatment of Parkinson′s disease: a Meta-analysis of randomized controlled trails

Changqing Zhou1,(), Chang Gao1, Guoguang Peng2   

  1. 1. Department of Neurology, People′s Hospital of Bishan District, Chongqing 402760, China
    2. Department of Neurology, the First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China
  • Received:2019-02-03 Published:2020-01-15
  • Corresponding author: Changqing Zhou
  • About author:
    Corresponding author: Zhou Changqing, Email:
引用本文:

周长青, 高唱, 彭国光. 长效与标准非麦角类多巴胺受体激动剂治疗帕金森病的Meta分析[J/OL]. 中华临床医师杂志(电子版), 2020, 14(01): 52-61.

Changqing Zhou, Chang Gao, Guoguang Peng. Long-acting versus standard non-ergot dopamine agonists in treatment of Parkinson′s disease: a Meta-analysis of randomized controlled trails[J/OL]. Chinese Journal of Clinicians(Electronic Edition), 2020, 14(01): 52-61.

目的

运用Meta分析的方法,系统评价长效非麦角类多巴胺受体激动剂(NEDA)与标准NEDA在帕金森病(PD)中的有效性、耐受性和安全性。

方法

制定检索策略后,检索PubMed,EMBASE,Cochrane图书馆和Web of Knowledge等数据库,同时进行参考文献的追溯和手工检索(截至2019年8月15日)。按照纳入标准和排除标准进行文献筛选,然后进行文献质量评价和数据提取。采用权重均数差(WMD)、相对危险度(RR)以及95%CI作为统计量,运用Cochrane协作网提供的RevMan 5.3软件和Stata 12.0对数据进行分析。

结果

(1)共纳入11个随机对照研究,共3280例患者。(2)Meta分析结果如下。有效性方面:长效NEDA与标准NEDA间在减少UPDRS Ⅱ部分评分(WMD=-0.15,95%CI:-0.63~0.33),Ⅲ部分评分(WMD=0.04,95%CI:-0.24~0.33)和UPDRS Ⅱ+Ⅲ部分总和评分(WMD=0.12,95%CI:-1.25~1.49)上差异均无统计学意义(P>0.05)。耐受性方面:两种制剂在总的退出人数(RR=1.11,95%CI:0.95~1.31)、因为不良事件退出的人数(RR=1.14,95%CI:0.90~1.45)上,差异无统计学意义(P>0.05)。安全性方面:两种制剂在总的不良事件的发生风险(RR=1.02,95%CI:0.97~1.07)和严重不良事件(RR=0.96,95%CI:0.73~1.26)的发生风险上,差异均无统计学意义(P>0.05)。

结论

对PD患者,长效NEDA与标准NEDA在有效性、耐受性和安全性上相似。

Objective

To evaluate the efficacy, tolerability, and safety of long-acting versus standard non-ergot dopamine agonists (NEDAs) in the treatment of Parkinson′s disease by performing a Meta-analysis of randomized controlled trials (RCTs).

Methods

The PubMed, EMBASE, Cochrane Library databases, and Web of Knowledge were searched up to August 15, 2019. The pooled weighted mean difference (WMD) and relative risk (RR) with 95%CI were calculated. Review Manager software version 5.3 and Stata 12.0 were used to analyze the data.

Results

Eleven large-scale RCTs, involving 3280 patients, were included in this Meta-analysis. The results of Meta-analysis showed that compared with the standard NEDAs, long-acting NEDAs exhibited similar improvements in UPDRSⅡ score (WMD=-0.15, 95% CI: -0.63-0.33), UPDRSⅢ score (WMD=0.04, 95% CI: -0.24-0.33) and UPDRSⅡ+ Ⅲ score (WMD=0.12, 95% CI: -1.25-1.49); there was no differences in overall withdrawals (RR=1.11, 95% CI: 0.95-1.31), or withdrawals due to adverse events (RR=1.14, 95% CI: 0.90-1.45) between the two formulations; and there was no differences in the risks of adverse events (RR=1.02, 95% CI: 0.97-1.07) and serious adverse event (RR=0.96, 95% CI: 0.73-1.26).

Conclusion

Our Meta-analysis shows that long-acting NEDAs are similar to standard NEDAs in efficacy, tolerability, and safety in the treatment of Parkinson′s disease.

