Department of Neurology, Qingdao Municipal Hospital, Nanjing Medical University, Nanjing, China.
Department of Neurology, Qingdao Municipal Hospital, Nanjing Medical University, Nanjing, China Department of Neurology, Qingdao Municipal Hospital, School of Medicine, Qingdao University, Qingdao, China Department of Neurology, Qingdao Municipal Hospital, College of Medicine and Pharmaceutics, Ocean University of China, Qingdao, China.
J Neurol Neurosurg Psychiatry. 2015 Feb;86(2):135-43. doi: 10.1136/jnnp-2014-307659. Epub 2014 May 14.
Recently, several large randomised controlled trials about the treatments of cognitive impairment or dementia due to Parkinson's disease (CIND-PD or PDD) and dementia with Lewy bodies (DLB) were completed. Here, we systematically reviewed the studies (including the recent reports) to provide updated evidence for the treatments of CIND-PD, PDD and DLB.
We searched Cochrane Dementia and Cognitive Improvement Group Specialised Register, Pubmed, Embase, and other sources for eligible trials. We selected global impression and cognitive function as primary efficacy outcomes, and dropouts and adverse events as safety outcomes. Furthermore, Meta-analysis and trial sequential analysis (TSA) were used here.
Ten trials were included in this study. Cholinesterase inhibitors and memantine produced small global efficacy on clinicians' global impression of change (CGIC), from a weighted mean difference of -0.40 (95% CI -0.77 to -0.03) to -0.65 (95% CI -1.28 to -0.01); however, cholinesterase inhibitors but not memantine significantly improved cognition on Mini-Mental State Examination (MMSE), from 1.04 (95% CI 0.43 to 1.65) to 2.57 (95% CI 0.90 to 4.23). Additionally, both of them had good safety outcomes, although rivastigmine showed an increased risk on adverse events than placebo (risk ratio, RR 1.19, TSA adjusted 95% CI 1.04 to 1.36), these events were usually mild or moderate, and the risk disappeared on serious adverse events.
Cholinesterase inhibitors and memantine slightly improve global impression; however, only cholinesterase inhibitors enhance cognitive function. Besides, all the drugs have good safety outcomes. But the limited trials precluded the generalisation of these outcomes.
最近，几项关于帕金森病认知障碍或痴呆（CIND-PD 或 PDD）和路易体痴呆（DLB）治疗的大型随机对照试验已经完成。在这里，我们系统地回顾了这些研究（包括最近的报告），为 CIND-PD、PDD 和 DLB 的治疗提供了更新的证据。
我们在 Cochrane 痴呆和认知改善组专业注册库、PubMed、Embase 和其他来源中搜索了合格的试验。我们选择总体印象和认知功能作为主要疗效结局，失访和不良事件作为安全性结局。此外，还使用了 Meta 分析和试验序贯分析（TSA）。
本研究纳入了 10 项试验。胆碱酯酶抑制剂和美金刚对临床医生总体印象变化（CGIC）的总体疗效产生了较小的影响，从加权均数差-0.40（95%置信区间-0.77 至-0.03）到-0.65（95%置信区间-1.28 至-0.01）；然而，只有胆碱酯酶抑制剂而非美金刚显著改善了简易精神状态检查（MMSE）的认知，从 1.04（95%置信区间 0.43 至 1.65）到 2.57（95%置信区间 0.90 至 4.23）。此外，它们都有良好的安全性结局，尽管加兰他敏的不良事件风险高于安慰剂（风险比，RR 1.19，TSA 调整的 95%置信区间 1.04 至 1.36），但这些事件通常是轻度或中度的，且在严重不良事件中风险消失。
胆碱酯酶抑制剂和美金刚可轻度改善总体印象；然而，只有胆碱酯酶抑制剂能增强认知功能。此外，所有药物都有良好的安全性结局。但是，有限的试验限制了这些结果的推广。
