不同剂量甘露醇对急性中、重症脑卒中患者有效性和安全性研究

目的：探讨急性中、重症脑卒中患者使用2种剂量20%甘露醇治疗的有效性和安全性。方法：2007年3月至2008年3月收治的急性中、重症脑卒中（大面积脑梗死或大容积自发性脑出血）患者54例,随机分为2组：大剂量组用20%甘露醇250ml静脉滴注,1次/6h,连续用药5d,以后改为125ml,1次/6h,连续用5d;小剂量组用20%甘露醇125ml静脉滴注,1次/6h,连用10d。有效性评估指标为用药第1、3、5、7、10天格拉斯哥昏迷量表（GCS）评分和脑疝形成率,以评分无变化或增加/无脑疝形成或脑疝改善为有效。安全性评估指标为不良反应事件。预后评估指标为发病后第7天和第90天病死率,以及发病后第90天改良Rankin量表（mRS）评分。结果：大剂量组有效22例（81.5%）,小剂量组23例（85.2%）,2组比较差异无统计学意义（P〉0.05）。安全性比较：大剂量组和小剂量组的急性肾损伤分别为11.1%与3.7%,血清电解质紊乱分别为40.7%与44.4%,血浆渗透压失衡分别为29.6%与14.8%,无1例急性心力衰竭发生,2组不良反应类型和发生率比较差异均无统计学意义（P〉0.05）。预后比较：发病后第7天,2组病死率均为18.5%;发病后第90天,大剂量组病死率为22.2%,小剂量组为25.9%,2组间病死率比较差异均无统计学意义（P〉0.05）。发病后第90天,大剂量组预后不良（mRS评分4～6分）为77.8%,小剂量组为70.4%,2组预后不良比较差异亦无统计学意义（P〉0.05）。结论：小剂量甘露醇治疗急性中、重症脑卒中患者可能是安全有效的。

Efficacy and safety of different doses of mannitol for treating patients with acute moderate-to-severe stroke

Objective： To compare the efficacy and safety of two different doses of mannitol 20% for treating the patients with acute moderate-to-severe stroke. Methods： Fifty-four patients with acute moderate-to-severe stroke （massive cerebral infarction or large-volum spontaneous intracerebral hemorrhage） were randomly divided into the high-dose group （27 cases） and the low-dose group （27 cases） from march 2007 to march 2008. The patients in the high-dose group were given an IV infusion of 250 ml of mannitol 20% every 6 hours for 5 days, then changed to 125 ml of mannital 20% every 6 hours for 5 days. The patients in the low-dose group were given an IV infusion of 125 ml of mannitol 20% every 6 hours for 10 days. The efficacy was evaluated by Glasgow Coma Scale （GCS） score and the incidence of brain hernia on day 1, 3, 5, 7, and 10 of therapy. No changes or no increase in GCS scores, no brain hernia, or brain hernia improvements were regarded as effectiveness. The safety was evaluated by the type and incidence of adverse reactions. The prognosis was assessed by case fatality rates on day 7 and 90 and modified Rankin Scale （mRS） score on day 90 after stroke onset. Results： The efficacy was confirmed in 20 cases （81.5%） in the high-dose group and 23 cases （85.2%） in the low- dose group. There was no statistically significant difference between the two groups （P 〉 0.05）. In safety comparison of the high-dose group and the low-dose group, the incidences of acute renal damage, electrolyte abnormality, and osmolality disturbance were 11.1% versus 3.7%, 40.7% versus 44.4%, and 29.6% versus 14.8%, respectively. No acute heart failure was observed. There was no statistically significant difference in the type and incidence of adverse reactions between the two group （ P 〉 0.05 ）. In comparison of prognosis, on day 7 after onset, the case fatality rate was 18.5% in both groups. On day 90 after onset, the case fatality rate was 22. 2% in the high-dose group and 25.9% in the low-dose group.