一种新型可编程阀治疗特发性常压脑积水:成本、疗效和安全性的前瞻性评估

Rodolfo Casimiro Reis, Renata Harumi Gobbato Yamashita, Davi Jorge Fontoura Solla, Laís Fajardo Ramin, Manoel Jacobsen Teixeira, Fernando Campos Gomes Pinto
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摘要

【摘要】目的与固定压力瓣膜相比,可编程瓣膜在治疗特发性常压脑积水(iNPH)患者中具有相同或更好的神经预后,且并发症更少。这些治疗的长期成本在文献中还没有得到适当的比较。我们试图比较使用可编程阀Sphera Pro和固定压力阀治疗1年iNPH患者的成本、疗效和安全性。材料与方法采用可编程瓣膜治疗iNPH患者的前瞻性队列与采用固定压力瓣膜治疗iNPH患者的历史队列进行比较。我们的主要终点是治疗iNPH长达1年的平均直接成本。治疗iNPH的有效性和安全性作为次要结果进行评估。统计分析比例的比较采用卡方检验或Fisher精确检验。正态分布变量的比较采用学生t检验或Mann-Whitney U检验。使用广义估计方程评估变量随时间变化的差异。所有检验均为双侧检验,α为0.05。结果每组共分析19例患者,平均年龄75岁,男性居多。两组患者的合并症和临床表现相似。随着时间的推移,固定压力和可编程瓣膜患者的神经功能均有所改善(p <0.001),但组间无差异(p = 0.104)。固定压力阀组并发症发生率高于可编程阀组(52.6% vs. 10.5%, p = 0.013)。固定压力瓣膜组每位患者的年治疗费用为3,820±2,231美元,可编程瓣膜组为3,108±553美元。可编程阀组的平均差异为712美元(95%可信区间,393 - 1805)。结论spsphera Pro带重力单元瓣膜1年治疗费用不高于固定压力瓣膜,且疗效相近,并发症少。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Treatment of Idiopathic Normal Pressure Hydrocephalus with a Novel Programmable Valve: Prospective Evaluation of Costs, Efficacy, and Safety
Abstract Objective Programmable valves provide an equal or superior neurological outcome when compared with fixed pressure ones, with fewer complications, in treating idiopathic normal pressure hydrocephalus (iNPH) patients. Long-term costs of these treatments have not been properly compared in literature. We sought to compare costs, efficacy, and safety of 1-year treatment of iNPH patients with programmable valve Sphera Pro and a fixed pressure valve. Materials and Methods A prospective cohort of iNPH patients treated with programmable valve was compared with a historical cohort of iNPH patients treated with fixed pressure valve. Our primary outcome was mean direct cost of treating iNPH up to 1 year. Efficacy in treating iNPH and safety were assessed as secondary outcomes. Statistical Analysis Proportions were compared using chi-square or Fisher's exact tests. Normally distributed variables were compared using the Student's t-test or the Mann–Whitney's U test. Differences in the evolution of the variables over time were assessed using generalized estimating equations. All tests were two-sided, with an α of 0.05. Results A total of 19 patients were analyzed in each group (mean age 75 years, the majority male). Comorbidities and clinical presentation were similar between groups. Both fixed pressure and programmable valve patients had neurological improvement over time (p < 0.001), but no difference was seen between groups (p = 0.104). The fixed pressure valve group had more complications than the programmable valve group (52.6% vs. 10.5%, respectively, p = 0.013). Annual treatment cost per patient was US$ 3,820 ± 2,231 in the fixed pressure valve group and US$ 3,108 ± 553 in the programmable valve group. Mean difference was US$712 (95% confidence interval, 393–1,805) in favor of the programmable valve group. Conclusion The Sphera Pro valve with gravitational unit had 1 year treatment cost not higher than that of fixed pressure valve, and resulted in similar efficacy and fewer complications.
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