目的 探討少腹逐瘀膠囊聯(lián)合復(fù)方炔諾酮片治療寒凝血瘀型原發(fā)性痛經(jīng)的臨床療效。方法 收集2022年12月—2023年11月就診于上海中醫(yī)藥大學(xué)附屬曙光醫(yī)院的痛經(jīng)患者126例，按照隨機(jī)數(shù)字表法分為對(duì)照組（63例）和治療組（63例）。對(duì)照組患者口服復(fù)方炔諾酮片，從經(jīng)期第5天開(kāi)始，1片/d，連續(xù)服用22 d，直到下個(gè)經(jīng)期第5天繼續(xù)服用。在對(duì)照組的基礎(chǔ)上，治療組口服少腹逐瘀膠囊，3粒/次，3次/d。兩組連續(xù)用藥3個(gè)月經(jīng)周期。觀察兩組患者臨床療效，比較治療前后兩組患者癥狀好轉(zhuǎn)時(shí)間，COX痛經(jīng)癥狀量表（CMSS）評(píng)分和視覺(jué)模擬疼痛評(píng)分（VAS），疼痛介質(zhì)因子前列腺素E₂（PGE₂）、β-內(nèi)啡肽（β-EP）、5-羥色胺（5-HT）、前列腺素F₂a（PGF₂a）水平，及子宮微循環(huán)指數(shù)子宮動(dòng)脈搏動(dòng)指數(shù)（PI）、動(dòng)脈血流阻力指數(shù)（RI）、收縮期峰值/舒張期峰值（S/D）。結(jié)果 治療后，治療組總有效率（96.83%）明顯高于對(duì)照組總有效率（84.13%，P＜0.05）。治療后，與對(duì)照組比較，治療組腹痛、惡心、頭暈、四肢冰冷好轉(zhuǎn)時(shí)間均明顯縮短（P＜0.05）。治療后，兩組患者CMSS評(píng)分和VAS評(píng)分明顯低于治療前（P＜0.05），且治療后，與對(duì)照組對(duì)比，治療組評(píng)分降低更明顯（P＜0.05）。治療后，兩組PGE₂、β-EP水平比治療前明顯升高，而5-HT和PGF₂a水平明顯降低（P＜0.05），且治療后治療組疼痛介質(zhì)因子水平均明顯好于對(duì)照組（P＜0.05）。治療后，兩組患者子宮微循環(huán)指數(shù)RI、PI、S/D比治療前明顯降低（P＜0.05），且治療組患者指數(shù)水平均明顯低于對(duì)照組（P＜0.05）。結(jié)論 復(fù)方炔諾酮片與少腹逐瘀膠囊協(xié)同聯(lián)合治療，能改善寒凝狀態(tài)下的子宮微循環(huán)情況，使機(jī)體內(nèi)疼痛介質(zhì)因子含量降低，痛經(jīng)癥狀好轉(zhuǎn)明顯。

Objective To explore the clinical efficacy of Shaofu Zhuyu Capsules combined with compound norethisterone in treatment of primary dysmenorrhea of cold coagulation and blood stasis. Methods Patients (126 cases) with primary dysmenorrhea of cold coagulation and blood stasis in Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from December 2022 to November 2023 were divided into control (63 cases) and treatment (63 cases) group according to random number table method. Patients in the control group were po administered with Compound Norethisterone Tablets from the 5 d of menstruation and continuously for 22 d until the next menstrual period, 1 tablet/time, once daily. Patients in the treatment group were po administered with Shaofu Zhuyu Capsules, 3 grains/time, three times daily. Patients in two groups were treated for 3 menstrual cycles. After treatment, the clinical evaluations were evaluated, the symptoms improved time, the scores of CMSS and VAS, the levels of pain mediators PGE₂, β-EP, 5-HT, and PGF₂a, and the uterine microcirculation indexes RI, PI, and S/D in two groups before and after treatment were compared. Results After treatment, the total effective rate in the treatment group (96.83%) was higher than that in the control group (84.13%, P < 0.05). After treatment, compared with the control group, the improvement time of abdominal pain, nausea, dizziness, cold limbs in treatment group was shortened (P < 0.05). After treatment, the CMSS score and VAS score in two groups were significantly lower than before treatment (P < 0.05), and compared with the control group, the score in the treatment group were decreased more significantly (P < 0.05). After treatment, the levels of PGE₂ and β-EP in two groups were significantly higher than before treatment, while the levels of 5-HT and PGF₂a were significantly lower (P < 0.05). After treatment, the levels of pain mediators in the treatment group were significantly better than those in the control group (P <0 .05). After treatment, the uterine microcirculation index RI, PI, and S/D of patients in two groups were significantly lower than those before treatment (P < 0.05), and index level of patients in treatment group was significantly lower than that in control group (P < 0.05). Conclusion The combination therapy of Compound Norethisterone Tablets and Shaofu Zhuyu Capsules can improve the microcirculation of the uterus in a cold coagulation state, reduce the content of pain mediators in the body, and significantly improve dysmenorrhea symptoms.

R984

上海市治未病技術(shù)處方項(xiàng)目[ZY(2021-2023)-0104-02-JS-01]