清经胶囊治疗月经先期的临床研究

Clinical Observation on Treatment of Advanced Menorrhea with QingJing Capsule

目的评价清经胶囊的疗效及安全性。方法采用随机双盲、双模拟、阳性药平行对照法,观察月经先期虚热证患者63例。其中,清经胶囊组32例,固经丸组31例。观察其对月经周期、中医证候、基础体温(BBT)、雌二醇(E2)、孕酮(P)以及宫内膜活检等指标的影响。结果清经胶囊组、固经丸组治疗月经先期的近期疗效愈显率分别为90.63%,77.42%;有效率分别为96.88%,93.55%。远期疗效愈显率分别为83.87%,67.74%;有效率分别为93.55%,80.65%,其中愈显率有显著性差异,清经胶囊组疗效明显高于固经丸组。结论清经胶囊为治疗月经先期虚热证的中药制剂,其清热凉血,滋肾养阴,调经止血的功效确切,临床试验未发现该制剂有明显的不良反应。

Objective To investigate the effect of Qingjing Capsule (QC) in treating advance menorrhea (AM) and to evaluate its safety. Methods Double- blind, double- imitating, parallel- controlled and randomized trial was performed in 63 cases of AM with deficiency- heat syndrome.Thirty- two cases was in QC group(Group A) and other 31 in Gujing pill group(Group B).The menstrual cycle, clinical symptoms and signs, basal body temperature (BBT), serum levels of estradiol (E2) and progesterone and endometrium biopsy were observed to evaluate the effects of QC. Results The short- term markedly- effective rate was 90.63% and 77.42% and the short- term effective rate was 96.88% and 93.55% in Group A and Group B respectively. The long- term markedly- effective rate was 83.87% and 67.74% and the long- term effective rate was 93.55% and 80.65% in Group A and Group B respectively. The long- term markedly- effective rate in QC group is superior to that in Gujing pill group, the differences being significant(P < 0.05). Conclusion Qingjing capsule exerts a definite effect in treating AM with deficiency- heat syndrome. No adverse reaction is found.