Lederer David J, Philip Nisha, Rybak Debbie, Arcasoy Selim M, Kawut Steven M
Department of Medicine, College of Physicians and Surgeons, Columbia University, New York City, New York, United States of America; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York City, New York, United States of America.
Department of Medicine, College of Physicians and Surgeons, Columbia University, New York City, New York, United States of America.
PLoS One. 2014 Aug 4;9(8):e103908. doi: 10.1371/journal.pone.0103908. eCollection 2014.
We aimed to determine the effects of treatment with intravenous immunoglobulin on bacterial infections in patients with hypogammaglobulinemia (HGG) after lung transplantation.
We performed a randomized, double-blind, placebo-controlled two-period crossover trial of immune globulin intravenous (IVIG), 10% Purified (Gamunex, Bayer, Elkhart, IN) monthly in eleven adults who had undergone lung transplantation more than three months previously. We randomized study participants to three doses of IVIG (or 0.1% albumin solution (placebo)) given four weeks apart followed by a twelve week washout and then three doses of placebo (or IVIG). The primary outcome was the number of bacterial infections within each treatment period.
IVIG had no effect on the number of bacterial infections during the treatment period (3 during IVIG and 1 during placebo; odds ratio 3.5, 95% confidence interval 0.4 to 27.6, p = 0.24). There were no effects on other infections, use of antibiotics, or lung function. IVIG significantly increased trough IgG levels at all time points (least square means, 765.3 mg/dl during IVIG and 486.3 mg/dl during placebo, p<0.001). Four serious adverse events (resulting in hospitalization) occurred during the treatment periods (3 during active treatment and 1 during the placebo period, p = 0.37). Chills, flushing, and nausea occurred during one infusion of IVIG.
Treatment with IVIG did not reduce the short-term risk of bacterial infection in patients with HGG after lung transplantation. The clinical efficacy of immunoglobulin supplementation in HGG related to lung transplantation over the long term or with recurrent infections is unknown.
Clinicaltrials.gov NCT00115778.
我们旨在确定静脉注射免疫球蛋白治疗对肺移植术后低丙种球蛋白血症（HGG）患者细菌感染的影响。
我们对11名3个多月前接受肺移植的成年人进行了一项随机、双盲、安慰剂对照的两阶段交叉试验，每月静脉注射10%纯化免疫球蛋白（Gamunex，拜耳公司，印第安纳州埃尔克哈特）。我们将研究参与者随机分为接受三剂免疫球蛋白静脉注射（或0.1%白蛋白溶液（安慰剂）），间隔四周给药一次，随后有12周的洗脱期，然后再接受三剂安慰剂（或免疫球蛋白静脉注射）。主要结局是每个治疗期内细菌感染的数量。
免疫球蛋白静脉注射对治疗期内细菌感染的数量没有影响（免疫球蛋白静脉注射期间有3例，安慰剂期间有1例；优势比3.5，95%置信区间0.4至27.6，p = 0.24）。对其他感染、抗生素使用或肺功能没有影响。免疫球蛋白静脉注射在所有时间点均显著提高了谷浓度IgG水平（最小二乘均值，免疫球蛋白静脉注射期间为765.3mg/dl，安慰剂期间为486.3mg/dl，p<0.001）。治疗期间发生了4起严重不良事件（导致住院）（积极治疗期间3起，安慰剂期间1起，p = 0.37）。在一次免疫球蛋白静脉注射过程中出现了寒战、脸红和恶心。
免疫球蛋白静脉注射治疗并未降低肺移植术后HGG患者细菌感染的短期风险。长期或复发性感染情况下，补充免疫球蛋白在与肺移植相关的HGG中的临床疗效尚不清楚。
Clinicaltrials.gov NCT00115778
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