安卡合并放射治疗鼻咽癌5年随访观察

A Clinical Trial of Irisquinones in Combination with Radiation Therapy in Nasopharyngeal Carcinoma

目的:马蔺子素(安卡胶囊)是从中草药马蔺子(Irisquinones)的种皮中所提取出来的一种醌类化合物,为观察安卡合并放射治疗鼻咽癌的增敏疗效进行本次观察.方法:1995年3月～1996年3月在广州中山医科大学附属肿瘤医院,将病理证实为鼻咽癌Ⅰ～Ⅳa期('92福州分期)的患者104例,随机分为单纯放疗组(简称单放组)52例和马蔺子素与放射联合治疗组(简称药放组)52例进行临床观察。采用Co60治疗机、能量为1.25MeV的γ射线连续照射,常规放疗。结果:5年生存随访结果提示:单放组5年生存率66%,药放组5年生存率67%,药放组生存率高于单放组,但是无统计学差异(P>0.05);同时还比较了两组患者在张口困难、听力下降、脑脊髓病等远期反应的发生率,无统计学差别。通过生存统计(Cox)模型,筛选出影响生存的主要因素是患者分期的早晚和是否出现放疗失败。结论:安卡配合放射治疗鼻咽癌能否提高远期疗效,仍需追踪观察和扩大病例、以及增加病种试验。

Objective: To compare the long-term survival of patients with nasopharyngeal carcinoma (NPC) who were treated with conventional radical radiotherapy (RT) plus Anka capsule (Irrisquinnones) and radiotherapy alone. Methods: 104 patients with histologically proven nasopharyngeal carcinoma were entered. They were randomized to receive Irradiation aid conventional radiotherapy (52 patients) or radiotherapy alone (52 patients). All patients received radical radiotherapy to the nasopharynx and neck with 60Co 1.25 Mev rays. Standardized external was delivered using prescribed tumor doses determined by clinical stage. Irrisquinnones was administered by 140mg/m2/day (70mg/m2 twice daily), to start one day before the onset of radiotherapy and then throughout the course of treatment. Results: After a median follow-up of 5 years, the 5-year overall survival rate for RT group was 66%, RT with Anka group was 67%, but the deference was no statistic(P>0.05). Conclusion: This prospective randomized trial has demonstrated the benefit of Irrisquinones to radiotherapy in the treatment of nasopharyngeal carcinoma. Still it is necessary to follow-up to demonstrate the efficacy of Irrisquninones associated with irradiation increasing the long-term survival rate.