中药预防性治疗急性放射性口腔黏膜炎的临床研究

Clinical study of Chinese medicine in preventive treatment on acute radiation oral mucositis

背景与目的：在放射治疗过程中，如何有效地预防性治疗急性放射性口腔黏膜炎，对于提高头颈部肿瘤患者的放射治疗效果至关重要，本研究旨在探讨中草药参麦饮预防性治疗急性放射性口腔黏膜炎的临床疗效。方法：1997年6月-2002年8月期间对150例头颈部肿瘤患者采用口服中草药参麦饮（双花10g，沙参9g，生地9g，麦冬9g，胖大海6g，甘草6g）的方法，预防性治疗其在放射治疗过程中发生的急性放射性口腔黏膜炎，并采用双盲法随机选择150例同类患者作为对照组进行临床对照观察，全部患者均采用6 MV X线常规分割照射，照射总剂量为66—74Gy。用药组患者自放射治疗开始的第1天起，于每次放射治疗之前1h口服中草药参麦饮水煎剂，直至放射治疗结束。对照组患者同步给于安慰剂，以消除其心理因素对本研究结果的影响。结果：用药组患者的Ⅰ、Ⅱ、Ⅲ、Ⅳ级急性放射性口腔黏膜炎的发生率分别为50．0％、38．1％、8．2％和3．7％；对照组分别为0％、5．6％、72．2％和22．2％，差异具有显著性（χ^2=136．9，P=0．000）。结论：参麦饮对减轻头颈部恶性肿瘤患者的放射治疗反应、缓解急性放射性口腔黏膜炎的症状，具有显著的临床疗效，值得临床推广和应用。

Background and purpose： Effective preventive treatment of acute radiation induced oral mucositis is very important to improve the tolerance of radiotherapy for head and neck cancer in radiotherapy. We investigated the clinical curative effect of Chinese herb medicine Shenmaiyin in the prevention of acute oral mucositis induced by radiation. Methods： Between June 1997 and August 2002, 300 patients with head-and-neck cancer were randomized into 2 groups by double blind method. The Shenmaiyin group received Shenmaiyin decoction （ Flos Lonicerae 10 g, Radix Adenophorae 9 g, Radix Rehmanniae 9 g, Radix Ophiopogonis 9 g, Semen Sterculiae Lychnophorae 6 g, Radix Glycyrrhizae 6 g ） per os an hour prior to radiotherapy throughout the radiotherapy, while the control group received placebo. A total dose of 66-74 Gy was delivered to all patients with 6 MV X ray. Results： The incidence of level Ⅰ, Ⅱ, Ⅲ, Ⅳ acute radiation oral mucositis was 50.0%, 38. 1%, 8.2% and 3.7% in Shenmaiyin group, and it was 0%, 5.6%, 72.2% and 22.2% in the control group, respectively. There was a statistically significant difference （χ^2 = 136.9, P = 0. 000）. Conclusions： Shenmaiyin has significant clinical curative effect on acute radiation-induced oral mucositis, it has a potential for clinical application.