目的 评价喜炎平注射液治疗急性扁桃体炎的有效性和安全性。方法 收集2017年4月16日—2021年5月25日就诊于赣南医学院第一附属医院等18家中心18～65周岁的急性扁桃体炎患者458例，以1∶1的比例随机分配到试验组和安慰剂组中。试验组采用喜炎平注射液联合常规治疗，安慰剂组采用喜炎平模拟注射液联合常规治疗。观察两组的临床疗效，比较两组治疗后急性扁桃体炎病症缓解时间及各项症状缓解时间，评价安全性。结果 治疗后，试验组可以使中位扁桃体炎缓解时间显著缩短12.7 h（P＜0.05），与安慰剂组比较具有优效性。治疗后，试验组可显著缩短各项症状缓解时间，咽痛、夜咳、日咳、发冷/出汗的中位缓解时间与安慰剂组比较分别缩短13.5、14.2、21.0、3.8 h，差异具有统计学意义（P＜0.05）。两组总体不良事件发生率相似，所有不良事件均恢复且无严重不良反应。结论 喜炎平注射液可缩短急性扁桃体炎患者的疾病缓解时间，提高临床治愈率，加快缓解各项症状，临床疗效安全可靠。

Objective To evaluate the efficacy and safety of Xiyanping Injection (喜炎平注射液) in the treatment of acute tonsillitis. Methods 458 patients aged 18 to 65 years old with acute tonsillitis admitted to 18 centers including the First Affiliated Hospital of Gannan Medical University from April 16, 2017 to May 25, 2021 were collected and randomly assigned to the experimental group and the placebo group in a 1︰1 ratio. The experimental group was treated with Xiyanping Injection combined with conventional treatment, and the placebo group was treated with Xiyanping simulated injection combined with conventional treatment. The clinical efficacy of the two groups was observed, and the remission time of acute tonsillitis and various symptoms after treatment were compared between the two groups, and the safety was evaluated. Results The median remission time of tonsillitis in the experimental group was significantly shortened by 12.7 h (P < 0.05), and had excellent efficacy. The median remission time of pharyngeal pain, night cough, day cough and chiller/sweating was shortened by 13.5, 14.2, 21.0 and 3.8 h, respectively, in the experimental group compared with the placebo group, and the difference was statistically significant (P < 0.05). The overall incidence of adverse events was similar between the two groups, and all adverse events recovered without serious adverse reactions. Conclusion Xiyanping Injection can shorten the remission time of acute tonsillitis, improve the clinical cure rate, accelerate the relief of symptoms, and the clinical efficacy is safe and reliable.

R285.64

科技部“十二五”重大新药创制专项：抗病毒感染中药“喜炎平注射液”的关键技术研究的延伸性研究课题—中药大品种“喜炎平注射液”上市后再评价（2014ZX09201025）