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脑出血的外科治疗(STICH):一项单中心随机临床试验

Surgical treatment for intracerebral hemorrhage (STICH): a single-center, randomized clinical trial.

作者信息

Morgenstern L B, Frankowski R F, Shedden P, Pasteur W, Grotta J C

机构信息

Department of Neurology, The University of Texas Medical School at Houston, 77030, USA.

出版信息

Neurology. 1998 Nov;51(5):1359-63. doi: 10.1212/wnl.51.5.1359.

DOI:10.1212/wnl.51.5.1359
PMID:9818860
Abstract

OBJECTIVE

To perform a single-center pilot investigation of early hematoma removal in patients with intracerebral hemorrhage (ICH).

BACKGROUND

Considerable debate remains regarding the utility of surgical clot evacuation for ICH.

METHODS

This was a prospective trial of open craniotomy within 12 hours of ICH symptom onset versus best medical therapy. Patients were eligible if they had a nontraumatic ICH >9 mL with significant neurologic impairment and were prepared for surgery within 12 hours of symptom onset. The study included a prospective registry of patients and a randomized trial.

RESULTS

The registry group included 34 medical and seven surgical patients. The surgical group had larger hemorrhages (median, 96 mL) and a lower Glasgow Coma Scale (GCS) score (median, 10) compared with the medical group (33 mL; GCS score, 13). Six-month mortality was less in the medical group (36%) compared with the surgical group (54%). In the randomized series, median ICH volumes were similar in the surgical group (n = 17; 49 mL) compared with the medical group (n = 17; 44 mL). Median GCS score was also similar (medical, 10; surgical, 11). Mortality was lower in the surgical group (6%) compared with the medical group (24%) at 1 month, but similar at 6 months (surgical group, 17%; medical group, 24%).

CONCLUSION

A trial of early surgery for ICH is feasible. This study represents the largest prospective, randomized series of surgery for ICH. A modest early mortality benefit for surgery is possible, but long-term benefit for surgery was not established in this single-center pilot investigation.

摘要

目的

对脑出血(ICH)患者进行早期血肿清除的单中心初步研究。

背景

关于脑出血手术清除血凝块的效用仍存在大量争议。

方法

这是一项前瞻性试验,比较脑出血症状发作12小时内开颅手术与最佳药物治疗的效果。如果患者患有非创伤性脑出血且出血量>9 mL并伴有明显神经功能障碍,且在症状发作12小时内准备好接受手术,则符合入选标准。该研究包括患者的前瞻性登记和随机试验。

结果

登记组包括34例接受药物治疗的患者和7例接受手术治疗的患者。与药物治疗组(出血量33 mL;格拉斯哥昏迷量表[GCS]评分13分)相比,手术组的出血量大(中位数为96 mL),GCS评分低(中位数为10分)。药物治疗组的6个月死亡率(36%)低于手术组(54%)。在随机分组系列中,手术组(n = 17;出血量49 mL)与药物治疗组(n = 17;出血量44 mL)的脑出血量中位数相似。GCS评分中位数也相似(药物治疗组为10分;手术组为11分)。手术组1个月时的死亡率(6%)低于药物治疗组(24%),但6个月时相似(手术组为17%;药物治疗组为24%)。

结论

脑出血早期手术试验是可行的。本研究是脑出血手术最大规模的前瞻性、随机系列研究。手术可能有适度的早期死亡率获益,但在这项单中心初步研究中未确立手术的长期获益。

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