目的 評價口炎清顆粒治療小兒皰疹性口炎（陰虛風(fēng)熱證）的有效性和安全性。方法 2013年—2016年由7家臨床評價中心采用隨機、雙盲、安慰劑平行對照、多中心臨床試驗方法同期完成，計劃納入144例患兒，按1∶1的比例隨機分為試驗組和對照組，分別給予口炎清顆粒、口炎清顆粒模擬劑，服用方法均為1~3歲口服1.5 g/次，3~6歲口服3 g/次，2次/d，療程均為7 d。結(jié)果 實際納入144例患兒，其中試驗組、對照組各72例。治療7 d，試驗組全分析數(shù)據(jù)集（FAS，下同）黏膜損傷痊愈率為83.33%，對照組痊愈率為27.78%，兩組痊愈率比較差異有統(tǒng)計學(xué)意義（P<0.05）；試驗組、對照組中醫(yī)證候愈顯率分別為88.89%、34.72%，兩組比較差異有統(tǒng)計學(xué)意義（P<0.05）。首次用藥后24 h，試驗組疼痛起效率為43.06%，對照組為11.11%，兩組比較差異有統(tǒng)計學(xué)意義（P<0.05）。試驗中共發(fā)現(xiàn)3例不良事件，試驗組1例（1.39%），對照組2例（2.78%），兩組不良事件發(fā)生率比較，差異無統(tǒng)計學(xué)意義。結(jié)論 口炎清顆粒治療小兒皰疹性口炎（陰虛風(fēng)熱證），可修復(fù)損傷黏膜、減輕疼痛癥狀，改善中醫(yī)證候，臨床應(yīng)用安全性較好。

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