图1 文献筛选流程图
图2 纳入研究偏倚风险
图3 长效NEDA组和标准NEDA组有效性森林图
表1 纳入研究的基本特征
研究作者及年份 试验设计 Hoehn-Yahr分级 随机比较 患者基本信息 报道指标
Giladi2007[6] 多中心,随机,双盲,对照研究(Ⅲ期) 1~3级 罗替戈汀vs.罗匹尼罗IR:215/228;治疗时间(周):37 平均年龄(岁):61/62;男性比例(%):55/60;PD病程(年):1.4/1.3 UPDRSⅡ+Ⅲ评分,退出人数,不良事件
Poewe2007[7] 多中心,随机,双盲,对照研究(Ⅲ期) 2~3级 罗替戈汀vs.普拉克索IR:204/201;治疗时间(周):23 平均年龄(岁):64/63;男性比例(%):66/56;PD病程(年):8.9/8.4 UPDRSⅡ、Ⅲ评分,关期时间,退出人数,不良事件
Stocchi2008[8] 多中心,随机,双盲,对照研究(Ⅲ期) 1~3级 罗匹尼罗PR vs.罗匹尼罗IR:70/80;治疗时间(周):12 平均年龄(岁):60/60;男性比例(%):62/52;PD病程(年):2.7/2.7 UPDRSⅡ、Ⅲ评分
Rascol2010[9] 多中心,随机,双盲,对照研究(Ⅲ期) 1~3级 普拉克索ER vs.普拉克索IR:104/52;治疗时间(周):9 平均年龄(岁):64/64;男性比例(%):55/60;PD病程(年):3.4/3.2 UPDRSⅡ、Ⅲ评分以及Ⅱ+Ⅲ评分,退出人数,不良事件
Poewe2011[10] 多中心,随机,双盲,对照研究(Ⅲ期) 1~3级 普拉克索ER vs.普拉克索IR:223/213;治疗时间(周):33 平均年龄(岁):61/62;男性比例(%):57/57;PD病程(年):1.0/1.1 UPDRSⅡ、Ⅲ评分以及Ⅱ+Ⅲ评分,退出人数,不良事件
Schapira2011[11] 多中心,随机,双盲,对照研究(Ⅲ期) 2~4级 普拉克索ER vs.普拉克索IR:165/175;治疗时间(周):18 平均年龄(岁):62/62;男性比例(%):56/56;PD病程(年):6.1/6.6 UPDRSⅡ、Ⅲ评分以及Ⅱ+Ⅲ评分,关期时间,退出人数,不良事件
Stocchi2011[12] 多中心,随机,双盲,对照研究(Ⅲ期) 2~4级 罗匹尼罗PR vs.罗匹尼罗IR:177/173;治疗时间(周):24 平均年龄(岁):65/66;男性比例(%):60/54;PD病程(年):7.9/7.5 UPDRSⅡ、Ⅲ评分,关期时间,退出人数,不良事件
Mizuno2012[13] 多中心,随机,双盲,对照研究(Ⅲ期) 2~4级 普拉克索ER vs.普拉克索IR:56/56;治疗时间(周):12 平均年龄(岁):69/66;男性比例(%):38/38;PD病程(年):2.9/3.1 UPDRSⅡ+Ⅲ评分,关期时间,退出人数,不良事件
Mizuno 2014[14] 多中心,随机,双盲,对照研究(Ⅲ期) 2~4级 罗替戈汀vs.罗匹尼罗IR:168/167;治疗时间(周):16 平均年龄(岁):65/67;男性比例(%):37/41;PD病程(年):7.0/6.8 UPDRSⅡ、Ⅲ评分以及Ⅱ+Ⅲ评分,关期时间,退出人数,不良事件
Wang 2014[15] 多中心,随机,双盲,对照研究(Ⅲ期) 2~4级 普拉克索ER vs.普拉克索IR:234/239;治疗时间(周):18 平均年龄(岁):62/62;男性比例(%):66/60;PD病程(年):5.1/4.8 UPDRSⅡ+Ⅲ评分,关期时间,退出人数,不良事件
李志霞2017[16] 单中心,对照研究(Ⅲ期) 1.5~4级 普拉克索ER vs.普拉克索IR:36/44;治疗时间(周):16 平均年龄(岁):68/67;男性比例(%):53/48;PD病程(年):3.0/3.0 UPDRSⅡ、Ⅲ评分以及Ⅱ+Ⅲ评分,关期时间,退出人数,不良事件
图4 长效NEDA组和标准NEDA组耐受性森林图
图5 长效NEDA组和标准NEDA组安全性森林图
图6 不良事件发生率
图7 发表偏移的漏斗图 图a为UPDRS II部分评分;图b为UPDRSIII部分评分;图c为总的退出人数;图d为总的不良事件
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