调经活血胶囊治疗原发性痛经的多中心临床研究

目的评价调经活血胶囊治疗原发性痛经的有效性。方法纳入300例原发性痛经妇女,按1∶2的比例随机分为对照组和治疗组,分别服用安慰剂和调经活血胶囊。连续服用3个月经周期后,使用视觉模拟评分(VAS评分)和中医证候积分评价调经活血胶囊对改善原发性痛经的临床疗效。结果治疗组患者连用3个月经周期后,VAS评分改善有效率达到62.43%,与对照组(23.33%)相比,差异显著(P0.01)。中医临床疗效结果显示,调经活血胶囊治疗3个月经周期后,临床疗效总进步率达76.30%,显著优于对照组(36.67%)。结论调经活血胶囊可有效缓解原发性痛经患者的痛经程度。

Multicenter clinical trial of Tiaojing Huoxue Capsules for primary dysmenorrhoea

Objective To assess the efficacy of Tiaojing Huoxue CapsuleS for the primary dysmenorrhoea (PD).Methods A total of 300 women with PD were enrolled and randomly divided into the control and treatment group, which were administrated with placebo and Tiaojing Huoxue Capsules for three menstrual cycles, respectively. The efficacy of Tiaojing Huoxue Capsule was evaluated by visual analogue scale (VAS) and traditional Chinese medicine (TCM) syndrome scores.Results The effective rate of VAS was 62.43% in the experiment group with statistical significance when compared with the control group (P < 0.01). Similarly, the total effective rate in the treatment group was 76.30% while that in the control group was 36.67% after treatment of three menstrual cycles.Conclusion Tiaojing Huoxue Capsules can relieve the alleviating pain for women with PD.