荆肤止痒颗粒与消风止痒颗粒对照治疗湿热型丘疹性荨麻疹临床研究

Clinical Control Research of Granule of Jing-fu Zhi-yang and Granule of Xiao-feng Zhi-yang on Papular Urticaria

目的:评价荆肤止痒颗粒治疗丘疹性荨麻疹湿热证的有效性与安全性。方法:采用区组随机、双盲、阳性药对照、多中心的方法进行临床研究。结果:荆肤止痒颗粒对丘疹性荨麻疹湿热证的试验组愈显率70.59%,总有效率94.12%;对照组愈显率53.85%,总有效率84.62%,均有统计学差异(P<0.05);对中医证候的试验组愈显率65.36%,总有效率94.12%;对照组愈显率46.15%,总有效率82.69%;两组比较,差异均有显著性意义。两组风团样丘疹、局部瘙痒与水疱的疗效等单项症状治疗前后组内比较,差异有显著性意义。该试验,对照组出现头痛1例,占1.89%。结论:荆肤止痒颗粒对丘疹性荨麻疹湿热证的治疗效果不劣于对照药消风止痒颗粒,且临床应用较之更为安全。

Objective： To evaluate the efficacy and safety of Granule of Jing -fu Zhi -yang on papular urticaria with damp - heat syndrome. Methods ： This research was applied with block randomized, double - blind, positive drug control, and multi center clinical study methods to complete. Results ： On damp -heat syndrome in treatment group the excellent rate was 70.59%, and the total effective rate was 94.12%. And in control group the excellent rate was 53.85% , and the total effective rate was 84.62%. There was significant difference between them （P 〈0.05 ）. On Chinese syndrome in treatment group the excellent rate was 65.36% , and the total effective rate was 94.12%. And in control group the excellent rate was 46.15%, and the total effective rate was 82.69%. There was significant difference between the two groups. And the difference was also significant between before and after treatment in each group on urticaria papules, local itching and blister. But in control group 1 case had a headache, accounted for 1.89%. Conclusion ： The therapeutic effect of Granule of Jing-fu Zhi- yang is not inferior to that of control drug Granule of Xiao -feng Zhi-yang. And Granule of Jing-fu Zhi-yang is safer in clinical application.