目的 評價疏清顆粒治療小兒急性上呼吸道感染（風(fēng)熱感冒證）的有效性和安全性。方法 采用隨機(jī)、雙盲雙模擬、陽性藥平行對照、多中心臨床研究方法，從11個研究中心共入選急性上呼吸道感染患兒240例，隨機(jī)分為試驗組（120例）和對照組（120例），分別口服疏清顆粒+雙黃連顆粒模擬劑、雙黃連顆粒+疏清顆粒模擬劑，療程均5 d。結(jié)果 兩組疾病痊愈的中位時間均為72 h，組間比較差異無統(tǒng)計學(xué)意義。試驗組、對照組的疾病痊愈率分別為95.33%、90.52%，率差95%置信區(qū)間（95% CI）為5.67%（-1.21%，12.55%），提示試驗組痊愈率不劣于對照組。試驗組、對照組48 h完全退熱率分別為79.44%、65.52%（PPS），率差95% CI為13.92%（2.15%，25.69%），組間差異有統(tǒng)計學(xué)意義，試驗組優(yōu)于對照組。中醫(yī)證候療效（愈顯率）、主要癥狀消失率（除咽紅腫痛外）的組間比較，差異均無統(tǒng)計學(xué)意義。報道臨床不良事件7例，兩組臨床不良事件發(fā)生率分別為3.33%、2.50%，差異無統(tǒng)計學(xué)意義，判斷為不良反應(yīng)的共0例。結(jié)論 疏清顆粒治療小兒急性上呼吸道感染（風(fēng)熱感冒證）的疾病療效、證候療效均不劣于雙黃連顆粒，48 h完全退熱率優(yōu)于雙黃連顆粒，且安全性好，有較好的臨床應(yīng)用價值。

Objective To evaluate the clinical efficacy and safety of Shuqing Granules in the treatment of pediatric acute upper respiratory infection (anemopyretic cold). Methods A random, double-blind and double-dummy, positive-drug parallel control, and multi-centered observational clinical approach were used. A total of 240 patients from 11 centers were randomly divided into experimental group (120 patients) and control group (120 patients), which were took Shuqing Granules plus simulant Shuanghuanglian Granules and Shuanghuanglian Granules plus simulant Shuqing Granules, respectively, each cause of treatment for 5 d. Results The median time of recovery of twogroups was both at 72 hours, with no statistical significance. The total cure rate of the experimental and control group were 95.33% and 90.52%, respectively, the 95% CI of rate difference between groups was 5.67% (-1.21%, 12.55%), which indicated that the total cure rate of the experimental group was no lower than that of the control group. The complete rate of the abatement of fever of the experimental group and control group after 48 h were 79.44% and 65.52% (PPS), respectively, The differences between groups were of statistical significance, the 95% CI of rate difference of the two groups is 13.92% (2.15%, 25.69%) and the experimental group was superior to the control group. The group differences of TCM syndrome curative effect (obvious curative rate) and cardinal symptom disappearing rate (except red and swollen throat) were of no statistical significance. Seven clinic adverse drug cases were reported and the occurrence rate of adverse drug cases of each group were 3.33% and 2.50%, respectively, with no statistical significance, among which no case was judged to be untoward reaction. Conclusion The curative effect and syndrome effect of Shuqing Granules in the treatment of pediatric acute upper respiratory infection is no worse than Shuanghuanglian Granules, the complete rate of which for the abatement of fever is superior to the Shuanghuanglian Granules within 48 h, and it is safer and has a better clinical application value.