口炎清颗粒治疗儿童复发性阿弗他溃疡（阴虚火旺证）的随机对照多中心临床试验

Efficacy of Kouyanqing Granule in treatment of children with recurrent aphthous ulcer (fire excess from yin deficiency syndrome): a randomized,controlled,multi-center clinical trial

关键词:  口炎清颗粒  儿童  复发性阿弗他溃疡  中药  随机对照试验

Key words:  Kouyanqing Granule  children  recurrent aphthous ulcer  traditional Chinese medicine  randomized controlled trial

摘要:

[目的] 评价口炎清颗粒治疗儿童复发性阿弗他溃疡（阴虚火旺证）缩短病程的作用，以及减少复发、缓解疼痛和改善中医证候作用，并观察安全性。[方法] 采用随机、双盲、安慰剂平行对照、多中心临床研究的设计方法。计划纳入144例，按照1：1的比例随机分为试验组和安慰剂组，分别服用口炎清颗粒、口炎清颗粒模拟剂，疗程14 d。[结果] 共纳入144例。试验期间，因脱落、超窗、违背纳排标准，试验组6例、安慰剂组4例未纳入符合方案数据集（PPS），下同。试验组溃疡消退中位时间为12 d，安慰剂组14 d，两组比较，差异有统计学意义（P<0.05）。试验组溃疡复发率为42.11%，对照组为76.47%，两组比较，差异有统计学意义（P<0.05）。疗后第5~14天，试验组的疼痛视觉模拟评分（VAS）与安慰剂组比较，差异均有统计学意义（P<0.05）。试验组中医证候疗效的总有效率为100%，安慰剂组50%，两组等级疗效和总有效率比较，差异均有统计学意义（P<0.05）。试验中，共发现不良事件4例，试验组1例（1.45%），安慰剂组3例（4.35%）。两组不良事件发生率比较，差异无统计学意义（P>0.05）。[结论] 口炎清颗粒治疗儿童复发性阿弗他溃疡（阴虚火旺证），可明显缩短溃疡发作期病程，减少复发，缓解疼痛和改善中医证候，且临床应用安全较好。

Abstract:

[Objective] To evaluate the efficacy of Kouyanqing Granules in the treatment of children with recurrent aphthous ulcer (fire excess from yin deficiency syndrome),in shortening the course,reducing recurrence and relieving pain,and observe the safety of clinical application. [Methods] A randomized,double-blind,placebo-controlled,multi-center clinical study was used. The trial intended to include 144 patients,who were randomly divided into treatment group and control group according to 1:1 ratio. The treatment group was given Kouyanqing Granules and the control group with kouyanqing Granules placebo for 14 days. [Results] A total of 144 patients were assigned to this study. During the experiment,6 patients in the test group and 4 patients in the placebo group were not included in the FAS due to dropping out,out of visit window and violation of inclusion and exclusion criteria. The median ulcer healing time was 12 days in the treatment group and 14 days in the placebo group (P<0.05). The recurrence rate was 42.11% in the treatment group and 76.47% in the placebo group (P<0.05). From the 5th day to the 14th day,the differences between the pain VAS score of the treatment group and the placebo group were statistically significant (P<0.05). And the effective rate of traditional Chinese medicine syndromes was 100% and 51.39% (P>0.05). In this trial,there were 1 case (1.45%) of adverse events in the treatment group and 3 cases (4.35%) in the control group (P>0.05). [Conclusion] Kouyanqing Granules in the treatment of children with recurrent aphthous ulcer (fire excess from yin deficiency syndrome) can shorten the course clearly,reduce recurrence,relieve pain and improve traditional Chinese medicine syndromes,and the security is good.