红花逍遥片治疗经前期综合征随机双盲双模拟、多中心临床研究

Multicenter randomized clinical trial of safflower Xiaoyao tablet in the treatment of premenstrual syndrome

目的探讨红花逍遥片治疗经前期综合征(肝郁气滞血瘀证)的临床疗效和安全性。方法采用随机双盲双模拟、多中心临床研究法,288例患者随机分为试验组144例,对照组和安慰剂组各72例,分别口服红花逍遥片、经前平颗粒和安慰剂,连续使用2个月经周期。比较临床疗效、单项症状疗效和安全性。结果试验组、对照组和安慰剂组临床有效率分别为95.14%、86.11%和8.33%,试验组和对照组明显较高;与安慰剂组相比,试验组及对照组各单项症状改善均更明显;与对照组相比,试验组的肿胀、眩晕及乳房肿块的改善更明显,差异有统计学意义(P<0.05)。三组患者均未观察到明显不良反应出现。结论红花逍遥片治疗经前期综合征(肝郁气滞血瘀证)有效且安全,值得推广。

Objective To observe the clinical effects and safety of Honghua xiaoyao tablets on the treatment of premenstrual syndrome （liver depression, stagnation of qi and blood stasis）. Methods A randomized, double-blind, double-dummy and multi-center clinical study was adopted, 288 cases were randomly divided into study group （144 cases）, control group （72 cases） and placebo group （72 cases）, and Honghua xiaoyao tablets, Jingqianping granules and placebo were taken respectively. All treated for 2 menstrual cycles. The clinical efects, individual symptoms efficiency and safety were compared. Results The clinical efficiency in study group and control group was 95.14% and 86.11%, respectively, both were higher than that of placebo group of 8.33% （P〈0.05）. Compared with those in placebo group, the individual symptoms improved greatly in study group and control group （P〈0.05）. Compared with those in control group, the tumidness, dizziness and breast lump improved greatly in study group （P〈0.05）. There were no obvious adverse reactions were observed in all three groups. Conclusion Honghua xiaoyao tablets are efective and safe for premenstrual syndrome （liver depression, stagnation of qi and blood stasis） and is worthy of widely clinical use.