目的 評價小兒肺熱清顆粒治療小兒急性支氣管炎痰熱壅肺證的有效性和安全性。方法 采用區(qū)組隨機、雙盲雙模擬、陽性藥平行對照、多中心臨床研究的方法。208例患者進入符合方案數(shù)據(jù)集,治療組102例,對照組106例。治療組服用小兒肺熱清顆粒和急支顆粒模擬藥;對照組服用急支顆粒和小兒肺熱清顆粒模擬藥。所有藥物均將每瓶用溫開水沖至100 mL后分次服用,用量均為3次/d,1～2歲,每次10 mL;3～6歲,每次15 mL;7～11歲,每次20 mL;12～14歲,每次30 mL,療程5 d。觀察兩組的臨床療效、中醫(yī)證候療效和單項證候療效,并對其依從性和安全性進行評價。結果 治療組和對照組臨床療效的愈顯率分別為86.27%、74.53%,中醫(yī)證候療效的愈顯率分別為90.2%、75.47%,且治療組的療效優(yōu)于對照組,差異有統(tǒng)計學意義(P < 0.05)。兩組治療前后自身比較,各單項癥狀差異均具有統(tǒng)計學意義(P < 0.001);治療前后兩組咳嗽、舌苔積分的差值比較,治療組優(yōu)于對照組,差異有統(tǒng)計學意義(P < 0.05)。兩組均未發(fā)現(xiàn)不良反應。結論 小兒肺熱清顆粒對小兒急性支氣管炎痰熱壅肺證具有良好的療效,且安全性良好。

Objective To evaluate the efficacy and safety of Xiao'er Feireqing Granules in treatment of lung phlegm heat syndrome in children with acute bronchitis bronchitis. Methods The stratified random, double blind, double dummy, parallel control of positive drugs, and multi- center clinical method was applied to this study. Patients (208 cases) were included into per protocol analysis of the data set, and there were 102 and 106 cases in treatment and control group. Patients in the treatment group were administered with Xiao'er Feireqing Granules and simulation of Jizhi Granules, while patients in control group were administered with Jizhi Granules and simulation of Xiao'er Feireqing Granules. Every bottle of all medicine was dissolved into 100 mL with warm water, and take divides. The dosage was 3 times/d, 1 — 2 years old patients: 10 mL/time; 3 — 6 years old patients: 15 mL/time; 7 — 11 years old patients: 20 mL/time; 12 — 14 years old patients: 20 mL/time. The patients in two groups were treated for 5 d. Clinical efficacy, traditional Chinese medicine syndrome, and single syndrome curative effect were observed. And the medication compliance and security were evaluated. Results The curative rates of treatment and control groups in clinical efficacy were 86.27% and 74.53%, and the clinical curative rates of both groups in traditional Chinese medicine syndrome effect were 90.2% and 75.47%. These of treatment group were better than those of control group, and there were significant differences between the two groups (P < 0.05). Compared with same group before treatment, there were significant differences between the two groups in single syndrome curative effect (P < 0.001). There were significant differences between the two groups in the difference value of cough and tongue fur integrals before and after treatment, and treatment group were better than control group with significant (P < 0.05). There was no side effect in both groups. Conclusion Xiao'er Feireqing Granules has a definite effect on lung phlegm heat syndrome in children with acute bronchitis with good safety.