荷兰莱顿大学医学中心Niels A. van der Gaag团队比较了地塞米松与手术治疗慢性硬膜下血肿的疗效与安全性。2023年6月14日出版的《新英格兰医学杂志》发表了这项成果。

未经手术清除的糖皮质激素在治疗慢性硬膜下血肿中的作用尚不清楚。

在这项多中心、开放标签、对照、非劣效性试验中，研究组以1:1的比例将有症状的慢性硬膜下血肿患者随机分配给19天的地塞米松减量疗程或钻孔引流术。主要终点是随机化后3个月的功能预后，通过改良Rankin量表的评分进行评估（范围为0[无症状]至6[死亡]）。非劣效性定义为，地塞米松与手术组相比获得更好功能预后的优势比的95%置信区间下限为0.9及以上。次要终点包括症状严重程度的Markwalder分级量表和扩展格拉斯哥结果量表的得分。

从2016年9月到2021年2月，研究组招募了252名患者，计划样本量为420人；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预后问题，数据和安全监测委员会提前终止了该试验。

与手术相比，地塞米松治疗3个月时改良Rankin量表评分较低（较好）的校正后共同优势比为0.55（95%置信区间，0.34至0.90），这未能显示地塞米松的非劣效性。Markwalder评分量表和扩展格拉斯哥结果量表的得分通常支持初步分析的结果。地塞米松组59%的患者和手术组32%的患者出现并发症，分别有55%和6%的患者进行了额外手术。

研究结果表明，在这项涉及慢性硬膜下血肿患者并提前停止的试验中，未发现地塞米松治疗在功能预后方面不劣于钻孔引流术，并且与更多并发症和更大的后期手术可能性有关。

附：英文原文

Title: Dexamethasone versus Surgery for Chronic Subdural Hematoma

Author: Ishita P. Miah, M.D., Ph.D.,, Dana C. Holl, M.D., Ph.D.,, Jurre Blaauw, M.D.,, Hester F. Lingsma, Ph.D.,, Heleen M. den Hertog, M.D., Ph.D.,, Bram Jacobs, M.D., Ph.D.,, Nyika D. Kruyt, M.D., Ph.D.,, Joukje van der Naalt, M.D., Ph.D.,, Suzanne Polinder, Ph.D.,, Rob J.M. Groen, M.D., Ph.D.,, Kuan H. Kho, M.D.,, Fop van Kooten, M.D., Ph.D.,, Clemens M.F. Dirven, M.D., Ph.D.,, Wilco C. Peul, M.D., Ph.D.,, Korné Jellema, M.D., Ph.D.,, Ruben Dammers, M.D., Ph.D.,, and Niels A. van der Gaag, M.D., Ph.D.

Issue&Volume: 2023-06-14

Abstract:

Background

The role of glucocorticoids without surgical evacuation in the treatment of chronic subdural hematoma is unclear.

Methods

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.

Results

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.

Conclusions

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.

DOI: 10.1056/NEJMoa2216767

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2216767