地塞米松治療慢性硬膜下血腫可顯著降低二次手術風險
作者：
小柯機器人發布時間：2020/12/18 21:29:04
英國劍橋大學Peter J. Hutchinson團隊研究了地塞米松治療慢性硬膜下血腫的療效。2020年12月16日，該研究發表在《美國醫學會雜誌》上。
慢性硬膜下血腫是一種常見的神經系統疾病，在老年人中尤為普遍。地塞米松治療慢性硬膜下血腫患者對預後的影響尚未明確。
2015年8月至2019年11月，研究組在英國進行了一項多中心、隨機試驗，納入了748名有症狀的慢性硬膜下血腫的成年患者。將其按1：1隨機分配，其中375名接受逐漸減量的口服地塞米松治療，373名接受安慰劑治療，均為期2周。由主治醫生決定手術排空血腫。主要結局為隨機分組後6個月，改良Rankin量表為0到3分，代表預後良好。
患者的平均年齡為74歲，94%的患者在指數評估期間接受手術清除血腫；兩組中均有60%的人在入組時改良Rankin量表得分為1-3分。共680名患者進入修改後的意向性治療分析中，其中地塞米松組341例患者中有286例（83.9％）預後良好，安慰劑組339例患者中有306例（90.3％），組間差異顯著。
在可獲得數據的患者中，地塞米松組349例患者中有6例（1.7％）接受了血腫復發的二次手術，安慰劑組350例中有25例（7.1％），差異顯著。地塞米松組比安慰劑組發生更多的不良事件。
綜上，對於有症狀的慢性硬膜下血腫的成年人，大多數在入院期間接受了手術清除血腫，與安慰劑相比，地塞米松治療6個月時的不良事件更多，但重複手術風險顯著降低。
附：英文原文
Title: Trial of Dexamethasone for Chronic Subdural Hematoma
Author: Peter J. Hutchinson, Ph.D., F.R.C.S. (SN), F.Med.Sci.,, Ellie Edlmann, Ph.D., M.R.C.S.,, Diederik Bulters, B.Sc., F.R.C.S. (SN),, Ardalan Zolnourian, M.R.C.S.,, Patrick Holton, M.R.C.S.,, Nigel Suttner, F.R.C.S. (SN),, Kevin Agyemang, M.R.C.S.,, Simon Thomson, F.R.C.S. (SN),, Ian A. Anderson, F.R.C.S. (SN),, Yahia Z. Al-Tamimi, M.D., F.R.C.S. (SN),, Duncan Henderson, M.R.C.S.,, Peter C. Whitfield, Ph.D., F.R.C.S. (SN),, Monica Gherle, M.D.,, Paul M. Brennan, Ph.D., F.R.C.S. (SN),, Annabel Allison, M.Sc.,, Eric P. Thelin, Ph.D.,, Silvia Tarantino, B.Sc.,, Beatrice Pantaleo, M.Pharm.,, Karen Caldwell, B.Sc.,, Carol Davis-Wilkie, B.Sc.,, Harry Mee, M.R.C.P.,, Elizabeth A. Warburton, D.M., F.R.C.P.,, Garry Barton, Ph.D.,, Aswin Chari, M.R.C.S.,, Hani J. Marcus, Ph.D., F.R.C.S. (SN),, Andrew T. King, F.R.C.S. (SN),, Antonio Belli, M.D., F.R.C.S. (SN),, Phyo K. Myint, M.D., F.R.C.P.,, Ian Wilkinson, D.M., F.R.C.P.,, Thomas Santarius, Ph.D., F.R.C.S. (SN),, Carole Turner, M.Sc.,, Simon Bond, Ph.D.,, and Angelos G. Kolias, Ph.D., F.R.C.S. (SN)
Issue&Volume: 2020-12-16
Abstract:
Background
Chronic subdural hematoma is a common neurologic disorder that is especially prevalent among older people. The effect of dexamethasone on outcomes in patients with chronic subdural hematoma has not been well studied.
Methods
We conducted a multicenter, randomized trial in the United Kingdom that enrolled adult patients with symptomatic chronic subdural hematoma. The patients were assigned in a 1:1 ratio to receive a 2-week tapering course of oral dexamethasone, starting at 8 mg twice daily, or placebo. The decision to surgically evacuate the hematoma was made by the treating clinician. The primary outcome was a score of 0 to 3, representing a favorable outcome, on the modified Rankin scale at 6 months after randomization; scores range from 0 (no symptoms) to 6 (death).
Results
From August 2015 through November 2019, a total of 748 patients were included in the trial after randomization — 375 were assigned to the dexamethasone group and 373 to the placebo group. The mean age of the patients was 74 years, and 94% underwent surgery to evacuate their hematomas during the index admission; 60% in both groups had a score of 1 to 3 on the modified Rankin scale at admission. In a modified intention-to-treat analysis that excluded the patients who withdrew consent for participation in the trial or who were lost to follow-up, leaving a total of 680 patients, a favorable outcome was reported in 286 of 341 patients (83.9%) in the dexamethasone group and in 306 of 339 patients (90.3%) in the placebo group (difference, 6.4 percentage points [95% confidence interval, 11.4 to 1.4] in favor of the placebo group; P=0.01). Among the patients with available data, repeat surgery for recurrence of the hematoma was performed in 6 of 349 patients (1.7%) in the dexamethasone group and in 25 of 350 patients (7.1%) in the placebo group. More adverse events occurred in the dexamethasone group than in the placebo group.
Conclusions
Among adults with symptomatic chronic subdural hematoma, most of whom had undergone surgery to remove their hematomas during the index admission, treatment with dexamethasone resulted in fewer favorable outcomes and more adverse events than placebo at 6 months, but fewer repeat operations were performed in the dexamethasone group.
DOI: 10.1056/NEJMoa2020473
Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2020473