Mattila Eero, Anttila Veli-Jukka, Broas Markku, Marttila Harri, Poukka Paula, Kuusisto Kaisa, Pusa Liana, Sammalkorpi Kari, Dabek Jan, Koivurova Olli-Pekka, Vähätalo Markku, Moilanen Veikko, Widenius Tom
Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital, Finland.
Scand J Infect Dis. 2008;40(9):702-8. doi: 10.1080/00365540801964960.
A prospective, randomized, double-blind study was designed to compare Clostridium difficile immune whey (CDIW) with metronidazole for treatment of laboratory-confirmed, recurrent, mild to moderate episodes of Clostridium difficile-associated diarrhoea (CDAD). CDIW was manufactured by immunization of cows in their gestation period with inactivated C. difficile vaccine. The resulting colostrum was processed, immunoglubulins were concentrated and the end-product containing high titres of C. difficile immunoglobulin was used as CDIW. 20 patients received metronidazole at a dosage of 400 mg t.i.d. and 18 patients CDIW 200 ml t.i.d. The study was interrupted early because of the bankruptcy of the sponsor. After 14 d of treatment, all 20 (100%) of 20 patients had responded to metronidazole therapy, compared with 16 (89%) of 18 who had received CDIW. 70 d after the beginning of treatment, sustained responses were observed in 11 (55%) of 20 patients receiving metronidazole and 10 (56%) of 18 patients treated with CDIW. In this preliminary study CDIW was as effective as metronidazole in the prevention of CDAD recurrences and it was well tolerated.
一项前瞻性、随机、双盲研究旨在比较艰难梭菌免疫乳清（CDIW）与甲硝唑治疗实验室确诊的复发性轻至中度艰难梭菌相关性腹泻（CDAD）。CDIW是通过在妊娠期用灭活的艰难梭菌疫苗免疫奶牛而制成的。对所得初乳进行加工，浓缩免疫球蛋白，将含有高滴度艰难梭菌免疫球蛋白的终产品用作CDIW。20例患者接受甲硝唑治疗，剂量为400mg，每日3次，18例患者接受CDIW治疗，剂量为200ml，每日3次。由于赞助商破产，该研究提前中断。治疗14天后，20例接受甲硝唑治疗的患者中有20例（100%）对治疗有反应，而接受CDIW治疗的18例患者中有16例（89%）有反应。治疗开始70天后，接受甲硝唑治疗的20例患者中有11例（55%）观察到持续反应，接受CDIW治疗的18例患者中有10例（56%）观察到持续反应。在这项初步研究中，CDIW在预防CDAD复发方面与甲硝唑一样有效，且耐受性良好。
