目的 观察小儿风热清合剂治疗急性上呼吸道感染（风热感冒证）患儿的有效性及安全性。方法 采用随机、双盲双模拟、阳性药物平行对照、多中心临床试验设计，纳入14个临床评价中心共240例患儿，利用区组随机法分为试验组120例和阳性药物对照组120例，试验组给予小儿风热清合剂及小儿宝泰康颗粒模拟剂，对照组给予小儿宝泰康颗粒及小儿风热清合剂模拟剂，疗程均为5 d，用药满72 h后临床痊愈者，随时停药，按完成病例处理。采用全分析数据集（FAS）、符合方案数据集（PPS）与安全数据集（SS）分析，评价两组患儿主要症状（发热、鼻塞、流浊涕、咽红肿痛、咳嗽）的消失时间、完全退热时间、即时退热时间、中医证候积分及单项症状积分变化情况，并进行安全性评价。结果 FAS分析显示：试验组中位主要症状消失时间为67.50 h、对照组为69.00 h，中位完全退热时间两组均为46.00 h；中位即时退热时间两组均为4.00 h；用药5 d后，试验组有效率为99.12%、对照组有效率为95.69%，上述4个指标两组比较差异无统计学意义；治疗3 d，试验组患儿鼻塞及咽红肿痛的临床痊愈率高于对照组（P<0.05），两组患儿不良事件发生比较差异无统计学意义；试验期间均未见不良反应发生。结论 小儿风热清合剂治疗急性上呼吸道感染疗效较好，在改善鼻咽部症状方面优于小儿宝泰康颗粒，且安全性好。

Objective To evaluate the curative effect and safety of Xiaoer Fengreqing Mixture in treating Acute Upper Respiratory Infection (anemopyretic cold) in Children. Methods A multicenter randomized, double-blind, double-dummy, positive drug parallel control clinical trial was designed. A total of 240 children in 14 centers were divided into the test group of 120 cases and the positive control group of 120 cases with randomized-block method. The test group was given Xiaoer Fengreqing Mixture and Xiaoer Baotaikang Granules simulant; while the control group was given Xiaoer Baotaikang Granules and Xiaoer Fengreqing Mixture simulant. The course in both groups was 5 days. Patients clinically cured can stop medication after treating for 72 h, which was processed as the completed case. Using full analysis set (FAS), per-protocol set (PPS) and safety set (SS) analysis, the two groups of children were evaluated for the disappearance time of the main symptoms (fever, nasal congestion, runny nose, pharyngeal swelling and pain, cough), complete antipyretic time, immediate antipyretic time, Traditional Chinese Medicine (TCM) syndrome score and individual symptom score changes, and safety evaluation. Results In FAS, the median disappearance time of the main symptoms was 67.50 h in the test group, and 69.00 h in the control group. The median time for complete antipyretic time were 46.00 h in both groups. The median immediate antipyretic time was four hour in both groups. After 5 days of treatment, the effective rate of the test group was 99.12%, and the effective rate of the control group was 95.69%. There was no statistically significant difference between the two groups in the above four indicators (P>0.05). After three days of treatment, the clinical recovery rate of nasal congestion and pharyngeal swelling and pain in the test group was higher than that in the control group (P<0.05). There was no significant difference in the occurrence of adverse events between the two groups of children; there was no side effect during the experiment. Conclusion Xiaoer Fengreqing Mixture has a good effect in treating acute upper respiratory tract infection, and is better than Xiaoer Baotaikang Granules in improving nasopharyngeal symptoms, and has good safety.

R287.5

国家卫计委药政司“中药儿童用药相关政策建议”课题示范项目（zyxhekkt014）