The Effects Of Different Agents On Prophylaxis And Management Of Acute Radiation Dermatitis On Neck In Nasopharyngeal Carcinoma Patients Receiving Radiotherapy

ObjectiveThis study was undertaken to investigate the clinical effects of new soft silicone foam dressing Mepilex Lite, Kangfuxin and MEBO in radiation-induced dermatitis in nasopharyngeal carcinoma patients receiving radiation therapy. A clinical randomized controlled trial was conducted to compare their effects on prophylaxis and management of acute radiation dermatitis on neck in nasopharyngeal carcinoma patients receiving radiation therapy and evaluate their clinical safety.MethodsThis study was a clinical randomized controlled trial. According to the inclusion and exclusion criteria, patients with nasopharyngeal carcinoma undergoing radiotherapy who were charged in Radiotherapy Department of Hunan Provincial Tumor Hospital between March and October2010were selected as participants of this study. Patients were recruited and randomly divided into Mepilex Lite group, Kangfuxin group and MEBO group with28cases in each group. Except for regular care, patients’irradiated field skin was treated with Mepilex, Kangfuxin and MEBO respectively two days before starting radiotherapy till the end. Data collection instruments included general questionnaire designed by researchers, RTOG and RISRAS (The Radiation-Induced Skin Reaction Assessent Scale) for acute radiation dermatitis. Patients’ neck skin of radiation were assessed weekly as well as on the base line using RISRAS. The RISRAS score was recorded to observe the change of skin situation. This measurement was repeated six times. At the end of measurement all the patients’s skin of irradiated field were graded by using RTOG grading standards. Statistic analysis were performed with SPSS13.0. Statistical methods included statistical description, one way analysis of variance,x2test, repeated measurement ANOVA and Kruskal-Wallis H test.Results1. The comparison of social demographic characteristics of patients with nasopharyngeal carcinoma showed that the differences among three groups were insignificant statistically (P>0.05). The comparsion of clinical diagnosis and treatment data of patients with nasopharyngeal carcinoma showed that the differences among three groups were insignificant statistically (P>0.05). Three groups were well-balanced and comparable.2. The incidence of acute radiation dermatitis in the three groups of patients with grade II or severe acute radiation dermatitis were7.69%,20.0%and37.5%respectively. The incidence of acute radiation dermatitis was significantly different among three groups (Pearson x2=6.647, P=0.036).3. Results of repeated measurements analysis of variance showed that time’s main effect (A) of the RISRAS score was significantly different among three groups (F=2506.049, P<0.001), suggesting that the outcome variable (RISRAS score) was changed with the trend of time. There was an interaction effect between time A and group B (F=12.796, P＜0.001). The main effect (B) of RISRAS score was significantly different among goups (F=51.724, P＜0.001). The presence of an interaction was directly confirmed by the interaction contour map:RISRAS score of different groups basically displayed the same trend with time, gradually increasing as the time went by.4. The results of ANOVA showed that T1-T4the difference of RISRAS score was statistically significant among three groups(P<0.001). The results of SNK test showed that pairwise differences were statistically significant (P<0.05). Compared with control group, the RISRAS score of Mepilex group were significantly lower (P<0.05) than Kangfuxin and MEBO group, but the RISRAS score had no significant difference between Kangfuxin and MEBO group at T1-T2(P>0.05). At T3-T4pairwise differences were statistically significant among three groups (P<0.05). At T5-T6Kruskal-Wallis H test was used and showed statistically significant difference among there groups (P<0.05).5. Security analysis:Among three groups of patients, one case of allergic reaction was reported by the patient and then withdrawed from this study due to Mepilex dressing. Other adverse drug reactions such as skin rashes and so on were not found in other patients.Conclusion1. Mepilex Lite and Kangfuxin are effective on the prophylaxis and manament of acute radiation-induced dermatitis on neck in patients with nasopharyngeal carcinoma. The prophylactic use of Mepilex and Kangfuxin can effectively reduce the incidence of acute radiation skin toxicity caused by radiotherapy.2. The radiation-induced dermatitis symptoms get worsen with the increasing overall radiation dose. And Mepilex and Kangfuxin can attenuate radiation-induced dermatitis by exerting protective effects.3. In terms of clinical effects on the prophylaxis and management of acute radiation dermatitis, Mepilex Lite can prevent irradiated skin from radiation-induced injuries, relieve radiation-induced dermatitis symptom and promote comfort. The effect of Mepilex is better than than that of kangfuxin and MEBO and Kangfuxin is better than MEBO.4. Mepilex and Kangfuxin have good clinical safety and are worthy of large scale clinical application.