Yan Junqiang, Ma Hongxia, Liu Anran, Huang Jiarui, Wu Jiannan, Yang Jianxue
Key Laboratory of Neuromolecular Biology, The First Affiliated Hospital, College of Clinical Medicine of Henan University of Science and Technology, Luoyang, China.
Department of Neurology, The First Affiliated Hospital, College of Clinical Medicine of Henan University of Science and Technology, Luoyang, China.
Front Neurol. 2021 Oct 21;12:722892. doi: 10.3389/fneur.2021.722892. eCollection 2021.
The effects of rotigotine transdermal patch (RTG) on the neuropsychiatric symptoms of Parkinson's disease (PD) outcomes remain controversial. The aim of this review was to determine the efficacy and safety of RTG on the neuropsychiatric symptoms of PD. In this systematic review and meta-analysis, PubMed, Cochrane Library, EMBASE, and Web of Science were searched for randomized controlled trials comparing RTG and placebo in PD up to May 10, 2021. We analyzed the data using Review Manager 5.2 software. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation Approach. In order to avoid false-positive results caused by random error, we use TSA software for trial sequential analysis (TSA). We included 10 studies (1,844 patients). The meta-analysis showed that, compared with placebo, RTG can significantly improve the scores for Apathy Scale (MD = -1.68, 95% confidence interval, CI: -2.74 to -0.62, = 0.002; moderate certainty), Beck Depression Inventory-II (MD = -1.19, 95% CI: -2.26 to -0.11, = 0.03; moderate certainty), the Non-Motor Symptoms Scale (MD = -3. 66, 95% CI: -4. 30 to -3.01, < 0.00001; moderate certainty), the sleep/fatigue domains of the Parkinson's Disease Non-motor Symptom Assessment Scale (MD = -2.03, 95% CI: -3.08 to -0.98, = 0.0001; moderate certainty), the mood/apathy domains of the Non-motor Symptom Scale (MD = -2.48, 95% CI: -4.07 to -0.89, = 0.002; high certainty), the eight-item Parkinson's Disease Questionnaire (MD = -4. 93, 95% CI: -6.79 to -3.07, < 0.00001; moderate certainty), and the 39-item Parkinson's Disease Questionnaire (MD = -3.52, 95% CI: -5.25 to -1.79, < 0.0001; high certainty). However, there was no statistically significant difference on the Snaith-Hamilton Pleasure Scale (MD = -0.12, 95% CI: -0.58 to 0.34, = 0.61). Our results showed that RTG exerts a positive effect on sleep. According to the TSA, the results implied that, except for the Beck Depression Inventory-II, conclusive evidence have been obtained in the RTG group. It has been proven in our meta-analysis that rotigotine has good safety and tolerability. RTG can effectively improve the neuropsychiatric symptoms, sleep quality, and quality of life in patients with PD.
罗替戈汀透皮贴剂(RTG)对帕金森病(PD)神经精神症状的疗效仍存在争议。本综述旨在确定RTG对PD神经精神症状的疗效和安全性。在这项系统评价和荟萃分析中,检索了截至2021年5月10日的PubMed、Cochrane图书馆、EMBASE和Web of Science,以查找比较RTG和安慰剂治疗PD的随机对照试验。我们使用Review Manager 5.2软件分析数据。采用推荐分级评估、制定和评价方法对证据质量进行评估。为避免随机误差导致的假阳性结果,我们使用TSA软件进行试验序贯分析(TSA)。我们纳入了10项研究(1844例患者)。荟萃分析表明,与安慰剂相比,RTG可显著改善冷漠量表评分(MD=-1.68,95%置信区间,CI:-2.74至-0.62,P=0.002;中等确定性)、贝克抑郁量表第二版(MD=-1.19,95%CI:-2.26至-0.11,P=0.03;中等确定性)、非运动症状量表(MD=-3.66,95%CI:-4.30至-3.01,P<0.00001;中等确定性)、帕金森病非运动症状评估量表的睡眠/疲劳领域(MD=-2.03,95%CI:-3.08至-0.98,P=0.0001;中等确定性)、非运动症状量表的情绪/冷漠领域(MD=-2.48,95%CI:-4.07至-0.89,P=0.002;高确定性)、帕金森病问卷8项版(MD=-4.93,95%CI:-6.79至-3.07,P<0.00001;中等确定性)以及帕金森病问卷39项版(MD=-3.52,95%CI:-5.25至-1.79,P<0.0001;高确定性)。然而,在斯奈斯-汉密尔顿快乐量表上无统计学显著差异(MD=-0.12,95%CI:-0.58至0.34,P=0.61)。我们的结果表明RTG对睡眠有积极影响。根据TSA,结果表明,除贝克抑郁量表第二版外,RTG组已获得确凿证据。我们的荟萃分析已证明罗替戈汀具有良好的安全性和耐受性。RTG可有效改善PD患者的神经精神症状、睡眠质量和生活质量。