目的 探索經(jīng)痛平膠囊治療原發(fā)性痛經(jīng)寒凝血瘀證的臨床療效.方法 本研究采用隨機(jī)、雙盲、安慰劑對照、多中心、優(yōu)效性檢驗的方法.239 例患者進(jìn)入全數(shù)據(jù)分析集(FAS),治療組120 例,對照組119 例.217 例進(jìn)入符合方案數(shù)據(jù)集,治療組112 例,對照組105 例.治療組服用經(jīng)痛平膠囊,對照組服用經(jīng)痛平膠囊模擬劑,3 粒/次,3 次/d.于每次月經(jīng)來潮前(6±1)d 開始服藥,連續(xù)服用至此次月經(jīng)來潮結(jié)束.兩組均連續(xù)治療3 個月經(jīng)周期.觀察兩組患者的痛經(jīng)綜合療效、中醫(yī)證候療效,同時比較兩組NRS-11 評分和痛經(jīng)持續(xù)時間.結(jié)果 FAS 中對照組、治療組的綜合療效總有效率分別為26.89%、80.83%;PPS 中兩組總有效率分別為26.67%、83.93%,FAS 和PPS 中兩組總有效率比較差異均有統(tǒng)計學(xué)意義(P< 0.05).兩組FAS 中醫(yī)證候療效總有效率分別為48.74%、84.17%;PPS 中分別為51.43%、87.50%,兩組比較差異均具有統(tǒng)計學(xué)意義(P< 0.05).治療組NRS-11 評分、痛經(jīng)持續(xù)時間均小于對照組,兩組比較差異均有統(tǒng)計學(xué)意義(P< 0.05).結(jié)論 經(jīng)痛平膠囊治療原發(fā)性痛經(jīng)具有較好的臨床療效,其綜合療效、中醫(yī)證候療效均顯著優(yōu)于對照組,能有效緩解痛經(jīng)疼痛程度、減少痛經(jīng)持續(xù)時間,有進(jìn)一步開展Ⅲ期臨床試驗進(jìn)行療效確證的價值.

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.