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用于吉兰-巴雷综合征的血浆置换

Plasma exchange for Guillain-Barré syndrome.

作者信息

Raphaël J C, Chevret S, Hughes R A, Annane D

机构信息

Service de Réanimation Médicale, Hôpital Raymond Poincaré, Garches, France, 92380.

出版信息

Cochrane Database Syst Rev. 2002(2):CD001798. doi: 10.1002/14651858.CD001798.

Abstract

BACKGROUND

Guillain-Barré syndrome is an acute symmetric, usually ascending and usually paralysing illness, due to inflammation of peripheral nerves. It is thought to be caused by autoimmune factors, such as antibodies. Plasma exchange removes antibodies and other potentially injurious factors from the blood stream. It involves connecting the patient's blood circulation to a machine which exchanges the plasma for a substitute solution, usually albumin. Several studies have evaluated plasma exchange for Guillain-Barré syndrome.

OBJECTIVES

To systematically review the evidence concerning the efficacy of plasma exchange for treating Guillain-Barré syndrome.

SEARCH STRATEGY

Search of the Cochrane Neuromuscular Disease Trial Register for randomised trials concerning plasma exchange in Guillain-Barré syndrome, search of the bibliographies of identified papers and enquiry from the authors of the papers.

SELECTION CRITERIA

Randomised and quasi-randomised trials of plasma exchange versus sham exchange or supportive treatment.

DATA COLLECTION AND ANALYSIS

Potentially relevant papers were scrutinised by two reviewers and the selection of eligible studies was agreed by them and a third reviewer. Data were extracted by one reviewer and checked by a second reviewer. Some missing data were obtained from the authors of studies.

MAIN RESULTS

Six eligible trials concerning 649 patients were identified, all comparing plasma exchange versus supportive treatment alone. Primary outcome measures bulletTime to recover walking with aid In the only two trials for which this measure was reported, the median time to recover this ability was faster in the plasma exchange than the control group. bulletTime to onset of motor recovery in mildly affected patients In the one trial for which this measure was available, the time was significantly shortened in the plasma exchange group. Secondary outcome measures bulletImprovement in disability grade at four weeks In five trials, there were significantly more patients who had improved by one disability grade or more in the plasma exchange group as compared to the control group. Patients treated with plasma exchange fared significantly better in the following secondary outcome measures: time to recover walking without aid, percentage of patients requiring artificial ventilation, duration of ventilation, full muscle strength recovery after one year, and severe sequelae after one year. There were less patients with infectious events and cardiac arrhythmias in the plasma exchange than the control group. Subgroup analyses Plasma exchange was beneficial in patients with mild, moderate and severe (needing ventilation) Guillain-Barré syndrome. It was beneficial in patients with a disease duration of seven or less days and also in those with disease lasting more than seven days. However, in the only trial that enrolled patients up to 30 days from disease onset, the benefit of plasma exchange in patients treated after seven days was less apparent. Type of treatment Single studies showed that two plasma exchanges were significantly superior to none for mild Guillain-Barré syndrome and four to two for moderate Guillain-Barré syndrome, but that six were not superior to four for severe Guillain-Barré syndrome requiring ventilation. One study suggested that continuous flow plasma exchange was significantly superior to intermittent flow. Another study found no significant difference between the two techniques. The same study found a significantly higher rate of adverse events with fresh frozen plasma as the replacement fluid than albumin. Plasma exchange compared with cerebrospinal fluid filtration A single trial comparing these two treatments did not show any difference in outcomes but was too small to demonstrate equivalence.

REVIEWER'S CONCLUSIONS: Plasma exchange is the first and only treatment that has been proven to be superior to supportive treatment alone in Guillain-Barré syndrome. Consequently, plasma exchange should be regarded as the treatment against which new treatments, such as intravenous immunoglobulin, should be judged. In mild Guillain-Barré syndrome two sessions of plasma exchange are superior to none. In moderate Guillain-Barré syndrome four sessions are superior to two. In severe Guillain-Barré syndrome six sessions are no better than four. Continuous flow plasma exchange machines may be superior to intermittent flow machines and albumin to fresh frozen plasma as the exchange fluid. Plasma exchange is more beneficial when started within seven days after disease onset rather than later, but was still beneficial in patients treated up to 30 days after disease onset. The value of plasma exchange in children less than 12 years old is not known. There is insufficient evidence to determine whether cerebrospinal fluid filtration is equivalent to plasma exchange.

