爱维治防治放化疗鼻咽癌所致急性口腔黏膜炎的随机对照多中心研究

摘要

目的 应用爱维治对接受放化疗的鼻咽癌患者进行前瞻性随机对照多中心临床观察,以评价其防治急性几腔黏膜炎的疗效及安全性.方法 161例Ⅱ～ⅣA期初诊鼻咽癌患者随机分为预防组(50例)、治疗组(59例)和对照组(52例).全部患者均接受同期化放疗±诱导化疗,3个组采用的放疗技术和剂龄基本一致.预防组和治疗组分别十放疗第1灭和放疗至出现2级黏膜炎时开始静脉使用爱维治30 ml,1次/d,5 d/周,直至放疗结束.采用NCI CTC 2.0和VRS标准分别评价急性几腔黏膜炎和疼痛程度.结果 可进入疗效评价者154例,其中预防组49例,治疗组53例,对照组52例.预防组和对照组3+4级黏膜炎发生率分别为31%和56%(χ2=6.49,P=0.011),2+3级疼痛发生率分别为59%和83%(χ2=6.81,P=0.009).治疗组与对照组同样发生2级以上黏膜炎的48例患者作比较,其3+4级黏膜炎(38%:60%)和2+3级疼痛发牛率(70%:90%)不同(χ2=5.19,P=0.023;χ2=5.98,P=0.014).预防组比对照组2级黏膜炎发生率明显降低(76%:92%;χ2=5.34,P=0.021),发牛时间明显延长(22 d:18 d;t=2.68,P=0.009).末见明显药物副反应.结论 预防性和治疗性静脉使用爱维治均可明显减轻放化疗引起的急性几腔黏膜炎和疼痛程度,预防性用约还可推迟和减少2级黏膜炎的发生,值得临床推广应用.%Objective To evaluate the efficacy and safety of actovegin against acute oral mucositis through a randomized controlled multicenter trial for nasopharyngeal carcinoma(NPC) patients treated by chemo-radiotherapy. Methods From February 2006 to May 2007,a total of 161 patients with newly diagnosed stage Ⅱ-ⅣA(1992 Fuzhou Stage) NPC were randomly assigned to the prevention group,the treatment group and the control group. All patients received current chemo-radiotherapy ± neoadjuvant chemotherapy. Radiation technique and dose were similar among the three groups. Intravenous infusion of aeovegin was started when radiation started in the prevention group and when grade 2 mueositis occurred in the treatment group,which was given 30 ml daily ,5 times per week until the end of radiotherapy. Criteria of NCI CTC 2.0 and VRS were used to evaluate acute oral mueositis and pain degree,respectively. Results 154 patients were eligible for the efficacy analysis,including 49 in the prevention group,53 in the treatment group and 52 in the control group. In the prevention group and the control group, the incidence was 31% and 56% (P=0.011) for grade 3-4 mucositis,59% and 83% (P=0.009) for grade 2-3 pain. In the treatment group and the control group,the corresponding number was 38% and 60% (P=0.023) ,70% and 90%, (P=0.014). The prevention group had a lower incidence(P=0.021) and longer average interval(P=0.009) of grade 2 mucositis when comparing with the control group. No drug-related adverse event was observed. Conclusions Prophylactic or therapeutic use of actovegin by intravenous infusion can significantly reduce the severity of ehemo-radiotherapy induced oral mucositis and pain. The prophylactic use may also postpone and decrease the incidence of grade 2 mucositis,which deserves clinic application.