采用开放制备技术进行富血小板血浆膝关节内注射不会增加关节感染的风险：对 91 项随机对照试验和 5914 次注射的系统回顾

IF 2 Q2 ORTHOPEDICS

Journal of Experimental Orthopaedics Pub Date : 2024-09-23 DOI:10.1002/jeo2.70002

Mohammad Sami Alazzeh, Hamza Adnan Mohammad Naseh, Angelo Vasiliadis, Markus Laupheimer, Georgios Kalifis, Ayyoub Al-Dolaymi, Luca Macchiarola, Theodorakys Marín Fermín

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引用次数: 0

摘要

目的比较过去十年间发表的随机对照试验（RCT）中开放式和封闭式膝关节内富血小板血浆（PRP）注射技术的感染率。方法按照《系统综述和荟萃分析首选报告项目》指南，使用 "富血小板血浆"、"PRP"、"膝关节 "和 "胫骨股骨 "等词单独或与布尔运算符 AND/OR 结合使用，于 2022 年 10 月检索了 PubMed、Scopus 和虚拟健康图书馆。过去 10 年中发表的评估 PRP 膝关节内注射的 RCT 研究均符合条件。如果未说明试剂盒/制备技术，则排除研究。数据以单项研究的绝对值、总计和汇总百分比表示。采用 ROBIS 工具评估发表偏倚。结果 91项研究符合预定的资格标准。其中 41 项采用封闭式技术，50 项采用开放式技术。所有采用封闭式技术的研究都公开了其商业试剂盒。只有 16 项研究（17.58%）未报告关节感染情况。在报告关节感染结果的研究中，30 项采用了封闭式技术，共有 1195 名患者接受了 1921 次膝关节内注射，患者随访率为 95.44%。另一方面，45 项研究采用了开放式技术，共有 2290 名患者接受了 3993 次膝关节内注射，随访率为 97.07%。在纳入的研究中，没有患者发生关节感染。有 33 项研究在受控环境中制备 PRP（36.26%）。大多数研究未报告制备地点（48.35%）。只有 12 项研究披露在制备过程中使用了层流技术（13.19%）。每 1000 次膝关节注射中，两种技术的感染率均为 0。结论开放式 PRP 制备技术不会带来更高的关节感染风险，如果有适当的设施，还能降低生产成本。但是，PRP制备设置和层流实施数据不足，而且良好生产规范的最低要求需要进一步研究，同时要遵守当地和区域法规。证据等级 I 级，RCT 系统回顾。

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Platelet-rich plasma intra-articular knee injections from open preparation techniques do not pose a higher risk of joint infection: A systematic review of 91 randomized controlled trials and 5914 injections

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Purpose

To compare the infection rate of intraarticular platelet-rich plasma (PRP) knee injections between open and closed techniques in randomized controlled trials (RCTs) published in the last decade.

Methods

Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, PubMed, Scopus and Virtual Health Library were accessed in October 2022 using the terms ‘platelet-rich plasma’, ‘PRP’, ‘knee’ and ‘tibiofemoral’ alone and in combination with Boolean operators AND/OR. RCTs published during the last 10 years evaluating PRP intra-articular knee injections were considered eligible. Studies were excluded if the kit/preparation technique was not described. Data were presented using individual studies' absolute values, totals, and pooled percentages. Publication bias was assessed using the ROBIS tool.

Results

Ninety-one studies met the predetermined eligibility criteria. Forty-one implemented a closed technique, while 50 were open. All studies implementing a closed technique disclosed their commercial kits. Only 16 studies (17.58%) failed to report joint infections. Among the studies reporting joint infections as outcomes, 30 implemented a closed technique with 1195 patients, 1921 intra-articular knee injections and 95.44% of patient follow-up. On the other hand, 45 of them implemented an open technique with 2290 patients, 3993 intra-articular knee injections and 97.07% of patient follow-up. No patient had a joint infection among the included studies. Thirty-three studies prepared their PRP in controlled environments (36.26%). Most studies did not report where the preparation occurred (48.35%). Only twelve studies disclosed using laminar flow during preparation (13.19%). The infection rate for both techniques was 0 per 1000 knee injections.

Conclusion

Open PRP preparation techniques do not pose a higher risk of joint infection and can lower manufacturing costs when appropriate facilities are available. However, PRP preparation setting and laminar flow implementation data are deficient, and minimal requirements for good manufacturing practices demand further studies while adhering to local and regional regulations.