Saito Geisi, Zapata Rodrigo, Rivera Rodrigo, Zambrano Héctor, Rojas David, Acevedo Hernán, Ravera Franco, Mosquera John, Vásquez Juan E, Mura Jorge
Department of Anaesthesiology, Instituto de Neurocirugía Asenjo, Providencia, Santiago, Chile.
Neurosurgery Service, Hospital Regional Libertador Bernardo O'Higgins, Rancagua, Santiago, Chile.
Surg Neurol Int. 2017 Dec 27;8:304. doi: 10.4103/sni.sni_266_17. eCollection 2017.
Functional recovery after aneurysmal subarachnoid hemorrhage (SAH) remains a significant problem. We tested a novel therapeutic approach with long-chain omega-3 polyunsaturated fatty acids (n-3 PUFAs) to assess the safety and feasibility of an effectiveness trial.
We conducted a multicentre, parallel, randomized, open-label pilot trial. Patients admitted within 72 hours after SAH with modified Fisher scale scores of 3 or 4 who were selected for scheduled aneurysm clipping were allocated to receive either n-3 PUFA treatment (parenteral perioperative: 5 days; oral: 8 weeks) plus usual care or usual care alone. Exploratory outcome measures included major postoperative intracranial bleeding complications (PIBCs), cerebral infarction caused by delayed cerebral ischemia, shunt-dependent hydrocephalus, and consent rate. The computed tomography evaluator was blinded to the group assignment.
Forty-one patients were randomized, but one patient had to be excluded after allocation. Twenty patients remained for intention to treat analysis in each trial arm. No PIBs (95% confidence interval [CI]: 0.00 to 0.16) or other unexpected harm were observed in the intervention group (IG). No patient suspended the intervention due to side effects. There was a trend towards improvements in all benefit-related outcomes in the IG. The overall consent rate was 0.91 (95% CI: 0.78 to 0.96), and there was no consent withdrawal.
Although the balance between the benefit and harm of the intervention appears highly favourable, further testing on SAH patients is required. We recommend proceeding with amendments in a dose-finding trial to determine the optimal duration of parenteral treatment.
动脉瘤性蛛网膜下腔出血（SAH）后的功能恢复仍然是一个重大问题。我们测试了一种使用长链ω-3多不饱和脂肪酸（n-3多不饱和脂肪酸）的新型治疗方法，以评估有效性试验的安全性和可行性。
我们进行了一项多中心、平行、随机、开放标签的试点试验。将在SAH后72小时内入院、改良Fisher量表评分为3或4且被选进行计划动脉瘤夹闭的患者分配接受n-3多不饱和脂肪酸治疗（围手术期肠外给药：5天；口服：8周）加常规护理或仅接受常规护理。探索性结局指标包括主要术后颅内出血并发症（PIBC）、延迟性脑缺血引起的脑梗死、分流依赖性脑积水和同意率。计算机断层扫描评估者对分组情况不知情。
41例患者被随机分组，但1例患者在分配后必须排除。每个试验组有20例患者留作意向性分析。干预组（IG）未观察到PIBC（95%置信区间[CI]：0.00至0.16）或其他意外伤害。没有患者因副作用而中止干预。IG中所有与益处相关的结局都有改善的趋势。总体同意率为0.91（95%CI：0.78至0.96），且没有撤回同意。
尽管干预的利弊平衡似乎非常有利，但仍需要对SAH患者进行进一步测试。我们建议在剂量探索试验中进行修正，以确定肠外治疗的最佳持续时间。
