目的 评价调经活血胶囊治疗原发性痛经的有效性。方法 收集2013年3月—2013年10月在山西医科大学第二医院和陕西中医药大学附属医院门诊就诊的原发性痛经患者64例，随机分为对照组（33例）和试验组（31例）。对照组患者口服安慰剂胶囊，试验组患者口服调经活血胶囊，4粒/次，3次/d。从月经前5 d开始服药至月经第2天，共连续服药7 d后停药。连用3个月经周期。比较两组的VAS疼痛疗效和中医症状疗效，比较两组治疗1、2、3个月的VAS评分和中医症状评分的变化情况。结果 治疗后，对照组和治疗组VAS疼痛疗效的总显效率分别为12.12%、74.19%，总有效率分别为30.30%、87.10%，两组总显效率、总有效率比较差异均有统计学意义（P<0.05）。治疗后，对照组和治疗组中医症状疗效的总显效率分别为0、29.03%，总进步率分别为39.39%、74.19%，两组总显效率、总进步率比较差异均有统计学意义（P<0.05）。治疗2、3个月后，两组VAS评分、中医症状积分均显著降低，同组治疗前后比较差异有统计学意义（P<0.05）；治疗2、3个月后，治疗组VAS评分、中医症状积分显著低于对照组，两组比较差异有统计学意义（P<0.05）。结论 调经活血胶囊治疗气滞血瘀型原发性痛经疗效显著，可显著降低VAS评分和中医症状积分，具有一定的临床推广应用价值。

Objective To evaluate the efficacy of Tiaojing Huoxue Capsules in treatment of qi stagnation and blood stasis primary dysmenorrhea. Methods Patients (64 cases) with qi stagnation and blood stasis primary dysmenorrhea in outpatient service from Second Hospital of Shanxi Medical University and Affiliated Hospital of Shaanxi University of Chinese Medicine from March 2013 to October 2013 were randomly divided into control (33 cases) and treatment (31 cases) groups. Patients in the control group were po administered with Placebo Capsules, and patients in the control group were po administered with Tiaojing Huoxue Capsules, 4 grains/time, three times daily. They started from 5 d before menstruation until the second day of menstruation, and they were treated for 7 d. Patients in two groups were treated for 3 menstrual cycles. After treatment, the VAS efficacies and TCM syndrome efficacies was evaluated, and the changes of VAS score and TCM syndrome score in two groups in two groups before and after treatment were compared. Results After treatment, the total efficiency of VAS pain curative effect in the control and treatment groups were 12.12%, 74.19%, and the clinical efficacy were 30.30%, 87.10%, and there were differences between two groups (P < 0.05). After treatment, the total efficiency of TCM syndrome efficacies in the control and treatment groups were 0, 29.03%, and the total progress rate were 39.39%, 74.19%, and there were differences between two groups (P < 0.05). After 2 and 3 months of treatment, VAS score and TCM symptom score in two groups were significantly decreased, and there were differences in the same group (P < 0.05). After treatment, VAS score and TCM symptom score in the treatment group were lower than those in the control group, and there were differences between two groups (P < 0.05). Conclusion Tiaojing Huoxue Capsules has significant clinical effect in treatment of qi stagnation and blood stasis primary dysmenorrhea, and can significantly reduce the VAS score and TCM symptom score, which has a certain clinical application value.