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慢性硬膜下血肿钻孔引流术后使用引流管与不使用引流管的比较:一项随机对照试验

Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial.

作者信息

Santarius Thomas, Kirkpatrick Peter J, Ganesan Dharmendra, Chia Hui Ling, Jalloh Ibrahim, Smielewski Peter, Richards Hugh K, Marcus Hani, Parker Richard A, Price Stephen J, Kirollos Ramez W, Pickard John D, Hutchinson Peter J

机构信息

Department of Neurosurgery, Addenbrooke's Hospital, University of Cambridge, Cambridge, UK.

出版信息

Lancet. 2009 Sep 26;374(9695):1067-73. doi: 10.1016/S0140-6736(09)61115-6.

Abstract

BACKGROUND

Chronic subdural haematoma causes serious morbidity and mortality. It recurs after surgical evacuation in 5-30% of patients. Drains might reduce recurrence but are not used routinely. Our aim was to investigate the effect of drains on recurrence rates and clinical outcomes.

METHODS

We did a randomised controlled trial at one UK centre between November, 2004, and November, 2007. 269 patients aged 18 years and older with a chronic subdural haematoma for burr-hole drainage were assessed for eligibility. 108 were randomly assigned by block randomisation to receive a drain inserted into the subdural space and 107 to no drain after evacuation. The primary endpoint was recurrence needing redrainage. The trial was stopped early because of a significant benefit in reduction of recurrence. Analyses were done on an intention-to-treat basis. This study is registered with the International Standard Randomised Controlled Trial Register (ISRCTN 97314294).

FINDINGS

Recurrence occurred in ten of 108 (9.3%) people with a drain, and 26 of 107 (24%) without (p=0.003; 95% CI 0.14-0.70). At 6 months mortality was nine of 105 (8.6%) and 19 of 105 (18.1%), respectively (p=0.042; 95% CI 0.1-0.99). Medical and surgical complications were much the same between the study groups.

INTERPRETATION

Use of a drain after burr-hole drainage of chronic subdural haematoma is safe and associated with reduced recurrence and mortality at 6 months.

FUNDING

Academy of Medical Sciences, Health Foundation, and NIHR Biomedical Research Centre (Neurosciences Theme).

摘要

背景

慢性硬膜下血肿会导致严重的发病率和死亡率。5%至30%的患者在手术清除血肿后会复发。引流管可能会降低复发率,但未被常规使用。我们的目的是研究引流管对复发率和临床结局的影响。

方法

2004年11月至2007年11月期间,我们在英国的一个中心进行了一项随机对照试验。对269例年龄在18岁及以上、因慢性硬膜下血肿需行钻孔引流的患者进行了资格评估。108例患者通过区组随机化被随机分配,在血肿清除后接受硬膜下腔置入引流管,107例患者不置入引流管。主要终点是需要再次引流的复发情况。由于在降低复发率方面有显著益处,该试验提前终止。分析基于意向性治疗原则进行。本研究已在国际标准随机对照试验注册库(ISRCTN 97314294)注册。

结果

置入引流管的108例患者中有10例(9.3%)复发,未置入引流管的107例患者中有26例(24%)复发(p = 0.003;95%置信区间0.14 - 0.70)。6个月时,死亡率分别为105例中有9例(8.6%)和105例中有19例(18.1%)(p = 0.042;95%置信区间0.1 - 0.99)。两个研究组的内科和外科并发症大致相同。

解读

慢性硬膜下血肿钻孔引流后使用引流管是安全的,且与6个月时复发率降低和死亡率降低相关。

资金来源

医学科学院、健康基金会和英国国家卫生研究院生物医学研究中心(神经科学主题)。

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