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Volume 41 Issue 8
Aug.  2023
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ZHAO Ling, WU Yanan, XU Mingyuan. Clinical effect of Kangfuxin solution combined with lidocaine and gentamicin in the treatment of oral ulcer[J]. Journal of Pharmaceutical Practice and Service, 2023, 41(8): 515-518. doi: 10.12206/j.issn.2097-2024.202207080
Citation: ZHAO Ling, WU Yanan, XU Mingyuan. Clinical effect of Kangfuxin solution combined with lidocaine and gentamicin in the treatment of oral ulcer[J]. Journal of Pharmaceutical Practice and Service, 2023, 41(8): 515-518. doi: 10.12206/j.issn.2097-2024.202207080

Clinical effect of Kangfuxin solution combined with lidocaine and gentamicin in the treatment of oral ulcer

doi: 10.12206/j.issn.2097-2024.202207080
  • Received Date: 2022-07-21
  • Rev Recd Date: 2022-10-27
  • Publish Date: 2023-08-25
  •   Objective  To investigate the clinical efficacy of Kangfuxin solution combined with lidocaine and gentamicin in the treatment of oral ulcers.   Method  A total of 120 patients with oral ulcer admitted to Tongzhou District Maternity and Child Health Care Hospital of Beijing from May 2019 to July 2021 were selected and divided into observation group and control group randomly. 58 patients were treated with lidocaine as a control group and 62 patients in the observation group were treated with Kangfuxin solution combined with lidocaine and gentamicin. The clinical efficacy, including oral ulcer condition, visual analogue scale (VAS score) after 3d and 5d of treatment, inflammatory factor levels and adverse reactions were observed and compared between the two groups before and after treatment.   Results  The overall effective rate of the treatment group (95.12%) was higher than that of the control group (74.36%) and the difference was statistically significant (P<0.05). The ulcer area, ulcer healing time, and chewing improvement period were remarkably reduced compared with those in the control group (P<0.05). The VAS scores after 3d and 5d of treatment, the levels of tumor necrosis factor-α (TNF-α), C-reactive protein (CRP) and interleukin-6 (IL-6) between the two groups were statistically significant (P<0.05). There was no significant difference in the incidence of adverse reactions (3.22%) between the observation group and the control group (6.90%) (P>0.05).   Conclusion  Kangfuxin solution combined with lidocaine and gentamicin showed better curative effect on oral ulcer. This treatment regimen could effectively ameliorate various clinical symptoms of patients with oral ulcer, reduce patient pain and downregulate the levels of inflammatory factors, and help patients recover with high safety profile.
  • [1] 刘晓慧, 刘永红, 张晓光. 甘草泻心汤治疗寒热错杂型复发性口腔溃疡临床研究[J]. 陕西中医, 2021, 42(7): 922-925.
    [2] 魏德增. 黄连甘草汤加减对复发性口腔溃疡患者血清IL-6、IL-10、IL-17水平的影响[J]. 四川中医, 2020, 38(6): 170-173.
    [3] 李群, 谭劲, 刘寻, 等. rb-bFGF联合利多卡因治疗儿童复发性口腔溃疡的效果及对患儿Treg细胞的影响[J]. 疑难病杂志, 2021, 20(6): 597-601.
    [4] 宋小勇, 陈勇, 刘小兰, 等. 康复新液对放射性口腔溃疡患者免疫功能和炎性因子水平的影响[J]. 现代药物与临床, 2021, 36(6): 1245-1249.
    [5] 夏秀梅, 周伟, 鲁斌, 等. 康复新液联合美沙拉嗪治疗轻度溃疡性结肠炎的效果及其对患者血小板计数及血清肿瘤坏死因子-α、γ干扰素水平的影响[J]. 中国医学前沿杂志(电子版), 2020, 12(3): 120-123.
    [6] 邓金良. 临床常见口腔溃疡的分类与诊断要点[J]. 中国实用医药, 2010,5(24): 230-231.
    [7] 孙兵, 车晓明. 视觉模拟评分法(VAS)[J]. 中华神经外科杂志, 2012, 28(6): 645.
    [8] 朱东飞, 胡倩. 西帕依固龈液联合维生素治疗复发性口腔溃疡的疗效及对血清TNF-α水平的影响[J]. 中国医药科学, 2021, 11(16): 80-83.
    [9] 刘月, 刘娜, 李晓彦, 等. 复发性口腔溃疡的激光治疗[J]. 现代口腔医学杂志, 2020, 34(1): 45-48.
    [10] 刘波. 六神丸联合利多卡因治疗口腔溃疡患者的疗效分析[J]. 山西医药杂志, 2021, 50(18): 2679-2681. doi:  10.3969/j.issn.0253-9926.2021.18.022
    [11] 韩轶臻, 朱鲲鹏. 雷尼替丁结合康复新液治疗老年复发性口腔溃疡效果及对免疫功能、疼痛程度的影响[J]. 武警后勤学院学报(医学版), 2021, 30(5): 46-48, 68.
    [12] 陈雁南, 段优. 加味甘草干姜汤联合维生素B12治疗复发性口腔溃疡的临床效果[J]. 世界中医药, 2020, 15(21): 3308-3312.
    [13] 秦爱丽, 郑蕾, 蒋海晓, 等. 康复新液治疗复发性口腔溃疡患儿的临床效果研究[J]. 中华全科医学, 2020, 18(9): 1516-1518, 1522.
    [14] 毛琛. 康复新液联合利多卡因辅助氧疗治疗复发性口腔溃疡对炎性因子及复发率的作用[J]. 吉林医学, 2021, 42(5): 1149-1150. doi:  10.3969/j.issn.1004-0412.2021.05.048
    [15] 胡小梦.维生素E联合利多卡因治疗口腔溃疡患儿的临床疗效分析[J].中国现代药物应用,2021,15(2):223-224.
    [16] 项海东, 王一龙, 刘从娜, 等. 康复新液联合利多卡因辅助氧疗治疗复发性口腔溃疡的临床研究[J]. 河北医科大学学报, 2020, 41(5): 574-578.
    [17] 张志苓, 侯惠敏, 王素梅, 等. 小儿清热片联合康复新液治疗儿童口腔溃疡的临床研究[J]. 现代药物与临床, 2020, 35(2): 304-308.
    [18] 孙妮娜, 徐雪锋. 微信群发平台辅助健康教育对口腔溃疡患者的影响[J]. 检验医学与临床, 2021, 18(4): 519-522. doi:  10.3969/j.issn.1672-9455.2021.04.027
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Clinical effect of Kangfuxin solution combined with lidocaine and gentamicin in the treatment of oral ulcer

