Garavito Andrés Avila, Cardona Andrés Felipe, Reveiz Ludovic, Ospina Edgar, Yepes Andrés, Ospina Vannesa
Clinical Oncology and Hematology Department, Clínica de Oncología Astorga and Unidad de Trasplante de Médula Osea Clínica SOMA, Medellín, Colombia.
Palliat Support Care. 2008 Dec;6(4):371-6. doi: 10.1017/S147895150800059X.
Oral mucositis (OM) is a frequently encountered problem as a complication of cancer treatment. We investigated whether daily washings with colchicine solution improved mucositis in patients with hematological malignancies undergoing chemotherapy.
This study was a one-arm, nonrandomized clinical trial that used a historical control group. Patients were included in the study from the first day of mucositis and followed up until discharge. Patients received 2 mg colchicine mouthwashes daily for 5 days or saline solution. OM was assessed once daily until symptom resolution, using the WHO grading scale of 0-4 and a visual analogue scale. We determined that at least 40 patients in the colchicine group would be needed to detect a 20% difference in the duration of OM between Groups A and B, with a 95% confidence level and a power of 80%.
82 patients were included in the final analysis, 40 in the colchicine group and 42 in the control group. Median duration of OM was significantly different among groups; 9 days (range 1-17 days) for the control group versus 6 days (range 3-13 days) for those exposed to colchicine mouthwash (p = .028). The median days of regression of mucosal lesions were significantly different (p = .047) among the control group (7 days [range 3-20]) compared to the colchicine group (4 days [range 2-14]).
Although our findings suggest that colchicine mouthwash is helpful in reducing the severity and duration of chemotherapy-induced OM, randomized trials are needed to confirm these results.
口腔黏膜炎（OM）是癌症治疗中常见的并发症。我们研究了秋水仙碱溶液每日冲洗是否能改善接受化疗的血液系统恶性肿瘤患者的黏膜炎。
本研究为单臂、非随机临床试验，采用历史对照组。患者从黏膜炎第一天起纳入研究，随访至出院。患者每日接受2毫克秋水仙碱漱口水，共5天，或生理盐水。使用世界卫生组织0至4级分级量表和视觉模拟量表，每天评估一次OM，直至症状缓解。我们确定，在95%的置信水平和80%的检验效能下，秋水仙碱组至少需要40名患者才能检测到A组和B组之间OM持续时间有20%的差异。
82例患者纳入最终分析，秋水仙碱组40例，对照组42例。各组间OM的中位持续时间有显著差异；对照组为9天（范围1至17天），而接受秋水仙碱漱口水的患者为6天（范围3至13天）（p = 0.028）。对照组（7天[范围3至20]）与秋水仙碱组（4天[范围2至14]）相比，黏膜病变消退的中位天数有显著差异（p = 0.047）。
尽管我们的研究结果表明秋水仙碱漱口水有助于降低化疗引起的OM的严重程度和持续时间，但仍需要进行随机试验来证实这些结果。
