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

       慢性硬膜下血肿是一种常见的神经系统疾病，尤其常见于老年人。地塞米松对慢性硬膜下血肿患者预后的影响尚未得到很好的研究。

    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).

方法

       我们在英国进行了一项多中心随机试验，招募了有症状的慢性硬膜下血肿的成年患者。这些患者按1:1的比例被分配，接受2周逐渐减量的口服地塞米松治疗，开始剂量为8mg，每天两次，或安慰剂。由主治医师决定手术清除血肿。根据改良Rankin量表内随机分组后6个月，主要结果为0到3分，代表良好的结果;评分范围从0(无症状)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.

结果

       2015年8月至2019年11月，经过随机分组，共有748名患者被纳入试验——375名被分配到地塞米松组，373名被分配到安慰剂组。患者的平均年龄为74岁，94%的患者在指数范围内入院期间接受手术清除血肿;两组中均有60%的人在入院时的改良Rankin量表得分为1至3分。修改意向性治疗分析中，排除了不同意参与试验或失访病人, 留下680名患者。地塞米松组的341名患者中有286名(83.9%)，安慰剂组的339名患者中有306名(90.3%) 结果良好, (差异,−6.4个百分点 【95%置信区间,11.4−−1.4】倾向于安慰剂组;P = 0.01)。在已有资料的患者中，地塞米松组349例患者中6例(1.7%)和安慰剂组350例患者中有25例(7.1%)行血肿复发的二次手术。地塞米松组比安慰剂组发生更多的不良事件。

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.

结论

       在有症状的慢性硬膜下血肿的成人患者中，大多数在入院时接受了血肿清除手术。和安慰剂相比，地塞米松治疗在6个月后产生的有利结果较少，而不良事件较多，但地塞米松组行重复手术较少。