Department of Urology, Santa Chiara Regional Hospital, Trento, Italy.
Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
World J Urol. 2021 Sep;39(9):3433-3440. doi: 10.1007/s00345-020-03580-7. Epub 2021 Jan 13.
To evaluate the efficacy of Lactobacillus paracasei CNCM I-1572 (L. casei DG®) in both prevention of symptomatic recurrences and improvement of quality of life in patients with chronic bacterial prostatitis (CBP).
Patients with CBP attending a single Urological Institution were enrolled in this phase IV study. At enrollment, all patients were treated with antibiotics in agreement with EAU guidelines and then were treated with L. casei DG® (2 capsules/day for 3 months). Clinical and microbiological analyses were carried out before (enrollment, T0) and 6 months (T2) after the treatment. Both safety and adherence to the treatment were evaluated 3 months (T1) after the enrollment. NIH Chronic Prostatitis Symptom Index (CPSI), International Prostate Symptom Score (IPSS) and Quality of Well-Being (QoL) questionnaires were used. The outcome measures were the rate of symptomatic recurrence, changes in questionnaire symptom scores and the reduction of antibiotic use.
Eighty-four patients were included. At T2, 61 patients (72.6%) reported a clinical improvement of symptoms with a return to their clinical status before symptoms. A time dependent improvement in clinical symptoms with significant changes in NIH-CPSI, IPSS and QoL (mean difference T2 vs T0: 16.5 ± 3.58; - 11.0 ± 4.32; + 0.3 ± 0.09; p < 0.001), was reported. We recorded that L. casei DG® treatment induced a statistically significant decrease in both (p < 0.001) symptomatic recurrence [1.9/3 months vs 0.5/3 months] and antibiotic use [- 7938 UDD]. No clinically relevant adverse effects were reported.
L. casei DG® prevents symptomatic recurrences and improves the quality of life in patients with CBP, reducing the antibiotic use.
评估干酪乳杆菌 CNCM I-1572（L. casei DG®）在预防慢性细菌性前列腺炎（CBP）患者症状复发和提高生活质量方面的疗效。
本研究为一项 IV 期临床试验，纳入了在单一泌尿科机构就诊的 CBP 患者。在入组时，所有患者均根据 EAU 指南接受抗生素治疗，随后接受 L. casei DG®（每天 2 粒，持续 3 个月）治疗。在治疗前（入组时，T0）和治疗后 6 个月（T2）进行临床和微生物分析。在入组后 3 个月（T1）评估安全性和治疗依从性。使用 NIH 慢性前列腺炎症状指数（CPSI）、国际前列腺症状评分（IPSS）和生活质量（QoL）问卷进行评估。主要疗效指标为症状复发率、问卷症状评分变化和抗生素使用减少。
共纳入 84 例患者。在 T2 时，61 例（72.6%）患者报告症状得到临床改善，恢复到症状出现前的临床状态。临床症状随时间改善，NIH-CPSI、IPSS 和 QoL 评分显著变化（T2 与 T0 时的平均差值：16.5±3.58；-11.0±4.32；+0.3±0.09；p<0.001）。我们记录到 L. casei DG®治疗可显著降低症状复发[1.9/3 个月比 0.5/3 个月]和抗生素使用[减少 7938 UDD]的发生率（均 p<0.001）。未报告临床相关不良反应。
L. casei DG®可预防 CBP 患者症状复发，提高生活质量，减少抗生素使用。
