Burgess Sarah, Abu-Laban Riyad B, Slavik Richard S, Vu Erik N, Zed Peter J
University of British Columbia, Vancouver, BC, Canada.
University of British Columbia, Vancouver, BC, Canada VCHRI Centre for Clinical Epidemiology and Evaluation, Vancouver, BC, Canada.
Ann Pharmacother. 2016 Apr;50(4):291-300. doi: 10.1177/1060028016628893. Epub 2016 Jan 29.
To comparatively evaluate hypertonic sodium (HTS) and mannitol in patients following acute traumatic brain injury (TBI) on the outcomes of all-cause mortality, neurological disability, intracranial pressure (ICP) change from baseline, ICP treatment failure, and serious adverse events.
PubMed, EMBASE, CENTRAL, Cochrane Database of Systematic Reviews, ClinicalTrials.gov, and WHO ICTRP (World Health Organization International Clinical Trials Registry Platform) were searched (inception to November 2015) using hypertonic saline solutions, sodium chloride, mannitol, osmotic diuretic, traumatic brain injury, brain injuries, and head injury. Searches were limited to humans. Clinical practice guidelines and bibliographies were reviewed.
Prospective, randomized trials comparing HTS and mannitol in adults (≥16 years) with severe TBI (Glasgow Coma Scale score ≤8) and elevated ICP were included. ICP elevation, ICP reduction, and treatment failure were defined using study definitions.
Of 326 articles screened, 7 trials enrolling a total of 191 patients met inclusion criteria. Studies were underpowered to detect a significant difference in mortality or neurological outcomes. Due to significant heterogeneity and differences in reporting ICP change from baseline, this outcome was not meta-analyzed. No difference between HTS and mannitol was observed for mean ICP reduction; however, risk of ICP treatment failure favored HTS (risk ratio [RR] = 0.39; 95% CI = 0.18-0.81). Serious adverse events were not reported.
Based on limited data, clinically important differences in mortality, neurological outcomes, and ICP reduction were not observed between HTS or mannitol in the management of severe TBI. HTS appears to lead to fewer ICP treatment failures.
比较评估高渗钠（HTS）和甘露醇对急性创伤性脑损伤（TBI）患者全因死亡率、神经功能障碍、颅内压（ICP）相对于基线的变化、ICP治疗失败及严重不良事件等结局的影响。
检索了PubMed、EMBASE、CENTRAL、Cochrane系统评价数据库、ClinicalTrials.gov及世界卫生组织国际临床试验注册平台（WHO ICTRP）（起始至2015年11月），检索词为高渗盐溶液、氯化钠、甘露醇、渗透性利尿剂、创伤性脑损伤、脑损伤和头部损伤。检索限于人类研究。对临床实践指南和参考文献进行了回顾。
纳入前瞻性、随机试验，比较HTS和甘露醇对成人（≥16岁）重度TBI（格拉斯哥昏迷量表评分≤8）且ICP升高患者的影响。ICP升高、ICP降低及治疗失败依据研究定义进行界定。
在筛选的326篇文章中，7项试验共纳入191例患者，符合纳入标准。这些研究的样本量不足以检测出死亡率或神经功能结局方面的显著差异。由于存在显著异质性且在报告ICP相对于基线的变化方面存在差异，因此未对该结局进行荟萃分析。HTS和甘露醇在平均ICP降低方面未观察到差异；然而，ICP治疗失败的风险HTS更低（风险比[RR]=0.39；95%置信区间[CI]=0.18 - 0.81）。未报告严重不良事件。
基于有限的数据，在重度TBI的治疗中，HTS和甘露醇在死亡率、神经功能结局及ICP降低方面未观察到具有临床意义的差异。HTS似乎导致ICP治疗失败的情况更少。
