| [Objective]To observe the clinical efficacy of modified Yangyin Qingfei Decoction in the prevention and treatment of radiation induced xerostomia,and provide objective evidence for the prevention and treatment of radiation induced xerostomia with traditional Chinese medicine.[Methods]A total of 68 patients who met the inclusion criteria and were hospitalized in Jiaxing First Hospital from September 2021 to December 2022 were randomly divided into treatment group and control group,with 34 patients in each group.The control group was treated with radiotherapy and conventional treatment while the treatment group was treated with oral Chinese medicine Yangyin Qingfei Decoction,with a dose of 100ml/time,twice a day,from the first day of radiotherapy to the end of radiotherapy.Adverse reactions during treatment in both groups were treated in the same routine symptomatic manner.Xerostomia questionnaire Chinese version,VAS score,and TCM Syndrome Score were used to record the two groups of related indicators;The unstimulated whole saliva was measured every 2 weeks in both groups;The severity of acute radiation induced salivary gland injury,adverse reactions,and safety indicators were recorded in both groups;The number of cases of radiation induced xerostomia accumulated to different radiation doses during radiotherapy was statistically analyzed.SPSS 25 statistical software was used for statistical analysis.[Results]1.A total of 68patients were included in this study.During the study period,one patient was excluded from the treatment group(due to throat pain and severe oral ulcers,who refused to take traditional Chinese medicine and fell off),while two patients were excluded from the control group(one patient fell off due to excessive entries in the scale and refused to cooperate with the test,and one patient fell off due to refusal to cooperate with unstimulated whole saliva measurement).The rest of the patients completed the test as required.The final cases included in the statistical analysis were 65 cases,33 cases in the treatment group and 32 cases in the control group;Comparison of baseline data such as gender,age,tumor stage,XQ-C before intervention,VAS score,TCM syndrome score,ECOG score,and UWS between the two groups showed no significant difference(P>0.05),and the two groups were equally comparable.2.Xerostomia Questionnaire Chinese version:The total effective rate in the treatment group was 87.88%,while the total effective rate in the control group was 59.38%.According to the rank sum test,Z=-1.924,P=0.045<0.05,and there was a statistically significant difference in the efficacy between the two groups after treatment.3.Grading of dry mouth in the two groups:The number of cases of G1,G2,G3,and G4 was calculated based on the VAS score.The lower the score,the lighter the degree of dry mouth;There was a significant difference in the degree of dry mouth between the two groups(Z=-2.589,P=0.01<0.05),indicating that the degree of dry mouth in the test group was relatively mild.4.Acute radiation induced salivary gland injury:There was no significant difference in the degree of salivary gland injury between the two groups at the second week of radiotherapy(P>0.05);At the 4th and 6th weeks of radiotherapy,the degree of salivary gland damage in the treatment group was lighter than that in the control group,with a statistically significant difference(χ2=6.52,P=0.031<0.05).5.Unstimulated Whole Saliva:With the accumulation of radiation dose,the saliva flow rate in both groups showed a downward trend,with a significant difference compared to before radiotherapy(P<0.05).However,the decrease in the treatment group was milder than that in the control group,with a decrease rate of nearly 50%in the 2-4 weeks of the control group,while the decrease rate in the treatment group was 39.9%,with a significant difference(P<0.05).One month after radiotherapy,the saliva flow rate in both groups increased slightly compared to that at the end of radiotherapy,but the saliva flow rate in the treatment group increased more,with an increase of about 14.63%in the treatment group.However,the recovery trend of the saliva flow rate in the control group was not significant,with 5.45%.There was a significant difference between the two groups(P<0.05).6.Comparison of curative effects of TCM syndromes:the total effective rate in the treatment group was 84.8%,while the total effective rate in the control group was 53.1%;After treatment,there was a statistically significant difference between the two groups,Z=-2.339,P=0.036<0.05,indicating that the treatment group was superior to the control group in improving TCM syndromes.7.The number of cases of radiation induced xerostomia in the two groups accumulated to the same radiation dose:The number of cases of xerostomia in the test group was significantly lower than that in the control group when the two groups accumulated to the same radiation dose.By rank sum test,Z=-1.483,P=0.017<0.05,with statistical significance.[Conclusion]Modified Yangyin Qingfei Decoction can effectively alleviate the degree of acute radiation induced salivary gland injury,effectively delay the occurrence of radiation induced xerostomia by improving the salivary flow rate,significantly reduce the degree of xerostomia,and has high safety. |
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