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Phytoproflex®:骨关节炎的辅助管理:一项补充剂登记研究

Phytoproflex®: supplementary management of osteoarthrosis: a supplement registry.

作者信息

Belcaro Gianni, Dugall Mark, Luzzi Roberta, Hosoi Morio, Ledda Andrea, Feragalli Beatrice, Hu Shu, Ganguly Apurba, Eggenhoffner Roberto, Corti Ambra, Giacomelli Luca

机构信息

Irvine Vascular Labs, Chieti-Pescara University, Pescara, Italy -

Irvine Vascular Labs, Chieti-Pescara University, Pescara, Italy.

出版信息

Minerva Med. 2018 Apr;109(2):88-94. doi: 10.23736/S0026-4806.17.05460-X.

Abstract

BACKGROUND

Curcumin is a powerful anti-oxidant that can be used to treat inflammation and pain in chronic conditions such as osteoarthrosis (OA). Phytoproflex® is characterized by an innovative delivery system that improves bioavailability of curcuminoids and could be useful in the management of OA.

METHODS

This 4-week registry included 56 patients with knee OA treated according to the best standard management for symptomatic OA. On top of that, 24 patients used Phytoproflex® supplement preparation (an extract containing boswellic acid 90%, curcumin 20% and valeric acid 0.8%). Patients' control of symptoms and functional capacity were evaluated through the Karnofsky Scale and standardized treadmill test, together with measurement of oxidative stress levels and use of rescue medication.

RESULTS

No problems of tolerability or safety were reported among subjects using the supplement. After 4 weeks, patients treated with the supplement reported a significant decrease in pain (P<0.05), and a significant improvement in the fitness scale (P<0.05), indicating that subjects were able to perform normal daily tasks. Less subjects in the supplement group had to use rescue medication (P<0.05), while oxidative stress levels, which were high at inclusion, significantly decreased in both groups (P<0.05). Moreover, the variation in pain-free walking distance and the Karnofsky Scale were significantly more improved (P<0.05) in patients taking the supplement compared to controls.

CONCLUSIONS

This preliminary registry study indicates that Phytoproflex® can be safely used as an effective, supplementary management in most OA patients.

摘要

背景

姜黄素是一种强大的抗氧化剂,可用于治疗骨关节炎(OA)等慢性疾病中的炎症和疼痛。Phytoproflex®的特点是采用了创新的给药系统,可提高姜黄素类化合物的生物利用度,可能对OA的管理有用。

方法

这项为期4周的登记研究纳入了56例膝骨关节炎患者,这些患者均按照症状性OA的最佳标准管理方案进行治疗。除此之外,24例患者使用了Phytoproflex®补充制剂(一种含有90%乳香酸、20%姜黄素和0.8%戊酸的提取物)。通过卡诺夫斯基量表和标准化跑步机测试评估患者的症状控制和功能能力,同时测量氧化应激水平并记录急救药物的使用情况。

结果

使用该补充剂的受试者中未报告耐受性或安全性问题。4周后,接受补充剂治疗的患者报告疼痛显著减轻(P<0.05),健康量表评分显著改善(P<0.05),这表明受试者能够完成正常的日常任务。补充剂组中需要使用急救药物的受试者较少(P<0.05),而两组在入组时较高的氧化应激水平均显著降低(P<0.05)。此外,与对照组相比,服用补充剂的患者在无痛步行距离和卡诺夫斯基量表上的变化有更显著的改善(P<0.05)。

结论

这项初步的登记研究表明,Phytoproflex®可安全地用作大多数OA患者的有效补充治疗。

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