Cai Tommaso, Tiscione Daniele, Gallelli Luca, Verze Paolo, Palmieri Alessandro, Mirone Vincenzo, Bartoletti Riccardo, Malossini Gianni
Department of Urology, Santa Chiara Regional Hospital, Trento.
Arch Ital Urol Androl. 2016 Oct 5;88(3):177-182. doi: 10.4081/aiua.2016.3.177.
To date, the management of patients with chronic bacterial prostatitis (CBP) is not satisfactory, especially in terms of symptoms relief. Here, we evaluated the efficacy and the safety of a combination of serenoa repens, selenium and lycopene extract + bromelain and methylsulfonylmethane extract associated with levofloxacin in patients with CBP.
All patients with clinical and instrumental diagnosis of CBP, admitted to a single Urological Institution from March to June 2015 were enrolled in this phase III study. All enrolled patients were randomized into two groups: Group A received levofloxacin 500 mg o.d. for 14 days associated with lycopene and methylsulfonylmethane; Group B received levofloxacin (500 mg o.d. for 14 days) only. Clinical and microbiological analyses were carried out at the time of admission (T0) and during the followups at 1 month (T1) and 6 months (T2) from the end of the treatment. NIH Chronic Prostatitis Symptom Index (CPSI), International Prostatic Symptom Score (IPSS) and Quality of Well-Being (QoL) questionnaires were used. The main outcome measures were the rate of microbiological cure and the improvement in questionnaire results from baseline at the end of the follow-ups period.
Forty patients were enrolled in Group A and 39 in Group B. During the follow-up (T1), we recorded a significant changes in terms of NIH-CPSI and IPSS in Group A (mean difference: 17.6 ± 2.65; 12.2 ± 2.33; p < 0.01; p < 0.05, respectively) and versus Group B at the intergroup analysis (mean difference: -9 ± 1.82; -8.33 ± 1.71; p < 0.05; p < 0.05, respectively). No differences were reported in terms of microbiological findings between the two groups. At the second follow-up visit (T2), questionnaire results demonstrated statistically significant differences between groups (p < 0.001). One patient in Group A (2.5%) and 7 patients (17.9%) in Group B showed a symptomatic and microbiological recurrence (p = 0.02).
The combination of serenoa repens, selenium, lycopene + bromelain and methylsulfonylmethane extracts improved the clinical efficacy of levofloxacin in patients affected by CBP without the development of side effects.
迄今为止，慢性细菌性前列腺炎（CBP）患者的治疗效果并不理想，尤其是在症状缓解方面。在此，我们评估了锯叶棕、硒和番茄红素提取物+菠萝蛋白酶与甲基磺酰甲烷提取物联合左氧氟沙星治疗CBP患者的疗效和安全性。
2015年3月至6月入住单一泌尿外科机构的所有经临床和仪器诊断为CBP的患者均纳入本III期研究。所有入选患者随机分为两组：A组接受左氧氟沙星500mg每日一次，共14天，联合番茄红素和甲基磺酰甲烷；B组仅接受左氧氟沙星（500mg每日一次，共14天）。在入院时（T0）以及治疗结束后1个月（T1）和6个月（T2）的随访期间进行临床和微生物学分析。使用美国国立卫生研究院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。主要观察指标为微生物学治愈率以及随访期末问卷结果相对于基线的改善情况。
A组纳入40例患者，B组纳入39例患者。在随访期间（T1），我们记录到A组在NIH-CPSI和IPSS方面有显著变化（平均差异分别为：17.6± 2.65；12.2±2.33；p<0.01；p<0.05），组间分析时与B组相比也有显著变化（平均差异分别为：-9±1.82；-8.33±1.71；p<0.05；p<0.05）。两组在微生物学检查结果方面未报告有差异。在第二次随访（T2）时，问卷结果显示两组间存在统计学显著差异（p<0.001）。A组有1例患者（2.5%）和B组有7例患者（17.9%）出现症状和微生物学复发（p=0.02）。
锯叶棕、硒、番茄红素+菠萝蛋白酶与甲基磺酰甲烷提取物联合使用可提高左氧氟沙星对CBP患者的临床疗效，且未产生副作用。
