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Plasma exchange for Guillain-Barré syndrome

  • Review
  • Intervention

Authors


Abstract

Background

Guillain-Barré syndrome is an acute paralysing disease caused by peripheral nerve inflammation. This is an update of a review first published in 2001 and last updated in 2008.

Objectives

To assess the effects of plasma exchange for treating Guillain-Barré syndrome.

Search methods

We searched the Cochrane Neuromuscular Disease Group Specialized Register (14 June 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (2011, Issue 2), MEDLINE (January 1966 to June 2011) and EMBASE (January 1980 to June 2011).

Selection criteria

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

Data collection and analysis

Two review authors agreed the selection of eligible studies and independently assessed the risk of bias in included studies. Data were extracted by one review author and checked by a second review author. Likewise data for adverse events were extracted by one review author and checked by a second review author.

Main results

In the first version of this review there were six eligible trials concerning 649 participants comparing plasma exchange with supportive treatment. No new eligible trials have been identified in subsequent updates. Overall the included trials had a low risk of bias.

Primary outcomes
In one trial with 220 severely affected participants, the median time to recover walking with aid was significantly faster; with plasma exchange (30 days) than without (44 days). In another trial with 91 mildly affected participants, the median time to onset of motor recovery was significantly shorter with plasma exchange (six days) than without (10 days). After four weeks, combined data from three trials accounting for a total of 349 patients showed that plasma exchanged significantly increased the proportion of patients who recovered the ability to walk with assistance (risk ratio (RR) 1.60, 95% confidence interval (CI) 1.19 to 2.15).

Secondary outcomes
In five trials with 623 participants in total, the RR of being improved by one or more grades after four weeks was 1.64 (95% CI 1.37 to 1.96) in favour of plasma exchange. Participants treated with plasma exchange also fared significantly better in time to recover walking without aid (three trials with 349 participants, RR 1.72 (95% CI 1.06 to 2.79)) and requirement for artificial ventilation (five trials with 623 participants, RR 0.53 (95% CI 0.39 to 0.74)). There were significantly more participants with relapses by the end of follow-up in the plasma exchange than the control group (6 trials with 649 participants, RR 2.89 (95% CI 1.05 to 7.93)). Despite this, at one year the likelihood of full muscle strength recovery was significantly greater with plasma exchange than without (five trials with 404 participants, RR 1.24 (95% CI 1.07 to 1.45)) and the likelihood of severe motor sequelae was significantly less (six trials with 649 patients, RR 0.65 (95% CI 0.44 to 0.96)). There was no significant difference in deaths (six trials with 649 participants, RR 0.86 (95% CI 0.45 to 1.65)) or participants with adverse events (three trials with 556 participants), except fewer arrhythmias in plasma exchange treated participants (RR 0.75 (95% CI 0.56 to 1.00)).

Authors' conclusions

Moderate-quality evidence shows significantly more improvement with plasma exchange than supportive care alone in adults with Guillain-Barré syndrome without a significant increase in serious adverse events. There was a small but significant increase in the risk of relapse during the first six to 12 months after onset in people treated with plasma exchange compared with those that were not treated. Despite this, after one year, full recovery was significantly more likely and severe residual weakness less likely with plasma exchange.

Résumé scientifique

Objectifs

Évaluer les effets de la plasmaphérèse pour traiter le syndrome de Guillain-Barré.

Stratégie de recherche documentaire

Nous avons effectué une recherche dans le registre spécialisé du Groupe Cochrane sur les maladies neuromusculaires (14 juin 2011), le registre Cochrane des essais contrôlés (CENTRAL) (2011, numéro 2), MEDLINE (de janvier 1966 à juin 2011) et EMBASE (de janvier 1980 à juin 2011).

Critères de sélection

Essais randomisés et quasi randomisés sur la plasmaphérèse par rapport à un échange fantôme ou un traitement de soutien.

Notes de traduction

Resumo

Plasmaférese para síndrome de Guillain-Barré

Introdução

A sindrome de Guillain-Barré é uma forma de paralisia aguda causada pela inflamação dos nervos periféricos. Esta é a segunda atualização de uma revisão sistemática publicada originalmente em 2001 e que já foi atualizada em 2008.

Objetivos

Avaliar os efeitos da plasmaférese no tratamento da síndrome de Guillain-Barré.

Métodos de busca

As buscas foram realizadas nas seguintes bases de dados eletrônicas: Cochrane Neuromuscular Disease Group Specialized Register (14 de junho de 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (2011, Issue 2), MEDLINE (de janeiro de 1966 a junho de 2011) e EMBASE (de janeiro de 1980 a junho de 2011).

Critério de seleção

Ensaios clínicos randomizados ou quasi-randomizados que compararam plasmaférese versus plasmaférese “simulada” ou tratamento de apoio.

Coleta dos dados e análises

Dois autores da revisão realizaram a seleção dos estudos e avaliaram de forma independente o risco de viés dos estudos incluídos. Um autor extraiu os dados e outro autor confirmou a acurácia desse processo. O mesmo foi feito para a extração dos dados sobre eventos adversos.

