Chen Junhui, Li Mingchang, Chen Lei, Chen Weiliang, Zhang Chunlei, Feng Yi, Wang Yuhai, Chen Qianxue
Department of Neurosurgery, Renmin Hospital of Wuhan University, Wuhan, China.
Department of Neurosurgery, Wuxi Clinical College of Anhui Medical University, 904th Hospital of Joint Logistic Support Force of PLA, Wuxi, China.
Front Neurol. 2020 Feb 18;11:107. doi: 10.3389/fneur.2020.00107. eCollection 2020.
Experimental evidence has indicated the benefits of intraoperative controlled decompression for the treatment of severe traumatic brain injury (sTBI). Intraoperative rapid decompression (conventional decompression) for the treatment of sTBI may result in intra- and post-operative complications. Controlled decompression may reduce these complications. Previous clinical trials in China have not yielded conclusive results regarding controlled decompression for sTBI. Therefore, we explored whether controlled decompression treatment decreases the rates of complications and improves the outcomes of patients with sTBI. We performed this randomized, controlled trial at our hospital. Patients with sTBI aged 18-75 years old were randomly (1:1) divided into controlled decompression surgery ( = 124) or rapid decompression surgery groups ( = 124). The primary outcome measures were the Extended Glasgow Outcome Scale (GOS-E) score at 6 months and 30-days all-cause mortality. The secondary outcomes were the incidences of intraoperative brain swelling, post-traumatic cerebral infarction, and delayed hematoma. Compared with the rapid decompression group, the controlled decompression group had reduced 30-days all-cause mortality (18.6 vs. 30.8%, = 0.035) and improved the 6-months GOS-E scores, and the difference was significant. In addition, the patients in the controlled decompression group had a lower intraoperative brain swelling rate (13.3 vs. 24.3%, = 0.036), a lower delayed hematoma rate (17.7 vs. 29.0%, = 0.048) and a relatively lower post-traumatic cerebral infarction rate (15.0 vs. 22.4%, = 0.127) than those in the rapid decompression group. Our data suggest that controlled decompression surgery significantly improves sTBI outcomes and decreases the rates of sTBI-related complications. However, this was a single-hospital study, and well-designed multicenter randomized controlled trials are needed to evaluate the effects of controlled decompression surgery for the management of patients with sTBI. Chinese Clinical Trial Registry; Date: 14/Dec/2013; Number: ChiCTR-TCC-13004002.
实验证据表明术中控制性减压治疗重度创伤性脑损伤（sTBI）具有益处。术中快速减压（传统减压）治疗sTBI可能会导致术中和术后并发症。控制性减压可能会减少这些并发症。此前中国的临床试验尚未就sTBI的控制性减压得出确凿结果。因此，我们探讨了控制性减压治疗是否能降低并发症发生率并改善sTBI患者的预后。我们在我院开展了这项随机对照试验。年龄在18至75岁的sTBI患者被随机（1:1）分为控制性减压手术组（n = 124）或快速减压手术组（n = 124）。主要结局指标为6个月时的扩展格拉斯哥预后量表（GOS-E）评分和30天全因死亡率。次要结局为术中脑肿胀、创伤后脑梗死和迟发性血肿的发生率。与快速减压组相比，控制性减压组30天全因死亡率降低（18.6%对30.8%，P = 0.035），6个月GOS-E评分改善，差异具有统计学意义。此外，控制性减压组患者术中脑肿胀发生率较低（13.3%对24.3%，P = 0.036），迟发性血肿发生率较低（17.7%对29.0%，P = 0.048），创伤后脑梗死发生率相对较低（15.0%对22.4%，P = 0.127）。我们的数据表明，控制性减压手术显著改善了sTBI的预后并降低了sTBI相关并发症的发生率。然而，这是一项单中心研究，需要设计良好的多中心随机对照试验来评估控制性减压手术治疗sTBI患者的效果。中国临床试验注册中心；日期：2013年12月14日；编号：ChiCTR-TCC-13004002。
