防风通圣颗粒治疗急性荨麻疹的随机、安慰剂对照观察

A randomized,placebo controlled study on Fangfeng Tonghseng Granule in treatment of acute urticaria

目的评价防风通圣颗粒治疗急性荨麻疹(表寒里热,表里俱实证)的有效性、安全性。方法采用中心分层、区组随机的设计方法,将108例患者分成试验组72例和对照组36例。试验组服用防风通圣颗粒,对照组服用防风通圣颗粒模拟剂,用法用量均为每次3 g,每天2次,疗程为14 d。观察两组中医证候疗效、皮肤症状疗效、单项症状疗效及不良事件。结果试验组完成试验70例,对照组完成试验36例。中医证候疗效:用药2周后,试验组愈显率为41.43%(29/70),对照组为5.56%(2/36),试验组优于对照组,差异有统计学意义(P<0.05)。中医证候积分:用药2周后,试验组下降(7.87±3.85),对照组下降(2.42±3.20),试验组下降幅度大于对照组,差异有统计学意义(P<0.05)。皮肤症状疗效:用药2周后,试验组愈显率40.00%(28/70),对照组为5.56%(2/36),试验组优于对照组,,差异有统计学意义(P<0.05)。皮肤症状积分:试验组下降(11.94±6.72),对照组下降(3.67±4.93),试验组下降幅度大于对照组,差异有统计学意义(P<0.05)。单项症状疗效:用药2周后,在单项皮肤症状、单项中医症状的改善方面,试验组均优于对照组,差异有统计学意义(P<0.05)。试验过程中无明显与药物有关的不良事件。结论防风通圣颗粒治疗急性荨麻疹(表寒里热,表里俱实证)安全、有效。

Objective To evaluate the effectiveness and safety of Fangfeng Tongsheng Granule in the treatment of acute urticaria(superficial cold and interior heat syndrome,exterior and interior excess syndrome).Methods Totally 108 patients were enrolled and assigned to two groups:72 patients in the test group and 36 patients in the control group,in the block randomized,multi-centered study.Those in the test group took Fangfeng Tongsheng Granule with the dose of 3 g,twice a day,while those in the control group took simulated agent granules with the same dose.The therapeutic course lated for 14 days.The efficacies in TCM syndrome,dermal symptoms,single symptom and adverse events were observed.Results 70 cases in the test group and 36 cases in the control group completed the clinical trial.As for TCM syndrome,after the medication for 2 weeks,the cure rate was 41.43%(29/70)in the test group and 5.56%(2/36)in the control group,with a statistical difference between the two groups(P<0.05).Regarding the TCM score,after the medication for 2 weeks,the test group decreased by(7.87±3.85),while the control group decreased by(2.42±3.20),indicating a statistical difference between the two groups(P<0.05).As for the efficacy of dermal symptoms,after the medication for 2 weeks,the cure rate was 40.00%(28/70)in the test group and 5.56%(2/36)in the control group,with a statistical difference between the two groups(P<0.05).Regarding the TCM score,after the medication for 2 weeks,the test group decreased by(11.94±6.72),while the control group decreased by(3.67±4.93),indicating a statistical difference between the two groups.As for the curative effect of single symptom,after 2 weeks of medication,the improvement of single skin symptom and single TCM symptom in the experimental group was better than that in the control group,with a statistical difference between the two groups(P<0.05).There was no significant adverse event caused by Fangfeng Tongsheng Granule.Conclusion Fangfeng Tongsheng Granule was effective and safe in treating acute urticaria(superficial cold and interior heat syndrome,exterior and interior excess syndrome).