目的复方芩兰口服液治疗儿童急性上呼吸道感染（风热感冒证）的有效性及安全性评价。方法采用多中心、随机对照、剂量探索、临床研究的方法，将108例急性上呼吸道感染（风热感冒证）患儿随机分为3组，高剂量组患儿口服复方芩兰口服液，2支/次，3次/d。低剂量组患儿口服复方芩兰口服液，1支/次，3次/d；复方芩兰口服液模拟剂，1支/次，3次/d。对照组患儿口服复方芩兰口服液模拟剂，2支/次，3次/d。疗程均为3 d。观察3 d痊愈率及中医证候疗效。结果对照组、低剂量组、高剂量组的全分析数据集（FAS）3 d痊愈率分别为47.22%、80.56%和91.67%，低剂量组和高剂量组3 d痊愈率显著优于对照组（P<0.05）。在中医证候疗效方面，以痊愈、未痊愈分布分析结果显示：对照组和高剂量组的主症鼻塞、对照组和低剂量组的主症流浊涕和兼症口渴组间比较，差异有统计学意义（P<0.05）。以有效、显效、痊愈和无效分布情况分析中医证候疗效，3组间总有效率无统计学差异。研究中未发生严重不良事件。结论复方芩兰口服液治疗儿童急性上呼吸道感染（风热感冒证）疗效确切，安全性好，高剂量使用能明显改善鼻塞症状，低剂量使用在改善流浊涕、口渴症状方面显示出良好作用。

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

国家重大新药创制科技重大专项（2018ZX09721003）