Treatment with Monoclonal Antibodies against Clostridium difficile Toxins
Treatment with Monoclonal Antibodies against Clostridium difficile Toxins
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DOI：
10.1056/nejmoa0907635
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发表时间：
2010-01-21
影响因子：
158.5
通讯作者：
Ambrosino, Donna M.
中科院分区：
文献类型：
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作者：
Lowy, Israel;Molrine, Deborah C.;Ambrosino, Donna M.
背景艰难梭菌感染的发病率、严重性和高复发率的增加需要新的治疗方法。方法我们对艰难梭菌毒素A(CDA1)和B(CDB1)两种中和的全人单抗进行了随机、双盲、安慰剂对照研究。在接受甲硝唑或万古霉素的有症状的艰难梭菌感染患者中，这些抗体作为单次注射一起注射，每公斤体重10毫克。结果在200名入选的患者中(抗体组101人，安慰剂组99人)，接受单抗治疗的患者艰难梭菌感染的复发率较低(7%对25%；95%可信区间7-29；P
BACKGROUNDNew therapies are needed to manage the increasing incidence, severity, and high rate of recurrence of Clostridium difficile infection.METHODSWe performed a randomized, double-blind, placebo-controlled study of two neutralizing, fully human monoclonal antibodies against C. difficile toxins A (CDA1) and B (CDB1). The antibodies were administered together as a single infusion, each at a dose of 10 mg per kilogram of body weight, in patients with symptomatic C. difficile infection who were receiving either metronidazole or vancomycin. The primary outcome was laboratory-documented recurrence of infection during the 84 days after the administration of monoclonal antibodies or placebo.RESULTSAmong the 200 patients who were enrolled (101 in the antibody group and 99 in the placebo group), the rate of recurrence of C. difficile infection was lower among patients treated with monoclonal antibodies (7% vs. 25%; 95% confidence interval, 7 to 29; P