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初次全关节置换术(TJA)后增加聚维酮碘(碘伏)冲洗液浓度的非劣效性及安全性

Non-inferiority and Safety of Increased Povidone-Iodine (Betadine) Concentration for Irrigation Following Primary Total Joint Arthroplasty (TJA).

作者信息

Zvi Yoav S, Follett Lisa Y, Reddy Hemant, Seref-Ferlengez Zeynep, Weiser Mitchell C, Kamara Eli

机构信息

Orthopedic Surgery, Montefiore Medical Center, Bronx, USA.

出版信息

Cureus. 2024 Feb 2;16(2):e53453. doi: 10.7759/cureus.53453. eCollection 2024 Feb.

DOI:10.7759/cureus.53453
PMID:38435161
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10909383/
Abstract

Introduction Diluted Betadine (Purdue Pharma, Stamford, Conn) irrigation following primary total joint arthroplasty (pTJA) may reduce the risk of periprosthetic joint infection (PJI). A recent study found a minimal inhibitory concentration (MIC) of 0.63% Povidone-iodine (Betadine) for several bacterial isolates. This study reports outcomes of patients undergoing TJA using 0.54% Betadine irrigation compared to a historical cohort using 0.3% Betadine irrigation. Methods A retrospective chart review of patients who underwent pTJA from September 2017 to December 2020. 0.3% Betadine was used in a historical cohort and 0.54% Betadine in the experimental group. Patient demographics, intra-operative data, all-cause revision, and infection data were collected for the three-month post-operative period. Outcome frequencies between groups were compared using Fisher-Exact tests. Results Six hundred sixty-one patients underwent pTJA: 308 total knee arthroplasty (TKA), and 353 total hip arthroplasty (THA). 0.3% Betadine group had seven (3.1%) revisions: five (2.2%) underwent a revision for non-infectious reasons, and two (0.9%) for PJI. 0.54% Betadine group had 11 (2.5%) revisions: nine (2.1%) underwent revision for non-infectious reasons, two (0.4%) for PJI. No significant difference was found for rates of all-cause revision or infection between groups. No adverse intra-operative events occurred with the higher Betadine concentration. Conclusion This study demonstrated no difference in rates of all-cause revision or PJI when using 0.3% Betadine versus 0.54% Betadine for irrigation following pTJA. No adverse intraoperative events occurred with 0.54% Betadine irrigation. Given recent data supporting increased Betadine MIC, our results showed safety and non-inferiority with respect to three-month post-operative complication rates. Further investigation through a large powered randomized controlled study is needed to determine the optimal Betadine irrigation concentration for PJI prevention is required.

摘要

引言

初次全关节置换术(pTJA)后使用稀释的碘伏(普渡制药公司,康涅狄格州斯坦福德)冲洗可能会降低假体周围关节感染(PJI)的风险。最近一项研究发现,聚维酮碘(碘伏)对几种细菌分离株的最低抑菌浓度(MIC)为0.63%。本研究报告了与使用0.3%碘伏冲洗的历史队列相比,使用0.54%碘伏冲洗进行全关节置换术(TJA)患者的结果。方法:对2017年9月至2020年12月接受pTJA的患者进行回顾性病历审查。历史队列中使用0.3%碘伏,实验组中使用0.54%碘伏。收集患者人口统计学、术中数据、全因翻修和术后三个月的感染数据。使用Fisher精确检验比较组间结局频率。结果:661例患者接受了pTJA:308例全膝关节置换术(TKA)和353例全髋关节置换术(THA)。0.3%碘伏组有7例(3.1%)翻修:5例(2.2%)因非感染性原因进行翻修,2例(0.9%)因PJI进行翻修。0.54%碘伏组有11例(2.5%)翻修:9例(2.1%)因非感染性原因进行翻修,2例(0.4%)因PJI进行翻修。两组间全因翻修率或感染率未发现显著差异。较高浓度的碘伏未发生术中不良事件。结论:本研究表明,pTJA后使用浓度为0.3%的碘伏与0.54%的碘伏冲洗,全因翻修率或PJI发生率无差异。0.54%碘伏冲洗未发生术中不良事件。鉴于最近支持碘伏MIC增加的数据,我们的结果显示了术后三个月并发症发生率的安全性和非劣效性。需要通过大型随机对照研究进行进一步调查,以确定预防PJI的最佳碘伏冲洗浓度。

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