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一项比较静脉注射免疫球蛋白与血浆置换治疗吉兰-巴雷综合征的随机试验。荷兰吉兰-巴雷研究组。

A randomized trial comparing intravenous immune globulin and plasma exchange in Guillain-Barré syndrome. Dutch Guillain-Barré Study Group.

作者信息

van der Meché F G, Schmitz P I

机构信息

Department of Neurology, Academic Hospital Rotterdam, The Netherlands.

出版信息

N Engl J Med. 1992 Apr 23;326(17):1123-9. doi: 10.1056/NEJM199204233261705.

Abstract

BACKGROUND

The subacute demyelinating polyneuropathy known as Guillain-Barré syndrome improves more rapidly with plasma exchange than with supportive care alone. We conducted a multicenter trial to determine whether intravenous immune globulin is as effective as the more complicated treatment with plasma exchange.

METHODS

To enter the study, patients had to have had Guillain-Barré syndrome for less than two weeks and had to be unable to walk independently. They were randomly assigned to receive either five plasma exchanges (each of 200 to 250 ml per kilogram of body weight) or five doses of a preparation of intravenous immune globulin (0.4 g per kilogram per day). The predefined outcome measure was improvement at four weeks by at least one grade on a seven-point scale of motor function.

RESULTS

After 150 patients had been treated, strength had improved by one grade or more in 34 percent of those treated with plasma exchange, as compared with 53 percent of those treated with immune globulin (difference, 19 percent; 95 percent confidence interval, 3 percent to 34 percent; P = 0.024). The median time to improvement by one grade was 41 days with plasma exchange and 27 days with immune globulin therapy (P = 0.05). The immune globulin group had significantly fewer complications and less need for artificial ventilation.

CONCLUSIONS

In the acute Guillain-Barré syndrome, treatment with intravenous immune globulin is at least as effective as plasma exchange and may be superior.

摘要

背景

被称为吉兰 - 巴雷综合征的亚急性脱髓鞘性多发性神经病,采用血浆置换治疗比单纯支持治疗恢复得更快。我们进行了一项多中心试验,以确定静脉注射免疫球蛋白是否与更为复杂的血浆置换治疗效果相同。

方法

要进入该研究,患者必须患有吉兰 - 巴雷综合征少于两周且无法独立行走。他们被随机分配接受五次血浆置换(每次每千克体重200至250毫升)或五剂静脉注射免疫球蛋白制剂(每天每千克体重0.4克)。预先确定的结局指标是四周时运动功能在七点量表上至少提高一个等级。

结果

在150例患者接受治疗后,血浆置换治疗的患者中有34%的人力量提高了一个等级或更多,而接受免疫球蛋白治疗的患者中这一比例为53%(差异为19%;95%置信区间为3%至34%;P = 0.024)。力量提高一个等级的中位时间,血浆置换组为41天,免疫球蛋白治疗组为27天(P = 0.05)。免疫球蛋白组的并发症明显较少,对人工通气的需求也较少。

结论

在急性吉兰 - 巴雷综合征中,静脉注射免疫球蛋白治疗至少与血浆置换一样有效,而且可能更优。

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