Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Radiation Oncology, Peking University Cancer Hospital and Institute, Beijing, China.
Key Laboratory of High-Incidence-Tumor Prevention & Treatment (Guangxi Medical University), Ministry of Education, Department of Radiation Oncology, Cancer Hospital of Guangxi Medical University, Nanning, China.
Int J Radiat Oncol Biol Phys. 2018 Feb 1;100(2):418-426. doi: 10.1016/j.ijrobp.2017.10.013. Epub 2017 Oct 13.
PURPOSE: Oral mucositis is a common unpreventable complication associated with chemoradiation therapy. Shuanghua Baihe tablets have been approved by the Chinese Food and Drug Administration for treating recurrent oral mucosa ulceration. This study assessed whether Shuanghua Baihe tablets could prevent oral mucositis during chemoradiation therapy for locally advanced nasopharyngeal carcinoma. METHODS AND MATERIALS: This multicenter, randomized, double-blind, placebo-controlled trial was conducted at 11 hospitals in China between January 22, 2014, and September 21, 2015. Eligible patients (N=240, 18-70 years old) with pathologically diagnosed locally advanced nasopharyngeal carcinoma were randomly assigned (computer-block randomization; 1:1) to receive Shuanghua Baihe tablets or a placebo (4 tablets, 3 times a day, for 7 weeks) at the initiation of chemoradiation therapy. Administration of Shuanghua Baihe tablets could be ended if grade 3 or higher oral mucositis developed and patients were unwilling to continue taking the drug. The primary endpoints were oral mucositis incidence and latency. RESULTS: The incidence of oral mucositis during this study was significantly lower in the Shuanghua Baihe group (85.0%; 95% confidence interval [CI], 78.6%-91.4%) than in the placebo group (96.6%; 95% CI, 93.4%-99.9%; P=.0028). The median latency period was 28 days in the Shuanghua Baihe group and 14 days in the placebo group (hazard ratio, 0.17; 95% CI, 0.12-0.23; P<.0001). Compared with placebo, Shuanghua Baihe tablets significantly reduced the oral mucositis severity scores recorded by the investigators (Oral Mucositis Score, 24.0 [range, 0.0-67.8] vs 57.5 [range, 0.0-98.0]; P<.0001), full-time nurses (Oral Assessment Guide score, 462.0 [range, 392.0-664.7] vs 520.4 [range, 392.0-714.0]; P<.0001), and patients (score for soreness of mouth and throat, 4.0 [range, 0-10] vs 6.0 [range, 0-10]; P<.0001). No serious adverse events were observed, and the incidence of mild or moderate gastrointestinal adverse events associated with Shuanghua Baihe tablets was 3.3%. The short-term response rate was similar in patients receiving Shuanghua Baihe tablets and those receiving placebo during chemoradiation therapy during this study. CONCLUSIONS: Shuanghua Baihe tablets reduced the occurrence, latency, and severity of oral mucositis in patients with nasopharyngeal cancer during chemoradiation therapy treatment.
目的：口腔黏膜炎是一种与放化疗相关的常见且无法预防的并发症。双花百合片已获得中国食品药品监督管理局批准，用于治疗复发性口腔黏膜溃疡。本研究评估了双花百合片是否可以预防局部晚期鼻咽癌放化疗期间的口腔黏膜炎。
方法和材料：这是一项多中心、随机、双盲、安慰剂对照试验，于 2014 年 1 月 22 日至 2015 年 9 月 21 日在中国 11 家医院进行。符合条件的患者（N=240，18-70 岁）经病理诊断为局部晚期鼻咽癌，随机（计算机区组随机化；1:1）接受双花百合片或安慰剂（4 片，每日 3 次，持续 7 周）治疗，于放化疗开始时服用。如果发生 3 级或更高级别的口腔黏膜炎且患者不愿继续服用药物，可停止服用双花百合片。主要终点是口腔黏膜炎的发生率和潜伏期。
结果：与安慰剂组（96.6%[95%置信区间，93.4%-99.9%]）相比，双花百合组（85.0%[95%置信区间，78.6%-91.4%]）在研究期间口腔黏膜炎的发生率显著降低（P=.0028）。双花百合组的中位潜伏期为 28 天，安慰剂组为 14 天（风险比，0.17；95%置信区间，0.12-0.23；P<.0001）。与安慰剂相比，双花百合片可显著降低研究者记录的口腔黏膜炎严重程度评分（口腔黏膜炎评分，24.0[范围，0.0-67.8] vs 57.5[范围，0.0-98.0]；P<.0001）、全职护士（口腔评估指南评分，462.0[范围，392.0-664.7] vs 520.4[范围，392.0-714.0]；P<.0001）和患者（口腔疼痛评分，4.0[范围，0-10] vs 6.0[范围，0-10]；P<.0001）。未观察到严重不良事件，与双花百合片相关的轻度或中度胃肠道不良事件的发生率为 3.3%。在研究期间，接受双花百合片和安慰剂的患者在放化疗期间的短期应答率相似。
结论：双花百合片可降低鼻咽癌患者放化疗期间口腔黏膜炎的发生、潜伏期和严重程度。
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