口外与口内光生物调节在儿童肿瘤高剂量甲氨蝶呤治疗期间预防口腔黏膜炎方面具有相当疗效：一项单盲随机对照试验。
完整摘要 · 中文译文
目的：这项前瞻性随机对照临床研究比较了口内（IO）与口外（EO）光生物调节（PBM）在儿科肿瘤患者中预防化疗所致口腔黏膜炎（OM）的效果。 方法：共155例因白血病、淋巴瘤或骨肉瘤接受大剂量甲氨蝶呤（HDMTX）治疗的患者（1~18岁）被随机分为PBM-IO组（n = 73）或PBM-EO组（n = 82）。预防性PBM自入院至出院每日进行。两种方案均使用红光且剂量学参数相同（660 nm，100 mW，每点1 J）。PBM-EO每次仅需30秒，而PBM-IO约需6分钟，不包括患者摆位时间。在HDMTX输注后第0、3、5和10天评估OM发生率、严重程度（WHO分级）、菌斑指数和疼痛（数字评分量表）。 结果：OM总发生率为35.5%，PBM-IO组（41.1%）与PBM-EO组（30.5%）之间无显著差异（p = 0.168）。在任何时间点，两组间OM严重程度、疼痛、唾液pH或菌斑指数均未观察到统计学显著差异（p > 0.05）。多变量有序logistic回归显示，PBM方式并非OM严重程度的独立相关因素。如预期所示，年龄越大（OR = 1.14；95% CI：1.04~1.25；p = 0.004）和HDMTX剂量越高（OR = 1.24；95% CI：1.03~1.49；p = 0.021）与更严重的OM显著相关。两组在所有评估时间点的中位疼痛评分均为0。 结论：口外PBM在OM预防方面显示出与口内相当的有效性。 n 在接受 HDMTX 化疗的儿科患者中，同时减少应用时间。
完整摘要 · 英文原文
PURPOSE: This prospective randomized controlled clinical study compared intraoral (IO) and extraoral (EO) photobiomodulation (PBM) for the prevention of chemotherapy-induced oral mucositis (OM) in pediatric oncology patients. METHODS: A total of 155 patients (1-18 years), receiving high-dose methotrexate (HDMTX) for leukemia, lymphoma, or osteosarcoma, were randomized to PBM-IO (n = 73) or PBM-EO (n = 82). Preventive PBM was administered daily from hospital admission through discharge. Both protocols used red light with equivalent dosimetry (660 nm, 100 mW, 1 J per point). PBM-EO required 30 s/session, whereas PBM-IO required approximately 6 min, excluding patient handling time. OM occurrence, severity (WHO scale), plaque index, and pain (numeric rating scale) were assessed on days 0, 3, 5, and 10 after HDMTX infusion. RESULTS: The overall OM occurrence was 35.5%, with no significant difference between PBM-IO (41.1%) and PBM-EO (30.5%) groups (p = 0.168). No statistically significant differences were observed between groups for OM severity, pain, salivary pH, or plaque index at any time point (p > 0.05). Multivariable ordinal logistic regression demonstrated that PBM modality was not independently associated with OM severity. As expected, increasing age (OR = 1.14; 95% CI: 1.04-1.25; p = 0.004) and higher HDMTX dose (OR = 1.24; 95% CI: 1.03-1.49; p = 0.021) were significantly associated with greater OM severity. Median pain scores remained 0 at all assessment points in both groups. CONCLUSION: Extraoral PBM demonstrated comparable effectiveness to intraoral for OM prevention in pediatric patients undergoing HDMTX chemotherapy, while reducing application time.