桑葚羹防治放射性口腔干燥的临床研究

Clinical Effect of Sangshen Soup on Prevention and Treatment of Radiation-Induced Xerostomia

目的:观察桑葚羹防治放射性口腔干燥(radiation-induced xerostomia,RX)的临床疗效。方法:采用多中心、前瞻、双盲随机对照的临床设计,将90例接受放疗的头颈部肿瘤患者随机分为治疗组和对照组,治疗组放疗同时服用桑葚羹,对照组服用安慰剂,直至放疗结束。观察两组口干症状评分、口腔粘膜反应评分、口腔疼痛评分、口腔干燥出现时间、接受的放射剂量、LASA生活质量评分、karnofsky评分以及安全性指标。结果:最终纳入可评价患者80例,治疗组39例,对照组41例。两组患者在年龄、性别、放疗后辨证分型、接受的放射剂量等一般情况均无统计学差异(P>0.05)。治疗组患者从21 d开始至试验结束,口干评分、口腔粘膜反应评分、口腔疼痛评分均明显低于对照组(P<0.05),而两组患者口干出现的时间和放射剂量均无统计学差异(P>0.05)。试验结束时治疗组KPS评分明显高于对照组(P<0.05),而LASA生活质量量表中食欲、睡眠两个维度评分治疗组明显高于对照组(P<0.05),一般活动、精神状态、情绪、与人交往、生活兴趣、总分等方面两组之间无统计学差异(P>0.05)。两组患者试验过程中RBC、HB、WBC、PLT、ALT、AST、BIL、BUN、Cr等指标均无统计学差异(P>0.05)。结论:持续口服3 w后,桑葚羹可有效减轻放射性口腔干燥,改善患者食欲、睡眠,提高患者生活质量,且临床应用安全可靠。

Objective:To observe the clinical efficacy of Sangshen Soup in preventing and treating radiation-induced xerostomia(RX).Methods:In this multi-center,prospective,double-blind,and randomized controlled trial,90 patients undergoing radiotherapy for head and neck tumors were randomly divided into a treatment group and a control group.Patients in the treatment group were treated with Sangshen Soup,while those in the control group with placebo until the end of radiotherapy.The scores of dry mouth,oral mucosal reaction,and oral pain,occurrence time of xerostomia,received radiation dose,the LASA quality of life score,karnofsky score,and safety indicators were observed.Results:A total of 80 evaluable patients were finally included,involving 39 in the treatment group and 41 in the control group.There was no statistical difference in such general information as age,gender,syndrome differentiation after radiotherapy,or received radiation dose of patients between the two groups(P>0.05).The scores of dry mouth,oral mucosal reaction,and oral pain in the treatment group were lower than those in the control group after the 21-d treatment(P<0.05),while the occurrence time of xerostomia and the radiation doses of the two groups were not statistically different from each other(P>0.05).After treatment,the KPS score and the appetite and sleep scores in LASA quality of life scale of the treatment group were significantly higher than those in the control group(P<0.05).No statistical difference was observed in general activities,mental state,mood,interaction with people,interest of life or total score between the two groups(P>0.05).During the treatment,there was no statistical difference in RBC,HB,WBC,PLT,ALT,AST,BIL,BUN,or Cr between the two groups(P>0.05).Conclusion:After three weeks of oral administration,Sangshen Soup effectively alleviates RX and improves the appetite,sleep,and the life quality of patients without inducing obvious side effects.