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血液惡性腫瘤和造血幹細胞移植的免疫球蛋白預防

Abstract

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Background

Patients undergoing hematopoietic stem cell transplantation (HSCT) and those with lymphoproliferative disorders (LPD) have a higher incidence of infections due to secondary hypogammaglobulinemia. One approach is the prophylactic administration of intravenous immunoglobulins (IVIG). Randomized controlled trials (RCTs) showed conflicting results in terms of type, schedule, dose and hematological patients benefiting from IVIG. We therefore performed a systematic review and meta‐analysis to evaluate the role of IVIG in these patients.

Objectives

To determine whether prophylaxis with IVIG reduces mortality or affects other outcomes in patients with hematological malignancies.

Search methods

PubMed (January 1966 to December 2007), CENTRAL (The Cochrane Library, up to 2007, issue 1), LILACS and conference proceedings published between 2002‐2007 were searched. The terms "immunoglobulins" or "gammaglobulins" or specific gammaglobulins and similar and the terms "hematologic neoplasms" or "hematologic malignancies" or "transplant" or "autotransplant" or "allotransplant" or "bone marrow transplant" or "peripheral stem cell transplant" and similar were selected. References of all included trials and reviews identified were scanned for additional trials.

Selection criteria

All RCTs comparing prophylaxis of IVIG with placebo, no treatment or another immunoglobulin preparation, different administration schedules or doses for patients with hematological malignancies were included. One author screened all abstracts identified through the search strategy and two reviewers independently inspected each reference identified by the search and applied inclusion criteria.

Data collection and analysis

For each trial, results were expressed as relative risks (RR) with 95% confidence intervals (CI) for dichotomous data and weighted mean differences for continuous data. We conducted meta‐analysis, where enough similar trials were available, using the fixed‐ effects model, unless significant heterogeneity was present. We performed sensitivity analyses to assess the effect of individual methodological quality measures on effect estimates, including allocation generation, concealment and blinding.

Main results

Forty trials were included: thirty included HSCT patients and ten included patients LPD. When polyvalent immunoglobulins or hyperimmune cytomegalovirus (CMV)‐IVIG was compared to control for HSCT, there was no difference in all‐cause mortality. Polyvalent immunoglobulins significantly reduced the risk for interstitial pneumonitis but increased the risk for veno‐occlusive disease and adverse events. In LPD, no benefit in terms of mortality IVIG could be demonstrated but there was a decrease in clinically and microbiologically documented infections.

Authors' conclusions

In patients undergoing HSCT, routine prophylaxis with IVIG is not supported. Its use may be considered in LPD patients with hypogammaglobulinemia and recurrent infections, for reduction of clinically documented infections.

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

淺顯易懂的口語結論

免疫球蛋白在血液惡性腫瘤的預防性角色

血液惡性腫瘤患者因免疫系統缺陷而容易發生感染。主要缺陷之一是免疫球蛋白降低。多年來,使用來自健康捐贈者的混合免疫球蛋白可能會逆轉這種缺陷。然而,隨機對照試驗在延長存活期、減少感染和治療副作用方面顯示出不同的結果。我們進行了一項系統性文獻回顧,評估了使用健康捐贈者的免疫球蛋白用於預防血液惡性腫瘤患者。我們的文獻表明,在骨髓移植的情況下,免疫球蛋白的施用對存活或其他結果沒有影響。另一方面,對於患有慢性淋巴性白血病或多發性骨髓瘤等淋巴細胞增多的患者,它大大降低了感染率。儘管成本較高,但預防性免疫球蛋白在該族群中可能具有成本效益。