To observe the clinical therapeutic effect and effect mechanism of regulating-yinyang moxibustion therapy for primary dysmenorrhea (PD) of cold induced blood stasis, and conduct cost-effectiveness analysis. Sixty-six patients with PD of cold induced blood stasis were randomly divided into an observation group (33 cases, 1 case dropped out) and a control group (33 cases, 3 cases dropped out). The patients in the observation group received regulating-yinyang moxibustion therapy. Centered at Mingmen (GV4) and Guanyuan (CV4), moxibustion therapy for warming yang and benefiting kidney and for warming kidney and uterus was operated within an 8 cm to 10 cm radius separately. Moxibustion therapy for warming yang and benefiting kidney was delivered 10 days before menstruation (60 min), and that for warming kidney and uterus was performed 2 days before menstruation (40 min). One course of regulating-yinyang moxibustion therapy consisted of 1 operation for warming yang and benefiting kidney and 1 for warming kidney and uterus, and the treatment for 3 menstrual cycles was required. In the control group, gentle moxibustion therapy was operated at Guanyuan (CV4), Shenque(CV8), and bilateral Sanyinjiao (SP6), for 20 min at each acupoint. The intervention began 10 days before menstruation, once every other day; 1 course of treatment consisted of 5 interventions, and the treatment for 3 menstrual cycles was required.Before and after treatment, as well as in follow-up for 3 menstrual cycles after treatment, the scores of visual analogue scale(VAS) for pain, Cox menstrual symptom scale (CMSS), and traditional Chinese medicine (TCM) clinical syndromes were observed in the two groups. Before and after treatment, the contents of nerve growth factor (NGF) and prostaglandin F2α(PGF2α) in serum were detected. After treatment, the clinical therapeutic effect was compared, the cost-effectiveness analysis performed, and the sensitivity analysis conducted to verify the reliability of the results in the two groups. After treatment and in follow-up, the VAS scores for pain were reduced in comparison with those before treatment in each group (P<0.05), and the scores in the observation group were lower than those of the control group (P<0.05). The scores for the severity and duration in CMSS were lower than those before treatment in the observation group (P<0.05), and lower when compared with those in the control group (P<0.05). When compared with the score before treatment, the TCM syndrome scores in the observation group were reduced after treatment and in follow-up (P<0.05), and the score in the control group was lower after treatment (P<0.05). In follow-up, the TCM syndrome score in the observation group was lower than that in the control group (P<0.05). After treatment, the serum contents of NGF and PGF2α decreased in comparison with those before treatment (P<0.05), and the contents in the observation group were lower than those in the control group (P<0.05).After treatment, the total effective rate was 81.3% (26/32) in the observation group and was 73.3% (22/30) in the control group, without statistical significance (P>0.05). The cost-effectiveness analysis showed that the cost-effectiveness ratio(CER) in the observation group was lower than that in the control group. The sensitivity analysis found that there was no significant fluctuation of CER in either group. Regulating-yinyang moxibustion therapy effectively alleviates pain and TCM syndromes in patients with PD of cold induced blood stasis, which may be related to the decrease of the contents of NGF and PGF2α in serum. This therapy shows its advantages in terms of health economics compared with the conventional gentle moxibustion therapy. 目的:观察阴阳调理灸治疗寒凝血瘀型原发性痛经(PD)的临床疗效及效应机制,并进行成本-效果分析。 方法:将66例寒凝血瘀型PD患者随机分为观察组(33例,脱落1例)和对照组(33例,脱落3例)。观察组采用阴阳调理灸法,分别以命门、关元穴为中心,在半径8~10 cm的圆形范围内施温阳益肾灸与温肾暖宫灸,月经来潮前10 d行温阳益肾灸(施灸时间60 min),月经来潮前2 d行温肾暖宫灸(施灸时间40 min),1次温阳益肾灸和1次温肾暖宫灸为一疗程,共治疗3个月经周期;对照组于关元、神阙、双侧三阴交行温和灸治疗,每穴施灸时间20 min,月经来潮前10 d开始治疗,隔日1次,5次为一疗程,共治疗3个月经周期。分别于治疗前、治疗后及治疗后随访3个月经周期,观察两组患者疼痛视觉模拟量表(VAS)评分、COX 痛经症状量表(CMSS)评分、中医证候评分;于治疗前、治疗后,检测两组患者血清神经生长因子(NGF)、前列腺素F2α(PGF2α)含量;治疗后比较两组临床疗效,进行成本-效果分析以及敏感性分析验证结果可靠性。 结果:治疗后及随访时,两组患者疼痛VAS评分较治疗前降低(P<0.05),观察组低于对照组(P<0.05);观察组患者CMSS症状严重程度和症状持续时间评分较治疗前降低(P<0.05),观察组低于对照组(P<0.05)。与治疗前比较,观察组患者治疗后及随访时中医证候评分降低(P<0.05),对照组患者治疗后中医证候评分降低(P<0.05);随访时,观察组患者中医证候评分低于对照组(P<0.05)。治疗后,两组患者血清NGF、PGF2α含量较治疗前降低(P<0.05),观察组低于对照组(P<0.05)。治疗后,观察组总有效率为81.3%(26/32),对照组为73.3%(22/30),差异无统计学意义(P>0.05)。两组进行成本-效果分析,观察组成本效果比值(CER)低于对照组;进行敏感性分析,两组患者CER值无明显波动。 结论:阴阳调理灸能有效减轻寒凝血瘀型PD患者疼痛,改善中医证候,其作用途径可能与降低血清NGF、PGF2α水平有关,较常规温和灸在卫生经济学上存在一定优势。.
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PubMed · 2026-05-12
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