放化疗结合肿节风治疗鼻咽癌的多中心临床研究

Multicenter Study of Radiotherapy Combined with Sarcandra Glabra for Nasopharyngeal Carcinoma

目的观察肿节风防治鼻咽癌同期放化疗毒副反应的临床疗效。方法 2006年6月至2008年8月经由病理活检确诊、初治的接受同期放化疗的Ⅲ～IVa期鼻咽癌患者100例,于放疗前3天开始口服肿节风,一次10g,一日3次,持续到放疗结束。放疗采用常规放疗方案,化疗采用PF方案,选择同期接受调强适型放疗联合PF方案同期化疗的100例Ⅲ～IVa期鼻咽癌患者进行对照研究。结果①两组原发灶和颈部淋巴结转移灶有效率100%,试验组原发灶及颈部淋巴结CR为69%,73%,对照组为80%,81%,差异无统计学意义。②两组急性放射反应中,白细胞下降及口干的发生率差异无统计学,而口腔黏膜炎及皮肤反应,对照组发生率及严重程度均低于试验组。③试验组的1年及2年总生存率、无瘤生存率、复发率以及远处转移率分别为:97%、86%;92%、70%;3%、11%;6%、19%;对照组为100%、93%;97%、81%;1%、5%;2%、12%,差异无统计学意义。④两组口干及放射性龋齿的发生率差异无统计学意义;张口困难及颈部软组织纤维化的发生率差异有统计学意义,对照组低于试验组。结论调强放疗在正常器官组织保护方面仍有着绝对的优势,而加用肿节风后的常规放疗组,对唾液分泌减少引起的口干及放射性龋齿有显著的缓解作用,可改善患者的生存质量,对于腮腺的保护接近调强放疗的效果。

Objective To observe the clinical effect of Sarcandra Glabra.Methods 100 patients with non-metastatic nasopharyngeal carcinoma in stage III^IVa and untreated before accepted the treatment plan of Sarcandra Glabra combined with chemoradiation in June 2006 to August 2008.Oral intake Sarcandra 3 days before the radiation therapy,once 10g,three times a day,until the end of treatment.Radiotherapy with conventional radiotherapy protocol,chemotherapy with PF program,100 cases were chosen who were staging III^IVa and received intensity modulated radiotherapy combined with concomitant chemotherapy for the program PF as the control study.Results ① Two groups of primary and cervical lymph node metastases,efficience rate are 100%,the test group primary and cervical lymph nodes CR is 69%,73%,and the control group is 80%,81%.There is no significant difference between them.②Two groups of acute radiation reactions,leukopenia,and xerostomia are of no difference.The incidence and severity of oral mucositis and skin reaction in control group were lower than test group.③In test group,the 1 year and 2 years,overall survival,disease-free survival,recurrence rate and distant metastasis rates were： 97%,86%,92%,70%,3%,11%,6%,19%;control group was 100%,93%,97%,81%,1%,5%,2%,12%.The difference was not statistically significant.④There is no statistically difference between two groups of xerostomia and the rate of radioactive tooth decay.There is statistically difference between two groups of difficulty in opening mouth and skin fibrosis,the control group is lower than the test group.Conclusion Intensity-modulated radiation therapy in normal organ tissue protection still has an absolute advantage.But combined chemoradiation plus sarcandra has a significant remission effect on the xerostomia and radioactive tooth decay caused by the deficiency of saliva secretion and it can improve the quality of patients＇ lives.It can protect parotid glands as well as intensity-modulated radiation therapy.