Effect Observation On Kangfupen Solution In Treatment And Prevention Of Acute Radiotherapy-induced Oral Mucositis

PurposeTo observe and evaluate the efficacy of Kangfupen Solution on acute mucositis induced by radiotherapy in head and neck cancer patients.MethodsThe trial was a multicenter,randomized controlled trial conducted at the Oncology Department of the Jiangsu Cancer Hospital and the Northern Jiangsu People’s Hospital Hospital.Select head and neck tumors(including nasopharyngeal carcinoma,left cervical squamous cell carcinoma,oropharyngeal cancer,root cancer,laryngeal malignant tumor,parotid malignant tumor,tongue root squamous cell carcinoma)that meet the inclusion criteria,complete clinical data,and signed informed consent.)patient enrollment.The random assignment code was simulated on the computer using SAS 9.1.3 software,and the subjects entered the test group or the control group according to the order of treatment.From 3 days before radiotherapy to one week after the end of radiotherapy,the test group and the control group were treated with Kangfupen Solution or saline respectively.The incidence of ROM and oral pain,the time of occurrence of ROM at various levels,and the cumulative dose were compared between the two groups by observing the patient’s functional status,dysphagia,and oral mucositis grading.The safety of clinical application was evaluated by analyzing the changes in basic vital signs(including indicators such as respiration,blood pressure,body temperature,resting heart rate,etc.)and drug-related adverse events.ResultsThe trial plan enrolled 108 patients,108 patients were actually enrolled,and 97 patients were completed(97 patients with the final validity of the analysis,including 46 in the experimental group and 51 in the control group),11 patients in the fall,and 0 in the rejection group.The completion rate was 90%,the dropout rate was 10%,and the rejection rate was 0%.Compared with the control group,the incidence of severe ROM in the test group was significantly lower(p<0.05),and the incidence of grade Ⅲ ROM in the test group and the control group were 8.70%,33.33%,respectively,and the difference was statistically significant(p=0.00).The incidence of grade III dysphagia in the test group and the control group were 13.04%.35.19%,respectively,and the difference was statistically significant(p=0.00).The time of oral mucositis in the experimental group and the control group were 14.15±7.30d、23.52±9.16d、32.50±5.92d and 9.69±8.10d、19.02±7.17d、25.50±4.59d(p=0.013,p=0.014,p=0.010,respectively).The cumulative doses of oral mucositis at all levels were 21.11±11.71 Gy、35.02±13.04Gy、50.22±7.99Gy and 15.85±12.07Gy、29.38±11.63Gy、40.44±6.78Gy(p=0.032,p=0.053,p=0.009,respectively).During the whole experiment,2 patients in the control group were out of the group due to severe radiotherapy side effects.There were 2 cases and 1 case of adverse events in the test group and the control group.There were no obvious drug-related adverse events in the two groups.ConclusionKangfupen Solution can delay the occurrence time of oral mucositis at all levels and improve the tolerated dose of acute oral mucositis at all levels in patients.