目的 评价不同剂量的蒲地蓝消炎口服液治疗小儿急性咽-扁桃体炎肺胃实热证的有效性和安全性。方法 采用随机、双盲、阳性药与安慰剂平行对照、多中心临床研究的方法。7家中心共入选本病证受试者324例，按照2：2：1：1的比例，随机分为蒲地蓝消炎口服液高剂量组108例（A组）、低剂量组108例（B组）、阳性药组54例（即小儿咽扁颗粒组，C组）和安慰剂组54例（D组）。疗程5 d。观察咽痛、咽红肿疗效，以及咽痛起效和消失时间、中医证候疗效及其他单项症状体征疗效。结果 ①进入全分析数据集（FAS）317例，符合方案数据集（PPS）284例，安全性分析集（SS）324例。②有效性评价：咽痛、咽红肿总有效率的组间比较，差异均有统计学意义（P<0.001），A、B组均优于D组，且A、B组均非劣于C组、B组非劣于A组。中医证候总有效率的组间比较，差异有统计学意义（P<0.001）。咽痛起效中位时间的组间比较，经Log-Rank检验，差异有统计学意义（P<0.05）；咽痛消失中位时间的组间比较，经Log-Rank检验，差异有统计学意义（P<0.001）。其他单项症状总有效率的组间比较，除发热外的口臭、咳嗽、口渴、小便黄、大便干诸症，差异均有统计学意义（P<0.05）。PPS分析与FAS分析，结论一致。③安全性评价：未报告不良反应，不良事件发生率的组间比较，差异无统计学意义；理化检查未见具有临床意义的异常改变。结论 蒲地蓝消炎口服液高、低剂量治疗小儿急性咽-扁桃体炎肺胃实热证，相对于安慰剂均显示出疗效优势，且非劣于阳性药小儿咽扁颗粒，其高剂量未显示出相对于低剂量组的疗效优势。试验中，各组均未发现不良反应。推荐临床应用低剂量方案治疗。

Objective To evaluate the efficacy and safety of different dosages of Pudilan Xiaoyan Oral Liquid (PXOL) in treatment of infantile acute pharyngitis-tonsillitis with lung-stomach excess-heat syndrome. Methods A randomized controlled, double-blind, positive drug parallel controlled, and multi-center clinical trial was conducted. Totally 324 children from seven research centers were included, 108 cases in experimental high dose group (A Group), 108 cases in experimental low dose group (B Group), 54 cases in positive medicine group (Xiaoer yanbian Granula, C Group), and 54 cases in placebo group (D Group), with the ratios of 2:2:1:1.5 in a course. Results ① Totally 317 cases were in full analysis set (FAS), 284 cases in per-protocol set (PPS) and 324 cases in Safety Set (SS). ② Evaluation on effectiveness:There was significant difference (P<0.001) between each two groups in the total effective rate of pharyngalgia and pharyngeal swelling. A Group and B Group were both superior to D Group, and were non-inferior to C Group. B Group was non-inferior to A Group. There was significant difference (P<0.001) between each two groups in total effective rate of syndrome of traditional Chinese medicine. There was significant difference (P<0.05) between each two groups in the median time of improving pharyngalgia syndrome. There was significant difference (P<0.001) between each two groups in the median time of pharyngalgia syndrome disappearing. There were significant differences (P<0.05) between each two groups in total effective rate of halitosis, cough, thirst, deep-colored urine, and dry stool. The analysis on PPS agrees with that of FAS. ③ Evaluation on safety:No adverse reactions in clinical significant laboratory examination were found during the trial. Conclusion High and low dosages of PXOL show advantages over placebo and are non-inferior to the positive medicine Xiaoer Yanbian Granula. High dose group does not show advantage comparing with low dose group. No adverse reactions are found during the trial. Low dose therapy is recommended.