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使用MV140进行免疫预防对减少尿路感染有效——一项前瞻性实际应用研究。

Immunoprophylaxis with MV140 Is Effective in the Reduction of Urinary Tract Infections-A Prospective Real-Life Study.

作者信息

Lopes Filipe Abadesso, Miranda Miguel, Ye André, Rodrigues Joana, Pé-Leve Paulo, Palma Reis José, Pereira E Silva Ricardo

机构信息

Urology Department, Hospital de Santa Maria, 1649-028 Lisbon, Portugal.

Clínica Longeva, 1050-111 Lisboa, Portugal.

出版信息

Vaccines (Basel). 2024 Dec 18;12(12):1426. doi: 10.3390/vaccines12121426.

Abstract

BACKGROUND/OBJECTIVES: Urinary tract infections (UTI) represent a highly frequent and debilitating disease. Immunoactive prophylaxis, such as the polyvalent bacterial whole-cell-based sublingual vaccine MV140, have been developed to avoid antibiotic use. However, the effectiveness of this tool in the Portuguese population is still unknown. This study aims at assessing the effectiveness of treatment with MV140 in a cohort of Portuguese patients presenting with recurrent UTIs.

METHODS

Prospective observational real-life study of 125 patients with complicated and uncomplicated recurrent UTIs treated with MV140. The primary outcome was a reduction in frequency and severity of UTIs after a follow-up of 12 months. Overall satisfaction, adverse events, and assessment of the effectiveness of MV140 in subgroups of patients with specific risk factors for UTIs were secondary outcomes.

RESULTS

In the 12 months after treatment outset, 38% of patients were UTI-free, 34% reported 1 or 2 UTI episodes, and the remaining 28% presented 3 or more UTIs, corresponding to a mean reduction of 3.20 (2.87-3.53, 95% C.I.; < 0.001) UTI episodes per year per patient. The effectiveness of MV140 was the same regardless of sex, BMI, regular sexual activity, hypertension, diabetes mellitus, depression, paraplegia, performance of intermittent self-catheterization, indwelling bladder catheter, or previous use of other UTI-preventing vaccines. We observed a higher effectiveness in post-menopausal women compared to pre-menopausal (74.7% vs. 59.4%, respectively, = 0.029). A total of 73% of patients reported a reduction in symptom severity or days of disease, and the mean global satisfaction was 7.52/10.

CONCLUSIONS

MV140 demonstrated to be effective in the reduction rate of recurrent UTIs in a cohort of adult Portuguese patients.

摘要

背景/目的:尿路感染(UTI)是一种非常常见且使人虚弱的疾病。已经开发出免疫活性预防措施,如基于多价细菌全细胞的舌下疫苗MV140,以避免使用抗生素。然而,该工具在葡萄牙人群中的有效性仍然未知。本研究旨在评估MV140治疗一组患有复发性UTI的葡萄牙患者的有效性。

方法

对125例接受MV140治疗的复杂性和非复杂性复发性UTI患者进行前瞻性观察性现实生活研究。主要结局是随访12个月后UTI的频率和严重程度降低。总体满意度、不良事件以及MV140在具有特定UTI危险因素的患者亚组中的有效性评估为次要结局。

结果

在治疗开始后的12个月内,38%的患者无UTI,34%的患者报告有1或2次UTI发作,其余28%的患者有3次或更多次UTI发作,相当于每位患者每年UTI发作次数平均减少3.20次(2.87 - 3.53,95%置信区间;<0.001)。无论性别、体重指数、规律的性活动、高血压、糖尿病、抑郁症、截瘫、间歇性自我导尿、留置膀胱导管或先前是否使用过其他UTI预防疫苗,MV140的有效性均相同。我们观察到绝经后女性的有效性高于绝经前女性(分别为74.7%和59.4%,P = 0.029)。共有73%的患者报告症状严重程度或疾病天数有所减少,总体平均满意度为7.52/10。

结论

MV140在一组成年葡萄牙患者中显示出对降低复发性UTI发生率有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e10b/11728758/f187d9b0564c/vaccines-12-01426-g001.jpg

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