安经妥片治疗经前期综合征:一项在中国妇女中的前瞻性、多中心、随机、双盲、安慰剂平行对照研究

摘要

目的 研究安经妥片治疗经前期综合征(premenstrual syndrome,PMS)的疗效和安全性. 方法 采用多中心、随机、双盲、安慰剂平行对照研究,人组217例,完成202例.根据DSM-IV改编的PMS初筛问卷(SQ)初筛合格后,前瞻性记录基础体温和PMS日记(PMSD)2个月经周期,并采用经前期综合征自评量表(PMTS)2次评价后,诊断为中、重度PMS者随机分配到试验组(安经妥片1片,qd)和对照组(安慰剂1片,qd),连续用药3个月经周期.采用PMSD和PMTS进行资料收集评价疗效. 结果 基线期PMSD黄体期(即月经出血前的最后7 d)平均分安经妥组与安慰剂组之间无显著性差异(分别为29.13和28.14,P＞0.05).治疗3个月经周期后,PMSD黄体期平均分安经妥组由29.13降至6.41,安慰剂组由28.14降至12.64；两组之间下降幅度的差异有统计学意义(P＜0.01).PMTS评分安经妥组由26.17降至9.92,安慰剂组由27.10降至14.59,与基线值比较有统计学差异(P＜0.01).在治疗的第1、2、3个周期PMSD临床有效率安经妥组分别为52.9％、67.3％和79.8％；安慰剂组分别为38.5％、47.1％和50.0％.两组在治疗的3个月经周期间PMSD临床有效率的差异均有统计学意义.研究期间共有19例发生了23件不良事件,但无严重不良事件发生.不良事件发生率安经妥组为8.5％,安慰剂组为9.4％,两组之间差异无统计学意义. 结论 安经妥片能有效、安全地治疗妇女PMS.%Objective: To investigate the efficacy and safety of Vitex agnus castus (VAC) extract (Agnucaston , VAC BNO 1095 corresponding to 40 mg herbal drug) in Chinese women suffering from moderate to severe premenstrual syndrome (PMS).Methods: A prospective, double-blind, placebo controlled, parallel-group, multi-center clinical trial design was employed. After screening and preparation phase lasting two cycles, 217 women were eligible to enter the treatment phase and randomly assigned into the treatment group (?=108) or the placebogroup (n=109). They were treated with VAC extract or placebo for three cycles. Efficacy was assessed using the Chinese version PMS-Diary (PMSD) and Premenstrual Tension Syndrome Self-Rating Scale (PMTS). A total of 208 patients provided the efficacy data (104 in treatment group, 104 in placebo group), and 202 completed the treatment phase (101 for each group).Results: There was no statistical difference for either PMSD scores or PMTS scores between treatment group and control group at baseline (P>0. 05). The mean total PMSD score decreased from 29. 13 at baseline to 6. 41 at the termination (3rd cycle) for the treatment group, and from 28.14 at baseline to 12. 64 at the termination for the placebo group. The total PMSD score of 3rd cycle was significantly lower than baseline in both groups (P<0. 001). The decline in mean PMSD scores from the baseline to the 3rd cycle in the treatment group (22. 71 ±10. 33) was significantly higher than that in the placebo group (15. 50 ± 12. 94) (P<0. 001). The results of PMTS between the two groups showed no significant difference, but the scores decreased significantly after treatment in both groups (P<0. 01). A placebo effect of 50% was found in the present study. No serious adverse events (SAE) occurred in either group.Conclusions: Vitex agnus castus was a safe, well tolerated and effective drug of the treatment for Chinese women with the moderate to sever PMS.