口炎清颗粒联合雷尼替丁、维生素C治疗复发性口腔溃疡临床研究

Clinical Study on Curative Effect of Kouyanqing Granules Combined with Ranitidine and Vitamin C on Recurrent Oral Ulcer

目的:观察口炎清颗粒联合雷尼替丁、维生素C治疗复发性口腔溃疡(ROU)的临床疗效。方法:选择108例ROU患者,按随机数字表法分为治疗组与对照组各54例,2组最终完成试验均为52例(治疗期间2组各剔除2例)。对照组给予雷尼替丁、维生素C治疗,治疗组在对照组基础上联合口炎清颗粒治疗。2组均治疗7 d。比较2组临床疗效、中医证候评分、氧化应激指标[血清丙二醛(MDA)、超氧化物歧化酶(SOD)]、血清炎症因子[肿瘤坏死因子-α (TNF-α)、超敏C-反应蛋白(hs-CRP)及白细胞介素-6 (IL-6)]水平及复发率。结果:治疗后,治疗组总有效率为100%,对照组为88.46%,2组比较,差异有统计学意义(P<0.05)。治疗后,2组中医证候评分均较治疗前降低(P<0.05),且治疗组中医证候评分低于对照组(P<0.05)治疗后,2组血清MDA水平均较治疗前降低(P<0.05),血清SOD水平均较治疗前升高(P<0.05);且治疗组血清MDA水平低于对照组(P<0.05),血清SOD水平高于对照组(P<0.05)。治疗后,2组血清TNF-α、hs-CRP、IL-6水平均较治疗前降低(P<0.05),且治疗组上述3项指标均低于对照组(P<0.05)。随访3个月,治疗组复发率为7.69%,对照组为21.74%,2组比较,差异有统计学意义(P<0.05)。结论:口炎清颗粒联合雷尼替丁、维生素C治疗ROU疗效显著,可缓解患者中医证候,改善机体抗氧化能力,减轻体内炎症反应,降低复发率。

Objective:To observe the clinical effect of Kouyanqing Granules combined with Ranitidine and vitamin C on recurrent oral ulcer(ROU).Methods:A total of 108 cases of patients with ROU were selected and randomly divided into the treatment group and the control group according to the random number table method,with 54 cases in each group.Finally,52 cases in each group completed the trial(two cases in each group were excluded during treatment).The control group was treated with Ranitidine and vitamin C,and the treatment group was additionally treated with Kouyanqing Granules based on the treatment of the control group.Both groups were treated for seven days.The clinical effects,the traditional Chinese medicine(TCM)syndrome scores,the levels of oxidative stress indexes[serum malondialdehyde(MDA),superoxide dismutase(SOD)]and serum inflammatory factors[tumor necrosis factor-α(TNF-α),hypersensitive C-reactive protein(hs-CRP)and interleukin-6(IL-6)]and the recurrence rates were compared between the two groups.Results:After treatment,the total effective rate was 100%in the treatment group and 88.46%in the control group,the difference being significant(P<0.05).After treatment,TCM syndrome scores in the two groups were decreased when compared with those before treatment(P<0.05),and the TCM syndrome score in the treatment group was lower than that in the control group(P<0.05).After treatment,the serum MDA levels in the two groups were decreased when compared with those before treatment(P<0.05),and the serum SOD levels were increased when compared with those before treatment.The serum MDA level in the treatment group was lower than that in the control group(P<0.05),and the serum SOD level in the observation group was higher than that in the control group(P<0.05).After treatment,the levels of TNF-α,hs-CRP,and IL-6 in serum in the two groups were decreased when compared with those before treatment(P<0.05),and the above three indexes in the treatment group were lower than those in the control group(P<0.05).After three months of follow-up,the recurrence rate was 7.69%in the treatment group and 21.74%in the control group,the difference being significant(P<0.05).Conclusion:Kouyanqing Granules combined with Ranitidine and vitamin C has a significant curative effect in the treatment of patients with ROU,which can relieve the TCM syndromes of patients,regulate the antioxidant capacity of the body,reduce inflammatory responses,and reduce the recurrence rates.