Abstract: 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 mucositis 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 mucositis 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 mucositis, alleviate pain and reduce the indication of grade III oral mucositis.

Key words: Oral mucositis, Oral cancer, Radiotherapy