doi: 10.12206/j.issn.2097-2024.202207080

Abstract:   Objective  To investigate the clinical efficacy of Kangfuxin solution combined with lidocaine and gentamicin in the treatment of oral ulcers.   Method  A total of 120 patients with oral ulcer admitted to Tongzhou District Maternity and Child Health Care Hospital of Beijing from May 2019 to July 2021 were selected and divided into observation group and control group randomly. 58 patients were treated with lidocaine as a control group and 62 patients in the observation group were treated with Kangfuxin solution combined with lidocaine and gentamicin. The clinical efficacy, including oral ulcer condition, visual analogue scale (VAS score) after 3d and 5d of treatment, inflammatory factor levels and adverse reactions were observed and compared between the two groups before and after treatment.   Results  The overall effective rate of the treatment group (95.12%) was higher than that of the control group (74.36%) and the difference was statistically significant (P<0.05). The ulcer area, ulcer healing time, and chewing improvement period were remarkably reduced compared with those in the control group (P<0.05). The VAS scores after 3d and 5d of treatment, the levels of tumor necrosis factor-α (TNF-α), C-reactive protein (CRP) and interleukin-6 (IL-6) between the two groups were statistically significant (P<0.05). There was no significant difference in the incidence of adverse reactions (3.22%) between the observation group and the control group (6.90%) (P>0.05).   Conclusion  Kangfuxin solution combined with lidocaine and gentamicin showed better curative effect on oral ulcer. This treatment regimen could effectively ameliorate various clinical symptoms of patients with oral ulcer, reduce patient pain and downregulate the levels of inflammatory factors, and help patients recover with high safety profile.

ZHAO Ling, WU Yanan, XU Mingyuan. Clinical effect of Kangfuxin solution combined with lidocaine and gentamicin in the treatment of oral ulcer[J]. Journal of Pharmaceutical Practice and Service, 2023, 41(8): 515-518. doi: 10.12206/j.issn.2097-2024.202207080
Citation: ZHAO Ling, WU Yanan, XU Mingyuan. Clinical effect of Kangfuxin solution combined with lidocaine and gentamicin in the treatment of oral ulcer[J]. Journal of Pharmaceutical Practice and Service, 2023, 41(8): 515-518. doi: 10.12206/j.issn.2097-2024.202207080
  • 口腔溃疡是一种发生于口腔粘膜表面的浅表溃疡,是一种比较常见的口腔疾病[1]。溃疡主要是圆形或椭圆形,常见的症状是局部口腔疼痛。该病在口腔黏膜疾病中发病率最高,具有一定的周期性和自限性[2]。目前该病的病因机制还不是很清楚,可能与遗传和感染密切相关[3]。该病会影响患者的正常饮食乃至语言功能,给患者带来极大的痛苦,发病后治疗不当会显著降低生活质量。如果不及时有效地治疗,很容易引起神经、心血管、消化和呼吸系统的疾病。因此,对口腔溃疡患者进行及时有效的临床治疗,制定科学合理的治疗方案,对于提高生活质量具有十分重要的临床意义。目前临床上对于口腔溃疡的方式有很多,药物治疗利多卡因及庆大霉素以及饮食治疗等,但是效果都不太理想[4]。康复新液是一种中药制剂,具有通利血脉、养阴生肌的功效,常用于治疗溃疡[5],利多卡因可以有效缓解疼痛,庆大霉素可以抗感染,因此本文采用康复新液联合利多卡因及庆大霉素治疗口腔溃疡,通过观察患者的临床疗效、炎症因子水平等的变化,记录该治疗方案对口腔溃疡有较好的临床疗效,可以减少炎症反应,现报道如下。

