化毒生肌散治疗胃癌化疗相关口腔黏膜炎的临床研究

Clinical observation of Huadu-shengji powders on the treatment of chemotherapy-related oral mucositis in patients with gastric cancer

目的观察化毒生肌散治疗胃癌化疗相关口腔黏膜炎的疗效及安全性。方法将90例胃癌化疗相关口腔黏膜炎患者随机分为2组,治疗组45例予化毒生肌散外敷患处,并用0.9%氯化钠注射液漱口;对照组45例予0.9%氯化钠注射液漱口。观察2组治疗前后口腔黏膜炎严重程度分级、疼痛数字评分法(NRS)评分变化,统计2组患者黏膜愈合时间,观察记录不良反应。结果从第5 d起,2组化疗相关口腔黏膜炎严重程度分级比较差异有统计学意义(P<0.05),治疗组较对照组明显减轻;第3、7、14 d 2组NRS评分比较差异有统计学意义(P<0.05),治疗组低于对照组;2组愈合时间比较差异有统计学意义(P<0.05),治疗组愈合时间早于对照组,且治疗组临床疗效优于对照组(P<0.05)。2组治疗过程中未发现明显不良反应。结论化毒生肌散治疗胃癌化疗相关口腔黏膜炎效果较好,且安全性高。

Objective To observe the efficacy and safety of Huadu - shengji powders on the treatment of chemotherapy-related oral mucositis in patients with gastric cancer. Methods 90 gastric cancer patients with chemotherapy-related oral mucositis were randomly divided into two groups. The treatment group（n = 45） were treated by external application of Huadu - shengji powders and mouthwash of 0. 9% sodium chloride injection,the control group（n = 45） were treated by simple mouthwash of 0. 9% sodium chloride injection. The severity grading of oral mucositis and the changes of Pain Digital Scoring（NRS） before and after treatment were observed in two groups.The mucosal healing time in two groups was evaluated and the adverse reactions were observed. Results There were statistical differences on severity grading of chemotherapy-related oral mucositis since the fifth day（P〈0. 05）. The severity degree in treatment group was significantly lighter than control group. The score of NRS in treatment group was lower than that in control group at the 3th,7th and 14 th day（P〈0. 05）. The healing time in treatment group was earlier than that in control group（P〈0. 05）. The clinical efficacy in treatment group was better than that in control group（P〈0. 05）. There were no serious adverse reactions occurred in two groups during treatment. Conclusion Huadu - shengji powders have good effects on chemotherapy-related oral mucositis after gastric cancer,with high security.