目的 评价小儿柴桂退热口服液治疗急性上呼吸道感染伴发热（表寒里热证），改善综合症状、提升患儿生活质量、退热、减少并发症的疗效及安全性。方法 采用多中心、区组随机、双盲双模拟、阳性药对照的临床研究方法。纳入28家研究中心共计504例病例，其中试验组为378例，对照组为126例。试验组予小儿柴桂退热口服液和小儿感冒舒颗粒模拟剂；对照组予小儿柴桂退热口服液模拟剂和小儿感冒舒颗粒，两组均连续治疗5 d。结果 共28家中心入选随机受试者504例，502例进入全分析集（FAS），其中试验组为376例，对照组为126例。治疗终点CARIFs综合症状维度痊愈率的FAS分析，试验组的痊愈率为92.82%、对照组为91.27%，组间比较无统计学意义。本研究共报道33例（6.55%）不良事件（AE），其中试验组报道23例（6.08%），对照组报道10例（7.94%），AE发生率的组间比较，差异无统计学意义。两组生命体征、各理化检查指标比较差异无统计学意义。结论 小儿柴桂退热口服液治疗急性上呼吸道感染伴发热（表寒里热证）改善综合症状、提升患儿生活质量、退热、减少并发症的疗效好，且具有较高安全性，可进行临床推广应用。

Objective To evaluate the efficacy and safety of Xiao’er Chaigui Tuire Oral Liquid in improving comprehensive symptoms, enhancing quality of life, reducing fever, and decreasing complications in children with acute upper respiratory tract infection (wind-cold exterior with interior heat syndrome). Methods A multicenter, block-randomized, double-blind, double-dummy, active-controlled clinical trial was conducted. The study enrolled 504 patients from 28 centers, with 378 assigned to the experimental group and 126 to the control group. The experimental group received Xiao’er Chaigui Tuire Oral Liquid and a placebo simulating Xiao’er Ganmao Shu Granules; The control group received a placebo simulating Xiao’er Chaigui Tuire Oral Liquid and the active Xiao’er Ganmao Shu Granules. Treatment continued for 5 d in both groups. Results A total of 504 subjects were randomized from 28 centers, with 502 included in the Full Analysis Set (FAS): 376 in the experimental group and 126 in the control group. In the FAS analysis, the recovery rate based on the comprehensive symptom dimension of CARIFs at the treatment endpoint was 92.82% in the experimental group and 91.27% in the control group, with no statistically significant difference between groups. Throughout the study, 33 adverse events (AEs) were reported in 33 subjects (6.55%), with 23 AEs (6.08%) in the experimental group and 10 AEs (7.94%) in the control group. The difference in AE incidence between groups was not statistically significant. No statistically significant differences were observed between the two groups regarding vital signs or various laboratory test parameters. Conclusion Xiao’er Chaigui Tuire Oral Liquid demonstrates good efficacy in improving comprehensive symptoms, enhancing quality of life, reducing fever, and decreasing complications in children with acute upper respiratory tract infection accompanied by fever (wind-cold exterior with interior heat syndrome). It also shows a favorable safety profile, supporting its clinical application and promotion.

R974