| BackgroundRadioactive dermatitis is an inflammatory skin damage caused by radiation,which brings great pain to patients,seriously affects the quality of life of cancer patients and the efficacy of radiotherapy.Scholars at home and abroad have tried to use a variety of drugs or methods to prevent and treat acute radiation dermatitis,but there is still no ideal drug or method for clinical use.Traditional Chinese medicine believes that radiation is a kind of pathogenic heat and toxin.The etiology and pathogenesis of acute radiation injury in patients with nasopharyngeal carcinoma are excessive heat and deficiency of both Qi and Yin.Therefore,the treatment of Chinese medicine should mainly focus on clearing heat and detoxification,enriching Qi and nourishing Yin.Some scholars have tried to use compound Kushen injection with clearing away heat and detoxifying effect to treat acute radiation injury of patients with nasopharyngeal carcinoma,and achieved a good effect.The main active ingredient of Compound Sophora Flavescens Injection is matrine.Modern pharmacological studies have found that matrine has a strong free radical scavenging effect.Radiation-induced free radicals play an important role in the occurrence of radiobiological effects.Therefore,we speculate that the mechanism of radioprotective effect of Compound Sophora Flavescens Injection may be due to its free radical scavenging effect.In order to verify whether Compound Sophora Flavescens Injection can alleviate acute radiation dermatitis and elucidate its mechanism,we have carried out basic and clinical research progress.Ⅰ、Effects of Compound Sophora Flavescens Injection on proliferation and apoptosis of human skin fibroblasts after radiationPurposeTo observe the effect of Compound Sophora Flavescens Injection on proliferation and apoptosis of human skin fibroblasts(HSF)after radiation,to evaluate whether Compound Sophora Flavescens Injection has radioprotective effect on HSF,and to explore its mechanism.MehthodsHSF cells were cultured in logarithmic phase and randomly divided into blank control group,simple radiation group and drug radiation group.Blank control group:no administration,no irradiation;simple radiation group:only irradiation,no administration;drug radiation group:irradiation after administration.Methyl thiazolyl tetrazolium assay(MTT)was used to detect the effect of Compound Sophora Flavescens Injection on HSF proliferation.Flow cytometry was used to detect the effect of Compound Sophora Flavescens Injection on HSF apoptosis.DCFH-DA fluorescent probe was used to detect intracellular oxygen free radicals.ResultsThe proliferation rate of HSF increased slightly after treatment with Compound Sophora Flavescens Injection for 24h,48h and 72h,and the effects of Compound Sophora Flavescens Injection on HSF were not toxic in the concentration range of 1mg/ml to 16mg/ml.The proliferation rate of HSF in radiation group and drug radiation group was(60.23±3.28)%,(82.81±2.94)%.The proliferation rate of HSF in drug radiation group was higher than that in radiation group.The difference was statistically significant(P<0.05).The apoptosis rate of HSF in radiation group and drug radiation group was(5.7±0.6)%,(1.9±0.3)%.The difference was statistically significant(P<0.05).After liquid treatment,the oxygen free radical activity of HSF in drug radiation group was significantly lower than that in simple radiation group(P<0.05),and the difference was statistically significant.Conclusion1.Compound Sophora flavescens injection can inhibit radiation-induced apoptosis of HSF and promote the proliferation of HSF after radiation.2.Compound Sophora flavescens injection has radioprotective effect on HSF by scavenging oxygen free radicals produced by radiation.Ⅱ、Radiosensitization of Compound Sophora Flavescens Injection on nasopharyngeal carcinoma CNE-2 cellsPurposeTo observe the effect of Compound Sophora Flavescens Injection on radiosensitivity of human nasopharyngeal carcinoma CNE-2 cells and explore its mechanism.MethodsHuman nasopharyngeal carcinoma CNE-2 cells were cultured in vitro.The proliferation inhibition rates of CNE-2 cells treated with different concentrations of Compound Sophora Flavescens Injection for 24,48 and 72 hours were detected by MTT method.The semi-inhibitory concentration(IC50)of Compound Sophora Flavescens Injection on CNE-2 cells was calculated.CNE-2 cells were divided into blank control group,radiation group and drug radiation group.Blank control group:no administration,no irradiation;simple radiation group:only irradiation,no administration;drug radiation group:irradiation after administration.The radiation group was treated with 2Gy and 4Gy X-ray irradiation,and the drug radiation group was treated with a certain concentration of Compound Sophora Flavescens Injection and then received the same dose of X-ray irradiation.MTT assay was used to detect the inhibition rate of cell proliferation,flow cytometry was used to detect the apoptotic rate of cells,and clone formation test was used to detect the survival rate of cells.ResultsIC50 of CNE-2 cells treated with Compound Sophora Flavescens Injection for 24,48 and 72 hours were 14.53,5.46 and 7.10 mg/ml,respectively.The toxicity of Compound Sophora Flavescens Injection to CNE-2 cells was dependent on dose and time.When the treatment time was 0-48 hours,the inhibition rate of Compound Sophora Flavescens Injection on CNE-2 cells was positively correlated with the treatment time,and the time-effect relationship was statistically significant(P<0.05).Therefore,48 hours was chosen as the time of treatment of CNE-2 cells by Compound Sophora Flavescens Injection,and 1/5 of IC50 