射干利咽口服液治疗小儿急性咽炎肺胃热盛证的多中心临床研究

Multi-center clinical trial of Shegan Liyan oral liquid in treating acute infantile pharyngitis with intenseness of heat in lung and stomach

[目的]评价射干利咽口服液治疗小儿急性咽炎肺胃热盛证的有效性和安全性。[方法]采用分层随机、双盲双模拟、阳性药平行对照、多中心临床研究的方法。480例患者按3∶1的比例分为试验组与对照组,分别服用射干利咽口服液和小儿咽扁颗粒,疗程为4 d。以中医证候疗效为主要观察指标。[结果]PPS、FAS分析试验组中医证候疗效愈显率为83.72%(83.04%),对照组为71.05%(69.83%),试验组疾病疗效愈显率为84.30%(83.62%),对照组70.17%(68.97%),两组比较,差异均有统计学意义(P=0.00),试验组优于对照组。试验组各单项中医症状有效率均明显高于对照组(P<0.05)。试验中,试验组出现1例胃胀痛不良事件,两组均未发现有临床意义的实验室指标异常改变。[结论]射干利咽口服液治疗小儿急性咽炎肺胃热盛证有效,优于对照药,且安全性较好。

[Objective] To observe the efficacy and safety of Shegan Liyan oral liquid n treating acute infantile pharungitis with intense- ness of heat in lung and stomach. [Methods] A method with randomized, positive-drug, parallel-controlled, doubled-blind, double-dum- my, multi-center trial was designed in the clinical study. The 360 cases were served as treatment group, taking oral Shegan Liyan liquid for 4 days. 120 cases as control group, receiving Yanbian granules for 4 days. The curative effectiveness in syndrome of TCM was the main observing paramete. [Results] The total effective rate of treatment group was 83.72% and that of the control group was 71.05%. The syndrome total effective rate of treatment group was 84.30% and that of control group was 70.17% with significant difference between two groups （P=0.00）.The single symptom effective rate in the treatment group was superior than that in the control group （P〈0.05）. One case with adverse event of stomach bursting pain was found in treatment group. No abnormal changes of laboratory indexes with clinical signif- icance were observed in both groups. [Conclusion] Shegan Liyan oral liquid is safe and effective in treating acute infantile pharyngitis with syndrome due to excess heat in the lung and stomach.