From the Department of Neurology, Amphia Hospital, Breda (I.P.M.), the Departments of Neurology (I.P.M., N.D.K.) and Neurosurgery (W.C.P., N.A.G.), Leiden University Medical Center, Leiden, the Departments of Neurology (I.P.M., K.J.) and Neurosurgery (W.C.P., N.A.G.), Haaglanden Medical Center, and the Department of Neurosurgery, Haga Teaching Hospital (W.C.P., N.A.G.), the Hague, the Stroke Center (D.C.H., F.K., C.M.F.D., R.D.) and the Departments of Neurosurgery (D.C.H., C.M.F.D., R.D.), Public Health (D.C.H., J.B., H.F.L., S.P.), and Neurology (F.K.), Erasmus Medical Center, Rotterdam, the Departments of Neurology (J.B., B.J., J.N.) and Neurosurgery (R.J.M.G.), University of Groningen, University Medical Center Groningen, Groningen, the Department of Neurology, Isala, Zwolle (H.M.H.), and the Department of Neurosurgery, Medisch Spectrum Twente, and the Clinical Neurophysiology Group, University of Twente, Enschede (K.H.K.) - all in the Netherlands.
N Engl J Med. 2023 Jun 15;388(24):2230-2240. doi: 10.1056/NEJMoa2216767.
The role of glucocorticoids without surgical evacuation in the treatment of chronic subdural hematoma is unclear.
In this multicenter, open-label, controlled, noninferiority trial, we randomly assigned symptomatic patients with chronic subdural hematoma in a 1:1 ratio to a 19-day tapering course of dexamethasone or to burr-hole drainage. The primary end point was the functional outcome at 3 months after randomization, as assessed by the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]). Noninferiority was defined by a lower limit of the 95% confidence interval of the odds ratio for a better functional outcome with dexamethasone than with surgery of 0.9 or more. Secondary end points included scores on the Markwalder Grading Scale of symptom severity and on the Extended Glasgow Outcome Scale.
From September 2016 through February 2021, we enrolled 252 patients of a planned sample size of 420; 127 were assigned to the dexamethasone group and 125 to the surgery group. The mean age of the patients was 74 years, and 77% were men. The trial was terminated early by the data and safety monitoring board owing to safety and outcome concerns in the dexamethasone group. The adjusted common odds ratio for a lower (better) score on the modified Rankin scale at 3 months with dexamethasone than with surgery was 0.55 (95% confidence interval, 0.34 to 0.90), which failed to show noninferiority of dexamethasone. The scores on the Markwalder Grading Scale and Extended Glasgow Outcome Scale were generally supportive of the results of the primary analysis. Complications occurred in 59% of the patients in the dexamethasone group and 32% of those in the surgery group, and additional surgery was performed in 55% and 6%, respectively.
In a trial that involved patients with chronic subdural hematoma and that was stopped early, dexamethasone treatment was not found to be noninferior to burr-hole drainage with respect to functional outcomes and was associated with more complications and a greater likelihood of later surgery. (Funded by the Netherlands Organization for Health Research and Development and others; DECSA EudraCT number, 2015-001563-39.).
在慢性硬脑膜下血肿的治疗中，不进行手术清除而单纯使用糖皮质激素的作用尚不清楚。
在这项多中心、开放标签、对照、非劣效性试验中，我们将症状性慢性硬脑膜下血肿患者按 1:1 的比例随机分配，接受为期 19 天的地塞米松逐渐减量疗程或颅骨钻孔引流。主要终点是随机分组后 3 个月时的功能结局，采用改良 Rankin 量表评分（范围：0 [无症状]至 6 [死亡]）评估。非劣效性定义为地塞米松治疗的功能结局优于手术的优势比的 95%置信区间下限大于或等于 0.9。次要终点包括症状严重程度的 Markwalder 分级量表评分和扩展格拉斯哥结局量表评分。
2016 年 9 月至 2021 年 2 月，我们纳入了计划样本量为 420 例患者中的 252 例；其中 127 例被分配至地塞米松组，125 例被分配至手术组。患者的平均年龄为 74 岁，77%为男性。由于地塞米松组的安全性和结局问题，数据和安全监测委员会提前终止了试验。在 3 个月时，地塞米松治疗的改良 Rankin 量表评分较低（更好）的调整常见比值比为 0.55（95%置信区间：0.34 至 0.90），未能显示地塞米松具有非劣效性。Markwalder 分级量表和扩展格拉斯哥结局量表的评分总体上支持主要分析结果。地塞米松组有 59%的患者出现并发症，手术组有 32%的患者出现并发症，分别有 55%和 6%的患者需要进一步手术。
在一项涉及慢性硬脑膜下血肿患者且提前终止的试验中，地塞米松治疗在功能结局方面并不劣于颅骨钻孔引流，且与更多并发症和更有可能进行后续手术相关。（由荷兰卫生研究与发展组织和其他组织资助；DECSA EudraCT 编号：2015-001563-39。）
