双花百合片联合重组牛碱性成纤维细胞生长因子治疗复发性重型口腔溃疡的临床疗效及安全性分析

Clinical Efficacy and Safety Analysis of Shuanghua Baihe Tablets Combined with Recombinant Bovine Basic Fibroblast Growth Factor on Severe Recurrent Oral Ulcer

目的:研究双花百合片联合重组牛碱性成纤维细胞生长因子(BFGF)治疗复发性重型口腔溃疡的临床疗效及安全性。方法:选取本院2019年1月~2020年1月纳入的96例复发性重型口腔溃疡患者为研究对象,采用随机数字表法分为对照组(BFGF凝胶联合地塞米松治疗)和试验组(BFGF凝胶联合双花百合片治疗),每组48例。分别比较治疗前后两组患者口腔菌群含量、视觉模拟(VAS)评分、口腔健康程度评定量表(OHIP-14)和免疫因子、炎症因子等水平,评价两组临床疗效、不良反应与复发情况。结果:试验组临床有效率(93.75%)高于对照组(79.17%,P <0.05);治疗后两组患者口腔细菌含量(链球菌、韦荣球菌)、免疫因子[免疫球蛋白A(Ig A)、免疫球蛋白G(Ig G)]指标均高于治疗前,且试验组改善程度好于对照组(P <0.05);治疗后两组患者炎症因子[肿瘤坏死因子-α(TNF-α)、白介素-10(IL-10)、C-反应蛋白(CRP)]和VAS、OHIP-14评分均低于治疗前,且试验组改善程度优于对照组(P <0.05)。治疗后对照组不良反应发生率为8.33%,试验组不良反应发生率为4.17%;3个月内对照组复发率为16.67%,试验组复发率为8.33%,无统计学差异(P> 0.05)。结论:双花百合片联合BFGF治疗复发性重型口腔溃疡,能维持口腔菌群平衡、提高免疫功能、减少炎症反应,且安全性较高。

Objective: To study the clinical efficacy and safety of Shuanghua Baihe tablets combined with recombinant bovine basic fibroblast growth factor( BFGF) on severe recurrent oral ulcer( ROU). Methods: A total of 96 patients with severe ROU during the period from January 2019 to January 2020 were selected as the research subjects. According to random number table,they were randomly divided into control group( BFGF gel combined with dexamethasone) and experiment group( BFGF gel combined with Shuanghua Baihe tablets),with 48 cases in each group. The contents of oral floras,scores of visual analogue scale( VAS) and oral health impact profile( OHIP-14),and levels of immune factors and inflammatory factors before and after treatment were compared between the two groups. The clinical efficacy,adverse reactions and recurrence in both groups were evaluated.Results: The clinical efficacy rate of experiment group( 93. 75%) was higher than that of control group( 79. 17%,P < 0. 05). After treatment,contents of oral floras( Streptococcus,Veillonella) and levels of immune factors[immunoglobulin A( Ig A),immunoglobulin G( Ig G) ]were increased in both groups,and the improvement was better in experiment group than that in control group( P < 0. 05). After treatment,levels of inflammatory factors[tumor necrosis factor-α( TNF-α),interleukin-10( IL-10),C-reactive protein( CRP) ],scores of VAS and OHIP-14 were decreased in both groups,and the improvement was better in experiment group than that in control group( P < 0. 05). After treatment,the incidence rates of adverse reactions in control group and experiment group were 8. 33% and 4. 17%,respectively. There was no significant difference in the recurrence rate within 3 months between control group and experiment group( 16. 67% vs 8. 33%,P > 0. 05). Conclusion: Shuanghua Baihe tablets combined with BFGF in the treatment of severe ROU can maintain the balance of oral floras,improve immune function,and reduce inflammation response with high safety.