复方竹叶石膏颗粒治疗复发性口腔溃疡的随机、双盲、对照临床研究  

Randomized Double-blinded Contrastive Study of Fufang Zhuye Shigao Granules in Treatment of Patients with Recurrent Oral Ulcer

作　　者：路军章[1] 李明伟[1] 孙志高[1] 樊金灼[1] LU Jun-zhang;LI Ming-wei;SUN Zhi-gao;FAN Jin-zhuo(Department of Traditional Chinese Medicine,Hainan Branch of General Hospital of PLA,Sanya,Hainan 572013,China)

机构地区：[1]解放军总医院海南分院中医科,海南三亚512013

出　　处：《解放军医药杂志》2018年第11期81-84,共4页Medical & Pharmaceutical Journal of Chinese People’s Liberation Army

基　　金：海南省重点研发项目(ZDYF201622)

摘　　要：目的观察验证复方竹叶石膏颗粒治疗复发性口腔溃疡(ROU)的有效性及安全性。方法选取2016年6月—2017年6月解放军总医院及解放军总医院海南分院就诊ROU 180例,随机分为治疗组和对照组,每组90例。治疗组口服复方竹叶石膏颗粒,对照组口服安慰剂,共服用2个疗程,观察并比较2组视觉模糊疼痛评分(VAS)、平均溃疡期判定短期疗效,治疗后6个月溃疡复发情况判定长期疗效。结果治疗组平均溃疡时间及VAS评分均明显低于治疗前(P <0. 05);治疗组短期总有效率高于对照组(P <0. 05),6个月内复发率低于对照组(P <0. 05),长期总有效率高于对照组(P <0. 05)。2组用药期间无不良反应发生。结论复方竹叶石膏颗粒可缩短ROU平均溃疡期,降低复发率,其安全性良好。Objective To observe and validate efficacy and safety of Fufang Zhuye Shigao Granules （FZSG） in treatment of patients with recurrent oral ulcer （ROU）. Methods A total of 180 ROU patients during June 2016 and June 2017 were randomly divided into treatment group and control group （ n =90 for each group）. Treatment group was treated with FZSG orally, while control group was treated with placebo, and all patients were treated for two courses of treatment. In two groups, visual analogue scales （VAS） scores were observed and compared. Short-term efficacy was evaluated by average ulcer period, and long-term efficacy was evaluated by condition of ulcer and recurrence in 6 months after treatment in each group. Results Values of average ulcer period and VAS scores after treatment were significantly lower than those before treatment in treatment group （ P 〈0.05）. The short-term total effective rate in treatment group was significantly higher than that in control group （ P 〈0.05）. In treatment group, in 6 months after treatment, recurrence rate was significantly lower than that in control group （ P 〈0.05）, while long-term total effective rate was significantly higher than that in control group （ P 〈0.05）. No adverse reaction was found during administration in two groups. Conclusion Fufang Zhuye Shigao Granules in treatment of patients with recurrent oral ulcer may shorten average ulcer period and reduce recurrence rate with good safe.

关 键 词：口腔溃疡 复发 复方竹叶石膏颗粒 竹叶石膏汤 

分 类 号：R781.5[医药卫生—口腔医学]