IRVINE3 Labs, Department of Medical, Oral and Biotechnological Sciences, Chieti-Pescara University, Pescara, Italy.
IAAPS, International Agency For Pharma Standard Supplements, Pescara, Italy.
Minerva Cardioangiol. 2020 Apr;68(2):146-152. doi: 10.23736/S0026-4725.19.05027-8.
The aim of this pilot study was the supplementary management of minimal, residual symptoms of systemic Lupus (SLE) with vasculitis (LV) in remission phases, using a natural, anti-inflammatory, antioxidant agent (Pycnogenol®) extracted from French maritime pine bark. Pycnogenol® has a significant clinical anti-inflammatory activity; it is a standardized supplement with a high-safety profile.
Subjects with Lupus vasculitis were included in the study. The standard management (SM) was used in all subjects for 8 weeks; one group added Pycnogenol® (150 mg/day) to SM.
The two groups completing 8 weeks were comparable at baseline with 12 subjects managed with SM and 14 subjects supplemented with Pycnogenol®. No side effects due to Pycnogenol® were observed; Pycnogenol® was associated with an optimal tolerability. The proportion of patients with photosensitivity, oral ulcers, renal-associated hematuria (minimal), leukopenia, lymphopenia, thrombocytopenia, positive anti-DNA and positive antiphospolipids tests were significantly lower in the Pycnogenol® group (P<0.05) at 8 weeks in comparison with controls. No difference in activity between SM and supplementation was observed for rash, serositis, anemia, neurological symptoms (all mild at inclusion) and anti-Smith. Considering additional clinical parameters such as the need for corticosteroids, peripheral ischemia, oxidative stress, the effects of Pycnogenol® appeared to be superior to SM alone (P<0.05). The decrease in oxidative stress was significantly higher with Pycnogenol® (P<0.05) compared to SM. This is particularly interesting as it has not been observed before in LV. Considering microvascular parameters, the number of subjects with 'cold' hypoperfused thermographic areas was significantly lower in the supplement group (P<0.05) and distal flux (laser Doppler) was higher with the supplement (P<0.05) at 8 weeks.
This pilot registry indicates that Pycnogenol® can be safely used in subjects with LV with mild symptoms (in remission) possibly avoiding some drug treatments that may cause side effects. A larger study in progress is evaluating the effects of Pycnogenol® on recurrent symptoms in subjects in remission.
本研究旨在使用从法国沿海松树皮中提取的天然抗炎、抗氧化剂（碧萝芷）对处于缓解期的系统性红斑狼疮（SLE）伴血管炎（LV）患者的最小残留症状进行补充治疗。碧萝芷具有显著的临床抗炎活性，是一种标准化补充剂，具有较高的安全性。
将患有狼疮血管炎的患者纳入本研究。所有患者均采用标准治疗（SM），为期 8 周；一组患者在 SM 的基础上加用碧萝芷（150mg/天）。
完成 8 周治疗的两组患者在基线时具有可比性，SM 组有 12 例患者，SM 加碧萝芷组有 14 例患者。未观察到碧萝芷的副作用，表明其具有较好的耐受性。与对照组相比，碧萝芷组在第 8 周时的光过敏、口腔溃疡、肾相关血尿（微量）、白细胞减少、淋巴细胞减少、血小板减少、抗 DNA 阳性和抗磷脂抗体阳性的患者比例显著降低（P<0.05）。SM 和补充治疗对皮疹、胸膜炎、贫血、神经症状（所有症状在纳入时均为轻度）和抗 Smith 无差异。考虑到其他临床参数，如皮质类固醇的需求、周围缺血、氧化应激，碧萝芷的效果似乎优于单独使用 SM（P<0.05）。与 SM 相比，碧萝芷组的氧化应激下降更为显著（P<0.05）。这一点特别有趣，因为之前在 LV 中没有观察到这种情况。考虑到微血管参数，补充组“冷”低灌注热成像区域的患者数量显著减少（P<0.05），补充组的远端流量（激光多普勒）更高（P<0.05）。
本注册研究表明，碧萝芷可安全用于处于缓解期、仅有轻微症状（LV）的患者，可能避免了一些可能导致副作用的药物治疗。正在进行的一项更大规模的研究正在评估碧萝芷对缓解期患者复发性症状的影响。
