经前平颗粒多中心、随机双盲双模拟对照治疗经前期综合征肝气逆证403例

Efficacy and safety of Jingqianping granule in treatment of 403 cases of the liver-qi invasion of premenstrual syndrome with multicentre, random,double-blind and double simulation and control method

目的 :对治疗经前期综合征新药经前平颗粒进行II期临床试验 ,评价其临床疗效和安全性。方法 :采用多中心、随机分组、双盲双模拟对照法 ,观察患者 30 3例 ,其中治疗组 2 0 2例 ,对照组 10 1例 ;其余 10 0例为开放治疗组 ,共计 4 0 3例。治疗组用经前平颗粒每次 15g ,po ,tid ;对照组用逍遥丸每次 9g ,po ,tid。各组均连续用 2个月经周期。结果 :采用随机双盲、双模拟对照的 30 3例患者中 ,治疗组经前平颗粒对经前期综合征的临床愈显率为77.72 % ,总有效率为 96 .0 4 % ;随访 3个月经周期愈显率为 83.6 4 % ,总有效率为 95 .76 % ;与对照组比较 ,均有显著性差异 ,治疗组显著优于对照组 ;总治疗组年龄、病程、病情与总疗效的关系经Ridit分析 ,年龄、病程与疗效无显著性差异 ;病情轻度与中度、重度患者比较 ,有显著性差异 (P <0 .0 5 ) ,病情中度与重度患者疗效比较无显著性差异(P >0 .0 5 )。未见明显不良反应。结论 :经前平颗粒治疗经前期综合征肝气逆证安全、有效 ,尤其适用于病情轻度患者。

Objective:To evaluate the efficacy and safety of Jingqianping granule of treating premenstrual syndrome (PMS) in phase Ⅱ clinical trail.Methods:Multicentre,random,double blind and double simulation and control method was adopted in this study.403 cases were divided into the treatment group( n =202),the control group( n =101) and the open treatment group( n =100).Results:For 303 cases with the method,clinical cure rate and notable curative effect rate of the treatment group were 77.72%,the total rate of curative effect was 96.04%;the cure rate and notable curative effect rate after 3 menstrual phases of succedent visit was 83.64%,the total rate of curative effect was 95.76%;there were significant difference compared with the control group ( P < 0.01). The toxic and adverse drug reaction was not observed.Conclusion:Jingqianping granule is effective and safe in treatment of the liver qi invasion of PMS,especially for the patients with mild symptoms.