Weisman L E, Cruess D F, Fischer G W
Department of Pediatrics, Uniformed Services University of the Health Sciences, Bethesda, Maryland.
Clin Perinatol. 1993 Mar;20(1):211-24.
Although current studies suggest that IVIg is safe, larger controlled trials will soon be published and will be important to confirm this observation. In addition, the current studies do not establish the efficacy of IVIg for either treating or preventing neonatal bacterial infections. Some studies with small numbers of infants suggest benefit of IVIg therapy and prophylaxis; however, the studies reviewed do not, individually or combined, prove efficacy. Clinicians and investigators must not confuse studies that prevent infection with those that treat infection because different therapeutic regimens may be necessary. Many questions remain concerning IVIg therapy, such as is IVIg efficacious in preventing or treating neonatal sepsis, what is the appropriate immunoglobulin dosage, and how variable is the pathogen-specific antibody activity of standard IVIg products. To determine the appropriate use of IVIg in neonates effectively, well-designed and carefully controlled trials are needed to address these issues using sufficiently large numbers of infants to arrive at valid scientific conclusions. Although many questions will be answered with the trials currently in progress, we must continue to base further recommendations for immunoglobulin therapy on solid scientific data.
尽管目前的研究表明静脉注射免疫球蛋白（IVIg）是安全的，但更大规模的对照试验很快将会发表，这对于证实这一观察结果至关重要。此外，目前的研究并未确立IVIg在治疗或预防新生儿细菌感染方面的疗效。一些针对少数婴儿的研究表明IVIg治疗和预防有好处；然而，所审查的这些研究，无论是单独来看还是综合起来，都没有证明其疗效。临床医生和研究人员绝不能将预防感染的研究与治疗感染的研究相混淆，因为可能需要不同的治疗方案。关于IVIg治疗仍有许多问题，例如IVIg在预防或治疗新生儿败血症方面是否有效、合适的免疫球蛋白剂量是多少，以及标准IVIg产品的病原体特异性抗体活性有多可变。为了有效地确定IVIg在新生儿中的适当用途，需要设计良好且严格对照的试验，使用足够数量的婴儿来解决这些问题，从而得出有效的科学结论。尽管目前正在进行的试验将回答许多问题，但我们必须继续基于可靠的科学数据对免疫球蛋白治疗提出进一步建议。
