Irvine3 Labs and IAPSS (International Agency For Pharma Standard Supplements), University of Chieti-Pescara, Pescara, Italy.
Irvine3 Labs and IAPSS (International Agency For Pharma Standard Supplements), University of Chieti-Pescara, Pescara, Italy -
Panminerva Med. 2020 Mar;62(1):13-18. doi: 10.23736/S0031-0808.18.03572-3.
The aim of this pilot study was to evaluate the effects of Pycnogenol® and CA (Centellicum®) on penile fibrosis and on associated signs and symptoms.
A group of 82 subjects with penile nodules and plaques was included in this registry study and followed up for 3 months; 32 were managed with standard management (SM) only. Twenty-four were managed with CA (Centellicum®: 3 capsules/day: 675 mg/day) in association with SM, and 26 subjects were managed with Pycnogenol® (150 mg/day) + CA (Centellicum® at the same dosage as in group 2) and SM.
Subjects in the 3 groups were comparable, including the distribution of plaques. The occurrence of any previous catheterizations was also comparable. Safety and tolerability were optimal, no subjects had to stop supplementation. The percentage of subjects with improved symptoms evaluated with a Visual Analogue Scale line was significantly higher with both supplements in comparison with SM (P<0.05). The combined management with Pycnogenol® and Centellicum® was superior to the other 2 managements (P<0.05). Erectile function assessed by the Index of Erectile Fuction questionnaire (IIEF) was significantly higher with the combination Pycnogenol®+Centellicum (P<0.05). The number of plaques and microplaques, the average total sectional area of the plaques in each subject and the grey scale median were all better improved with the combination. Both supplementations were superior to SM at 12 weeks (P<0.05). Oxidative stress resulted significantly better (P<0.05) with the combination. All blood tests were normal at inclusion and at 12 weeks. The minimal, penile curvature at baseline was reduced in both the supplement groups at 12 weeks more than in the SM group (P<0.05).
In conclusion Centellicum and Pycnogenol® appear to improve penile fibrosis reducing the keloidal aspects of penile plaques.
本初步研究旨在评估碧萝芷®和 CA（Centellicum®）对阴茎纤维化及相关症状的影响。
本注册研究纳入了 82 例有阴茎结节和斑块的患者，并对其进行了 3 个月的随访；32 例仅接受标准治疗（SM）；24 例接受 CA（Centellicum®：每天 3 粒，675mg/天）联合 SM 治疗；26 例接受碧萝芷®（150mg/天）+CA（Centellicum®剂量与组 2 相同）联合 SM 治疗。
3 组患者的可比性良好，包括斑块分布。以前进行过任何导尿术的患者比例也相似。安全性和耐受性均为最佳，无患者需要停止补充。用视觉模拟评分线评估，有改善症状的患者比例在接受两种补充剂治疗时均显著高于 SM（P<0.05）。碧萝芷®+Centellicum 联合治疗优于其他两种治疗（P<0.05）。通过勃起功能指数问卷（IIEF）评估的勃起功能明显更高，联合组（P<0.05）。结合两种补充剂治疗，斑块和微斑块的数量、每个患者斑块的平均总截面积和灰度中位数均有更好的改善。在 12 周时，两种补充剂均优于 SM（P<0.05）。联合治疗组的氧化应激明显改善（P<0.05）。所有血液检查在纳入时和 12 周时均正常。在 12 周时，补充组的最小阴茎弯曲度均较 SM 组改善（P<0.05）。
总之，Centellicum 和 Pycnogenol®似乎可以改善阴茎纤维化，减少阴茎斑块的硬结样外观。