Principais resultados

A primeira versão desta revisão incluiu 6 ensaios clínicos envolvendo 649 pacientes; esses estudos comparavam plasmaférese versus tratamento de apoio. Não encontramos nenhum novo estudo elegível que tivesse sido publicado depois dessa primeira revisão. De forma geral, os estudos tinham baixo risco de viés.

Desfechos primários
Um estudo, envolvendo 220 pacientes gravemente acometidos, relatou que o grupo que recebeu plasmaférese teve recuperação mais rápida do que o grupo controle em relação ao tempo necessário para voltar a andar com ajuda: 30 dias versus 44 dias (medianas). Em outro estudo, envolvendo 91 pacientes com formas leves da doença, o tempo mediano para início da recuperação da função motora foi significativamente menor no grupo da plasmaférese (6 dias) do que no grupo controle (10 dias). A metanálise de três estudos, incluindo um total de 349 pacientes, mostrou que, no seguimento de 4 semanas, a plasmaférese aumentou significativamente a probabilidade de os pacientes voltarem a andar com ajuda: razão de risco (RR) 1,60, intervalo de confiança de 95% (95% CI) 1,19 a 2,15.

Desfechos secundários
A metanálise de 5 estudos envolvendo 623 pacientes mostrou que a plasmaférese aumentou significativamente a chance de melhora em um ou mais pontos ao final de 4 semanas: RR 1,64, 95% CI 1,37 a 1,96. Os pacientes tratados com plasmaférese também tiveram maior chance de voltar a andar sem ajuda (RR 1,72, 95% CI 1,06 a 2,79, 3 estudos, 349 participantes) e menor risco de necessitar de ventilação mecânica (RR 0,53. 95% CI 0,39 a 0,74, 5 estudos, 623 participantes). O número de participantes com recidiva no último seguimento foi significativamente maior no grupo que recebeu plasmaférese do que no grupo controle (RR 2,89, 95% CI 1,05 a 7,93, 6 estudos, 649 participantes). Apesar disso, na avaliação de 1 ano, a probabilidade de recuperação muscular total foi significativamente maior no grupo da plasmaférese do que no grupo controle: RR 1,24, 95% CI 1,07 a 1,45, 5 estudos, 404 participantes. Nesse mesmo tempo de seguimento, o grupo tratado com plasmaférese teve probabilidade significativamente menor de sequelas motoras graves do que o grupo controle: RR 0,65, 95% CI 0,44 a 0,96, 6 estudos, 649 pacientes. Não houve diferença significativa entre os grupos (plasmaférese versus controle) em relação à mortalidade (RR 0,86, 95% CI 0,45 a 1,65, 6 estudos, 649 participantes) ou pacientes com efeitos adversos (3 estudos, 556 participantes), exceto por menor probabilidade de arritmia no grupo tratado com plasmaférese: RR 0,75, 95% CI 0,56 a 1,00.

Conclusão dos autores

Existe evidência de qualidade moderada de que a plasmaférese, em comparação ao tratamento de apoio, ajuda na recuperação dos pacientes com síndrome de Guillain-Barré e de que essa intervenção não aumenta significativamente o risco de eventos adversos graves. Os pacientes tratados com plasmaférese tiveram um pequeno (mas significativo) aumento no risco de recidiva nos primeiros 6 a 12 meses, em comparação com os pacientes que não receberam esse tratamento. Apesar disso, após um ano de seguimento, os pacientes tratados com plasmaférese tiveram probabilidade significativamente maior de terem se recuperado completamente e probabilidade significativamente menor de terem fraqueza muscular residual grave.

Notas de tradução

Tradução do Centro Cochrane do Brasil (Maria Regina Torloni)

Plain language summary

Plasma exchange for Guillain-Barré syndrome

Guillain-Barré syndrome is a rare but serious inflammatory disease of the peripheral nerves (nerves outside the central nervous system) that causes paralysis. Many people who develop Guillain-Barré syndrome have often had a recent chest or intestine infection that may cause an allergic response in the nerves. Autoimmune factors such as antibodies are thought to cause the disease, so plasma exchange is used to treat Guillain-Barré syndrome. Plasma exchange aims to remove these antibodies from the blood stream and replace them with artificial plasma, usually albumin. This review of six randomised controlled trials with a low risk of bias involving 649 participants found that plasma exchange helps speed recovery from Guillain-Barré syndrome without causing harm apart from being followed by a slightly increased risk of relapse. No new trials have been done since the first publication of this review in 2001.

