目的：观察升阳散火汤加味联合维生素B2 治疗恶性肿瘤靶向药物所致口腔溃疡的临床疗效。方 法：采用随机数字表法将64 例靶向治疗后口腔溃疡患者分为对照组和治疗组各32 例。2 组均给予口腔护理， 同时对照组给予维生素B2 口服治疗，治疗组在对照组基础上加用升阳散火汤加味治疗，2 组均连续治疗 14 d。比较2 组平均溃疡期、口腔溃疡分级、疼痛等级；比较2 组治疗前后溃疡症状评分、中医证候积分及血 清细胞因子、T 细胞亚群（CD3+、CD4+、CD8+、CD4+/CD8+）、B 细胞（CD19+） 及自然杀伤细胞（CD16+/CD56+） 水平；比较2 组临床疗效及不良反应发生情况。结果：治疗期间，对照组脱落2 例，完成研究30 例；治疗组 脱落1 例，完成研究31 例。治疗后，治疗组总有效率100%，高于对照组80.00%（P＜0.05）。治疗组口腔溃 疡分级、疼痛等级均轻于对照组（P＜0.05），平均溃疡期较对照组缩短（P＜0.05）。2 组治疗后口腔溃疡症状 评分、中医证候积分较治疗前降低（P＜0.05）；且治疗组治疗后口腔溃疡各项症状评分、中医证候积分均低于 对照组（P＜0.05）。2 组血清碱性成纤维细胞生长因子（bFGF）、超氧化物歧化酶（SOD） 水平均较治疗前升 高（P＜0.05），血清炎症因子[白细胞介素-2（IL-2）、白细胞介素-6 （IL-6）、肿瘤坏死因子-α （TNF-α） ]、 丙二醛（MDA） 水平均降低（P＜0.05）；治疗组治疗后血清bFGF、SOD 水平高于对照组（P＜0.05），血清 MDA、炎症因子水平均低于对照组（P＜0.05）。治疗后，治疗组CD3+及2 组CD4+、CD19+水平及CD4+/CD8+均 较治疗前升高（P＜0.05），CD8+、CD16+/CD56+水平降低（P＜0.05）；治疗组治疗后CD3+、CD4+、CD19+水平 及CD4+/CD8+均高于对照组（P＜0.05），CD16+/CD56+、CD8+水平低于对照组（P＜0.05）。2 组均未出现严重不 良反应。结论：升阳散火汤加味联合维生素B2 治疗恶性肿瘤靶向药物所致口腔溃疡疗效确切，能够缓解患者 口腔溃疡症状及疼痛，提高免疫功能，降低炎症反应，加快溃疡愈合，安全性较高。
Abstract： Objective： To observe the clinical effect of the therapy of Modified Shengyang Sanhuo Decoction combined with Vitamin B2 on oral ulcer due to targeted medicines for malignant tumor. Methods： A total of 64 patients with oral ulcer after targeted therapy were divided into the control group and the treatment group according to the random number table method，with 32 cases in each group. Both groups were given oral care，the control group was additionally given the oral administration of Vitamin B2 and the treatment group was additionally treated with Modified Shengyang Sanhuo Decoction based on the treatment of the control group. Both groups were treated for 14 days. The average ulceration stage，oral ulcer grading and pain level were compared between the two groups；the scores of oral ulcer symptoms， traditional Chinese medicine (TCM) syndrome scores， and levels of serum cell factors， T cell subgroup， including CD3+，CD4+，CD8+ and CD4+/CD8+，B cell，including CD19+，and natural killer cells，including CD16+/CD56+ were compared before and after treatment between the two groups；the clinical effects and incidence of adverse reactions were compared between the two groups. Results ： During treatment ， 2 cases fell off and 30 cases were completed in the control group；1 case fell off and 31 cases were completed in the treatment group. After treatment， the total effective rate was 100% in the treatment group，higher than that of 80.00% in the control group (P＜0.05). The oral ulcer grading and pain level in the treatment group were less than those in the control group (P＜0.05)，and the average ulceration stage was shortened when compared with that in the control group (P＜0.05). After treatment，the scores of oral ulcer symptoms，and TCM syndrome scores in both groups were decreased when compared with those before treatment，and the above scores in the treatment group were lower than those in the control group (P＜ 0.05). The levels of serum basic fibroblast growth factor (bFGF) and superoxide dismutase (SOD) in both groups were increased when compared with those before treatment (P＜0.05)， and the levels of serum inflammatory factors， including interleukin- 2 (IL- 2)， interleukin- 6 (IL- 6) and tumor necrosis factor- α (TNF- α)， and malondialdehyde (MDA) were decreased (P＜0.05)；the levels of serum bFGF and SOD in the treatment group were higher than those in the control group (P＜0.05)， and the levels of MDA and inflammatory factors were lower than those in the control group (P＜0.05). After treatment，the CD3+ level in the treatment group，levels of CD4+ and CD19+ in both groups，and the CD4+/CD8+ were increased when compared with those before treatment (P＜0.05)，and the levels of CD8+，CD16+/CD56+ were decreased (P＜0.05)；the levels of CD3+，CD4+ and CD19+ and the CD4+/CD8+ were higher than those in the control group (P＜0.05)，and the levels of CD8 +，CD16 +/CD56 + were lower than those in the control group (P＜ 0.05). There was no serious adverse reaction in both groups. Conclusion： The therapy of Modified Shengyang Sanhuo Decoction combined with Vitamin B2 has a definite curative effect on oral ulcer due to targeted medicines for malignant tumor， which can mitigate the oral ulcer symptoms and ulcer pain of patients， enhance the immunologic function， decreased the inflammatory responses and promote the recovery of oral ulcer with good safety.