Cambronero Javier, Osca-García Jose Manuel, Merino-Salas Sergio, Miguel Juan Manuel, Borralleras Cristina, López-Alcina Emilio
Servicio de Urología. Hospital Universitario Infanta Leonor. Madrid. España.
Servicio de Urología. Hospital Universitari Arnau de Vilanova. Valencia. España.
Arch Esp Urol. 2022 Apr;75(3):219-227.
To assess the effectivenessand tolerability of treatment with P africanum(P. africanum) in patients with lower urinary tractsymptoms (LUTS) associated with benign prostatichyperplasia (BPH) in routine clinical practice.
Cross-sectional observationalstudy in which 115 patients with LUTS/BPHtreated for 6 months with P. africanum (Tebetane® compuesto)in real-world clinical practice conditions wereincluded. The primary objective was to assess thequality of life (QoL) according to changes in the scoresof item 8 of the International Prostate Symptom Score(IPSS) questionnaire (a score ≥ 4 indicates a significantimpairment of QoL). Secondary objectives includedimprovement of urinary symptoms, urinary flow, satisfactionand compliance with treatment as well astolerability. Data were collected in a single scheduledvisit at 6 months of treatment with P. africanum andwere compared with data registered in the medicalrecords at the beginning of treatment.
After 6 months of treatment withP. africanum, the percentage of patient with significantimpairment of QoL was 22.6% as compared with45.2% at the initiation of treatment (P 0,-001). Theoverall IPSS score showed a mean decreas of -4,-5points (median -4,0, interquartile range [IQR] -7,-0 to-2,0) and 69 patients (60%) showed a clinically significantimprovement (reduction of ≥ 4 points). Therewere significant decreases in IPSS subscales of storage(mean -1,-8; median -2,-0, IQR -3,-0 to 0 (P 0,-001)and voiding (mean -1,-9; median -2,-0, IQR -3,-0 to 0)(P 0,-001) symptoms. The degree of satisfaction and compliance with treatment was high with mean scores(median) of 6,9 (7,0) and 9,2 (10), respectively in the1-10 visual analogue scale. Treatment-related adverseeffects did not occur.
Treatment with P. africanum during6 months improved significantly QoL and LUTS inpatients with BPH, with a high level of satisfaction andcompliance with treatment, without adverse events.
在常规临床实践中，评估非洲臀果木（P. africanum）治疗伴良性前列腺增生（BPH）的下尿路症状（LUTS）患者的有效性和耐受性。
一项横断面观察性研究，纳入了115例在现实临床实践条件下接受非洲臀果木（Tebetane® compuesto）治疗6个月的LUTS/BPH患者。主要目的是根据国际前列腺症状评分（IPSS）问卷第8项得分的变化评估生活质量（QoL）（得分≥4表明QoL有显著损害）。次要目的包括改善尿路症状、尿流、治疗满意度和依从性以及耐受性。在接受非洲臀果木治疗6个月时的一次预定访视中收集数据，并与治疗开始时病历中记录的数据进行比较。
接受非洲臀果木治疗6个月后，生活质量有显著损害的患者百分比为22.6%，而治疗开始时为45.2%（P<0.001）。IPSS总分平均下降-4.5分（中位数-4.0，四分位间距[IQR]-7.0至-2.0），69例患者（60%）显示出临床显著改善（降低≥4分）。IPSS储尿亚量表（平均-1.8；中位数-2.0，IQR-3.0至0）（P<0.001）和排尿亚量表（平均-1.9；中位数-2.0，IQR-3.0至0）（P<0.001）症状有显著下降。治疗满意度和依从性程度较高，在1-10视觉模拟量表中的平均得分（中位数）分别为6.9（7.0）和9.2（10）。未发生与治疗相关的不良反应。
非洲臀果木治疗6个月可显著改善BPH患者的生活质量和下尿路症状，治疗满意度和依从性高，且无不良事件。
