Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.
Neurourol Urodyn. 2020 Sep;39(7):1994-2002. doi: 10.1002/nau.24454. Epub 2020 Jul 10.
To compare the efficacy of cernitin pollen extract (cernitin) or tadalafil for treating persistent chronic pelvic pain despite α1-blocker monotherapy in men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and lower urinary tract symptoms (LUTS).
A total of 100 patients with refractory CP/CPPS despite ongoing α1-blocker monotherapy were randomized to receive add-on therapy with either cernitin (4 capsules/day) or tadalafil (5 mg/d) for 12 weeks. At week 12, changes from baseline in the patients' CP/CPPS, LUTS, and voiding function, as assessed using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), the International Prostate Symptom Score (IPSS), and uroflowmetry, respectively, were compared between the groups.
The final analysis included 42 and 45 patients in the cernitin and tadalafil groups, respectively. Although the NIH-CPSI total, NIH-CPSI pain sub-score, and NIH-CPSI quality of life sub-score significantly improved in both groups, the cernitin (vs tadalafil) group showed significantly greater improvements in the NIH-CPSI total score (-6.8 vs -4.6; P = .02) and NIH-CPSI pain sub-score (-4.1 vs -1.5; P < .001). Half (50%) of the patients in the cernitin group showed a reduction greater than 50% in their NIH-CPSI pain sub-score; in the tadalafil group, only four patients (8.9%) showed ≥50% improvement (P < .001). In contrast, the improvement in LUTS was significantly superior in the tadalafil group.
Both cernitin and tadalafil significantly ameliorated chronic pelvic pain in patients with refractory CP/CPPS. The add-on of cernitin was more effective than tadalafil for pelvic pain and discomfort.
比较西那卡塞花粉提取物(西那卡塞)或他达拉非治疗慢性前列腺炎/慢性骨盆疼痛综合征(CP/CPPS)伴下尿路症状(LUTS)患者持续慢性骨盆疼痛的疗效,这些患者尽管持续接受α1 受体阻滞剂单药治疗但仍存在难治性 CP/CPPS。
共有 100 例持续接受α1 受体阻滞剂单药治疗但仍存在难治性 CP/CPPS 的患者被随机分配,接受西那卡塞(4 粒/天)或他达拉非(5mg/d)加用治疗 12 周。在第 12 周,使用国立卫生研究院慢性前列腺炎症状指数(NIH-CPSI)、国际前列腺症状评分(IPSS)和尿流率分别评估患者 CP/CPPS、LUTS 和排尿功能的变化,比较两组间的变化。
最终分析纳入西那卡塞组和他达拉非组各 42 例和 45 例患者。尽管两组的 NIH-CPSI 总分、NIH-CPSI 疼痛亚评分和 NIH-CPSI 生活质量亚评分均显著改善,但西那卡塞组的 NIH-CPSI 总分改善更显著(-6.8 比-4.6;P=0.02)和 NIH-CPSI 疼痛亚评分(-4.1 比-1.5;P<0.001)。西那卡塞组中有一半(50%)患者的 NIH-CPSI 疼痛亚评分下降超过 50%;而在他达拉非组中,仅有 4 例(8.9%)患者的 NIH-CPSI 疼痛亚评分改善≥50%(P<0.001)。相比之下,他达拉非组的 LUTS 改善更显著。
西那卡塞和他达拉非均可显著改善难治性 CP/CPPS 患者的慢性骨盆疼痛。与他达拉非相比,加用西那卡塞治疗更有利于改善骨盆疼痛和不适。