神经内镜与锁孔显微手术治疗早期幕上自发性脑出血的疗效及安全性观察:一项前瞻性多中心随机对照试验

Clinical efficacy and safety of neuro-endoscopic evacuation and microsurgery via keyhole approach in early spontaneous supertentorial intracerebral hemorrhage:a prospective multicenter randomized controlled trial

目的探讨神经内镜与锁孔显微手术治疗早期幕上自发性脑出血的临床疗效及安全性差异。方法采用前瞻性多中心随机对照试验设计,选择南方医科大学顺德医院神经外科、江门市中心医院神经外科、延边大学医学院附属医院神经外科自2019年1月至2021年12月收治的存在手术指征的114例幕上自发性脑出血患者(起病至手术时间<6 h)为研究对象,依据手术方式不同分为内镜组(予神经内镜下脑内血肿清除,71例)与显微镜组(予锁孔显微镜下脑内血肿清除,43例),并经1:1倾向评分匹配校正2组患者的基线资料差异后,分析2组匹配后各33例患者间手术时间、血肿清除率、术后早期再出血率、术后7d格拉斯哥昏迷量表(GCS)评分、术后6个月日常生活能力(ADL)评分、死亡率以及手术相关并发症情况的差异。结果内镜组患者的手术时间[125(102,157)mins]明显低于显微镜组[175(125,260)min],差异有统计学意义(P<0.05),但2组患者间血肿清除率[93.00%(80.88%,96.52%)vs.93.31%(88.15%,96.03%)]、术后早期再出血率(15.2%vs.9.1%)、术后7dGCS评分[13(10,15)分vs.12(8,14)分]、术后6个月ADL评分[65(45,85)分vs.55(0,85)分]、死亡率(18.2%vs.21.2%)以及术后颅内感染、获得性肺部感染发生率的差异均无统计学意义(P>0.05)。结论神经内镜较锁孔显微手术治疗早期幕上自发性脑出血可更有效缩短手术时间,但二者在临床疗效及安全性方面无明显差异。

Objective To evaluate the clinical efficacy and safety of neuro-endoscopic evacuation and microsurgery via keyhole approach in early spontaneous supertentorial intracerebral hemorrhage(ICH).Methods A prospective multi-center randomized controlled trial was performed;114 patients with spontaneous supertentorial ICH(time from onset to surgery<6 h)admitted to Departments of Neurosurgery,Shunde Hospital of Southern Medical University,Jiangmen Central Hospital,Affiliated Hospital of School of Medicine of Yanbian University from January 2019 to December 2021 and met the surgical indications were selected.They were divided into endoscopic group(evacuation of intracerebral hematoma under neuroendoscope,n=71)and microscopic group(microsurgery of intracerebral hematoma via keyhole approach,n=43)according to different surgical methods.After 1:1 propensity score matching of the general data,surgical time,hematoma clearance rate,early postoperative re-bleeding rate,Glasgow coma scale(GCS)scores 7 d after surgery,activity of daily living(ADL)scores 6 months after surgery,mortality,and surgery-related complications of 66 patients(33 from each group after matching)were compared.Results The difference of surgical time between endoscopic group and microscopic group was statistically significant(125[102,157]mins vs.175[125,260]mins,P<0.05).However,hematoma clearance rate(93.00%[80.88%,96.52%]vs.93.31%[88.15%,96.03%]),early postoperative re-bleeding rate(15.2%vs.9.1%),GCS scores 7 d after surgery(13[10,15]vs.12[8,14]),ADL scores 6 months after surgery(65[45,85]vs.55[0,85]),mortality rate(18.2%vs.21.2%)and incidences of postoperative intracranial infection and acquired pulmonary infection were not statistically significant between the two groups(P>0.05).Conclusion Comparing with microsurgery via keyhole approach,neuro-endoscopy could shorten the surgical time,but not improve the prognosis or safety in early spontaneous supertentorial ICH patients.