本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(24)00686-X

摘要内容如下：

背景

慢性硬膜下血肿是一种常见的外科治疗的颅内急症。钻孔引流术用于清除慢性硬膜下血肿，包括三个要素：建立钻孔通路、冲洗硬膜下腔和插入硬膜下引流管。虽然硬膜下引流已被证实是有益的，但硬膜下冲洗的治疗效果尚未得到解决。

方法

FINISH试验是一项由研究者发起的、实用的、多中心的、全国性的、随机的、对照的、平行组的、非劣效性试验，在芬兰的五个神经外科单位进行，纳入了年龄在18岁或以上的需要钻孔引流的慢性硬膜下血肿患者。通过计算机生成的区块随机化将患者随机分配（1:1），区块大小为4、6或8，按部位分层，进行钻孔引流，伴或不伴硬膜下冲洗。除神经外科医生和手术室工作人员外，所有患者和工作人员均不接受治疗。两组均在血肿厚度最大的部位钻一个钻孔，在插入硬膜下引流管前冲洗或不冲洗硬膜下腔，引流管保留在原位48小时。术后6个月记录再次手术、功能结果、死亡率和不良事件。主要结果是6个月内的再手术率。非劣效性界值设定为7.5%。得出非劣效性结论所需的关键次要结果是具有不利功能结果的参与者比例（即改良Rankin量表评分为4-6，其中0表示无症状，6表示死亡）和6个月时的死亡率。在意向治疗人群和符合方案人群中进行了主要分析和关键次要分析。该试验已在ClinicalTrials.gov（NCT04203550）注册并完成。

调查结果

从2020年1月1日至2022年8月17日，我们评估了1644名患者的资格，589名（36%）患者被随机分配到治疗组并接受治疗（294名患者被分配到有冲洗的排液组，295名患者被分配到无冲洗的排液组；女性165人[28%]，男性424人[72%]）。6个月的随访期延长至2023年2月14日。在意向性治疗分析中，295名参与者中有54名（18.3%）需要再次手术，而294名参与者中有37名（12.6%）需要再次手术，前者被指定为不接受冲洗组，后者被指定为接受冲洗组（差异为6.0个百分点，95%CI 0.2-11.7；P=0.30；根据研究地点调整）。改良Rankin量表评分为4-6分的患者比例在两组间无显著差异（非灌洗组283人中有37人[13.1%]，灌洗组285人中有36人[12.6%]；P=0.89）或死亡率（非灌洗组18例[6.1%]，灌洗组21例[7.1%]；P=0.58）。主要意向治疗分析的结果在符合方案分析中未发生实质性改变。组间不良事件的数量无显著差异，最常见的严重不良事件是全身感染（295名未接受灌洗的受试者中有26名[8.8%]，294名接受灌洗的受试者中有22名[7.5%]）、颅内出血（13名[4.4%]，7名[2.4%]）、癫痫发作（5例[1.7%]vs 9例[3.1%]）。

解释

我们不能断定钻孔引流而不冲洗的非劣效性。钻孔引流术后无硬膜下冲洗的再手术率比硬膜下冲洗的再手术率高6.0个百分点。考虑到两组之间的功能结果或死亡率没有差异，该试验倾向于使用硬膜下冲洗。

英文原文如下：

Abstracts

BACKGROUND  Chronic subdural haematoma is a common surgically treated intracranial emergency. Burr-hole drainage surgery, to evacuate chronic subdural haematoma, involves three elements: creation of a burr hole for access, irrigation of the subdural space, and insertion of a subdural drain. Although the subdural drain has been established as beneficial, the therapeutic effect of subdural irrigation has not been addressed.

METHODS  The FINISH trial was an investigator-initiated, pragmatic, multicentre, nationwide, randomised, controlled, parallel-group, non-inferiority trial in five neurosurgical units in Finland that enrolled adults aged 18 years or older with a chronic subdural haematoma requiring burr-hole drainage. Patients were randomly assigned (1:1) by computer-generated block randomisation with block sizes of four, six, or eight, stratified by site, to burr-hole drainage either with or without subdural irrigation. All patients and staff were masked to treatment assignment apart from the neurosurgeon and operating room staff. A burr hole was drilled at the site of maximum haematoma thickness in both groups, and the subdural space was either irrigated or not irrigated before inserting a subdural drain, which remained in place for 48 h. Reoperations, functional outcome, mortality, and adverse events were recorded for 6 months after surgery. The primary outcome was the reoperation rate within 6 months. The non-inferiority margin was set at 7·5%. Key secondary outcomes that were also required to conclude non-inferiority were the proportion of participants with unfavourable functional outcomes (ie, modified Rankin Scale score of 4-6, where 0 indicates no symptoms and 6 indicates death) and mortality rate at 6 months. The primary and key secondary analyses were done in both the intention-to-treat and per-protocol populations. The trial was registered with ClinicalTrials.gov (NCT04203550) and is completed.

FINDINGS  From Jan 1, 2020, to Aug 17, 2022, we assessed 1644 patients for eligibility and 589 (36%) patients were randomly assigned to a treatment group and treated (294 assigned to drainage with irrigation and 295 assigned to drainage without irrigation; 165 [28%] women and 424 [72%] men). The 6-month follow-up period extended until Feb 14, 2023. In the intention-to-treat analysis, 54 (18·3%) of 295 participants required reoperation in the group assigned to receive no irrigation versus 37 (12·6%) of 294 in the group assigned to receive irrigation (difference of 6·0 percentage points, 95% CI 0·2-11·7; p=0·30; adjusted for study site). There were no significant between-group differences in the proportion of people with modified Rankin Scale score of 4-6 (37 [13·1%] of 283 in the no-irrigation group vs 36 [12·6%] of 285 in the irrigation group; p=0·89) or mortality rate (18 [6·1%] of 295 in the no-irrigation group vs 21 [7·1%] of 294 in the irrigation group; p=0·58). The findings of the primary intention-to-treat analysis were not materially altered in the per-protocol analysis. There were no significant between-group differences in the number of adverse events, and the most frequent severe adverse events were systemic infections (26 [8·8%] of 295 participants who did not receive irrigation vs 22 [7·5%] of 294 participants who received irrigation), intracranial haemorrhage (13 [4·4%] vs seven [2·4%]), and epileptic seizures (five [1·7%] vs nine [3·1%]).

INTERPRETATION  We could not conclude non-inferiority of burr-hole drainage without irrigation. The reoperation rate was 6·0 percentage points higher after burr-hole drainage without subdural irrigation than with subdural irrigation. Considering that there were no differences in functional outcome or mortality between the groups, the trial favours the use of subdural irrigation.

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