| Radiation dermatitis(RD)is one of the common clinical radiotherapy-related adverse reactions.Studies have shown that 91.4%of malignant tumor patients will experience RD during radiotherapy,and about 58.1%of patients will terminate radiotherapy due to severe RD.The mainly manifested of RD is skin erythema,dryness,dry peeling and wet peeling.With the accumulation of radiation doses,patients may develop ulcers,hemorrhage,necrosis,infection,which reduces the patient’s quality of life,increases the patient’s symptom burden,and increases risk of tumor recurrence.Patients with breast cancer and head and neck tumors have a high incidence about 9 5%-100%of RD due to factors such as tumor location.A number of clinical studies have been conducted on the prevention and treatment of RD in the past,but there is no high-quality evidence-based evidence,and there is currently no standard protocol for RD prevention.It is clinically found that the incidence of RD in unprotected patients is higher than that in protected patients.Therefore,it is of great significance to explore drugs that can prevent RD for high-risk groups of RD.This paper consists of two parts,including literature review and clinical research.Chapter 1 Literature ReviewThe literature review first summarizes the research progress of RD at home and abroad,including the mechanism of RD,evaluation criteria,treatment and prevention plans.This paper summarizes the mechanism of RD under the theory of modern medicine and traditional Chinese medicine.In view of the current situation of confusing evaluation methods,a single rating standard and multi-dimensional scale for RD are summarized.Summarize the traditional Chinese medicine,western medicine and physiotherapy used in the treatment of RD that have been tested in previous clinical trials.Various therapies for the prevention of RD that are widely used and verified by experiments are summarized,and the important position of preventive drugs in the prevention and treatment of RD is emphasized.Secondly,the research progress of traditional Chinese medicine in preventing and treating radiation skin injury is summarized.The purpose is to explore the advantages of traditional Chinese medicine in preventing and treating radiation-induced skin damage.Chapter 2 Clinical ResearchObjective:This trial included patients with head and neck tumors and breast cancer who were going to undergo radiotherapy as the research objects.To evaluate the efficacy and safety of topical traditional Chinese medicine in preventing RD through an open-label randomized controlled trial design.The advantages of traditional Chinese medicine were used.The prevention of diseases was first,and the focus was moved forward.Methods:From September 2020 to February 2022,a total of 72 patients with head and neck tumors or breast cancer patients who were diagnosed and planned to undergo radiotherapy were enrolled in the oncology department of Guang’anmen Hospital,China Academy of Chinese Medical Sciences in this study.According to the random number,they were divided into experimental group and control group.In addition to routine nursing care,the experimental group was given preventive application of topical Chinese medicine on the day before radiotherapy,and the topical Chinese medicine gel was evenly applied to the skin of the irradiation field for about 20 minutes at a time,2-3 times a day.On the day of the end of radiotherapy,or when RTOG grade Ⅳ skin damage occurs,the use of topical traditional Chinese medicine is stopped.The control group was given routine care.If RTOG grade Ⅱ skin damage occurred,topical traditional Chinese medicine gel was evenly applied to the damaged skin.One application time was about 20 minutes,2-3 times a day.On the day of the end of radiotherapy,or when RTOG grade Ⅳ skin damage occurs,the use of topical traditional Chinese medicine is stopped.Weekly visits until the end of radiotherapy.The incidence and degree of RD,the symptom burden of RD and its impact on quality of life,ECOG score,and adverse events were compared between the two groups at each visit point.The incidence and severity of RD in the two groups were evaluated using the RTOG acute radiation response scoring standard,and the symptom burden of RD in the two groups was evaluated by using Skindex-16.Results:(1)The incidence of RD in the experimental group was lower than that in the control group on the 7th,14th,21st,28th.35th.42nd and the end of the trial in the two groups of patients(P>0.05).At the end of the study,the incidence of RD in the control group was 52.78%,and the incidence of RD in the experimental group was 50%(P>0.05).The occurrence time of RD in the two groups was lower in the experimental group than in the control group(P>0.05).(2)In terms of symptom burden,the emotional dimension of the experimental group was lower than that of the control group on the 21st day of radiotherapy(P=0.03).On the 21st and 28th days of radiotherapy,the symptom dimension score,emotional dimension score,functional dimension score and total score of skindex-16 in the experimental group were lower than those in the control group(P>0.05).On the 28th day,the patients in the test group were less troubled by skin burning or stinging sensation than the control group(P=0.03).On the 21st and 28th day of radiotherapy,the patients’ distress level of skin itching,skin pain distress level,skin burning or stinging sensation level,and skin irritation level were lower in the experimental group than in the control group.(P>0.05).According to the analysis of the trend chart,the scores of each dimension and each symptom in the control group increased earlier than those in the experimental group.On the 7th,21st,28th day of radiotherapy and at the end of the trial,the number of people reporting symptom burden in the experimental group was lower than that in the control group(P>0.05).Linear regression analysis was performed on symptom dimensions,skin pain,burning or stinging sensation on day 28 of radiotherapy.There were differences in symptom dimension(P=7.39,P=0.04),skin pain(P=8.44,P=0.04),and burning or biting sensation(β=8.84,P=0.01).Using Cohen’d as an indicator of effect size.On the 21st day of radiotherapy,the differential effect size of emotional dimension(P=0.03)and total score(P=0.06)reached 0.5.The differential effect size for symptom dimension(P=0.25),burning or biting sensation(P=0.03),and skin pain(P=0.15)on day 28 of radiotherapy reached 0.5.(3)Statistics show that on the 7th day of radiotherapy,skin symptoms(Skindex-16 scale)can be found through patient-reported outcomes,while skin lesions assessed by doctors(RTOG score)can only be manifested on the 21st day of radiotherapy,which is significantly later than self-reported by patients.(4)There was no difference between the two groups in the ECOG score between the experimental group and the control group(P>0.05).In terms of quality of life,the 15 items of the QLQ-C30 scale were analyzed one by one,and there was no statistical difference between the groups(P>0.05).The top five adverse events with the incidence rate during the study period were radiation oral mucositis,bone marrow suppression,upper respiratory tract infection,fever,radiation pneumonitis(P>0.05),and no adverse reactions related to the test drug occurred.(5)Stratified analysis:The incidence of RD in the two groups of patients with head and neck malignant tumors on the 28th,35th,42nd day and the end of the trial was lower than that in the control group(P>0.05).At the end of the study,the incidence of RD in the control group was 80%,and the incidence of RD in the experimental group was 50%(P>0.05).Conclusion:(1)The preventive application of topical traditional Chinese medicine has a tendency to reduce the incidence of RD and delay the occurrence of RD in tumor patients.(2)External use of traditional Chinese medicine has the effect of relieving the patient’s mood,reducing skin burning or biting sensation,and skin pain,and can reduce the overall symptom burden of the patient.(3)The application of external Chinese medicine did not increase the adverse events during radiotherapy,did not affect the quality of life of patients,and reported no adverse reactions,with good safety.(4)Patient-reported outcomes can detect changes in symptoms as early as possible,which is helpful for early intervention and scientific evaluation of the advantages of traditional Chinese medicine.(5)External use of traditional Chinese medicine has a tendency to prevent RD in patients with head and neck tumors. |
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