Departments of 1 Neurosurgery and.
Translational Centre for Regenerative Medicine, University of Leipzig.
J Neurosurg. 2017 Dec;127(6):1376-1383. doi: 10.3171/2016.8.JNS16626. Epub 2017 Feb 24.
OBJECTIVE In clinical routines, neuroprotective strategies in neurosurgical interventions are still missing. A pilot study (n = 30) and an analogously performed Phase III trial (n = 112) pointed to a beneficial effect of prophylactic nimodipine and hydroxyethyl starch (HES) in vestibular schwannoma (VS) surgery. Considering the small sample size, the data from both studies were pooled. METHODS The patients in both investigator-initiated studies were assigned to 2 groups. The treatment group (n = 70) received parenteral nimodipine (1-2 mg/hour) and HES (hematocrit 30%-35%) from the day before surgery until the 7th postoperative day. The control group (n = 72) was not treated prophylactically. Facial and cochlear nerve functions were documented preoperatively, during the inpatient care, and 1 year after surgery. RESULTS Pooled raw data were analyzed retrospectively. Intent-to-treat analysis revealed a significantly lower risk for hearing loss (Class D) 12 months after surgery in the treatment group compared with the control group (OR 0.46, 95% CI 0.22-0.97; p = 0.04). After exclusion of patients with preoperative Class D hearing, this effect was more pronounced (OR 0.38, 95% CI 0.17-0.83; p = 0.016). Logistic regression analysis adjusted for tumor size showed a 4 times lower risk for hearing loss in the treatment group compared with the control group (OR 0.25, 95% CI 0.09-0.63; p = 0.003). Facial nerve function was not significantly improved with treatment. Apart from dose-dependent hypotension (p < 0.001), the study medication was well tolerated. CONCLUSIONS Prophylactic nimodipine is safe and may be recommended in VS surgery to preserve hearing. Prophylactic neuroprotective treatment in surgeries in which nerves are at risk seems to be a novel and promising concept. Clinical trial registration no.: DRKS 00000328 ( https://drks-neu.uniklinik-freiburg.de/drks_web/ ).
在临床常规中，神经外科干预措施中的神经保护策略仍然缺失。一项试点研究（n=30）和一项类似的 III 期试验（n=112）表明，预防性尼莫地平联合羟乙基淀粉（HES）在听神经瘤（VS）手术中具有有益作用。考虑到样本量较小，将两项研究的数据进行了汇总。方法：两项研究者发起的研究中的患者被分为 2 组。治疗组（n=70）在术前 1 天至术后第 7 天接受静脉内尼莫地平（1-2mg/h）和 HES（血细胞比容 30%-35%）治疗。对照组（n=72）未接受预防性治疗。术前、住院期间和术后 1 年记录面神经和耳蜗神经功能。结果：回顾性分析汇总原始数据。意向治疗分析显示，治疗组术后 12 个月听力损失（D 级）的风险显著低于对照组（OR 0.46，95%CI 0.22-0.97；p=0.04）。排除术前 D 级听力患者后，这种效果更加明显（OR 0.38，95%CI 0.17-0.83；p=0.016）。调整肿瘤大小的 logistic 回归分析显示，治疗组听力损失的风险比对照组低 4 倍（OR 0.25，95%CI 0.09-0.63；p=0.003）。治疗对面神经功能无明显改善。除了剂量依赖性低血压（p<0.001）外，研究药物的耐受性良好。结论：预防性尼莫地平是安全的，可在 VS 手术中推荐用于保护听力。预防性神经保护治疗在神经风险手术中似乎是一种新颖且有前途的概念。临床试验注册号：DRKS00000328（https://drks-neu.uniklinik-freiburg.de/drks_web/）。
