Wolff S N, Fay J W, Herzig R H, Greer J P, Dummer S, Brown R A, Collins R H, Stevens D A, Herzig G P
Bone Marrow Transplant Program, Vanderbilt University, Nashville, TN 37232-4535.
Ann Intern Med. 1993 Jun 15;118(12):937-42. doi: 10.7326/0003-4819-118-12-199306150-00004.
To determine whether intravenous immunoglobulin (IVIG) prevents severe infections during autologous bone marrow transplantation or equivalent high-dose myelosuppressive therapy.
Randomized, stratified, nonblinded study.
Three tertiary care university hospitals.
One hundred seventy patients entered the study; 82 received IVIG and 88 were untreated controls. The study groups were similar for parameters capable of influencing the likelihood of infection.
Intravenous immunoglobulin was given weekly at a dose of 500 mg/kg body weight from the initiation of cytotoxic therapy to the resolution of neutropenia.
The development of bloodstream or other clinically proven infection, platelet use, and the development of alloimmunity to platelet transfusion.
Clinical infection, bacteremia, and fungemia occurred in 43%, 35%, and 6% of the IVIG-treated patients and in 44%, 34%, and 9% of the control patients. Gram-positive bacteremia and gram-negative bacteremia occurred in 28% and 11% of the IVIG group and in 23% and 13% of the control group. Death due to infection occurred in 4.9% of IVIG recipients and in 2.3% of controls. None of these observations was statistically significant (P > 0.2). Survival to hospital discharge was achieved in 86.6% of the IVIG group and in 96.6% of the control group. The survival difference (10%; 95% CI, 1.7% to 18.3%; P = 0.02) was due to a higher incidence of regimen-related toxic death in the IVIG-treated group.
The use of IVIG did not prevent infection. Fewer deaths occurred among controls due to a higher incidence of fatal hepatic veno-occlusive disease in patients receiving IVIG.
确定静脉注射免疫球蛋白（IVIG）能否预防自体骨髓移植或等效高剂量骨髓抑制治疗期间的严重感染。
随机、分层、非盲研究。
三家三级护理大学医院。
170名患者进入研究；82名接受IVIG治疗，88名未治疗作为对照。研究组在可能影响感染可能性的参数方面相似。
从细胞毒性治疗开始至中性粒细胞减少症缓解，每周静脉注射免疫球蛋白，剂量为500mg/kg体重。
血流感染或其他经临床证实的感染的发生情况、血小板使用情况以及对血小板输血的同种免疫的发生情况。
接受IVIG治疗的患者中，临床感染、菌血症和真菌血症的发生率分别为43%、35%和6%，对照组患者分别为44%、34%和9%。IVIG组革兰氏阳性菌血症和革兰氏阴性菌血症的发生率分别为28%和11%，对照组分别为23%和13%。IVIG接受者中因感染导致的死亡率为4.9%，对照组为2.3%。这些观察结果均无统计学意义（P>0.2）。IVIG组86.6%的患者存活至出院，对照组为96.6%。生存差异（10%；95%CI，1.7%至18.3%；P=0.02）是由于IVIG治疗组中与方案相关的毒性死亡发生率较高。
使用IVIG不能预防感染。由于接受IVIG治疗的患者中致命性肝静脉闭塞病的发生率较高，对照组的死亡人数较少。
