Lorenzo-Gómez M F, Padilla-Fernández B, García-Criado F J, Mirón-Canelo J A, Gil-Vicente A, Nieto-Huertos A, Silva-Abuin J M
Servicio de Urología, Complejo Asistencial Universitario de Salamanca, Paseo San Vicente 58-182, Instituto de Investigación Biomédica de Salamanca, 37007, Salamanca, Spain.
Int Urogynecol J. 2013 Jan;24(1):127-34. doi: 10.1007/s00192-012-1853-5. Epub 2012 Jul 18.
Urinary tract infections (UTIs) are considered the most common bacterial infections, especially in women. The objective of this study was to evaluate the use of the sublingual bacterial vaccine Uromune® in order to prevent recurrent UTIs (RUTIs).
This study was conceived as a multicenter observational study. The clinical history of 319 women who presented at least 2 episodes of UTI in the last 6 months or 3 in 12 months was reviewed. Data related to treatment and clinical evolution were recorded and analyzed. A total of 159 patients received prophylactic treatment with Uromune® for a period of 3 months (group A) and 160 with sulfamethoxazole/trimethoprim 200/40 mg/day for a period of 6 months (group B). Uromune® contained an inactivated bacterial cell suspension of selected strains of Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, and Enterococcus faecalis.
Patients in group A experienced a highly significant reduction in the number of infections compared to patients in group B. In the first 3 months, the mean number of infections was 0.36 versus 1.60 (P < 0.0001), respectively. A significant reduction was also observed after 9 and 15 months (P < 0.0001). The numbers of patients who did not have any UTI at 3, 9, and 15 months were 101, 90, and 55 in group A versus 9, 4, and 0 in group B (P < 0.0001).
The results obtained in this study favor the use of this bacterial-based therapeutic vaccine as an effective strategy to reduce frequency, duration, severity, and costs of RUTIs.
尿路感染（UTIs）被认为是最常见的细菌感染，尤其是在女性中。本研究的目的是评估舌下细菌疫苗Uromune®预防复发性尿路感染（RUTIs）的效果。
本研究设计为多中心观察性研究。回顾了319名女性的临床病史，这些女性在过去6个月内至少发生2次UTI发作，或在12个月内发生3次。记录并分析了与治疗和临床进展相关的数据。共有159名患者接受了为期3个月的Uromune®预防性治疗（A组），160名患者接受了为期6个月的磺胺甲恶唑/甲氧苄啶200/40mg/天的治疗（B组）。Uromune®含有灭活的大肠杆菌、肺炎克雷伯菌、普通变形杆菌和粪肠球菌选定菌株的细菌细胞悬液。
与B组患者相比，A组患者的感染次数显著减少。在最初3个月，平均感染次数分别为0.36次和1.60次（P < 0.0001）。在9个月和15个月后也观察到显著减少（P < 0.0001）。A组在3个月、9个月和15个月时未发生任何UTI的患者人数分别为101、90和55人，而B组分别为9、4和0人（P < 0.0001）。
本研究获得的结果支持使用这种基于细菌的治疗性疫苗作为减少RUTIs频率、持续时间、严重程度和成本的有效策略。
