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氟罗沙星膜作为抗生素治疗慢性细菌性前列腺炎辅助药物的疗效:一项随机前瞻性试验

The Efficacy of Flogofilm in the Treatment of Chronic Bacterial Prostatitis as an Adjuvant to Antibiotic Therapy: A Randomized Prospective Trial.

作者信息

Barone Biagio, Mirto Benito Fabio, Falcone Alfonso, Del Giudice Francesco, Aveta Achille, Napolitano Luigi, Del Biondo Dario, Ferro Matteo, Busetto Gian Maria, Manfredi Celeste, Terracciano Daniela, Gambardella Raffaele, Pandolfo Savio Domenico, Trama Francesco, De Luca Ciro, Martino Raffaele, Capone Federico, Giampaglia Gaetano, Sicignano Enrico, Tataru Octavian Sabin, Lucarelli Giuseppe, Crocetto Felice

机构信息

Department of Neurosciences and Reproductive Sciences and Odontostomatology, University of Naples "Federico II", 80131 Naples, Italy.

Department of Maternal Infant and Urologic Sciences, Policlinico Umberto I Hospital, "Sapienza" University of Rome, 00161 Rome, Italy.

出版信息

J Clin Med. 2023 Apr 9;12(8):2784. doi: 10.3390/jcm12082784.

DOI:10.3390/jcm12082784
PMID:37109121
原文链接:
https://pmc.ncbi.nlm.nih.gov/articles/PMC10142953/
Abstract

INTRODUCTION

Bacterial prostatitis (BP) is a common prostatic infection characterized by a bimodal distribution in young and older men, with a prevalence between 5-10% among all cases of prostatitis and a high impact on quality of life. Although the management of bacterial prostatitis involves the use of appropriate spectrum antibiotics, which represent the first choice of treatment, a multimodal approach encompassing antibiotics and nutraceutical products in order to improve the efficacy of chosen antimicrobial regimen is often required.

OBJECTIVE

To evaluate the efficacy of Flogofilm in association with fluoroquinolones in patients with chronic bacterial prostatitis (CBP).

METHODS

Patients diagnosed with prostatitis (positivity to Meares-Stamey Test and symptoms duration > 3 months) at the University of Naples "Federico II", Italy, from July 2021 to December 2021, were included in this study. All patients underwent bacterial cultures and trans-rectal ultrasounds. Patients were randomized into two groups (A and B) receiving antibiotic alone or an association of antibiotics plus Flogofilm tablets containing Flogomicina for one month, respectively. The NIH-CPSI and IPSS questionnaires were administered at baseline, four weeks, twelve and twenty-four weeks.

RESULTS

A total of 96 (Group A = 47, Group B = 49) patients concluded the study protocol. The mean age was comparable, with a mean age of 34.62 ± 9.04 years for Group A and 35.29 ± 10.32 years for Group B ( = 0.755), and IPSS at the baseline was 8.28 ± 6.33 and 9.88 ± 6.89 ( = 0.256), respectively, while NIH-CPSI at baseline was 21.70 ± 4.38 and 21.67 ± 6.06 ( = 0.959), respectively. At 1, 3 and 6 months, the IPSS score was 6.45 ± 4.8 versus 4.31 ± 4.35 ( = 0.020), 5.32 ± 4.63 versus 3.20 ± 3.05 ( = 0.042) and 4.91 ± 4.47 versus 2.63 ± 3.28 ( = 0.005) for Groups A and B, respectively. Similarly, the NIH-CPSI total score at 1, 3 and 6 months was 16.15 ± 3.31 versus 13.10 ± 5.03 ( < 0.0001), 13.47 ± 3.07 versus 9.65 ± 4.23 ( < 0.0001) and 9.83 ± 2.53 versus 5.51 ± 2.84 ( < 0.0001), respectively.

CONCLUSIONS

Flogofilm, associated with fluoroquinolones, demonstrate a significant improvement in pain, urinary symptoms and quality of life in patients affected by chronic bacterial prostatitis in both IPSS and NIH-CPSI scores compared with fluoroquinolones alone.

摘要

引言

细菌性前列腺炎(BP)是一种常见的前列腺感染,在年轻男性和老年男性中呈双峰分布,在所有前列腺炎病例中的患病率为5%-10%,对生活质量有很大影响。尽管细菌性前列腺炎的治疗包括使用合适谱型的抗生素,这是首选治疗方法,但通常需要一种多模式方法,包括抗生素和营养保健品,以提高所选抗菌方案的疗效。

目的

评估Flogofilm联合氟喹诺酮类药物治疗慢性细菌性前列腺炎(CBP)患者的疗效。

方法

2021年7月至2021年12月期间,在意大利那不勒斯“费德里科二世”大学被诊断为前列腺炎(米尔斯-斯塔米试验阳性且症状持续时间>3个月)的患者纳入本研究。所有患者均接受细菌培养和经直肠超声检查。患者被随机分为两组(A组和B组),分别单独接受抗生素治疗或接受抗生素联合含氟戈米纳的Flogofilm片治疗1个月。在基线、4周、12周和24周时进行NIH-CPSI和IPSS问卷调查。

结果

共有96例(A组=47例,B组=49例)患者完成研究方案。平均年龄相当,A组平均年龄为34.62±9.04岁,B组为35.29±10.32岁(P=0.755),基线时IPSS分别为8.28±6.33和9.

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