Rotigotine transdermal patch in Parkinson's disease: a systematic review and meta-analysis.

Rotigotine transdermal patch in Parkinson's disease: a systematic review and meta-analysis.
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DOI:
10.1371/journal.pone.0069738
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发表时间:
2013
期刊:
影响因子:
3.7
通讯作者:
Peng GG
Peng GG
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Zhou CQ;Li SS;Chen ZM;Li FQ;Lei P;Peng GG

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在一些临床试验中研究了罗替戈汀透皮贴剂治疗帕金森病(PD)的有效性和安全性。我们对随机对照试验进行了系统回顾和荟萃分析,以评估罗替戈汀透皮贴剂与安慰剂治疗PD的疗效、耐受性和安全性。本荟萃分析纳入了6项随机对照试验(1789例患者)。与安慰剂相比,使用罗替戈汀可使统一帕金森病评定量表的日常生活活动评分得到更大的改善(加权平均差[WMD]-1.69,95%置信区间[CI] -2.18至-1.19),运动评分(WMD-3.86,95% CI-4.86 ~-2.86),日常生活活动和运动功能小计评分(WMD-4.52,95% CI-5.86 ~-3.17)。罗替戈汀与因不良事件而退出研究的比率显著较高相关(相对风险[RR] 1.82,95% CI 1.29-2.59),以及更高的给药部位反应率(RR 2.92,95% CI 2.29-3.72)、呕吐(RR 5.18,95% CI 2.25-11.93)和运动障碍(RR 2.52,95% CI 1.47-4.32)。头痛、便秘、背痛、腹泻或严重不良事件的相对风险没有差异。我们的荟萃分析表明,使用罗替戈汀可以减轻PD的症状。然而,与安慰剂相比,罗替戈汀也与更高的不良事件发生率相关,特别是应用部位反应。
The efficacy and safety of rotigotine transdermal patch in Parkinson’s disease (PD) were studied in some clinical trials. We performed a systematic review and meta-analysis of randomized controlled trials to evaluate the efficacy, tolerability, and safety of rotigotine transdermal patch versus placebo in PD. Six randomized controlled trials (1789 patients) were included in this meta-analysis. As compared with placebo, the use of rotigotine resulted in greater improvements in Unified Parkinson’s Disease Rating Scale activities of daily living score (weighted mean difference [WMD] –1.69, 95% confidence interval [CI] –2.18 to –1.19), motor score (WMD –3.86, 95% CI –4.86 to –2.86), and the activities of daily living and motor subtotal score (WMD –4.52, 95% CI –5.86 to –3.17). Rotigotine was associated with a significantly higher rate of withdrawals due to adverse events (relative risk [RR] 1.82, 95% CI 1.29–2.59), and higher rates of application site reactions (RR 2.92, 95% CI 2.29–3.72), vomiting (RR 5.18, 95% CI 2.25–11.93), and dyskinesia (RR 2.52, 95% CI 1.47–4.32) compared with placebo. No differences were found in the relative risks of headache, constipation, back pain, diarrhea, or serious adverse events. Our meta-analysis showed that the use of rotigotine can reduce the symptoms of PD. However, rotigotine was also associated with a higher incidence of adverse events, especially application site reactions, compared with placebo.
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