A long-term, multicenter, double-blind study of an Escherichia coli extract (OM-89) in female patients with recurrent urinary tract infections
A long-term, multicenter, double-blind study of an Escherichia coli extract (OM-89) in female patients with recurrent urinary tract infections
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DOI：
10.1016/j.eururo.2004.12.009
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发表时间：
2005-04-01
期刊：
影响因子：
23.4
通讯作者：
Schulman, CC
中科院分区：
文献类型：
--
作者：
Bauer, HW;Alloussi, S;Schulman, CC
目的：探讨免疫治疗药物OM-89与安慰剂在女性无并发症复发性尿路感染患者中的长期预防效果。方法：成年女性患者只要入选就诊时有急性尿路感染且尿检阳性(>；=10(3)菌/ml)，即可进入这项多中心双盲研究。患者接受免疫治疗的OM-89或与之匹配的安慰剂；每天1粒，连续90天，3个月不治疗，然后在第7、8和9个月的前10天，并在12个月内进行随访。以12个月以上尿路感染发生率、尿路感染分布和尿路感染患者比例为主要疗效标准。结果：共治疗453例患者，其中试验组231例，安慰剂组222例。活动组基线后尿路感染的平均发生率显著低于安慰剂组(0.84vs.1.28；p<；0.003)，相应地，使用OM-治疗的患者的尿路感染减少了34%。在活动组中，93名患者(40.3%)在基线后有185%的尿路感染，而安慰剂组有276例尿路感染(55.0%)(p=0.001)。OM-89的安全性良好，与以前的研究报道一致。结论：OM-89在3个月的治疗和3个10天的强化疗程期间，显著降低了尿路感染的发生率。这些结果证实OM-89是治疗复发性尿路感染的一个有价值的组成部分。(C)2004爱思唯尔B.V.保留所有权利。
Objective: To investigate the long-term preventive effect of the immunotherapeutic OM-89 versus placebo in uncomplicated recurrent UTI in a large cohort of female patients only.Methods: Adult female patients could enrol in this multicenter, double-blind study if they had acute UTI at the enrolment visit and positive results of urinalysis (>= 10(3) bacteria/ml). Patients received the immunotherapeutic OM-89 or a matching placebo; 1 capsule per day for 90 days, 3 months without treatment, then the first 10 days in Months 7, 8 and 9 and were followed up during 12 months. Primary efficacy criteria were UTI rates over 12 months, distribution of UTIs and proportion of patients with UTI.Results: A total of 453 patients were treated, 231 in the active group and 222 in the placebo group. Mean rate of post-baseline UTIs was significantly lower in the active group than in the placebo group (0.84 vs. 1.28; p < 0.003), corresponding to a 34% reduction of UTIs in patients treated with OM-89. In the active group, 93 patients (40.3%) had 185 post-baseline UTIs, compared to 276 UTIs in 122 patients (55.0%) in the placebo group (p = 0.001). The safety profile of OM-89 was good and consistent with that reported in previous studies.Conclusions: OM-89 significantly reduced the incidence of UTI during the 12 months of the study including 3 months of treatment and three 10-day booster courses. These results confirm that OM-89 is a valuable component of the management of recurrent UTI. (c) 2004 Elsevier B.V. All rights reserved.