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含rhGM-CSF漱口液治疗放射性口腔黏膜炎的前瞻性随机对照研究 被引量:24

Efficacy of rhGM-CSF in treatment of radiation-induced oral mucositis:A prospective randomized controlled trial
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摘要 目的:采用含重组人粒-巨噬细胞集落刺激因子(recombinant human granulocyte-macrophage-colony stimulating factor,rhGM-CSF)漱口液治疗鼻咽癌患者放射性口腔黏膜炎,并探讨其临床疗效及安全性。方法:将60例鼻咽癌放化疗患者(放疗总剂量为70 Gy)随机分为2组,自患者口腔黏膜炎出现起分别给予含rhGMCSF(1μg/mL)漱口液或复方氯己定漱口液(对照组)治疗,每日含漱4次,每次25 mL,每次含漱3 min,至口腔黏膜炎愈合或用药14 d后停药。记录患者口腔黏膜损伤程度、疼痛程度、咀嚼吞咽功能、停药时间及不良反应等情况。结果:2组患者用药7 d后,rhGM-CSF组口腔黏膜损伤程度较对照组明显减轻,美国国立癌症研究所通用不良事件标准3.0(National Cancer Institute-Common Terminology Criteria Adverse Events version 3.0,NCI-CTCAE v3.0)评分值分别为1.36±1.29和2.04±0.96(P=0.034);rhGM-CSF治疗组中口腔黏膜炎完全治愈的患者为11例(44.0%),而对照组仅4例(14.3%),差异有统计学意义(P=0.017);14 d后,治愈率分别为72.0%(18/25)和28.6%(8/28),治愈率被明显提高,差异有统计学意义(P=0.002)。用药期间,含rhGMCSF的漱口液能明显降低患者口腔黏膜损伤程度(P<0.001)和疼痛程度(P<0.001),明显改善患者口腔咀嚼吞咽功能(P<0.001)。结论:rhGM-CSF能显著提高放射性口腔黏膜炎的治愈率,有效降低口腔黏膜损伤程度和疼痛程度,改善患者咀嚼吞咽功能,促进口腔黏膜损伤愈合,以保证放化疗的顺利进行。 Objective: The aim of this study was to evaluate the efficacy and safety of recombinant human granulocyte macrophage colony-stimulating factor (rhGM-CSF) in treatment of nasopharyngeal cancer with radiation-induced oral mucositis. Methods: Sixty patients with nasopharyngeal cancer who received radiation (70 Gy) and chemotherapy were randomly divided into two groups: the patients (n = 30) in the experiment group rinsed their mouths with 25 mL of rhGM-CSF solution (1 μg/mL) for 3 minutes a time and four times daily from the occurrence of oral mucositis until the healing in the oral mucosa or completing 14 days of mouth rinse; the patients (n = 30) in the control group received chlorhexidine with the same dosage and administration. The serverities of mucosal damage and oral pain, the swallowing functions, time to treatment discontinuation and adverse reactions were recorded. Results: As compared with the control group, the degree of mucosal damage in the experiment group was significantly reduced with a lower score (2.04±0.96 vs 1.36±1.29, P = 0.034) after 7 days of rhGM-CSF administration. The numbers of patients with complete oral mucosal healing in the experiment group and the control group were 11 (44.0%) and 4 (14.3%), respectively (P = 0.017); the rates of oral mucosal healing were 72.0% (18/25) and 28.6% (8/28), respectively (P = 0.002) after 14 days of administration. The degrees of mucosal damage and oral pain were obviously reduced and the swallowing functions in the experiment group were significantly improved as compared with those in the control group (P 〈 0.001). Conclusion: rhGM-CSF can significantly improve the rate of oral mucosal healing, reduce the severities of mucosal damage and oral pain, and improve the swallowing functions, which can ensure the completion of chemotherapy and radiation therapy for nasopharynqeal cancer.
出处 《肿瘤》 CAS CSCD 北大核心 2014年第1期72-77,共6页 Tumor
关键词 鼻咽肿瘤 放射疗法 口腔黏膜炎 rhGM—CSF Nasopharyngeal neoplasms Radiotherapy Oral mucositis Recombinant humangranulocyte macrophage colony-stimulating factor
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