清热敛阴汤干预头颈部肿瘤放疗后放射性口腔黏膜炎及口干症临床研究

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

目的 观察清热敛阴汤对头颈部肿瘤患者放疗引起的口干和放射性黏膜炎防治效果。方法 采用项前瞻性随机对照研究,将2021年1月-2022年12月江阴市人民医院收治的80例头颈部肿瘤行首次放疗患者按1∶1比例随机至试验组及对照组;试验组放疗期间口服清热敛阴汤(至口腔黏膜炎症状消失停服);对照组仅当患者出现≥2级以上黏膜炎时应用利多卡因、地塞米松和庆大霉素混合液含服对症处理。比较两组放疗前、放疗期间、放疗后唾液腺功能及口腔黏膜炎分级等。结果 放疗10次,对照组2级放射性口腔黏膜炎5例,试验组0例,组间比较差异无统计学意义(P>0.05);放疗20次、放疗结束,试验组放射性黏膜反应均轻于对照组(P<0.05)。放疗结束后1、2、3、4周,试验组放射性黏膜反应平均分级均小于对照组(P<0.05),放疗10次、20次、放疗结束,试验组口感分级均轻于对照组(P<0.05);放疗结束后3个月,试验组口感分级均轻于对照组(P<0.05);放疗结束后6、9、12个月,两组口干程度比较,差异无统计学意义(P>0.05),放疗前两组患者唾液腺超声评分均为阴性,放疗结束时,试验组唾液腺超声评分小于对照组(P<0.05);放疗结束后3、6、9、12个月,两组唾液腺超声评分均有下降,放疗结束后3、6个月,试验组唾液腺超声评分小于对照组(P<0.05),放疗结束9、12个月,两组唾液腺超声评分比较,差异无统计学意义(P>0.05)。结论 清热敛阴汤对干预放疗引起的放射性口腔黏膜炎及口干症有效;唾液腺超声对于评估放射性口干症严重程度有一定参考价值。

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 radiation-inducedxerostomia.