经痛平胶囊治疗原发性痛经寒凝血瘀证的Ⅱ期临床研究

Phase Ⅱ clinical research of Jingtongping Capsules in treatment of congealing cold blood stasis syndrome with primary dysmenorrhea

目的探索经痛平胶囊治疗原发性痛经寒凝血瘀证的临床疗效。方法本研究采用随机、双盲、安慰剂对照、多中心、优效性检验的方法。239例患者进入全数据分析集(FAS),治疗组120例,对照组119例。217例进入符合方案数据集,治疗组112例,对照组105例。治疗组服用经痛平胶囊,对照组服用经痛平胶囊模拟剂,3粒/次,3次/d。于每次月经来潮前(6±1)d开始服药,连续服用至此次月经来潮结束。两组均连续治疗3个月经周期。观察两组患者的痛经综合疗效、中医证候疗效,同时比较两组NRS-11评分和痛经持续时间。结果 FAS中对照组、治疗组的综合疗效总有效率分别为26.89%、80.83%;PPS中两组总有效率分别为26.67%、83.93%,FAS和PPS中两组总有效率比较差异均有统计学意义(P<0.05)。两组FAS中医证候疗效总有效率分别为48.74%、84.17%;PPS中分别为51.43%、87.50%,两组比较差异均具有统计学意义(P<0.05)。治疗组NRS-11评分、痛经持续时间均小于对照组,两组比较差异均有统计学意义(P<0.05)。结论经痛平胶囊治疗原发性痛经具有较好的临床疗效,其综合疗效、中医证候疗效均显著优于对照组,能有效缓解痛经疼痛程度、减少痛经持续时间,有进一步开展Ⅲ期临床试验进行疗效确证的价值。

Objective To assess the efficacy of Jingtongping Capsules in treatment of congealing cold blood stasis syndrome with primary dysmenorrheal. Methods The stratified random, double blind, control of placebo, and multi-center, excellent efficiency test was applied to this study. Patients（239 cases） were included into full analysis data set（FAS）, and there were 120 and 119 cases in treatment and control groups, respectively. Patients（217 cases） were included into per protocol analysis of the data set（PPS）, and there were 112 and 105 cases in treatment and control groups. Patients in treatmenet group were po administered with Jingtongping Capsules, and patients in control group were po administered with simulation of Jingtongping Capsules, 3 grains/time, three times daily. Patients took drugs（6 ± 1） d before menstruating until the menstrual cycle finished. Two groups were treated for 3 menstrual cycles. After treatment, the comprehensive efficacy of dysmenorrheal and TCM syndrome effect in two groups were evaluated, and NRS-11 scores and duration of dysmenorrheal in two groups were compared. Results In FAS, the comprehensive efficacies in the control and treatment groups were 26.89% and 80.83%, respectively, while in PPS, the comprehensive efficacies in the control and treatment groups were 26.67% and 83.93%, respectively, and there were differences between two groups（P〈0.05）. In FAS, the TCM syndrome efficacies in the control and treatment groups were 48.74% and 84.17%, respectively, while in PPS, the TCM syndrome efficacies in the control and treatment groups were 51.43% and 87.50%, respectively, and there were differences between two groups（P〈0.05）. NRS-11 scores and duration of dysmenorrheal in treatment group were significantly shorter than those in the control group, and there were differences between two groups（P〈0.05）. Conclusion Jingtongping Capsule has clinical curative effect in treatment of congealing cold blood stasis syndrome with primary dysmenorrheal, and comprehensive efficacy of dysmenorrheal and TCM syndrome effect in treatment group were significantly better than the control group, and can effectively alleviate pain degree of dysmenorrhea, also can reduce the duration of dysmenorrheal, which has value to carry out Phase Ⅲ clinical research to corroborate the curative effect.