Department of Biology and Pharmacy, Guangxi Key Laboratory of Agricultural Resources Chemistry and Biotechnology, Yulin Normal University, Jiaoyudong Road No. 1303, Yuzhou District, Yulin, 537000, Guangxi Zhuang Autonomous Region, China.
Department of Pharmacy, Guangdong Province Hospital of Integrated Traditional Chinese and Western Medicine, Foshan, 528200, China.
Neurol Sci. 2020 Jan;41(1):101-109. doi: 10.1007/s10072-019-04050-8. Epub 2019 Aug 24.
The aim of this report was to systematically evaluate the efficacy and safety of rasagiline (R) plus levodopa (L) (R + L) for the treatment of Parkinson's disease (PD) compared with that of L monotherapy, in order to provide a reference resource for rational drug use.
Randomized controlled trials (RCTs) of R + L for PD published up to September 2018 were searched. Sensitivity analyses were also performed.
Fourteen RCTs with 2531 participants were included. Compared with L monotherapy, the pooled effects of R + L combination therapy on unified Parkinson's disease rating scale (UPDRS) score were (SMD - 0.50, 95% CI - 0.70 to - 0.30, P < 0.00001) for UPDRS motor score, (SMD - 0.59, 95% CI - 0.79 to - 0.39, P < 0.00001) for UPDRS activities of daily living (ADL) score, (SMD - 0.65, 95% CI - 0.81 to - 0.49, P < 0.00001) for UPDRS total score. R + L combination therapy was better than L monotherapy in reducing daily off-time (SMD - 1.15, 95% CI - 2.13 to - 0.17, P = 0.02), but there was a statistically nonsignificant result in daily on-time increase (SMD 1.39, 95% CI - 0.69 to 3.48, P = 0.19). There were no statistical differences in number of adverse events (OR 1.33, 95% CI 0.97 to 1.82, P = 0.07) and number of dropout (OR 0.88, 95% CI 0.65 to 1.19, P = 0.39) between R + L combination therapy and L monotherapy.
R + L combination therapy was superior to L monotherapy for improvement of UPDRS scores and off-time in PD patients. Moreover, R + L combination therapy and L monotherapy were similar in terms of safety and tolerability.
本报告旨在系统评估雷沙吉兰(R)联合左旋多巴(L)(R+L)治疗帕金森病(PD)的疗效和安全性,与 L 单药治疗相比,为合理用药提供参考资源。
检索截至 2018 年 9 月发表的 R+L 治疗 PD 的随机对照试验(RCT)。还进行了敏感性分析。
纳入了 14 项包含 2531 名参与者的 RCT。与 L 单药治疗相比,R+L 联合治疗对统一帕金森病评定量表(UPDRS)评分的综合影响为运动评分(SMD-0.50,95%CI-0.70 至-0.30,P<0.00001),日常生活活动(ADL)评分(SMD-0.59,95%CI-0.79 至-0.39,P<0.00001),总评分(SMD-0.65,95%CI-0.81 至-0.49,P<0.00001)。R+L 联合治疗在减少每日停药时间(SMD-1.15,95%CI-2.13 至-0.17,P=0.02)方面优于 L 单药治疗,但每日增加用药时间的结果无统计学意义(SMD 1.39,95%CI 0.69 至 3.48,P=0.19)。在不良事件的发生数量(OR 1.33,95%CI 0.97 至 1.82,P=0.07)和退出数量(OR 0.88,95%CI 0.65 至 1.19,P=0.39)方面,R+L 联合治疗与 L 单药治疗之间没有统计学差异。
R+L 联合治疗在改善 PD 患者 UPDRS 评分和停药时间方面优于 L 单药治疗。此外,R+L 联合治疗和 L 单药治疗在安全性和耐受性方面相似。