两种手术器械清洗质量评价方法的Meta分析

Meta analysis of two methods for evaluation of cleaning quality of surgical instruments

目的对比研究蛋白残留测试法与三磷酸腺苷(ATP)生物荧光测试法两种手术器械清洗质量评价方法。方法检索中国知网、万方数据库、维普数据库、PubMed、Embase和百度文库,检索时间为自建库至2021年1月,筛选蛋白残留测试法与ATP生物荧光测试法对器械清洗后质量评价效果的临床对比研究,以检测器械清洗质量不合格件数、器械清洗质量不合格率为主要效应指标,用固定效应模型对纳选的文献进行Meta分析。结果7篇对比研究文献符合纳入标准,共检测2 351件器械,其中试验组最小数量为35件常规器械,最多为1 000件腔镜器械,纳入研究的器械有常规手术器械、外来器械、达芬奇器械、腔镜类器械、专科器械等。Meta分析结果显示OR=0.93,95%CI(0.75~1.15),无统计学差异。结论从数据上看蛋白残留监测法检测器械清洗质量效果与ATP生物荧光法大致相同,但是ATP荧光检测结果易受干扰素影响,而蛋白质黏附性强,清洗难度大,且蛋白残留检测不受其他因素干扰,综上所述蛋白残留测试作为器械清洗质量评价方法甚佳,但成本高,不适合做日常监测。

OBJECTIVE To compare the cleaning quality of medical instruments between protein residue testing method and adenosine triphosphate(ATP) biofluorescence testing method. METHODS China National Knowledge Infrastructure, Wan Fang Database, Wei Pu Database, PubMed, Embase and Baidu Library were retrieved, the retrieval time was from the establishment of the database to January 2021, the clinical comparative studies involving the cleaning quality of surgical instruments evaluated by protein residue testing method and ATP biofluorescence testing method were screened out. The number of pieces of unqualified cleaning quality and unqualified rate of cleaning quality were the major effect indexes, the meta-analysis was performed for the included literatures by using fixed effect model. RESULTS Totally 7 pieces of research literatures met the inclusion criteria, and a total of 2 351 pieces of instruments were tested, the minimum volume was 35 pieces(routine instruments) in the experimental group, and the maximum volume was 1 000 pieces( endoscopic instruments). The instruments that were involved in the study included routine surgical instruments, foreign instruments, da Vinci instruments, laparoscopic instruments, specialized instruments and so on. The result of Meta-analysis showed that there was no significant difference(OR=0.93,95%CI0.75-1.15). CONCLUSION Judging from the data, the testing effects of the protein residue testing method and the ATP biofluorescence testing method are basically the same in evaluation of the cleaning quality of the instruments, however, the result of ATP biofluorescence testing method tends to be affected by interferons, proteins have strong adhesion, cleaning is difficult, and the protein residue testing is not interfered by other factors, above all, the protein residue testing method can be served as a preferred and ideal method for evaluation of cleaning quality of the instruments but is not suitable for daily surveillance due to high cost.