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细胞球蛋白(CytoGam)对中度低丙种球蛋白血症心脏移植受者的影响:一项单中心随机研究。

The impact of CytoGam on cardiac transplant recipients with moderate hypogammaglobulinemia: a randomized single-center study.

作者信息

Yamani Mohamad H, Avery Robin, Mawhorter Steven D, McNeill Ann, Cook Daniel, Ratliff Norman B, Pelegrin David, Colosimo Phyllis, Kiefer Karen, Ludrosky Kristin, Hobbs Robert, Taylor David, Buda Tiffany, Yeager Michael, Young James B, Smedira Nicholas, Starling Randall C

机构信息

Department of Cardiovascular Medicine, Kaufman Center for Heart Failure, Cleveland Clinic Foundation, Cleveland, OH, USA.

出版信息

J Heart Lung Transplant. 2005 Nov;24(11):1766-9. doi: 10.1016/j.healun.2004.11.016.

DOI:10.1016/j.healun.2004.11.016
PMID:16297779
Abstract

BACKGROUND

We have previously shown that the preemptive use of cytomegalovirus (CMV) immunoglobulin (Ig) replacement (CytoGam) decreases the incidence of opportunistic infections in cardiac transplant recipients with severe hypogammaglobulinemia. However, the impact of Ig replacement in moderately hypogammaglobulinemic patients is unknown.

METHODS

Periodic monitoring of the IgG levels was done in 300 heart transplant recipients. Moderate hypogammaglobulinemia (IgG, 350-500 mg/dl) developed in 56 patients (18.6%). Thirty-three patients declined randomization but agreed to have their IgG levels monitored. Twenty-three patients were randomized to placebo (n = 10) or CytoGam (n = 13) at 105 +/- 63 days after transplantation.

RESULTS

The baseline characteristics were similar. A significant reduction in CMV infection was noted in the CytoGam Group compared with the Placebo Group (15.4% [2/13] vs 60% [6/10], p = .039). Among patients who declined randomization, CMV infection developed in 13 (39.4%) of 33, and 6 (46.1%) of the 13 progressed to severe hypogammaglobulinemia. A trend for reduction in the average episodes of > or =grade 2 rejection during the 6-month period after randomization was noted in the CytoGam group (0.4 +/- 0.6 vs 1.4 +/- 1.3, p = 0.065).

CONCLUSIONS

The preemptive use of CytoGam decreases the incidence of CMV infection in patients with moderate hypogammaglobulinemia. A larger randomized study is needed to substantiate these results.

摘要

背景

我们之前已经表明,抢先使用巨细胞病毒(CMV)免疫球蛋白(Ig)替代疗法(赛妥珠单抗)可降低严重低丙种球蛋白血症心脏移植受者机会性感染的发生率。然而,Ig替代疗法对中度低丙种球蛋白血症患者的影响尚不清楚。

方法

对300名心脏移植受者进行定期的IgG水平监测。56名患者(18.6%)出现中度低丙种球蛋白血症(IgG,350 - 500mg/dl)。33名患者拒绝随机分组,但同意监测其IgG水平。23名患者在移植后105±63天被随机分为安慰剂组(n = 10)或赛妥珠单抗组(n = 13)。

结果

基线特征相似。与安慰剂组相比,赛妥珠单抗组的CMV感染显著减少(15.4% [2/13] 对60% [6/10],p = 0.039)。在拒绝随机分组的患者中,33名中有13名(39.4%)发生CMV感染,其中13名中有6名(46.1%)进展为严重低丙种球蛋白血症。赛妥珠单抗组在随机分组后6个月期间≥2级排斥反应的平均发作次数有减少趋势(0.4±0.6对1.4±1.3,p = 0.065)。

结论

抢先使用赛妥珠单抗可降低中度低丙种球蛋白血症患者的CMV感染发生率。需要更大规模的随机研究来证实这些结果。

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