Clinical Study on the Intervention of Traditional Chinese Medicine Formula Qingre Lianyin Decoction(清热敛阴汤)in Managing Radiation-Induced Mucositis and Xerostomia for Head and Neck Tumors
Objective o observe the preventive and therapeutic effects of Qingre Lianyin Decoction on radiation-induced xer-ostomia and mucositis in patients with head and neck tumors undergoing radiotherapy.Methods Using a prospective randomized controlled study design,80 patients with head and neck tumors who underwent their initial radiotherapy treatment at Jiangyin Peo-ples Hospital between January 2021 and December 2022 were randomly allocated in a 1:1 ratio to the experimental group and control group.The experimental group received oral administration of Qingre Lianyin Decoction during the course of radiotherapy(discontinued upon resolution of symptoms associated with oral mucositis),while the control group solely received symptomatic treatment comprising orally administered lidocaine,dexamethasone,and gentamicin mixed solution when grade≥2 mucositis was observed.Salivary gland function and grading of oral mucositis were compared between the two groups before,during,and after radiotherapy.Results After 10 fractions of radiotherapy,there were 5 cases of grade 2 radiation-induced oral mucositis in the control group,while there were no cases in the experimental group.The difference between the groups was not statistically signif-icant(P＜0.05).After 20 fractions of radiotherapy and at the end of treatment,the radiation-induced mucosal reactions in the experimental group were milder than those in the control group(P＜0.05).At weeks 1,2,3,and 4 after completion of radio-therapy,the average grading of radiation-induced mucosal reactions in the experimental group was lower than that in the control group(P＜0.05).For both 10 and 20 fractions of radiotherapy as well as at treatment completion,xerostomia grading in the ex-perimental group was lighter than that in the control group(P＜0.05).At three months after treatment completion,xerostomia grading in the experimental group remained lighter compared to that in the control group(P＜0.05).At 6,9,and 12 months af-ter the completion of radiotherapy,there was no statistically significant difference in the severity of xerostomia between the two groups(P＜0.05).Before radiotherapy,both groups had negative salivary gland ultrasound scores.However,at the end of ra-diotherapy,the experimental group had lower salivary gland ultrasound scores compared to the control group(P＜0.05).At 3,6,9,and 12 months after radiotherapy completion,both groups showed a decrease in salivary gland ultrasound scores.At 3 and 6 months post-radiotherapy,the experimental group had lower scores than the control group(P＜0.05),while at 9 and 12 months post-radiotherapy there was no statistically significant difference between the two groups(P＜0.05)regarding salivary gland ultrasound scores.ConclusionsThe effectiveness of Qingre Lianyin Decoction in managing radiation-induced oral mucositis and xerostomia has been demonstrated,while salivary gland ultrasound holds some reference value for assessing the severity of radi-ation-induced xerostomia.
head and neck tumorsradiation-induced xerostomiaoral mucositisQingre Lianyin Decoction(清 热敛阴汤)ultrasound evaluation
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