Department of Neurology, Affiliated Hospital of Guilin Medical University, China.
Medicine (Baltimore). 2021 Nov 19;100(46):e27653. doi: 10.1097/MD.0000000000027653.
It is necessary to conduct a meta-analysis of the clinical randomized controlled trials (RCTs) on ropinirole in the treatment of Parkinson disease (PD), to explore the effects and safety of ropinirole, and to provide a theoretical basis for clinically safe and rational drug use.
RCTs on the effectiveness and safety of ropinirole in the treatment of PD were searched. We searched Dutch medical literature database, Pubmed, Cochrane Library, China National Knowledge Infrastructure, Wanfang Knowledge Service Platform up to December 15, 2020. The Cochrane risk bias assessment tool was used to evaluate the quality of the included literature, and the RevMan5.3 software was used for meta-analysis.
A total of 12 RCTs with 3341 patients were included. The changes of Parkinson Disease Rating Scale Part II score (mean difference = -2.23, 95% confidence interval [CI] -2.82 to -1.64) and Parkinson Disease Rating Scale Part III scores (mean difference = -4.93, 95%CI -5.25 to -4.61) in the ropinirole group was significantly lower than that in the control group. The incidence of dizziness (odd risk [OR] = 1.85, 95%CI 1.50-2.28), nausea (OR = 2.17, 95%CI 1.81-2.59), vomiting (OR = 2.73, 95%CI 1.47-5.09), and lethargy (OR = 2.19, 95%CI 1.39-3.44) in the ropinirole group was significantly higher than that in the control group (all P < .05), and there were no significant differences in the incidence of headache (OR = 1.14, 95%CI 0.79-1.65) and insomnia (OR = 1.06, 95%CI 0.72-1.55) were found between 2 groups (all P > .05).
Ropinirole can help improve the ability of daily living and exercise function of PD patients, but it will increase the incidence of related adverse reactions, which needs to be further confirmed by subsequent large-scale, high-quality RCTs.
有必要对罗匹尼罗治疗帕金森病的临床随机对照试验(RCT)进行荟萃分析,以探讨罗匹尼罗的疗效和安全性,为临床安全合理用药提供理论依据。
检索罗匹尼罗治疗帕金森病有效性和安全性的 RCT。检索荷兰医学文献数据库、Pubmed、Cochrane Library、中国知网、万方知识服务平台,检索时限截至 2020 年 12 月 15 日。采用 Cochrane 偏倚风险评估工具评价纳入文献质量,采用 RevMan5.3 软件进行荟萃分析。
共纳入 12 项 RCT 共计 3341 例患者。罗匹尼罗组帕金森病评定量表第Ⅱ部分评分(均数差=-2.23,95%置信区间[CI]为-2.82 至-1.64)和帕金森病评定量表第Ⅲ部分评分(均数差=-4.93,95%CI 为-5.25 至-4.61)的变化均显著低于对照组。罗匹尼罗组头晕(比值比[OR]=1.85,95%CI 为 1.50 至 2.28)、恶心(OR=2.17,95%CI 为 1.81 至 2.59)、呕吐(OR=2.73,95%CI 为 1.47 至 5.09)、乏力(OR=2.19,95%CI 为 1.39 至 3.44)的发生率均显著高于对照组(均 P<0.05),而头痛(OR=1.14,95%CI 为 0.79 至 1.65)和失眠(OR=1.06,95%CI 为 0.72 至 1.55)的发生率在两组间差异无统计学意义(均 P>0.05)。
罗匹尼罗可改善帕金森病患者日常生活能力和运动功能,但会增加相关不良反应的发生率,尚需后续开展更大样本、高质量的 RCT 进一步验证。