关键词: PRP WESS-PQR efficacy platelet-rich plasma quality control regenerative medicine regulatory standards

来  源:   DOI:10.3390/jcm13154571   PDF(Pubmed)

Abstract:
Background: Platelet-rich plasma (PRP) is widely used in various medical and surgical specialties for its regenerative properties, including aesthetics (facial rejuvenation, hair restoration, and skin tightening) and orthopedics (treatment of tendinitis and osteoarthritis). However, the inconsistent literature on PRP\'s efficacy and safety leads to critical knowledge gaps. This systematic review evaluates quality control measures in PRP preparation and application and explores the regulatory environment governing its clinical use. Methods: Following PRISMA guidelines, a comprehensive search was conducted across multiple databases, including PubMed, EMBASE, and Web of Science, for studies published from January 2020 to April 2024. The review included randomized controlled trials (RCTs) involving human participants undergoing PRP treatment for aesthetic or regenerative purposes. Key parameters such as the PRP preparation methods, platelet concentration, and quality control measures were analyzed. The study protocol was registered with PROSPERO (ID: CRD42024557669). Results: Out of 75 RCTs involving 5726 patients, the review identified significant variability in PRP preparation methods and application techniques, including differences in centrifugation protocols and platelet concentration levels. A new evidence-based scoring system, the William-Eqram Scoring System for PRP Quality Reporting (WESS-PQR), was proposed to address these inconsistencies. Correlation analysis revealed a strong positive correlation (r = 0.79) between proper temperature control during preparation and PRP efficacy. Initial platelet count assessment showed a moderate positive correlation (r = 0.57) with efficacy. Conclusions: Standardized PRP preparation protocols and robust regulatory frameworks are urgently needed to ensure the safety and efficacy of PRP treatments. The proposed WESS-PQR scoring system can serve as a valuable tool for clinicians and researchers, promoting consistency and reliability in PRP applications.
摘要:
背景:富血小板血浆(PRP)因其再生特性而广泛应用于各种医学和外科专业,包括美学(面部年轻化,头发恢复,和皮肤收紧)和骨科(肌腱炎和骨关节炎的治疗)。然而,关于PRP疗效和安全性的文献不一致导致严重的知识差距。本系统综述评估了PRP制备和应用中的质量控制措施,并探讨了管理其临床使用的监管环境。方法:遵循PRISMA指南,在多个数据库中进行了全面搜索,包括PubMed,EMBASE,和WebofScience,对于2020年1月至2024年4月发表的研究。该综述包括随机对照试验(RCTs),涉及为美容或再生目的接受PRP治疗的人类参与者。PRP制备方法等关键参数,血小板浓度,并对质量控制措施进行了分析。研究方案注册于PROSPERO(ID:CRD42024557669)。结果:在涉及5726例患者的75例RCT中,审查确定了PRP制备方法和应用技术的显着差异,包括离心方案和血小板浓度水平的差异。一种新的基于证据的评分系统,用于PRP质量报告的William-Eqram评分系统(WESS-PQR),被提议解决这些不一致之处。相关分析显示,制备过程中适当的温度控制与PRP功效之间存在很强的正相关(r=0.79)。初始血小板计数评估显示与疗效呈中度正相关(r=0.57)。结论:迫切需要标准化的PRP制备方案和健全的监管框架,以确保PRP治疗的安全性和有效性。提出的WESS-PQR评分系统可以作为临床医生和研究人员的有价值的工具,提高PRP应用的一致性和可靠性。
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