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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。
Objective: To investigate the efficacy and safety of two doses of 20% mannitol in patients with acute stroke and severe stroke. Methods: From March 2007 to March 2008, 54 patients with acute stroke or severe stroke (large area cerebral infarction or large volume of spontaneous intracerebral hemorrhage) were randomly divided into two groups: high dose group with 20% mannitol 250ml intravenous infusion, once / 6h, continuous medication 5d, later changed to 125ml, 1 time / 6h, continuous use 5d; low dose group with 20% mannitol 125ml intravenous infusion, 1 / 6h, once every 10d. The validity evaluation index was Glasgow coma scale (GCS) score and herniation formation rate on the 1st, 3rd, 5th, 7th and 10th days of medication, and no change or increase / no hernia formation or improvement of hernia were effective. Safety assessment indicators for adverse events. The prognostic indicators were mortality at day 7 and day 90 after onset, and modified Rankin Scale (mRS) at 90 days after onset. Results: There were 22 cases (81.5%) in the high-dose group and 23 cases (85.2%) in the low-dose group. There was no significant difference between the two groups (P> 0.05). Safety comparison: The acute renal injury of high-dose group and low-dose group were 11.1% and 3.7%, the serum electrolyte disturbance was 40.7% and 44.4% respectively, and the plasma osmolality imbalance was 29.6% and 14.8% There was no significant difference in the type and incidence of adverse reactions between the two groups (P> 0.05). Prognosis comparison: On the 7th day after the onset, the fatality rates of both groups were 18.5%. On the 90th day after onset, the mortality rate of the high-dose group was 22.2% and that of the low-dose group was 25.9%. There was no statistical difference in mortality between the two groups Significance (P> 0.05). On the 90th day after onset, the high dose group had poor prognosis (mRS score 4-6) and low dose group (77.4% vs 70.4%, respectively). There was no significant difference between the two groups in the prognosis (P> 0.05). Conclusion: A small dose of mannitol in patients with acute stroke and severe stroke may be safe and effective.