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.
背景
慢性硬膜下血腫是一種常見的神經(jīng)系統(tǒng)疾病，尤其常見于老年人。地塞米松對(duì)慢性硬膜下血腫患者預(yù)后的影響尚未得到很好的研究。
METHODSWe 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).
方法
我們?cè)谟?guó)進(jìn)行了一項(xiàng)多中心隨機(jī)試驗(yàn)，招募了有癥狀的慢性硬膜下血腫的成年患者。這些患者按1:1的比例被分配，接受2周逐漸減量的口服地塞米松治療，開始劑量為8mg，每天兩次，或安慰劑。由主治醫(yī)師決定手術(shù)清除血腫。根據(jù)改良Rankin量表內(nèi)隨機(jī)分組后6個(gè)月，主要結(jié)果為0到3分，代表良好的結(jié)果;評(píng)分范圍從0(無癥狀)到6(死亡)。
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 groupand 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 groupand in 25 of 350 patients (7.1%) in the placebo group. More adverse events occurred in the dexamethasone group than in the placebo group.
結(jié)果
2015年8月至2019年11月，經(jīng)過隨機(jī)分組，共有748名患者被納入試驗(yàn)——375名被分配到地塞米松組，373名被分配到安慰劑組。患者的平均年齡為74歲，94%的患者在指數(shù)范圍內(nèi)入院期間接受手術(shù)清除血腫;兩組中均有60%的人在入院時(shí)的改良Rankin量表得分為1至3分。修改意向性治療分析中，排除了不同意參與試驗(yàn)或失訪病人, 留下680名患者。地塞米松組的341名患者中有286名(83.9%)，安慰劑組的339名患者中有306名(90.3%) 結(jié)果良好, (差異,?6.4個(gè)百分點(diǎn) 【95%置信區(qū)間,11.4??1.4】?jī)A向于安慰劑組;P = 0.01)。在已有資料的患者中，地塞米松組349例患者中6例(1.7%)和安慰劑組350例患者中有25例(7.1%)行血腫復(fù)發(fā)的二次手術(shù)。地塞米松組比安慰劑組發(fā)生更多的不良事件。
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.
結(jié)論
在有癥狀的慢性硬膜下血腫的成人患者中，大多數(shù)在入院時(shí)接受了血腫清除手術(shù)。和安慰劑相比，地塞米松治療在6個(gè)月后產(chǎn)生的有利結(jié)果較少，而不良事件較多，但地塞米松組行重復(fù)手術(shù)較少。
