李瑛¹

摘要：目的：对比针灸与激素替代疗法治疗围绝经期综合征患者的临床疗效差异，为针灸治疗围绝经期综合征提供可靠的研究依据。方法：本试验采用多中心、随机、对照试验设计，将符合纳入标准的围绝经期综合征患者，通过中央随机系统将患者随机分为试验组和对照组，试验组采用针刺加耳穴治疗，对照组采用克龄蒙治疗，共治疗12周，随访24周。临床疗效评价主要指标为MRS评分，次要指标为MENQOL评分、平均24小时烘热积分、性激素FSH、LH及E2水平、安全性及依从性评价。结果：与基线相比，两组经治疗后MRS评分均明显降低（p<0.05），治疗结束又出现回升。组间对比，入组第4周、第12周，针灸组MRS评分高于药物组，差异具有统计学意义（p<0.05），入组第16周、24周及36周，针灸组MRS评分低于药物组，差异具有统计学意义（p<0.05）。MENQOL评分方面，治疗4周时，药物组低于针灸组，且差异具有统计学意义（p<0.05）；治疗结束时，针灸组与药物组评分无明显差异（p >0.05）；随访期，针灸组评分低于药物组，差异具有统计学意义（p <0.05）。平均24小时烘热积分结果与MENQOL评分类似。性激素方面，仅E2水平在治疗后出现明显升高（p<0.05），仅在第12周，药物组E2水平高于针灸组，差异具有统计学意义（p<0.05）。两组不良事件发生例数及安全性等级评价差异无统计学意义（p>0.05）；针灸组依从性优于药物组（p<0.05）。结论：针灸和激素替代疗法均能改善围绝经期综合征患者相关症状、提高生存质量，并对性激素水平产生一定调节作用。与激素替代疗法相比，针灸在近期可能无疗效优势，而在远期疗效更优。综上所述，针灸可作为激素治疗替代疗法治疗围绝经期综合征，建议临床推广使用。

关键词：针灸；激素疗法；围绝经期综合征；随机对照研究

A Multicenter Randomized Controlled Trial of Treating Perimenopausal Syndrome with Acupuncture

Ying Li1

Abstract: Objective: To assess the effect of treating perimenopausal syndrome (PMS) with acupuncture therapy by compared with hormone replacement therapy(HRT), and to assure whether acupuncture could be an alternative therapy for PMS. Design: 206 PMS patients were recruited in this multicenter randomized controlled clinical trial. And they were randomized to receive acupuncture treatments plus auricular acupressure treatments or HRT (Climen®) within 12 weeks. The primary outcome was Menopause Rating Scale (MRS). And the secondary outcomes were Menopause-specific Quality of Life Questionnaire (MENQOL), average hot flash score during 24-hour and the levels of serum sex hormone, including estradiol (E2), follicle-stimulating hormone (FSH) and luteinizing hormone (LH). And these outcomes were assessed at baseline, the 4th, 12th, 16th, 24th and 36th week. Besides, safety analysis and compliance analysis were required in the study. Results: The results of the primary outcome: compared with baseline, the MRS scores of two groups declined during the therapeutic period significantly (p<0.05), and raised again in the follow-up period. And compared with the drug group, the MRS score of acupuncture group was higher at the end of the 4th and 12th week, but lower at the end of the 16th, 24th and 36th week, and these differences were significant (p<0.05). The results of the secondary outcome: the MENQOL scores and average flash hot score during 24-hour of both groups declined in the therapeutic period, but raised again in the follow-up period. Compared with the drug group, the MENQOL score of acupuncture group was significantly higher at the end of the 4th week (p<0.05), and significantly lower during the follow-up period (p<0.05), which were essentially in agreement with the results of average flash hot score during 24-hour. Additionally, about the results of serum sex hormone, only the levels of E2 in both groups rose up at the end of the 12th week. Compared with the drug group, the level of E2 in the acupuncture group was relatively lower, and the difference was significant. From the aspect of safety analysis, the rates of adverse events in both groups had no significant differences (p>0.05). And the patients’ compliance in the acupuncture group was better than that in the drug group (p<0.05). Conclusions: Both acupuncture therapy and HRT could relieve the symptoms of patients with PMS, improve the quality of life and regulate the level of E2 to some extent. Compared with HRT, acupuncture has advantages in long term, but not in short term, especially relieve psychological and physical symptoms. Overall, acupuncture could be an actively alternative therapy for treating PMS.

Key words: acupuncture, hormone therapy, perimenopausal syndrome, RCT