1 Department of Neurosurgery, Kawasaki Medical School, Okayama, Japan.
2 Department of Neurosurgery, Brain Research Institute, University of Niigata, Niigata, Japan.
J Neurotrauma. 2019 Feb 15;36(4):559-564. doi: 10.1089/neu.2018.5821. Epub 2018 Aug 10.
Over the decades, the problem of postoperative recurrence of chronic subdural hematoma (CSDH) has not been resolved. The objective of our study was to investigate whether the recurrence rate of CSDH is decreased when artificial cerebrospinal fluid (ACF) is used as irrigation solution for CSDH surgery. The present study was a multi-center, prospective, randomized, open parallel group comparison test of patients enrolled from 10 hospitals in Japan. Eligible patients with CSDH were randomly assigned to undergo burr hole drainage with either normal saline (NS) or ACF irrigation. The primary end-point was postoperative recurrence of ipsilateral CSDH. A total of 402 patients with newly diagnosed CSDH were enrolled during the study period. After applying inclusion and exclusion criteria, and taking into consideration cases lost to follow-up, our final study cohorts consisted of 177 ACF patients and 165 NS patients, representing 85.7% of the initial cohort. The overall recurrence rate was 11.4%, occurring in 39 of the 342 analyzed patients during 90 days of follow-up. Recurrence rates in the ACF and NS groups were 11.9% (21 of 177) and 10.9% (18 of 165), respectively. No significant difference was evident between groups (p = 0.87). In addition, no significant difference in time to recurrence was seen between groups (p = 0.74). No serious adverse effects related to irrigation fluid were seen in either group. Regarding the irrigation fluid for CSDH surgery, no differences in recurrence rate or time to recurrence were seen between the ACF and NS groups. However, ACF offers sufficient safety as irrigation fluid for CSDH.
数十年来，慢性硬脑膜下血肿（CSDH）术后复发的问题仍未得到解决。本研究旨在探讨人工脑脊液（ACF）作为 CSDH 手术冲洗液是否会降低 CSDH 的复发率。本研究为日本 10 家医院的多中心、前瞻性、随机、开放平行组比较试验，纳入了符合条件的 CSDH 患者，随机分为生理盐水（NS）或 ACF 冲洗的单纯钻孔引流组。主要终点为同侧 CSDH 的术后复发。在研究期间，共纳入了 402 例新诊断为 CSDH 的患者。在应用纳入和排除标准后，考虑到失访病例，我们的最终研究队列包括 177 例 ACF 患者和 165 例 NS 患者，占初始队列的 85.7%。总的复发率为 11.4%，在 90 天的随访中有 39 例（342 例分析患者中的 11.4%）出现复发。ACF 组和 NS 组的复发率分别为 11.9%（177 例中的 21 例）和 10.9%（165 例中的 18 例），两组之间无显著差异（p=0.87）。此外，两组之间复发时间也无显著差异（p=0.74）。两组均未出现与冲洗液相关的严重不良事件。对于 CSDH 手术的冲洗液，ACF 与 NS 组的复发率和复发时间无差异。然而，ACF 作为 CSDH 的冲洗液具有足够的安全性。
