Nickel J Curtis, Saz-Leal Paula, Doiron R Christopher
Department of Urology, Queen's University, Kingston, ON, Canada.
Inmunotek S.L., Alcalá de Henares, Madrid, Spain.
Can Urol Assoc J. 2020 Aug;14(8):281-287. doi: 10.5489/cuaj.6690.
We conducted a systematic review to examine the role of a novel sublingual vaccine - Uromune - for prevention of recurrent urinary tract infection (rUTI) to understand its potential role for Canadian women suffering from rUTI.
Databases were searched for studies published from 2010-2020 that investigated use of Uromune in the management of rUTI. Only original clinical studies that included use of Uromune as prophylaxis for uncomplicated rUTI in women that included UTI-free rate following initiation of vaccine as an outcome were included.
Of 73 publications related to Uromune and UTIs, 19 unique clinical studies were identified evaluating Uromune for prevention of rUTI. Five studies met our inclusion criteria for primary review. These included 1408 women treated with Uromune. In two retrospective comparative studies, subjects treated with Uromune daily for three months (519 women in total) had significantly higher UTI-free rates (35-90%) than subjects treated with six months of antibiotic prophylaxis (0% in 499 women in total) over 15 months (p<0.001 for both studies). In three prospective, uncontrolled studies, UTI-free rates for subjects treated with Uromune ranged from 33-78% over 9-24 months. No major safety issues were identified in these trials. Additional unique studies evaluating Uromune for rUTI that did not meet our criteria added consistent confirmation of the potential effectiveness and safety of Uromune to prevent rUTI.
Although these findings require confirmation in currently active, prospective clinical studies, including a randomized placebo-controlled trial, Uromune may be an alternative to antibiotics to prevent rUTI in Canadian women.
我们进行了一项系统综述,以研究一种新型舌下疫苗——泌尿免疫(Uromune)——在预防复发性尿路感染(rUTI)中的作用,从而了解其对患有rUTI的加拿大女性的潜在作用。
检索数据库,查找2010年至2020年发表的研究泌尿免疫在rUTI管理中应用的研究。仅纳入将泌尿免疫用作女性单纯性rUTI预防措施的原始临床研究,这些研究将疫苗接种开始后的无UTI率作为一项结果。
在73篇与泌尿免疫和UTI相关的出版物中,确定了19项评估泌尿免疫预防rUTI的独特临床研究。五项研究符合我们的初步审查纳入标准。这些研究共纳入了1408名接受泌尿免疫治疗的女性。在两项回顾性比较研究中,连续三个月每日接受泌尿免疫治疗的受试者(总共519名女性)在15个月内的无UTI率(35% - 90%)显著高于接受六个月抗生素预防治疗的受试者(总共499名女性,无UTI率为0%)(两项研究的p均<0.001)。在三项前瞻性、非对照研究中,接受泌尿免疫治疗的受试者在9至24个月内的无UTI率为33% - 78%。在这些试验中未发现重大安全问题。其他评估泌尿免疫预防rUTI但不符合我们标准的独特研究进一步证实了泌尿免疫预防rUTI的潜在有效性和安全性。
尽管这些发现需要在当前正在进行的前瞻性临床研究(包括随机安慰剂对照试验)中得到证实,但泌尿免疫可能是加拿大女性预防rUTI的抗生素替代药物。