目的復(fù)方芩蘭口服液治療兒童急性上呼吸道感染（風(fēng)熱感冒證）的有效性及安全性評價(jià)。方法采用多中心、隨機(jī)對照、劑量探索、臨床研究的方法，將108例急性上呼吸道感染（風(fēng)熱感冒證）患兒隨機(jī)分為3組，高劑量組患兒口服復(fù)方芩蘭口服液，2支/次，3次/d。低劑量組患兒口服復(fù)方芩蘭口服液，1支/次，3次/d；復(fù)方芩蘭口服液模擬劑，1支/次，3次/d。對照組患兒口服復(fù)方芩蘭口服液模擬劑，2支/次，3次/d。療程均為3 d。觀察3 d痊愈率及中醫(yī)證候療效。結(jié)果對照組、低劑量組、高劑量組的全分析數(shù)據(jù)集（FAS）3 d痊愈率分別為47.22%、80.56%和91.67%，低劑量組和高劑量組3 d痊愈率顯著優(yōu)于對照組（P<0.05）。在中醫(yī)證候療效方面，以痊愈、未痊愈分布分析結(jié)果顯示：對照組和高劑量組的主癥鼻塞、對照組和低劑量組的主癥流濁涕和兼癥口渴組間比較，差異有統(tǒng)計(jì)學(xué)意義（P<0.05）。以有效、顯效、痊愈和無效分布情況分析中醫(yī)證候療效，3組間總有效率無統(tǒng)計(jì)學(xué)差異。研究中未發(fā)生嚴(yán)重不良事件。結(jié)論復(fù)方芩蘭口服液治療兒童急性上呼吸道感染（風(fēng)熱感冒證）療效確切，安全性好，高劑量使用能明顯改善鼻塞癥狀，低劑量使用在改善流濁涕、口渴癥狀方面顯示出良好作用。

Objective Effectiveness and safety evaluation of Compound Qinlan Oral Liquid in treatment of children with acute upper respiratory tract infection (wind-heat cold syndrome). Methods A total of 108 children with acute upper respiratory (wind-heat cold syndrome) were randomly divided into three groups by the method of multi-center, randomized control, dose exploration and clinical study. The high-dose group were po administered with Compound Qinlan Oral Liquid, 2 tubes/time, three times daily. Low-dose group were po administered with Compound Qinlan Oral Liquid, 1 tube/time, three times daily, Compound Qinlan Oral Liquid simulation, 1 tube/time, three times daily. Control group were po administered with Compound Qinlan Oral Liquid simulation, 2 tubes/time, three times daily. The course of treatment was 3 days. Observe the cure rate of 3 days and the curative effect of TCM syndrome. Results The 3-day cure rate (FAS) in control group, low-dose group, and high-dose group was 47.22%, 80.56% and 91.67%, respectively. The 3-day cure rate in low-dose group and high-dose group was significantly better than that in control group (P < 0.05). In terms of the curative effect of TCM syndromes, the distribution analysis results of cured and uncured showed that there was statistical significance in the comparison between the control group and the high-dose group with the main symptoms of nasal obstruction, and the control group and the low-dose group with the main symptoms of nasal turbidness and concurrent thirst (P < 0.05). The distribution of effective, effective, cured and ineffective syndromes of TCM was analyzed, and there was no statistical difference in the total effective rate between the three groups. No serious adverse events occurred during the study. Conclusions Compound Qinlan Oral Liquid has definite efficacy and good safety in treatment of children with acute upper respiratory tract infection (wind-heat cold syndrome). High dose can significantly improve the symptoms of nasal congestion, while low dose can significantly improve the symptoms of turffy nose and thirst.

R974

國家重大新藥創(chuàng)制科技重大專項(xiàng)（2018ZX09721003）