A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease.
A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease.
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布拉氏酵母菌与标准抗生素联合治疗艰难梭菌病的随机安慰剂对照试验。
DOI：
10.1001/jama.1994.03510480037031
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发表时间：
1994
期刊：
影响因子：
--
通讯作者：
D. Greenwald
中科院分区：
文献类型：
--
作者：
LynneV. McFarland;C. Surawicz;Richard N. Greenberg;R. Fekety;G. Elmer;Kris A. Moyer;Sally A. Melcher;K. Bowen;J. L. Cox;Z. Noorani;Gregory Harrington;Moshe Rubin;D. Greenwald
目的--确定一种新的联合疗法治疗艰难梭菌相关性疾病(CDD)的安全性和有效性。该治疗将布拉酵母与抗生素(万古霉素或甲硝唑)相结合。设计--活动期CDD患者的双盲、随机、安慰剂对照、平行组干预研究。患者接受标准抗生素、S布地奈德或安慰剂治疗4周，治疗后再随访4周。通过比较两组中CDD的复发率，用多因素分析控制CDD的其他危险因素，以确定疗效。单位--来自三个主要研究协调中心的全国门诊或住院患者转诊研究。患者--共有12 4名符合条件的成年患者同意，包括，他们最初患有CDD，以及60名至少有一次CDD发作史的患者。3个月内因获得性免疫缺陷综合征或癌症化疗而免疫抑制的患者不符合条件。干预-口服S布地奈德(1g/d，连续4周)或安慰剂联合标准抗生素治疗。主要观察指标--活动期CDD复发。结果--CDD发作史显著增加了进一步复发的可能性。多因素分析显示，与安慰剂组和标准抗生素组相比，S组和标准抗生素组的慢性阻塞性肺疾病复发的相对危险度(RR)显著降低(RR=0.43；95%可信区间0.20~0.97)。复发组复发率为34.6%，安慰剂组为64.7%(P=.04)，初发组为19.3%，安慰剂组为24.2%(P=.86)。未见与S布地尔有关的严重不良反应。结论--标准抗生素联合S布拉地尼治疗复发性慢性阻塞性肺疾病是安全有效的；而对于初发的慢性阻塞性肺疾病患者，S布拉地尔治疗无效。
OBJECTIVE--To determine the safety and efficacy of a new combination treatment for patients with Clostridium difficile-associated disease (CDD). The treatment combines the yeast Saccharomyces boulardii with an antibiotic (vancomycin hydrochloride or metronidazole). DESIGN--A double-blind, randomized, placebo-controlled, parallel-group intervention study in patients with active CDD. Patients received standard antibiotics and S boulardii or placebo for 4 weeks, and were followed up for an additional 4 weeks after therapy. Effectiveness was determined by comparing the recurrence of CDD in the two groups using multivariate analysis to control for other risk factors for CDD. SETTING--National referral study of ambulatory or hospitalized patients from three main study coordinating centers. PATIENTS--A total of 124 eligible consenting adult patients, including 64 who were enrolled with an initial episode of CDD, and 60 who had a history of at least one prior CDD episode. Patients who were immunosuppressed due to acquired immunodeficiency syndrome or cancer chemotherapy within 3 months were not eligible. INTERVENTION--Treatment with oral S boulardii (1 g/d for 4 weeks) or placebo in combination with a standard antibiotic. MAIN OUTCOME MEASURE--Recurrence of active CDD. RESULTS--A history of CDD episodes dramatically increased the likelihood of further recurrences. Multivariate analysis revealed that patients treated with S boulardii and standard antibiotics had a significantly lower relative risk (RR) of CDD recurrence (RR, 0.43; 95% confidence interval, 0.20 to 0.97) compared with placebo and standard antibiotics. The efficacy of S boulardii was significant (recurrence rate 34.6%, compared with 64.7% on placebo; P = .04) in patients with recurrent CDD, but not in patients with initial CDD (recurrence rate 19.3% compared with 24.2% on placebo; P = .86). There were no serious adverse reactions associated with S boulardii. CONCLUSIONS--The combination of standard antibiotics and S boulardii was shown to be an effective and safe therapy for these patients with recurrent CDD; no benefit of S boulardii was demonstrated for those with an initial episode of CDD.
影响因子：
29.4
作者：
POTHOULAKIS, C;KELLY, CP;LAMONT, JT
通讯作者：
LAMONT, JT
艰难梭菌抗生素耐药性遗传基础的表征。
DOI：
10.1093/jac/33.3.419
发表时间：
1994
期刊：
The Journal of antimicrobial chemotherapy
影响因子：
--
作者：
Roberts,MC;McFarland,LV;Mullany,P;Mulligan,ME
通讯作者：
Mulligan,ME