康复新液预防与治疗鼻咽癌放疗所致口腔黏膜炎的效果观察

Effect of Kangfuxin Solution on the Prevention and Treatment of Radiotherapyinduced Oral Mucositis in Patients with Nasopharyngeal Carcinoma

目的:观察康复新液对鼻咽癌放疗所致口腔黏膜炎预防与治疗的有效性。方法:采用随机、平行对照、多中心临床研究,入选患者在放疗开始同时使用药物漱口防治黏膜炎,试验组给予康复新液,对照组给予复方硼砂含漱液。采用CTCAE v3.0口腔黏膜炎分级标准和VRS疼痛分级标准,评价两组患者在试验过程中和试验结束时的口腔黏膜炎和口腔疼痛的的发生率及其程度变化。结果:实际入组240例,可评价疗效215例;其中试验组107例,对照组108例。试验组能显著降低试验过程中和试验结束时的口腔黏膜炎的发生率,差异具有统计学意义(P=0.021,P=0.008);能减轻口腔黏膜炎的严重程度,降低黏膜炎等级,差异有统计学意义(P=0.010)。能显著延迟口腔黏膜炎的发生时间;当出现不同等级黏膜炎的时候,试验组完成的累积放疗剂量显著高于对照组,差异均具有统计学意义(P<0.001,P=0.038,P<0.001);试验组能降低口腔疼痛的发生率,差异具有统计学意义(P=0.001);能减轻口腔疼痛的严重程度(P<0.001)。结论:康复新液能有效防治鼻咽癌放疗所致口腔黏膜炎和口腔疼痛,疗效优于复方硼砂含漱液,值得临床推广应用。

Objective： To evaluate the efficacy of Kangfuxin Solution on oral mucositis induced by radiotherapy in patients with nasopharyngeal carcinoma. Methods： A total of 240 patients were enrolled into a randomized,parallel-group,multicenter clinical trial. Patients were randomized to receive either Kangfuxin Solution（ test group） or compound borax gargle（ control group） at the beginning of radiotherapy. Oral mucositis and pain were evaluated by Common Terminology Criteria for Adverse Events（ CTCAE） v3. 0 and the Verbal Rating Scale（ VRS）. Results： Of 240 patients enrolled,215 were eligible for efficacy analysis. Compared with the control group（ n = 108）,the incidence of oral mucositis in the test group（ n = 107） were significantly reduced during the process of this study and after the study（ P = 0. 021,P = 0. 008; respectively）. In addition,the severity and grade of oral mucositis in the test group were significantly reduced（ P = 0. 010）.The time to different grade of oral mucositis occurrence was longer in test group,and the accumulated radiation dose was higher in test group comparing to the control group（ P〈0. 001,P = 0. 038,P〈0. 001; respectively）. The test group showed lower incidence and severity of oral pain than the control group（ P = 0. 001,P〈0. 001; respectively）. Conclusion：Kangfuxin Solution can effectively prevent and treat oral mucositis and oral pain induced by radiotherapy in patients with NPC. The efficacy is better than compound borax gargle,worthy of clinical application.