Résumé simplifié

Plasmaphérèse dans le syndrome de Guillain-Barré

Notes de traduction

எளியமொழிச் சுருக்கம்

குயில்லன்- பார்ரே நோய்க்குறியீடு ஊனீர் (plasma) பரிமாற்றம்

குயில்லன்-பார்ரே நோய்க்குறியீடு ஒரு அரிய ஆனால் வாதம் ஏற்படுத்தும் ஒரு கடுமையான புறநரம்பு (மைய நரம்பு மண்டல தவிர்த்து பிறநரம்புகள்) அழற்சி நோய். குயில்லன்-பார்ரே கூட்டறிகுறி நோய் வந்த பலர் சமீபத்திய மார்பு அல்லது குடல் தொற்று தாக்கி அது நரம்புகளில் ஒரு ஒவ்வாமை நிகழ்வை ஏற்படுத்லாம். தன்னுடல் தாக்குமை காரணிகளான பிறபொருளெதிரி காரணிகள் நோய் காரணமாக இருப்பதாக எண்ணப்படுகிறது, எனவே ஊனீர் (plasma) பரிமாற்றம் குயில்லன்- பார்ரே நோய்க்குறியீடிற்கு சிகிச்சையாக பயன்படுத்தப்படுகிறது. ஊனீர் (plasma) பரிமாற்றம் வழக்கமாக இரத்த ஓட்டத்தில் இருந்து இந்த பிறபொருளெதிரிகளை நீக்கி அதற்குப் பதிலாக பொதுவாக அல்புமின் செயற்கை ஊனீர் (plasma) முலம் தரப்படுகிறது. 649 பங்கேற்பாளர்கள் சம்பந்தப்பட்ட ஒருதலைச் சார்பு குறைந்த அபாயம் கொண்ட ஆறு சமவாய்ப்பு கட்டுப்பாட்டு சோதனைகள் ஊனீர் (plasma) பரிமாற்றம் சிகிச்சை குயில்லன்-பார்ரே கூட்டறிகுறிக்கு மறுகிளைப்பு (relapse) ஏற்படுவதற்கான ஆபத்தை சற்று அதிகரிப்பதை தவிர தீங்கு விளைவிக்காமல் மீட்சியை சற்று துரிதமாக்கும் என்று காண்பித்தது. 2001 இல் இந்த ஆய்வு வெளியீட்ட முதல் புதிய ஆராய்ச்சிகள் செய்யப்பட்டவில்லை.

மொழிபெயர்ப்பு குறிப்புகள்

மொழிபெயர்ப்பு: க.ஹரிஓம், வை. பிரகாஷ், மற்றம் சி.இ.பி.என்.அர் குழு

Laički sažetak

Plazmafereza za liječenje Guillain-Barréovog sindroma

Guillain-Barréov sindrom je rijetka, ali ozbiljna upalna bolest perifernih živaca (živaca izvan središnjeg živčanog sustava) koja uzrokuje paralizu. Mnogi ljudi koji razviju Guillain-Barreov sindrom često su nedavno imali infekciju prsišta ili crijeva koje mogu izazvati alergijsku reakciju u živcima. Smatra se da bolest izazivaju autoimuni faktori kao što su antitijela, tako da se plazmafereza koristi za liječenje Guillain-Barreovog sindroma. Plazmafereza ima za cilj uklanjanje tih antitijela iz krvi te njihovu zamjenu s umjetnom plazmom, uglavnom albuminima. Ovaj sustavni pregled šest nasumičnih kontroliranih pokusa s niskim rizikom od pristranosti uključuje 649 sudionika i potvrđuje da plazmafereza pomaže da dođe do bržeg oporavka od Guillain-Barréovog sindroma bez štetnih posljedica, osim što postoji blago povećan rizik od recidiva. Nisu rađena nova ispitivanja od prvog objavljivanja ovog pregleda u 2001. godini.

Bilješke prijevoda

Hrvatski Cochrane
Prevela: Jasna Safić
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Resumo para leigos

Plasmaférese para síndrome de Guillain-Barré

A síndrome de Guillain-Barré é uma doença rara, mas grave. Ela é causada pela inflamação dos nervos periféricos (os nervos que ficam fora do cérebro e da medula espinhal); essa inflamação leva à paralisia. Muitas pessoas que desenvolvem essa doença tiveram um episódio recente de infecção, por exemplo nos pulmões ou nos intestinos. A lesão dos nervos seria uma forma de reação alérgica de algumas pessoas aos micróbios que causaram essas infecções. Como a síndrome de Guillain-Barré poderia ser causada por anticorpos que a pessoa desenvolve contra seu próprio organismo (autoimunidade), a substituição do plasma do sangue da pessoa tem sido usada para tratar essa doença. O plasma é a parte líquida do sangue e essa substituição, feita por uma máquina, se chama plasmaférese. O objetivo da troca de plasma é eliminar da circulação esses autoanticorpos que a pessoa criou e injetar de volta no corpo dela um plasma artificial limpo, geralmente composto por albumina. A revisão sistemática encontrou seis estudos com baixo risco de viés, que envolveram 649 pacientes com a síndrome de Guillain-Barré. Os resultados indicam que a troca de plasma ajuda a acelerar a recuperação dos pacientes com síndrome de Guillain-Barré e não causa efeitos adversos graves, exceto por um risco um pouco maior de a pessoa ter recidiva da doença. Não foram feitos novos estudos desde que a revisão foi publicada pela primeira vez, em 2001.

Notas de tradução

Tradução do Centro Cochrane do Brasil (Maria Regina Torloni)

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