Reações adversas à imunoglobulina humana endovenosa no tratamento de pacientes com imunodeficiência primária
Adverse reactions to intravenous human immunoglubulin for the treatment of patients with primary immunodeficiency
Danielli C. Bichuetti-Silva; Fernanda P. Furlan; Fernanda A. Nobre; Camila T. M. Pereira; Tessa R. T. Gonçalves; Mariana Gouveia-Pereira; Rafael Rota; Juliana T. L. Mazzucchelli; Beatriz T. Costa-Carvalho
Resumo
Objetivos: Avaliar a incidência e gravidade das reações adversas à infusão de imunoglobulina endovenosa (IgEV) em pacientes com imunodeficiência primária (IDP) e identificar fatores de risco associados. Métodos: Estudo prospectivo das infusões ocorridas no período de agosto/2011 a junho/2012 em centro de referência para atendimento de pacientes com IDP. Foi realizada análise descritiva e não paramétrica (teste do qui-quadrado) através do software Minitab 16®. O valor de p < 0,05 foi considerado significante. Resultados: Um total de 741 infusões de IgEV foram realizadas em 93 pacientes, sendo 34% mulheres e 66% homens. A faixa etária variou de 6 meses a 77 anos, e os pacientes foram divididos em 3 grupos: < 10 anos (33,3%); 10–18 anos (21,5%); >18 anos (12,9%). A maioria foi representada por pacientes com deficiências humorais (70,9%). As marcas de IgEV utilizadas foram: Octagam® (31,6%), Flebogama® (28%), Tegeline® (27,2%), Imunoglobulin® (8,6%), Vigam® (2,6%), e Kiovig® (0,9%). A incidência de reações foi 2,8%, ocorrendo em 21 infusões, (IC95% 1,6–4,0%), sendo 86% de intensidade leve/moderada. O grupo com maior incidência de reações adversas foi o de pacientes < 10 anos. Não houve diferença significante (p = 0,743) entre os que receberam IgEV com ou sem processo infeccioso agudo. Quanto às reações adversas, 81,2% (13) ocorreram em infusões com velocidade ≤ 4 mg/kg/ min, e 18,8% no grupo com velocidade acima desta; não houve diferença significante entre os grupos (p=0.21). O uso de Tegeline® quando comparado ao uso de outras preparações de IgEV representou fator de risco significante para reação (p=0,002). Conclusão: IgEV mostrou ser uma droga segura, com baixa incidência de reações adversas, sendo a maioria não graves.
Palavras-chave
Abstract
Objectives: To assess the incidence and severity of adverse events (AE) to intravenous immunoglobulin (IVIg) infusion in patients with pprimary iimmunodeficiency (PID), and to identify associated risk factors. Methods: All infusion records issued from August 2011 to June 2012 at a referral center for patients with PID were prospectively assessed for AE using a descriptive, non-parametric approach (chi-square test). The Minitab 16 software was used for all analyses; significance was set at p<0.05. Results: Ninety-three patients received 741 infusions; 34% were female and 66% male. Age ranged from 6 months to 77 years and was distributed in three groups: <10 years old (33.3%); 10-18 years old (21.5%); and >18 years old (12.9%). Most patients had antibody deficiencies (70.9%). The following IVIg brands were used: Octagam® (31.6%), Flebogama® (28%), Tegeline® (27.2%), Imunoglobulin® (8.6%), Vigam® (2.6%), and Kiovig® (0.9%). AE were observed in 21 infusions (2.8%, 95%CI 1.6-4.0), mostly classified as mild/moderate (86%). There was a higher incidence of AE in the <10 year-old group. No significant differences were found (p=0.743) between the groups with and without infectious conditions. Thirteen adverse reactions (81.2%) occurred at an infusion rate of ≤ 4 mg/kg/min, whereas 18.8% were associated with higher rates, with no significant differences between the groups (p=0.21). The use of Tegeline® was associated with a significantly increased risk for AE (p=0.002). Conclusion: IVIg infusion in patients with PID seems to be a safe procedure, with a low incidence of AE, mostly non-severe.
Keywords
Referências
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Submetido em:
28/01/2014
Aceito em:
02/11/2014
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