| Objective The clinical efficacy and safety evaluation of Sancao Yuyang Decoction in the prevention and treatment of oral mucositis(OM)after high-dose methotrexate(HD-MTX)chemotherapy.The mechanism of action of Sancao Yuyang Decoction was analyzed from the perspective of oxidative stress.Lay the foundation for follow-up research and clinical promotion.Methods ①The 76 patients who met the inclusion and exclusion criteria were diagnosed with primary osteosarcoma as the research objects.They were randomly divided into the experimental group of 39 cases and the control group of 37 cases by using the random number table method.Both groups were treated with HD-MTX-containing MAP protocol For chemotherapy,on the basis of routine oral care in both groups,the experimental group was given Sancao Yuyang Decoction and the control group was given Kangfuxin.②Compare the scores of TCM clinical symptoms,oral mucositis grades,and oral condition assessment between the two groups before and after treatment to evaluate the clinical efficacy of the two groups.③Regularly monitor the patient’s blood routine,liver and kidney function,electrolytes,electrocardiogram and other conditions during the study to evaluate the safety of the drug.④The whole blood was drawn from the two groups of patients on the first day and the third day of MAP chemotherapy,and the supernatant was collected by centrifugation to detect the oxidative stress indicators SOD(superoxide dismutase)and GSH-PX(glutathione Peroxidase),GSH(reduced glutathione),LPO(lipid peroxide)and MDA(malondialdehyde)expressions,compare the differences within and between groups before and after intervention,and explore the three herbs The oxidative stress mechanism of Yuyang Decoction.Results ① There was no statistically significant comparison between the test group and the control group in terms of gender,age,location of onset,smoking,and drinking(P>0.05).②The incidence of OM in the experimental group was 43.6%;the incidence of OM in the control group was 67.6%.There was a statistical difference in the incidence of OM between the two groups(P<0.05).③The incidence of OM in patients with a history of smoking was statistically significant(OR=5.000,95%CI 1.014-24.649,P=0.048);the incidence of OM in patients with a history of drinking was not statistically significant(OR=2.667,95%)CI0.502-14.161,P=0.250).④Based on the efficacy evaluation of clinical symptom scores in traditional Chinese medicine,the two groups were compared.In the test group,10 cases were completely relieved,3 cases were markedly effective,3 cases were effective,and 1 case was ineffective;in the control group,5 cases were completely relieved,9 cases were markedly effective,7 cases were effective,and 4 cases were ineffective.For example,the Z value is-2.235,P<0.05,there is a statistical difference between the two groups.⑤Comparing the NCI classification of oral mucositis between the two groups,the Z value was-1.060,P>0.05.There was no statistical difference between the two groups.The incidence of oral mucositis toxicity in the test group was 29.5%,and the control group had Ⅲ-The incidence of grade Ⅳoral mucositis toxicity was 48%.⑥Based on the OAG(Oral Assessment Guideline)scale,comparing the oral conditions of the two groups,the points of the two groups on the 3rd,5th,7,9th,and 11th days,P<0.05,the points of the two groups are statistically different;the points of the two groups on the 0th and 15th days,P>0.05,there is no statistical difference in points between the two groups.⑦In the control group,the content of MDA before and after treatment P<0.05,the content of GSH-PX,GSH,SOD and LPO P>0.05,there was a statistical difference in MDA expression before and after treatment,and there was no statistics on the expression of GSH-PX,GSH,SOD and LPO before and after treatment.Learn the difference.⑧The expressions of antioxidant factors GSH-PX,GSH and SOD in the experimental group were higher than before treatment,and the expressions of oxidative damage factors LPO and MDA were lower than before treatment,P<0.05,and the expression of each oxidative stress index before and after treatment was statistically significant difference.⑨The expressions of GSH-PX,GSH and SOD in the test group were higher than those in the control group after the two groups were treated,and the expressions of LPO and MDA in the test group were lower than those in the control group,P<0.05.There were statistical differences in the oxidative stress indexes between the two groups after treatment.Conclusion ①Compared with Kangfuxin Liquid,Sancao Yuyang Decoction can significantly reduce the incidence of oral mucositis caused by HD-MTX chemotherapy,improve the overall condition of the oral cavity,and reduce the incidence of severe oral mucositis.②Sancao Yuyang Decoction can increase the expression of antioxidant factors SOD,GSH-PX and GSH,and reduce the expression of oxidative damage factors LPO and MDA,thereby reducing oxidative stress damage.③ Sancao Yuyang Decoction has a positive effect,no obvious side effects,high patient acceptance,and it is worthy of further clinical promotion. |