“新净界漱口水”对放射性口腔黏膜炎的防治效果观察

Effect of “Xinjingjie mouthrinse” on prevention and treatment of radiation-induced oral mucositis

目的:前瞻性随机双盲研究"新净界漱口水"对放射性口腔黏膜炎的防治效果。方法 :60例拟行放疗的口腔癌患者随机分为试验组和对照组;试验组30例,自放疗第1天起,每天使用"新净界漱口水"含漱4次,每次5 m L,含漱5 min,直至放疗结束。对照组30例使用生理盐水含漱,方法同试验组。按RTOG口腔黏膜炎分级标准评价2组患者的口腔黏膜炎严重程度,记录疼痛程度,并照相存档。3级口腔黏膜炎视为终止指标,发生者给予其他药物治疗。应用Stata 12.0软件包对数据进行统计分析。结果:2组患者的年龄、性别、放疗技术和剂量无显著差异(P>0.05)。试验组首次观察到黏膜炎的发生时间较对照组晚(照射11.0次∶9.1次,P<0.05),且试验组在早期出现疼痛的比例较对照组低(36.7%∶70.0%,P<0.05)。另外,试验组3级口腔黏膜炎的出现时间较对照组晚(照射18.9次∶15.9次,P<0.05),发生率较对照组低(63.3%∶90.0%,P<0.05)。结论:"新净界漱口水"能延缓放疗所致口腔黏膜炎的发生时间,减轻患者的疼痛症状,并能减少3级口腔黏膜炎的发生率,值得临床使用。

PURPOSE： To investigate the effect of ＂Xinjingjie compound lysostaphin antibacterial collutorium＂ on prevention and treatment of radiation-induced oral mucositis in a prospective, randomized and double-blind clinical trial. METHODS： Sixty patients with oral cancer to be treated with radiotherapy were randomized into the experimental and control group. The experimental group （30 patients） was treated with ＂Xinjingjie mouthrinse＂ during the full course of radiotherapy, 4 times daily with 5 mL and 5 min each time. The control group （30 patients） rinsed the mouth in the same way with normal saline. Oral mucositis was assessed according to the RTOG criteria. The severity of mucositis and the degree of pain were recorded and photographed. Patients shouldn＇t be treated with other drugs until the level of oral mucositis reached above grade III. The results were statistically analyzed using Stata 12.0 software packages. RESULTS： Age, gender, radiotherapy techniques and dose showed no significant difference between the 2 groups （P〉0.05）. The first onset of oral mucositis in the experimental group was later than that in the control group （11.0 times：9.1 times,P〈0.05）, and the incidence of pain at the early time of radiotherapy was lower （36.7%： 70.0%,P〈0.05）. Also, the onset time of grade III oral mueositis in the emperimental group was later than that in the control group （18.9 times： 15.9 times ,P〈0.05）, and the incidence of grade III oral mueositis in the experimental group was lower （63.3% vs. 90.0%, P〈0.05）. CONCLUSIONS： ＂Xinjingjie mouthrinse＂ is worthwhile to be used in clinic because it can delay the occurrence time of radiation-induced oral mueositis, alleviate pain and reduce the indication of grade III oral mueositis.