小儿热速清颗粒治疗小儿外感发热(风热证)的有效性及安全性研究

Efficacy and Safety Study of Xiaoer Resuqing Granules for Treatment of Pediatric Exogenous Fever (Wind Hot Card)

目的:评价小儿热速清颗粒治疗小儿外感发热风热证的临床疗效及其安全性。对象与方法:选择符合感冒标准及风热证辨证的患者,进行开放性的随机对照临床试验,评价小儿热速清颗粒和小儿宝泰康颗粒的疾病疗效、中医证候疗效。结果:实验表明,治疗3天后,疾病疗效分析中愈显率分别为小儿热速清颗粒组75.5%,小儿宝泰康颗粒组67.0%;总有效率分别为小儿热速清颗粒组86.5%,小儿宝泰康颗粒组80.7%在疾病疗效分析、中医症候分析方面小儿热速清颗粒组非劣于小儿宝泰康颗粒组,两组均无统计学差异;在完全退热时间分析、退热起效时间分析方面小儿热速清组明显优于对照组小儿宝泰康颗粒组,两者具有统计学差异。结论:小儿热速清颗粒对小儿外感发热(风热证)具有较好的治疗作用且安全性好。

Objective：Evaluation on the clinical curative effect of wind and its safety of Xiaoer Resuqing Granules in treating pediatric fever heat syndromes differentiation.Methods：Option meets cold wind heat syndromes differentiation standard and the patients,for opening randomized controlled trials,Evaluation on the disease clinical efficacy and syndromes curative effect of Xiaoer Resuqing Granules and Xiaoerbaotaikang.Results：Experiments showed that the treatment in three days,the disease and greater efficacy analysis in Xiaoer resuqing pediatric group is 75.5%,Xiaoer baotaikang particle group 67.0% treasure,the total effective rate respectively for Xiaoer resuqing Granules group,infantile 86.5% Xiaoer baotaikang particle group in 80.7% treasure efficacy analysis,Chinese medicine symptomatic disease analysis in Xiaoer Resuqing particle group non-inferior Xiaoer baotaikang particle group,without treasure both groups was not statistically significant.In completely antifebrile time analysis,antifebrile effect-acting period analysis in Xiaoer resuqing group was better than control Xiaoer baotaikang Granules group,two has statistically significant.Conclusion：Xiaoer Resuqing Granules in pediatrics exogenous fever（wind hot card） has good therapeutic effects and good safety.