Placebo-Controlled Effectiveness of Idiopathic Normal Pressure Hydrocephalus Shunting: A Randomized Pilot Trial.
Placebo-Controlled Effectiveness of Idiopathic Normal Pressure Hydrocephalus Shunting: A Randomized Pilot Trial.
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DOI：
10.1227/neu.0000000000002225
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发表时间：
2023-03-01
期刊：
影响因子：
4.8
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中科院分区：
文献类型：
--
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多项前瞻性非随机研究表明，60%至70%的特发性常压脑积水（iNPH）患者通过分流手术得到改善，但需要多中心安慰剂对照试验数据来确定其有效性。通过一项试点研究，在4个月时比较开放和安慰剂分流组，评估脑脊液分流治疗iNPH的有效性。患者被随机分配到Codman Certas Plus瓣膜（Integra LifeSciences），设置为4（开放式分流组）或8（“虚拟关闭”，安慰剂组）。治疗组与患者及评估员均为盲法。主要结局指标为10米步态速度。次要结果测量包括膀胱控制功能量表、日常生活活动、抑郁和生活质量。在4个月的评估后，立即将所有分流器以盲法调整为主动设置，并在分流后随访12个月。共有18例患者被随机分组。在4个月的评估中，开式分流术组的步态速度增加了0.28±0.28 m/s，而安慰剂组的步态速度增加了0.04±0.17 m/s。估计处理差异为0.22 m/s （[P = 0.071]， 95% CI为−0.02 ~ 0.46）。与安慰剂组相比，开放式分流术组膀胱过动症短期症状困扰问卷显著改善（P = 0.007）。4个月的治疗延迟并没有降低主动分流的后续反应，也没有增加12个月时的不良事件发生率。这项多中心、随机的试点研究证明了安慰剂对照试验在iNPH中的有效性、安全性和可行性，并发现了一种趋势，表明开式分流术组的步态速度比安慰剂组改善得更多。
Multiple prospective nonrandomized studies have shown 60% to 70% of patients with idiopathic normal pressure hydrocephalus (iNPH) improve with shunt surgery, but multicenter placebo-controlled trial data are necessary to determine its effectiveness. To evaluate the effectiveness of cerebrospinal fluid shunting in iNPH through comparison of open vs placebo shunting groups at 4 months using a pilot study. Patients were randomized to a Codman Certas Plus valve (Integra LifeSciences) set at 4 (open shunt group) or 8 (“virtual off”; placebo group). Patients and assessors were blinded to treatment group. The primary outcome measure was 10-m gait velocity. Secondary outcome measures included functional scales for bladder control, activities of daily living, depression, and quality of life. Immediately after 4-month evaluation, all shunts were adjusted in a blinded fashion to an active setting and followed to 12 months after shunting. A total of 18 patients were randomized. At the 4-month evaluation, gait velocity increased by 0.28 ± 0.28 m/s in the open shunt group vs 0.04 ± 0.17 m/s in the placebo group. The estimated treatment difference was 0.22 m/s ([P = .071], 95% CI −0.02 to 0.46). Overactive Bladder Short Form symptom bother questionnaire significantly improved in open shunt vs placebo (P = .007). The 4-month treatment delay did not reduce the subsequent response to active shunting, nor did it increase the adverse advents rate at 12 months. This multicenter, randomized pilot study demonstrates the effectiveness, safety, and feasibility of a placebo-controlled trial in iNPH, and found a trend suggesting gait velocity improves more in the open shunt group than in the placebo group.
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影响因子：
2
作者：
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通讯作者：
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影响因子：
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