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

doi:10.3877/cma.j.issn.1674-0785.2020.01.012

Abstract

Abstract:

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.

Key words: Parkinson′s disease, Extended release pramipexole, Ropinirole prolonged release, Rotigotine transdermal patch, Systematic review, Non-ergot dopamine agonist

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]. Chinese Journal of Clinicians(Electronic Edition), 2020, 14(01): 52-61.

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Figures/Tables 8

References 28

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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

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

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