【摘要】 目的：评估经前期针灸刺激任脉对原发性痛经患者的有效性及安全性。方法：采取前瞻性队列设计，暴露因素为是否刺激任脉，最终纳入108例接受针灸治疗的原发性痛经患者。依据受试者接受针灸治疗的实际情况分为任脉组（73例）和非任脉组（35例）。依据患者情况决定针灸方式及穴位，持续治疗3个月经周期，并在此后随访1个月经周期。比较两组治疗期间与随访期COX痛经症状量表（CMSS）评分（包括严重程度与持续时间）。比较两组治疗前后各项中医证候积分与总分。并对两组近期临床疗效和随访期临床疗效进行比较。结果：治疗第1、第2、第3月经周期及随访期，两组的CMSS评分（严重程度和持续时间）均较治疗前下降（P<0.01）；随着疗程推进，两组CMSS评分（严重程度和持续时间）均呈下降趋势（P<0.01）。在随访期，任脉组的CMSS评分（严重程度和持续时间）低于非任脉组（P<0.05）。运用重复测量方差分析对CMSS评分数据进行检验，结果显示暴露因素与时间因素之间存在交互作用（P<0.05），两者均为CMSS评分的重要影响因素；但两者主体间效应分析差异无统计学意义（P>0.05）。治疗后，两组各项中医证候积分及总分均较治疗前下降（P<0.01）。治疗后任脉组是否有血块、乳房胀痛、行经量少中医证候积分及总分均低于非任脉组（P<0.05）。两组近期临床疗效比较，差异无统计学意义（P>0.05）；任脉组随访期疗效优于非任脉组（P<0.05）。结论：经前期针灸刺激任脉治疗原发性痛经展现出优良的疗效和高安全性，为临床治疗原发性痛经提供了高质量的真实世界证据。更多还原

【Abstract】 Objective:To evaluate the efficacy and safety of premenstrual acupuncture and moxibustion stimulation of the Ren meridian in the treatment of primary dysmenorrhea(PD). Methods:This study adopted a prospective cohort design,with the exposure factor being whether the Ren meridian was stimulated. Eventually,108 patients with primary dysmenorrhea who received acupuncture and moxibustion treatment were included. According to the actual situation of the subjects receiving acupuncture and moxibustion treatment,they were divided into the Ren meridian group(73 cases) and the non-Ren meridian group(35 cases). The acupuncture method and acupoints are determined based on the patient’s condition. The treatment was continued for three menstrual cycles,followed up for one menstrual cycle thereafter. The COX Menstrual Symptom Scale(CMSS) scores(including severity and duration) during the treatment period and the follow-up period were compared between the two groups. The scores of various traditional Chinese medicine(TCM) syndromes and the total scores of the two groups before and after treatment were compared. The short-term clinical efficacy and the clinical efficacy during the follow-up period of the two groups were compared. Results:During the first,second and third menstrual cycles of treatment and the follow-up period,the CMSS scores(severity and duration) of both groups decreased compared with those before treatment(P<0.05). With the advancement of the treatment course,the CMSS scores(severity and duration) of both groups showed a decreasing trend(P<0.01). During the follow-up period,the CMSS score(severity and duration) of the Ren meridian group was lower than that of the non-Ren meridian group(P<0.05). Repeated measures analysis of variance was used to test the CMSS score data. The results showed that there was an interaction between exposure factors and time factors(P<0.05),and both were important influencing factors of the CMSS score. However,there was no statistically significant difference in the analysis of the effects between the two subjects(P>0.05). After treatment,each TCM syndrome score and total scores of both groups decreased compared with those before treatment(P<0.01). After treatment,the TCM syndrome scores of whether there were blood clots,breast distension and pain,and scanty menstruation and total scores in the Ren meridian group were all lower than those in the non-Ren meridian group(P<0.05). There was no statistically significant difference in the short-term clinical efficacy between the two groups(P>0.05). The therapeutic effect of the Ren meridian group during the follow-up period was better than that of the non-Ren meridian group(P<0.05). Conclusions:Premenstrual acupuncture and moxibustion stimulation of the Ren meridian has demonstrated excellent efficacy and high safety in the treatment of primary dysmenorrhea,providing high-quality real-world evidence for the clinical treatment of primary dysmenorrhea.更多还原