目的 评价口炎清颗粒治疗小儿疱疹性口炎（阴虚风热证）的有效性和安全性。方法 2013年—2016年由7家临床评价中心采用随机、双盲、安慰剂平行对照、多中心临床试验方法同期完成，计划纳入144例患儿，按1∶1的比例随机分为试验组和对照组，分别给予口炎清颗粒、口炎清颗粒模拟剂，服用方法均为1~3岁口服1.5 g/次，3~6岁口服3 g/次，2次/d，疗程均为7 d。结果 实际纳入144例患儿，其中试验组、对照组各72例。治疗7 d，试验组全分析数据集（FAS，下同）黏膜损伤痊愈率为83.33%，对照组痊愈率为27.78%，两组痊愈率比较差异有统计学意义（P<0.05）；试验组、对照组中医证候愈显率分别为88.89%、34.72%，两组比较差异有统计学意义（P<0.05）。首次用药后24 h，试验组疼痛起效率为43.06%，对照组为11.11%，两组比较差异有统计学意义（P<0.05）。试验中共发现3例不良事件，试验组1例（1.39%），对照组2例（2.78%），两组不良事件发生率比较，差异无统计学意义。结论 口炎清颗粒治疗小儿疱疹性口炎（阴虚风热证），可修复损伤黏膜、减轻疼痛症状，改善中医证候，临床应用安全性较好。

objective To evaluate the efficacy and safety of Kouyanqing Granule in the treatment of infantile herpetic stomatitis (syndrome of yin-deficiency and wind-heat). Methods A randomized, double-blind, placebo-controlled, multicenter clinical trial was conducted. This study was completed in 2013-2016 by 7 hospitals. It was planned to include 144 children, who were randomly divided into the experimental group and the control group according to the ratio of 1:1, and took Kouyanqing Granules and its placebo for 7 days, respectively. The dosage was 1.5 g/time for children of 1-3 years old, 3 g/time for children of 3-6 years old, twice a day. Results A total of 144 cases were included, including 72 cases in the experimental group and 72 cases in the control group. After 7 days of treatment, the recovery rate of mucosal injury in the experimental group (FAS, the same below) was 83.33%, and that of the control group was 27.78%. The difference between the two groups was statistically significant (P<0.05). The recovery rates of TCM syndromes in the experimental group and the control group were 88.89% and 34.72%, respectively. The difference was statistically significant (P<0.05). The pain onset efficiency in the first 24 hours after initial prescription was 43.06% and 11.11%, respectively. The difference was statistically significant (P<0.05). During the study, a total of 3 cases of adverse events were reported, including 1 case in the experimental group (1.39%) and 2 cases in the control group (2.78%). There was no statistically significant difference in the incidence of adverse events between groups. Conclusion Kouyanqing Granule can repair the damaged mucosa, relieve the pain symptoms, improve the traditional chinese medicine syndromes in the treatment of children with herpes stomatitis yin-deficiency and wind-heat syndrome.

R287.5;R978.7