摘要

背景

吉兰 - 巴雷综合征是一种急性对称性疾病,通常呈上行性且常导致瘫痪,病因是周围神经炎症。一般认为其由自身免疫因素如抗体引起。血浆置换可从血流中清除抗体及其他潜在有害因素。该过程需将患者血液循环与一台机器相连,机器会用替代溶液(通常是白蛋白)置换血浆。已有多项研究评估血浆置换治疗吉兰 - 巴雷综合征的效果。

目的

系统评价血浆置换治疗吉兰 - 巴雷综合征疗效的相关证据。

检索策略

检索Cochrane神经肌肉疾病试验注册库中关于吉兰 - 巴雷综合征血浆置换的随机试验,检索已识别论文的参考文献并向论文作者咨询。

选择标准

血浆置换与假置换或支持治疗的随机及半随机试验。

数据收集与分析

两名评审员仔细审查潜在相关论文,他们与第三名评审员共同确定符合条件的研究。由一名评审员提取数据,另一名评审员检查。部分缺失数据从研究作者处获取。

主要结果

共识别出6项涉及649例患者的符合条件试验,均为比较血浆置换与单纯支持治疗。主要结局指标:

  • 借助辅助恢复行走的时间:在仅有的两项报告该指标的试验中,血浆置换组恢复此能力的中位时间比对照组更快。

  • 轻度受累患者运动恢复开始的时间:在有该指标的一项试验中,血浆置换组的时间显著缩短。

次要结局指标

  • 四周时残疾等级的改善:在五项试验中,与对照组相比,血浆置换组中残疾等级改善一个及以上等级的患者明显更多。接受血浆置换治疗的患者在以下次要结局指标方面表现显著更好:无需辅助恢复行走的时间、需要人工通气的患者百分比、通气持续时间、一年后肌肉力量完全恢复情况以及一年后严重后遗症情况。血浆置换组发生感染事件和心律失常的患者比对照组少。

亚组分析

血浆置换对轻度、中度和重度(需要通气)吉兰 - 巴雷综合征患者均有益。对病程七天及以内的患者和病程超过七天的患者均有益。然而,在唯一一项纳入发病30天内患者的试验中,发病七天后接受治疗的患者血浆置换的益处不太明显。治疗类型:单项研究表明,对于轻度吉兰 - 巴雷综合征,两次血浆置换显著优于不进行置换;对于中度吉兰 - 巴雷综合征,四次优于两次;但对于需要通气的重度吉兰 - 巴雷综合征,六次并不优于四次。一项研究表明,持续流动血浆置换明显优于间歇流动血浆置换。另一项研究发现两种技术无显著差异。同一研究发现,用新鲜冷冻血浆作为置换液的不良事件发生率显著高于白蛋白。

血浆置换与脑脊液滤过比较

一项比较这两种治疗方法的单项试验未显示结局有任何差异,但样本量过小无法证明等效性。

评审员结论

血浆置换是首个且唯一被证明在吉兰 - 巴雷综合征中优于单纯支持治疗的治疗方法。因此,血浆置换应被视为评判新治疗方法(如静脉注射免疫球蛋白)的对照治疗。在轻度吉兰 - 巴雷综合征中,两次血浆置换优于不进行置换。在中度吉兰 - 巴雷综合征中,四次优于两次。在重度吉兰 - 巴雷综合征中,六次并不比四次更好。持续流动血浆置换机可能优于间歇流动血浆置换机,白蛋白作为置换液可能优于新鲜冷冻血浆。发病七天内开始血浆置换比之后开始更有益,但发病30天内接受治疗的患者仍有益。血浆置换对12岁以下儿童的价值尚不清楚。尚无足够证据确定脑脊液滤过是否等同于血浆置换。

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