    • 将2019年5月至2021年7月在北京市通州区妇幼保健院收治的120例口腔溃疡患者,按随机数字表法分为观察组62例和对照组58例。观察组平均年龄(32.77±8.75)岁,平均体质指数(BMI)(21.10±1.17) kg/m2;对照组58例,平均年龄(31.31±9.54)岁,平均BMI(21.45±1.33) kg/m2。两组患者的一般临床资料相比较无统计学意义(P>0.05)。

    • ①符合口腔溃疡诊断标准的患者[6];②口腔溃疡部位易于评估治疗;③本次溃疡时间≤2 d,口腔黏膜上皮的完整性受到破坏,表面层坏死脱落形成凹陷;④愿意接受本治疗方案且依从性较好的患者。

    • ①伴有其他口腔疾病的患者,如癌性溃疡;②对研究中所使用的药物过敏者;③有自身免疫性疾病;④有精神障碍的患者;⑤近1个月内使用过抗生素药物的患者;⑥临床资料不完全,影响治疗前后指标观察的患者。

    • 对照组患者采用利多卡因治疗,于患处涂抹盐酸利多卡因凝胶(国药准字H11022396,华润紫竹药业有限公司,规格:2%),1次/d。观察组在对照组的基础上加用康复新液和庆大霉素治疗,康复新液(国药准字Z53020054,昆明赛诺制药股份有限公司,规格:50 ml),1次/d,10 ml/次,在患处含漱5 min后吞下,0.5 h内禁止饮食饮水,消毒棉签蘸取庆大霉素注射液(国药准字H37020278,山东新华制药股份有限公司,规格:1 ml∶2万单位)轻涂口腔内溃疡面,每日4次,即三餐后和睡前,涂上药液,0.5 h内禁止饮食饮水。两组均连续治疗直至痊愈。

    • 观察并记录所有患者治疗后溃疡面积、溃疡愈合时间及进食改善时间。

    • 分别于治疗前、治疗3 d、治疗5 d后采用视觉模拟评分量表(VAS评分表)对患者的口腔溃疡疼痛情况进行评估,分数越高说明疼痛越严重[7]

    • 在治疗之前以及治疗3 d后清晨,空腹取静脉血3 ml,室温静置约0.5 h后,以3 000 r/min,离心半径144 mm,离心10 min,收集上清液冷冻保存待测。采用酶联免疫法检测患者血清中肿瘤坏死因子-α(TNF-α)、C反应蛋白(CRP)、细胞白介素-6(IL-6)水平。

    • 观察并记录患者出现的不良反应,如恶心呕吐、头痛、高血压、皮疹等。

    • 痊愈:术后溃疡全部痊愈,临床症状全部消除,炎症因子水平恢复正常;显效:患者溃疡面明显愈合,大部分临床症状消失,炎症因子的含量基本达到正常值;有效:病人的胃溃疡局部痊愈,临床症状减轻,炎性因子没有恢复;无效:病人的溃疡未愈合,或有增大的趋势,临床表现不佳或有恶化的倾向。总有效率= [(治愈例数+显效例数+有效例数)/总例数]×100%。

    • 采用 SPSS 26.0软件对实验数据进行分析;计量资料用($\bar x $±s)表示,两组间的比较采用独立t检验,得到t值和P值,计数资料以例或百分率表示,采用x2检验;P<0.05差异有统计学意义。

    • 观察组总有效率96.77%,明显高于对照组84.48%(x2=5.437,P=0.020),见表1

      组别例数痊愈显效有效无效总有效率(%)
      观察组62311514260(95.12)*
      对照组58211810949(74.36)
      x25.437
      P0.020
      注:* P<0.05,与对照组比较
    • 观察组溃疡面积、溃疡愈合时间、进食改善时间与对照组比较均显著下降(P均<0.05),见表2

