A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile -: Associated diarrhea, stratified by disease severity
A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile -: Associated diarrhea, stratified by disease severity
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DOI：
10.1086/519265
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发表时间：
2007-08-01
影响因子：
11.8
通讯作者：
Davis, Melinda B.
中科院分区：
文献类型：
--
作者：
Zar, Fred A.;Bakkanagari, Srinivasa R.;Davis, Melinda B.
背景。艰难梭菌相关性腹泻（CDAD）的发病率和严重程度一直在增加，最近也有甲硝唑治疗失败的报道。甲硝唑仍常被用作CDAD的一线治疗，但从未在前瞻性、随机、双盲、安慰剂对照试验中与万古霉素进行比较。我们进行了这样一项试验，根据疾病严重程度对患者进行分层，以调查一种药物是否更适合治疗轻度或重度疾病。从1994年10月至2002年6月，根据临床标准，将CDAD患者按病情轻重进行分层，随机分为口服甲硝唑（250 mg 4次/天）或口服万古霉素（125 mg 4次/天），疗程10天。两组患者在服用研究药物的同时还服用口服安慰剂。患者随访21天，评估治愈、治疗失败、复发或不耐受情况。172名患者入组，其中150名患者成功完成了试验。在轻度CDAD患者中，甲硝唑和万古霉素治疗的临床治愈率分别为90%和98% （P = 0.36）。在重症CDAD患者中，甲硝唑和万古霉素治疗的临床治愈率分别为76%和97% （P = 0.02）。甲硝唑组和万古霉素组的临床症状复发率分别为15%和14%。我们的研究结果表明，甲硝唑和万古霉素对轻度CDAD的治疗同样有效，但万古霉素对重度CDAD的治疗效果更好。
Background. The incidence and severity of Clostridium difficile-associated diarrhea (CDAD) has been increasing, and there have been recent reports of metronidazole treatment failure. Metronidazole is still commonly used as first-line treatment for CDAD but has never been compared with vancomycin in a prospective, randomized, double-blind, placebo-controlled trial. We conducted such a trial, stratifying patients according to disease severity, to investigate whether one agent was superior for treating either mild or severe disease.Methods. From October 1994 through June 2002, patients with CDAD were stratified according to whether they had mild or severe disease based on clinical criteria and were randomly assigned to receive oral metronidazole (250 mg 4 times per day) or oral vancomycin (125 mg 4 times per day) for 10 days. Both groups received an oral placebo in addition to the study drug. Patients were followed up for 21 days to assess cure, treatment failure, relapse, or intolerance.Results. One hundred seventy- two patients were enrolled, and 150 of these patients successfully completed the trial. Among the patients with mild CDAD, treatment with metronidazole or vancomycin resulted in clinical cure in 90% and 98% of the patients, respectively (P = .36). Among the patients with severe CDAD, treatment with metronidazole or vancomycin resulted in clinical cure in 76% and 97% of the patients, respectively (P = .02). Clinical symptoms recurred in 15% of the patients treated with metronidazole and 14% of those treated with vancomycin.Conclusions. Our findings suggest that metronidazole and vancomycin are equally effective for the treatment of mild CDAD, but vancomycin is superior for treating patients with severe CDAD.