摘要
目的应用爱维治时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，以评价处防治急性口腔黏膜炎的疗效及安全性，方法161例Ⅱ～ⅣA期初诊鼻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量基本一致。预防组和治疗组分别于放疗第1天和放疗至出现2级黏膜炎时开始静脉使用爱维治30ml，1次／d，5d／周，直至放疗结束，采用NCI CTC2．0和VRS标准分别评价急性口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％（X^2=6．49，P=0．011），2＋3级疼痛发生率分别为59％和83％（X^2=6．81，P=0．009）、治疗组与照组同样发生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级疼痛发生率（70％：90％）不同（X^2=5．19，P=0．023；X^2=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％；）（X^25．34，P=0．021），发生时间明显延长（22d：18d；t=2．68，P=0．009）。未见明显药物副反应。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口腔黏膜炎和疼痛程度，预防性用约还可推迟和减少2级黏腆炎的发生，值得临床推广应用。
Objective To evaluate the efficacy and safety of actovegin against acute oral mueositis through a randomized controlled muhicenter 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 -Ⅳ A （ 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 acovegin was started when radiatinn started in the prevention group and when grade 2 mucositis 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 mucositis and pain degree,respectively. Results 154 patients were eligible fur 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 conrresponding number was 38% and 60% （ P = 0. 023 ） , 70% and 90% , （ P = 0.0 14 ）. 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 chemo-radiotherapy induced oral mucositis and pain. The prophylactic use may also postpone and decrease the incidence of grade 2 mucositis,which deserves clinic application.
出处
《中华放射肿瘤学杂志》
CSCD
北大核心
2008年第6期422-426,共5页
Chinese Journal of Radiation Oncology
关键词
鼻咽肿瘤/放射疗法
鼻咽肿瘤/化学疗法
急性口腔黏膜炎
爱维治
Nasopharyngeal neoplasms/radiotherapy
Nasopharyngeal neoplasms/chemotherapy
Acute oralmucositis
Actovegin