      组别例数溃疡面积
      (mm2
      溃疡愈合时间
      (d)
      进食改善时间
      (d)
      观察组621.88±0.64*3.11±0.87*3.47±1.21*
      对照组582.68±0.734.28±1.124.64±1.25
      t6.3946.4145.209
      P<0.01<0.01<0.01
      注:* P<0.05,与对照组比较
    • 治疗前两组患者VAS评分比较(P>0.05),治疗后两组患者VAS评分呈下降趋势,且观察组治疗3 d、5 d后VAS评分均明显低于对照组(P<0.05)。见表3

      组别例数VAS评分
      治疗前治疗3 d后治疗5 d后
      观察组626.56±1.563.27±1.16*1.13±0.34*
      对照组586.60±1.694.52±1.34*2.24±0.60*
      t0.1355.47312.570
      P0.893<0.01<0.01
      注:* P<0.05,与治疗前比较
    • 治疗后两组患者的TNF-α、CRP、IL-6水平均显著降低,且观察组在治疗后炎症因子水平均显著低于对照组(P<0.05),见表4

      组别 例数 IL-6(pg/ml) CRP(mg/L) TNF-α(ng/L)
      治疗前 治疗后 治疗前 治疗后 治疗前 治疗后
      观察组 62 16.50±2.95 8.33±1.74* 26.19±4.41 14.94±3.77* 35.45±4.84 15.49±3.00*
      对照组 58 15.93±3.90 10.52±2.21* 25.72±4.43 17.15±5.35* 34.44±5.45 21.48±2.88*
      t 0.907 6.052 0.582 2.629 1.054 11.143
      P 0.367 <0.01 0.562 <0.01 0.294 <0.01
      注:* P<0.05,与治疗前比较
    • 观察组出现恶心呕吐1例、头痛1例,不良反应总发生率3.22%;对照组出现恶心呕吐3例、皮疹1例,不良反应率6.90%。两组不良反应总率相比较,无明显差异(x2=0.253,P=0.615)。

    • 口腔溃疡是口腔科常见的口腔黏膜疾病[9]。溃疡被定义为上皮完全破裂,被纤维蛋白腐肉覆盖并表现为被红斑包围的白色病变,临床上表现出明显的疼痛、发烧、吞咽困难和不适,其特征是反复发作。口腔剧烈的疼痛会给患者带来极大的痛苦,对患者的身体健康、生活、学习、工作造成很大的影响[10-11]。引起口腔溃疡的原因主要有:(1)口腔被细菌或病毒感染,当链球菌、韦荣氏菌等正常菌群数量降低时,使得口腔黏膜无法抵抗外来病原体的入侵,从而导致口腔黏膜糜烂、溃疡[12];(2)患者的免疫功能长期处于紊乱状态也会导致口腔黏膜溃疡[13]。目前,口腔溃疡的治疗主要有中医、西医、中西医结合等多种手段,然而,单一药物无法达到治疗口腔溃疡的理想效果。在临床实践中,常采用联合用药来提高疗效,快速缓解患者的痛苦。

      局部治疗口腔溃疡旨在预防重复感染、镇痛、减轻炎症,加速溃疡愈合[14],本研究采用康复新液联合利多卡因及庆大霉素治疗口腔溃疡,康复新液是一种富含多种活性成分的中药复方制剂,利多卡因具有镇痛作用,能明显缓解局部疼痛[15]。在口腔中会遇到浅表性和侵袭性细菌感染,主要发生在免疫功能低下的患者中,急性假膜性念珠菌病或急性萎缩性念珠菌病可能会导致口腔溃疡,使用庆大霉素能起到有效的抗菌作用。本研究结果显示,观察组总有效率明显高于对照组,并且能有效减少患者溃疡面积和进食时间,有助于患者恢复,与项海东[16]、张志苓等[17]研究结果相似。对炎症因子水平进行检测发现康复新液联合利多卡因及庆大霉素治疗能有效降低患者体内炎症因子水平,减少炎症反应,提高机体免疫调节能力,从而提高疗效,促进患者康复。严重口腔溃疡会给患者带来不适感和局部剧烈疼痛感,影响患者进食和日常生活[18],利多卡因具有镇痛作用,本研究中治疗3 d、5 d后,观察组VAS评分均低于对照组,说明该方案治疗镇痛效果明显,联合用药能有效缓解疼痛,改善患者生活质量。除此之外,观察组发生不良反应例数少于对照组,但两组进行比较无明显差异,表明康复新液与利多卡因及庆大霉素联合治疗的安全性高,提高了患者的临床疗效。

      综上所述,康复新液联合利多卡因及庆大霉素治疗口腔溃疡的疗效较好,能显著改善患者的临床症状、提高恢复速度、降低机体炎症反应、增强免疫功能,有良好的安全性和预后,值得进行更深入的临床研究。

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