Evaluation of correlation between dose and clinical outcomes in subcutaneous immunoglobulin replacement therapy.
Evaluation of correlation between dose and clinical outcomes in subcutaneous immunoglobulin replacement therapy.
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DOI：
10.1111/j.1365-2249.2012.04594.x
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发表时间：
2012-08
影响因子：
4.6
通讯作者：
Grimbacher B
中科院分区：
文献类型：
--
作者：
Orange JS;Belohradsky BH;Berger M;Borte M;Hagan J;Jolles S;Wasserman RL;Baggish JS;Saunders R;Grimbacher B
血清免疫球蛋白（IG）G浓度在原发性免疫缺陷疾病的IgG替代治疗中的重要性在某些情况下得到了确立。通常，IgG通过静脉内（IVIG）或皮下（SCIG）途径输注。对于IVIG输注，已发表的数据表明，较高的IgG剂量和谷水平为患者提供了更好的感染保护。对于SCIG，尚未接受相同的结论;然而，来自最近的两项III期研究和最近的事后分析的数据表明，较高的SCIG剂量和血清IgG浓度与IVIG观察到的感染发生率降低之间存在相同的相关性。其他临床疗效指标尚未进行类似考虑。因此，对这些和其他已发表的SCIG研究进行了综合分析;然而，对13项研究的全面比较受到非标准化定义和报告的限制。尽管存在这些局限性，我们的分析表明，某些临床结果在较高的SCIG剂量和相关的较高血清IgG浓度下得到改善，并表明可能有机会通过SCIG剂量调整来改善患者结局。
The importance of serum immunoglobulin (Ig)G concentration in IgG replacement therapy for primary immunodeficiency diseases is established in certain settings. Generally, IgG is infused via the intravenous (IVIG) or subcutaneous (SCIG) route. For IVIG infusion, published data demonstrate that higher IgG doses and trough levels provide patients with improved protection from infection. The same conclusions are not yet accepted for SCIG; data from two recent Phase III studies and a recent post-hoc analysis, however, suggest the same correlation between higher SCIG dose and serum IgG concentration and decreased incidence of infection seen with IVIG. Other measures of clinical efficacy have not been considered similarly. Thus, combined analyses of these and other published SCIG studies were performed; a full comparison of the 13 studies was, however, limited by non-standardized definitions and reporting. Despite these limitations, our analyses indicate that certain clinical outcomes improve at higher SCIG doses and associated higher serum IgG concentrations, and suggest that there might be opportunity to improve patient outcomes via SCIG dose adjustment.
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