背景:正常压力脑积水(NPH)发生在脑室扩张时,导致三合会的步态,认知,和泌尿障碍。它可以发生在明确的脑损伤后,如外伤,但也可以在没有明确原因的情况下发生(称为特发性,或iNPH)。非随机研究表明,在iNPH中,通过脑脊液(CSF)分流手术将心室液转移到较低压力区域的益处,但从历史上看,证实这一点的随机对照试验(RCT)数据有限.
目的:确定iNPH患者的CSF分流与无CSF分流的效果以及iNPH患者的CSF分流不良反应的频率。
方法:我们搜索了Cochrane痴呆和认知改善组的登记册,Cochrane中央对照试验登记册(中央),MEDLINE(OvidSP),Embase(OvidSP),PsycINFO(OvidSP),CINAHL(EBSCOhost),WebofScience核心合集(Clarivate),LILACS(BIREME),ClinicalTrials.gov,和世界卫生组织国际临床试验注册平台于2023年2月15日。
方法:我们只纳入了有步态症状的患者的随机对照试验,认知,或伴有交通性脑积水(Evans指数>0.3)和脑脊液压力正常的尿液损害。对照组包括没有CSF分流的患者或处于“非活动”模式的CSF分流患者。
方法:我们使用标准Cochrane方法学程序。如有必要,我们联系了研究作者,要求他们提供论文中未提供的数据.我们使用GRADE评估了证据的总体确定性。
结果:我们包括四个RCT,其中三个被合并在荟萃分析中。四个RCT包括140名参与者(73名立即进行CSF分流,67名延迟进行CSF分流的对照),平均年龄为75岁。除步态速度外,所有平行组结果的偏倚风险均较低,认知功能(一般认知和符号数字测试)(一些问题)和不良事件,没有盲目评估。CSF分流可能在术后不到六个月时改善步态速度(标准化平均差(SMD)0.62,95%置信区间(CI)0.24至0.99;3项研究,116名参与者;中等确定性证据)。CSF分流可能会在手术后不到六个月时通过不确定的量改善定性步态功能(1项研究,88名参与者;低确定性证据)。CSF分流可能导致术后不到六个月的残疾大幅减少(风险比2.08,95%CI1.31至3.31;3项研究,118名参与者;中等确定性证据)。关于CSF分流手术后不到六个月时CSF分流对认知功能的影响的证据非常不确定(SMD0.35,95%CI-0.04至0.74;2项研究,104名参与者;非常低的确定性证据)。关于CSF分流手术对不良事件的影响的证据也非常不确定(1项研究,88名参与者;非常低的确定性证据)。没有关于脑脊液分流对生活质量影响的数据。
结论:我们发现中度确定性证据表明,CSF分流可能在短期内改善iNPH的步态速度和残疾。关于认知和不良事件的证据非常不确定。我们没有任何预设结果的长期RCT数据。需要更多的研究来提高这些发现的确定性。此外,需要更多有关患者种族和CSF分流对生活质量的影响的信息.
BACKGROUND: Normal pressure hydrocephalus (NPH) occurs when the brain ventricles expand, causing a triad of gait, cognitive, and urinary impairment. It can occur after a clear brain injury such as trauma, but can also occur without a clear cause (termed idiopathic, or iNPH). Non-randomised studies have shown a benefit from surgically diverting ventricular fluid to an area of lower pressure by cerebrospinal fluid (CSF)-shunting in iNPH, but historically there have been limited randomised controlled trial (RCT) data to confirm this.
OBJECTIVE: To determine the effect of CSF-shunting versus no CSF-shunting in people with iNPH and the frequency of adverse effects of CSF-shunting in iNPH.
METHODS: We searched the Cochrane Dementia and Cognitive Improvement Group\'s register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost), Web of Science Core Collection (Clarivate), LILACS (BIREME), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform on 15 February 2023.
METHODS: We included only RCTs of people who had symptoms of gait, cognitive, or urinary impairment with communicating hydrocephalus (Evans index of > 0.3) and normal CSF pressure. Control groups included those with no CSF shunts or those with CSF shunts that were in \'inactive\' mode.
METHODS: We used standard Cochrane methodological procedures. Where necessary, we contacted study authors requesting data not provided in the papers. We assessed the overall certainty of the evidence using GRADE.
RESULTS: We included four RCTs, of which three were combined in a meta-analysis. The four RCTs included 140 participants (73 with immediate CSF-shunting and 67 controls who had delayed CSF-shunting) with an average age of 75 years. Risk of bias was low in all parallel-group outcomes evaluated apart from gait speed, cognitive function (general cognition and Symbol Digit Test) (some concerns) and adverse events, which were not blind-assessed. CSF-shunting probably improves gait speed at less than six months post-surgery (standardised mean difference (SMD) 0.62, 95% confidence interval (CI) 0.24 to 0.99; 3 studies, 116 participants; moderate-certainty evidence). CSF-shunting may improve qualitative gait function at less than six months post-surgery by an uncertain amount (1 study, 88 participants; low-certainty evidence). CSF-shunting probably results in a large reduction of disability at less than six months post-surgery (risk ratio 2.08, 95% CI 1.31 to 3.31; 3 studies, 118 participants; moderate-certainty evidence). The evidence is very uncertain about the effect of CSF-shunting on cognitive function at less than six months post-CSF-shunt surgery (SMD 0.35, 95% CI -0.04 to 0.74; 2 studies, 104 participants; very low-certainty evidence). The evidence is also very uncertain about the effect of CSF-shunt surgery on adverse events (1 study, 88 participants; very low-certainty evidence). There were no data regarding the effect of CSF-shunting on quality of life.
CONCLUSIONS: We found moderate-certainty evidence that CSF-shunting likely improves gait speed and disability in iNPH in the relative short term. The evidence is very uncertain regarding cognition and adverse events. There were no longer-term RCT data for any of our prespecified outcomes. More studies are required to improve the certainty of these findings. In addition, more information is required regarding patient ethnicity and the effect of CSF-shunting on quality of life.