Barcaro Francesco, Cerino Alessandro, Cervini Armando Francesco, Gaffuri Mario, Vaso Nikoleta, Vela Mario
Istituti Clinici Città di Brescia, Via Bartolomeo Gualla 15, 25128 Brescia, Italy.
Cerino Center, Via Silvio Baratta 121, 84134 Salerno, Italy.
J Clin Med. 2025 Apr 28;14(9):3043. doi: 10.3390/jcm14093043.
Natural-origin PN HPT™ (Polynucleotides High Purification Technology) protect and revitalize chondrocytes, synoviocytes, and cartilage with a regenerative medicine perspective following intra-articular injection. This six-month, open-label data collection aimed to validate the benefits documented in previous studies of a single intra-articular injection of a proprietary PN HPT™/HA-based medical device in improving both subjective and objective manifestations of knee osteoarthritis in real-life ambulatory patients of both genders with unilateral or bilateral knee osteoarthritis. Efficacy and safety assessments, conducted at baseline before a single PN HPT™/HA injection and after three and six months of follow-up, included the Lequesne index and the patient-assessed Numeric Pain Rating Scale (NPRS), which focuses on pain intensity, as primary endpoints. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was a secondary endpoint. After three and six months, the mean baseline Lequesne index score improved by 43.8% and 51.4%, respectively. Concurrently, the mean NPRS score improvements were 42.2% and 54.7%. Furthermore, 32% of investigators and 15.5% of treated patients deemed optimal the clinical outcomes with no clinical worsening. With some limitations due to the uncontrolled design and relying on subjective rating scales only, the study confirms all previous findings about the benefits of combining PN HPT™ and HA in the same medical device for intra-articular injection in knee osteoarthritis.
天然来源的PN HPT™(多核苷酸高纯化技术)从再生医学角度出发,在关节腔内注射后可保护并激活软骨细胞、滑膜细胞以及软骨。这项为期六个月的开放标签数据收集旨在验证此前一项研究中记录的益处,该研究为单次关节腔内注射一种基于PN HPT™/透明质酸(HA)的专利医疗器械,以改善患有单侧或双侧膝关节骨关节炎的现实生活中门诊患者的膝关节骨关节炎主观和客观表现。在单次PN HPT™/HA注射前的基线以及随访三个月和六个月后进行的疗效和安全性评估,包括Lequesne指数以及患者评估的数字疼痛评分量表(NPRS,侧重于疼痛强度),作为主要终点。西安大略和麦克马斯特大学骨关节炎指数(WOMAC)为次要终点。在三个月和六个月后,基线Lequesne指数平均得分分别提高了43.8%和51.4%。同时,NPRS平均得分改善分别为42.2%和54.7%。此外,32%的研究者和15.5%接受治疗的患者认为临床结果最佳,且无临床恶化情况。尽管由于设计未受控制且仅依赖主观评分量表存在一些局限性,但该研究证实了此前所有关于在同一关节腔内注射用医疗器械中联合使用PN HPT™和HA的益处的研究发现。