Department of Internal Medicine, Division of Gastroenterology, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.
Dig Dis Sci. 2011 Jan;56(1):19-26. doi: 10.1007/s10620-010-1411-2. Epub 2010 Oct 6.
Clostridium difficile infection (CDI) has increased sharply in incidence, mortality rate, and burden on the healthcare system over the past decade. Therefore, novel treatment modalities have been developed, including intravenous immunoglobulin (IVIG). The level of immune response to Clostridium difficile colonization is the major determinant of the magnitude and duration of clinical manifestations. This effect is mediated predominantly by serum IgG anti-toxin A antibodies. Based on this finding, anti-toxin A and B antibodies were successfully used in multiple in vitro and in vivo experimental settings to passively immunize hamsters in CDI models. In humans, IVIG was used as the source of those antibodies. Fifteen small, mostly retrospective and non-randomized reports documented IVIG's success in the treatment of protracted, recurrent, or severe CDI. Diarrhea resolution rates were higher in the former patient group, but the recurrence rates were similar. IVIG mechanism of action is neutralization of mainly toxin A through IgG anti-toxin A antibodies. Purified anti-toxin A and B antibodies were successfully used to decrease CDI recurrence rates among patients with no or one previous CDI episodes. In conclusion, the efficacy of IVIG for CDI treatment in animal models has been convincingly demonstrated. However, only few small non-randomized, mostly uncontrolled reports have been published on human subjects. A phase II trial results support the use of purified anti-toxin A and B antibodies to decrease CDI recurrence rates. Therefore, IVIG should currently only be used as adjunct therapy until results from large, randomized controlled trials are available.
艰难梭菌感染（CDI）在过去十年中的发病率、死亡率和对医疗系统的负担急剧增加。因此，已经开发了新的治疗方法，包括静脉注射免疫球蛋白（IVIG）。对艰难梭菌定植的免疫反应水平是决定临床表现的严重程度和持续时间的主要决定因素。这种作用主要通过血清 IgG 抗毒素 A 抗体介导。基于这一发现，抗毒素 A 和 B 抗体已成功用于多种体外和体内实验设置，以在 CDI 模型中被动免疫仓鼠。在人类中，IVIG 被用作这些抗体的来源。十五项小型研究，主要是回顾性和非随机的，记录了 IVIG 在治疗迁延性、复发性或严重 CDI 方面的成功。在前一组患者中，腹泻缓解率更高，但复发率相似。IVIG 的作用机制是通过 IgG 抗毒素 A 抗体中和主要毒素 A。纯化的抗毒素 A 和 B 抗体已成功用于降低首次或仅有一次 CDI 发作患者的 CDI 复发率。总之，IVIG 治疗 CDI 的疗效在动物模型中得到了令人信服的证明。然而，仅在人类受试者中发表了少数小的、非随机的、大多不受控制的报告。一项 II 期试验结果支持使用纯化的抗毒素 A 和 B 抗体来降低 CDI 的复发率。因此，IVIG 目前仅应作为辅助治疗，直到有大型随机对照试验的结果可用。
