Department of Neurology, The Second People's Hospital of Gansu Province, Lanzhou, Gansu, China.
J Neurol Sci. 2013 Jan 15;324(1-2):21-8. doi: 10.1016/j.jns.2012.08.030. Epub 2012 Oct 22.
To assess the efficacy and safety of istradefylline as an adjunct to levodopa in patients with Parkinson's Disease (PD).
In this study, we searched the Cochrane Library, MEDLINE, Embase, China Academic Journal Full-text Database (CNKI), China Biomedical Literature Database (CBM), Chinese Scientific Journals Database (VIP), and Wanfang Database. The quality of included studies was strictly evaluated. Data analyses were performed by the Cochrane Collaboration's RevMan5.0 software.
Five randomized controlled trials (RCTs) were included. The result showed a significant reduction of the awake time per day spent in the OFF state and improvement of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III in the ON state when receiving istradefylline compared with patients receiving placebo. There was no significant difference between the istradefylline 20mg and the istradefylline 40 mg groups in the UPDRS Part III in the ON state (WMD=1.27, 95% CI [-0.40, 2.95]). The results showed significant differences in dyskinesia (RR=1.63, 95% CI [1.16, 2.29]) compared to istradefylline 40 mg with placebo. There was no significant statistical difference with regard to other adverse events.
The present study showed that istradefylline is safe and effective as an adjunct to levodopa in patients with PD. Future large-scale, higher-quality, long-treatment, and placebo-controlled trials are needed.
评估伊曲茶碱作为帕金森病(PD)患者左旋多巴辅助治疗的疗效和安全性。
本研究检索了 Cochrane 图书馆、MEDLINE、Embase、中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、中国科学期刊数据库(VIP)和万方数据库。严格评价纳入研究的质量。数据分析采用 Cochrane 协作 RevMan5.0 软件进行。
纳入了 5 项随机对照试验(RCT)。结果显示,与安慰剂组相比,接受伊曲茶碱治疗的患者清醒时间明显减少,处于“ON”状态时的统一帕金森病评定量表(UPDRS)第 III 部分改善。处于“ON”状态时,伊曲茶碱 20mg 组与伊曲茶碱 40mg 组的 UPDRS 第 III 部分无显著差异(WMD=1.27,95%CI[-0.40,2.95])。与伊曲茶碱 40mg 相比,伊曲茶碱与安慰剂相比,异动症的差异有统计学意义(RR=1.63,95%CI[1.16,2.29])。其他不良反应无显著统计学差异。
本研究表明,伊曲茶碱作为左旋多巴的辅助治疗对 PD 患者是安全有效的。未来需要进行大规模、高质量、长期治疗和安慰剂对照试验。