METHODS: A comprehensive search of four databases, including PubMed, Embassy, Web of Science, and Scopus, was conducted to identify studies reporting frequency and severity of oral mucositis in association with GVHD prophylactic regimens. RevMan 5.4 was used to perform the meta-analysis. Risk of bias assessment was carried out using the Rob-2 tool for randomized clinical trials (RCTs) and ROBINS-I tool for observational studies.
RESULTS: Twenty-five papers, including 11 RCTs and 14 observational studies, met the inclusion criteria. The pooled results from eight RCTs showed a higher risk of SOM in patients receiving MTX or MTX-inclusive GVHD prophylaxis versus non-MTX alternatives (RR = 1.50, 95% CI [1.20, 1.87], I2 = 36%, P = 0.0003). Mycophenolate mofetil (MMF) and post-transplant cyclophosphamide (Pt-Cy) consistently showed lower risk of mucositis than MTX. Folinic acid (FA) rescue and mini-dosing of MTX were associated with reduced oral mucositis severity.
CONCLUSIONS: Patients receiving MTX have a higher SOM risk compared to other approaches to prevent GVHD, which should be considered in patient care. When appropriate, MMF, FA, and a mini-dose of MTX may be an alternative that is associated with less SOM. This work also underlines the scarcity of RCTs on MTX interventions to provide the best evidence-based recommendations.
方法:对四个数据库进行全面搜索,包括PubMed,大使馆,WebofScience,还有Scopus,进行了研究以确定报告与GVHD预防方案相关的口腔粘膜炎的频率和严重程度的研究。使用RevMan5.4进行荟萃分析。偏倚风险评估使用Rob-2工具进行随机临床试验(RCTs)和ROBINS-I工具进行观察性研究。
结果:25篇论文,包括11项RCT和14项观察性研究,符合纳入标准。来自8个RCT的汇总结果显示,与非MTX替代方案相比,接受MTX或包含MTX的GVHD预防的患者发生SOM的风险更高(RR=1.50,95%CI[1.20,1.87],I2=36%,P=0.0003)。与MTX相比,霉酚酸酯(MMF)和移植后环磷酰胺(Pt-Cy)始终显示较低的粘膜炎风险。亚叶酸(FA)抢救和MTX的小剂量与口腔粘膜炎严重程度降低有关。
结论:与其他预防GVHD的方法相比,接受MTX的患者有更高的SOM风险,这应该在病人护理中考虑。在适当的时候,MMF,FA,和小剂量的MTX可能是与较少的SOM相关的替代方案。这项工作还强调了MTX干预措施RCT的稀缺性,以提供基于证据的最佳建议。