was chosen to determine the radiosensitization of drugs.The inhibition rates of proliferation of CNE-2 cells in drug-radiation group were(54.10±2.77)%、(57.18±4.30)%,in simple radiation group were(37.97±2.38)%、(40.56±1.72)%.The difference was statistically significant(P<0.05).The apoptotic rates of CNE-2 cells in drug-radiation group and radiation group were(8.3±2.6)%and(4.3±1.0)%,respectively,and the survival rates were(33.5±3.8)%and(42.3±3.6)%.The difference was statistically significant(P<0.05).Conclusion1.Compound Sophora flavescens injection can increase the radiosensitivity of nasopharyngeal carcinoma CNE-2 cells,and its mechanism is mainly to promote radiation-induced apoptosis of CNE-2 cells.2.Compound Sophora flavescens injection has radioprotective effect on human skin fibroblasts,and radiosensitizing effect on nasopharyngeal carcinoma CNE-2 cells,which meets the basic requirements of radioprotective agents.Ⅲ、Clinical researchPurposeIn this study,a randomized controlled trial design was used to evaluate the clinical efficacy of Compound Sophora Flavescens Injection in alleviating acute radiation dermatitis and lay a foundation for large-scale clinical trials.MethodsSixty-two patients with nasopharyngeal carcinoma were randomly divided into control group and experimental group.All patients received radical radiochemical therapy.From the first day to the end of radiotherapy,the patients in the experimental group received 20 ml of Compound Sophora Flavescens Injection+NS250ml daily intravenously,and received routine nursing and symptomatic support treatment,while the patients in the control group received the same routine nursing and symptomatic support treatment as the experimental group.To observe the severity of acute radiation dermatitis and other radiation injury after radiotherapy in two groups,to understand the quality of life of patients after radiotherapy,and to evaluate the short-term efficacy of nasopharyngeal carcinoma patients.Results1.Baseline of clinical trialsFrom June 2014 to July 2018,62 patients with nasopharyngeal carcinoma admitted to the Department of Radiotherapy of Guangdong Province Traditional Chinese Medical Hospital were randomly divided into two groups.During the course of treatment,2 patients withdrew from the clinical trial because of their personal wishes,and the remaining 60 patients completed the trial smoothly as planned.There was no significant difference in age,sex,occupation and education level between the two groups(P>0.05).The clinical factors affecting acute radiation dermatitis,such as KPS score,body mass index,tumor stage,chemotherapy,TCM syndromes,had no significant difference between the two groups(P>0.05),which was comparable.2.Grading comparison of acute radiation dermatitisAt the end of radiotherapy,the incidence of grade Ⅲ and IV radiation dermatitis was 30.0%and 13.3%in the experimental group,56.7%and 20.0%in the control group,respectively.The incidence of severe radiation dermatitis in the experimental group was lower than that in the control group,with statistical significance(P<0.05).When the total dose of radiotherapy was more than 40 Gy,the RISRAS score of acute radiation dermatitis in the experimental group was lower than that in the control group,and the difference was statistically significant(P<0.05).3.Other acute radiation injuriesThe incidence of grade Ⅲ and IV acute radiation-induced oral mucositis in the experimental group was lower than that in the control group(P<0.05).There was no significant difference in the severity of acute radiation injury of salivary gland between the two groups(P>0.05).There was no significant difference in the severity of hematological toxicity between the two groups(P>0.05).4.Comparison of quality of lifeAfter radiotherapy,the scores of emotional state(EWB),functional state(FWB),head and neck module(H&N)and total quality of life in the experimental group were higher than those in the control group(P<0.05),but there was no significant difference in physical and physiological status(PWB)and social and family status(SWB)between the two groups(P>0.05).5.Comparison of short-term efficacyThe complete remission rate(CR)and partial remission rate(PR)of the control group were 80.0%and 20.0%respectively,while the CR and PR rates of the experimental group were 66.7%and 33.3%respectively.There was no significant difference in short-term efficacy between the two groups(P>0.05).6.Change of TCM Syndrome TypeAfter radiotherapy,the number of cases of Accumulation of Heat and Deficiency of Fluid Syndrome and Qi-Yin Deficiency Syndrome in the two groups increased compared with that before radiotherapy,but the number of cases of Accumulation of Heat and Deficiency of Fluid Syndrome and Qi-Yin Deficiency Syndrome in the experimental group was fewer than that in the control group.The difference of distribution of TCM syndromes in the two groups after radiotherapy was statistically significant(P<0.05).Conclusion1.Compound Sophora flavescens injection can effectively reduce the severity of acute radiation dermatitis in patients with nasopharyngeal carcinoma during radiotherapy,and will not affect the short-term efficacy of radiotherapy.2.Compound Sophora flavescens injection during radiotherapy can improve the overall quality of life of patients with nasopharyngeal carcinoma.3.Sophora flavescens injection can alleviate the influence of heat and toxicity on the body during radiotherapy for nasopharyngeal carcinoma patients,and reduce the situation of Qi Deficiency Syndrome and Yin Deficiency Syndrome after radiotherapy for nasopharyngeal carcinoma patients. |
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