Department of Hematology and Bone Marrow Transplantation, Medical University of Silesia, Katowice, Poland.
Support Care Cancer. 2012 Sep;20(9):2223-9. doi: 10.1007/s00520-012-1489-5. Epub 2012 Jun 27.
Of patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT), 75% or more experience oral mucositis, a painful acute complication that can delay discharge, interrupt treatment, and threaten life. To evaluate the efficacy of a supersaturated calcium phosphate rinse (SCPR), we compared it with customary care--topical mouth solutions--on measures of severity and consequent interventions and complications.
In this randomized controlled trial, 40 patients undergoing allogeneic HSCT were randomized: 20 to SCPR four times daily and 20 to solutions made with salvia leaf extract, iodine-povidine, and fluconazole. Treatment extended from initiation of conditioning treatment until the granulocyte count was ≥0.2 g/L. Mucositis severity was measured daily by a hematologist according to a World Health Organization (WHO) scale and self-assessed by patients. Need for interventions [analgesics, total parenteral nutrition (TPN), and granulocyte colony-stimulating factor] and complications (acute graft-versus-host disease and infections) were also assessed.
In comparison with the control group, the SCPR group had significantly lower mean measures of WHO oral toxicity (0.9 vs. 1.8; P = 0.02), disease course (3.2 vs. 7.1 days; P = 0.02), and peak mouth pain (0.85 vs. 1.75; P = 0.005). Analgesic need was significantly shorter (1.1 vs. 3.4 days; P = 0.047) and the need for TPN significantly lower (0 vs. 6 patients; P = 0.02; 0 vs. 1.9 mean days; P = 0.009). Measures of complications were lower in the SCPR group, but not significantly so. Trial limitations include the impracticality of achieving double blinding with agents so different in appearance and in preadministration preparation.
Compared with the control group, the SCPR group had significantly lower mean measures of oral toxicity, peak mouth pain, and disease course duration. These results warrant confirmation in controlled, multicenter, randomized trials.
在接受异基因造血干细胞移植 (HSCT) 的患者中，75%或更多的患者经历口腔黏膜炎，这是一种痛苦的急性并发症，可导致出院延迟、治疗中断，并威胁生命。为了评估过饱和磷酸钙漱口液 (SCPR) 的疗效，我们将其与常规护理（局部口腔溶液）进行了比较，比较的指标是严重程度以及由此产生的干预措施和并发症。
在这项随机对照试验中，将 40 名接受异基因 HSCT 的患者随机分为两组：SCPR 组每天使用 4 次，溶液组使用桑叶提取物、碘-聚维酮和氟康唑。治疗从开始进行预处理治疗一直持续到粒细胞计数≥0.2 g/L。根据世界卫生组织 (WHO) 量表，由血液科医生每日评估口腔黏膜炎的严重程度，并由患者进行自我评估。还评估了干预措施（镇痛药、全胃肠外营养 (TPN) 和粒细胞集落刺激因子）和并发症（急性移植物抗宿主病和感染）的需求。
与对照组相比，SCPR 组的 WHO 口腔毒性平均评分（0.9 与 1.8；P=0.02）、疾病持续时间（3.2 与 7.1 天；P=0.02）和峰值口腔疼痛（0.85 与 1.75；P=0.005）均显著较低。镇痛药需求时间显著缩短（1.1 与 3.4 天；P=0.047），TPN 需求显著降低（0 与 6 例患者；P=0.02；0 与 1.9 天；P=0.009）。SCPR 组的并发症测量值较低，但无统计学意义。试验局限性包括对于外观和预处理差异如此之大的药物实现双盲试验不切实际。
与对照组相比，SCPR 组的口腔毒性、峰值口腔疼痛和疾病持续时间的平均测量值显著较低。这些结果需要在对照、多中心、随机试验中得到证实。
