目的 探讨少腹逐瘀胶囊联合复方炔诺酮片治疗寒凝血瘀型原发性痛经的临床疗效。方法 收集2022年12月—2023年11月就诊于上海中医药大学附属曙光医院的痛经患者126例，按照随机数字表法分为对照组（63例）和治疗组（63例）。对照组患者口服复方炔诺酮片，从经期第5天开始，1片/d，连续服用22 d，直到下个经期第5天继续服用。在对照组的基础上，治疗组口服少腹逐瘀胶囊，3粒/次，3次/d。两组连续用药3个月经周期。观察两组患者临床疗效，比较治疗前后两组患者症状好转时间，COX痛经症状量表（CMSS）评分和视觉模拟疼痛评分（VAS），疼痛介质因子前列腺素E₂（PGE₂）、β-内啡肽（β-EP）、5-羟色胺（5-HT）、前列腺素F₂a（PGF₂a）水平，及子宫微循环指数子宫动脉搏动指数（PI）、动脉血流阻力指数（RI）、收缩期峰值/舒张期峰值（S/D）。结果 治疗后，治疗组总有效率（96.83%）明显高于对照组总有效率（84.13%，P＜0.05）。治疗后，与对照组比较，治疗组腹痛、恶心、头晕、四肢冰冷好转时间均明显缩短（P＜0.05）。治疗后，两组患者CMSS评分和VAS评分明显低于治疗前（P＜0.05），且治疗后，与对照组对比，治疗组评分降低更明显（P＜0.05）。治疗后，两组PGE₂、β-EP水平比治疗前明显升高，而5-HT和PGF₂a水平明显降低（P＜0.05），且治疗后治疗组疼痛介质因子水平均明显好于对照组（P＜0.05）。治疗后，两组患者子宫微循环指数RI、PI、S/D比治疗前明显降低（P＜0.05），且治疗组患者指数水平均明显低于对照组（P＜0.05）。结论 复方炔诺酮片与少腹逐瘀胶囊协同联合治疗，能改善寒凝状态下的子宫微循环情况，使机体内疼痛介质因子含量降低，痛经症状好转明显。

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

上海市治未病技术处方项目[ZY(2021-2023)-0104-02-JS-01]