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一项比较颅骨钻孔冲洗术联合与不联合引流治疗慢性硬脑膜下血肿的随机对照试验:初步报告。

A randomized controlled trial comparing the outcome of burr-hole irrigation with and without drainage in the treatment of chronic subdural hematoma: a preliminary report.

机构信息

Sina Hospital Tehran University of Medical Sciences, Tehran, Iran.

出版信息

World Neurosurg. 2011 May-Jun;75(5-6):731-6; discussion 620-3. doi: 10.1016/j.wneu.2010.11.042.

DOI:10.1016/j.wneu.2010.11.042
PMID:21704944
Abstract

BACKGROUND

Burr-hole is the most frequently used neurosurgical treatment for chronic subdural hematoma (CSDH). Few data can be found in the literature confirming the impact of using drainage after evacuation and irrigation of the cavity containing CSDH on the outcome of the patients. It is not clear whether installing such a drainage system would reduce the recurrence rate.

OBJECTIVE

The aim of this study was to compare the postoperative recurrence rates and the chance of occurrence of other possible complications between a group treated by burr-hole irrigation without drainage (BI-D) and burr hole-irrigation with drainage (BI+D).

MATERIALS AND METHODS

Forty patients experiencing CSDH were included in a randomized controlled trial conducted between June 2007 and July 2009. All underwent surgery and were analyzed in this preliminary report. Twenty patients were assigned to BI+D group and the other 20 to the BD-I group. Inclusion and exclusion criteria are defined, and the cases happened to be well matched. All the epidemiologic, clinical, radiologic, procedure-related, and outcome variables were saved in the data sheaths and analyzed by the use of SPSS v 14. The patients were followed by an independent observer, who visited the patients at 1- and 6-month intervals.

RESULTS

There were 28 male and 12 female patients (2.3:1) with the age range between 18 and 96 years (mean, 67 years; SD, 18 years). Glasgow coma scale scores varied between 9 and 15 in 37 patients and less than 9 in the other 3 patients. A history of head trauma was established in 25 patients. Limb weakness, loss of consciousness, and headache were the most common presentations. Recurrence occurred in one patient (5%) in BI+D and in none of the patients in BI-D group after 1-month follow up, without significant statistical difference (P = 0.31). At the end of 6 months there was one more recurrence (5%) in BI-D group, and the recurrence rates became equal. Both patients who experience a recurrence used antiplatelet drugs, and the one in BI-D group also had diabetes. The morbidity and mortality rates were greater in BI+D group, but these finding were not statistically significant (P = 0.37 and 0.73, respectively). There were no significant differences between the two surgical approaches regarding their relation with the recurrence of CSDH, the patient's morbidity, or mortality. The relative risk was greater for BI+D when the primary and secondary outcome measures were taken into account, but it was not significant statistically.

CONCLUSION

Type of surgical technique does not seem to be a main variable improving the outcome of such patients and may act as a confounding factor. Age, neurological status, and comorbidities seem to have more significant impact upon the surgical outcome.

摘要

背景

颅骨钻孔是治疗慢性硬脑膜下血肿(CSDH)最常用的神经外科治疗方法。文献中几乎没有数据可以证实引流在清除并冲洗含有 CSDH 的腔后对患者的结果的影响。目前尚不清楚安装这种引流系统是否会降低复发率。

目的

本研究旨在比较颅骨钻孔冲洗后不引流(BI-D)与颅骨钻孔冲洗引流(BI+D)两组患者的术后复发率和其他可能并发症的发生几率。

材料和方法

2007 年 6 月至 2009 年 7 月期间进行了一项随机对照试验,共纳入 40 例 CSDH 患者。所有患者均接受手术治疗,并在本初步报告中进行了分析。将 20 例患者分配至 BI+D 组,其余 20 例患者分配至 BI-D 组。定义了纳入和排除标准,且病例情况匹配良好。所有流行病学、临床、影像学、手术相关和结果变量均保存在数据护套中,并使用 SPSS v14 进行分析。由独立观察员对患者进行随访,随访间隔为 1 个月和 6 个月。

结果

患者中男性 28 例,女性 12 例(2.3:1),年龄 1896 岁,平均 67 岁,标准差 18 岁。37 例患者的格拉斯哥昏迷量表评分在 915 分之间,3 例患者的评分低于 9 分。25 例患者有头部外伤史。肢体无力、意识丧失和头痛是最常见的表现。BI+D 组有 1 例(5%)患者复发,BI-D 组在 1 个月随访时无一例复发,差异无统计学意义(P = 0.31)。在 6 个月时,BI-D 组又有 1 例(5%)患者复发,复发率相等。2 例复发患者均使用抗血小板药物,BI-D 组中 1 例患者还患有糖尿病。BI+D 组的发病率和死亡率较高,但差异无统计学意义(P = 0.37 和 0.73)。两种手术方法与 CSDH 的复发、患者的发病率或死亡率之间无显著差异。考虑到主要和次要结局指标,BI+D 的相对风险更大,但无统计学意义。

结论

手术方式似乎不是改善此类患者预后的主要因素,可能是混杂因素。年龄、神经状态和合并症似乎对手术结果有更大的影响。

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