补肾活血方治疗肾虚血瘀型围绝经期睡眠障碍的临床研究  

Clinical study of Bushen Huoxue Recipe on perimenopausal sleep disorder of kidney defi-ciency and blood stasis type

作　　者：张涵 马堃[2] 李佳妮 高山凤 王洁楠 马林纳 李敏[2] ZHANG Han;MA Kun;LI Jia-ni;GAO Shan-feng;WANG Jie-nan;MA Lin-na;LI Min(Tianjin University of Traditional Chinese Medicine,Tianjin,301617 China;China Academy of Chinese Medical Sciences,Beijing,100700,China;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing,100091,China)

机构地区：[1]天津中医药大学,天津301617 [2]中国中医科学院,北京100700 [3]中国中医科学院西苑医院,北京100091

出　　处：《时珍国医国药》2023年第6期1417-1420,共4页Lishizhen Medicine and Materia Medica Research

基　　金：中国民族医药学会科研项目(2017KYXM-Z160-20);首都临床特色应用研究与成果推广(Z171100001017104);北京市自然科学基金资助项目(7212193)。

摘　　要：目的评价补肾活血方治疗围绝经期睡眠障碍的有效性和安全性;比较补肾活血方和克龄蒙各自的特点和优势,为围绝经期睡眠障碍患者选择合适的治疗方法提供临床数据支持。方法100例受试者随机分补肾活血方组和克龄蒙(戊酸雌二醇片/雌二醇环丙孕酮片)组,观察两组治疗前后PSQI评分、改良Kupperman评分、中医证候积分、血清性激素水平、凝血四项变化。结果补肾活血方组和克龄蒙组治疗后PSQI评分、改良Kupperman评分、中医证候积分均明显下降(P<0.01),补肾活血方可降低促卵泡素(FSH)水平、升高雌二醇(E2)水平(P<0.01),促黄体素(LH)水平变化无显著差异(P>0.05)。克龄蒙组治疗后FSH、LH水平均下降,E2水平升高(P<0.01)。两组治疗后对比,补肾活血方组和克龄蒙组PSQI评分总有效率相当,差异无明显统计学意义(P>0.05),补肾活血方组显效率高于克龄蒙组,差异有统计学意义(P<0.05),补肾活血方组降低中医证候积分作用优于克龄蒙组,克龄蒙组改善Kupperman评分、降低FSH、LH水平,升高E2水平的作用优于中药组(P<0.05)。结论补肾活血方治疗围绝经期睡眠障碍疗效显著,安全无不良反应,对轻度、中度的睡眠障碍有显著的疗效,且治疗后对镇静安眠药依赖性低于克龄蒙组(P<0.05);克龄蒙可维持月经,调节围绝经期激素水平,对轻度的睡眠障碍疗效明显。Objective To evaluate the efficacy and safety of Bushen Huoxue Recipe in the treatment of perimenopausal sleep dis-order;To compare the characteristics and advantages of Bushen Huoxue Fang and Climen,and provide clinical data support for the selection of appropriate treatment methods for perimenopausal patients with sleep disorders.Methods 100 subjects were ran-domly divided into the Bushen Huoxue Fang Group and Climen(estradiol valerate tablets/estradiol cycloprogesterone tablets)group.The changes in PSQI score modified Kupperman score,TCM syndrome score,serum sex hormone level,and coagulation in the two groups before and after treatment.Results After treatment,the PSQI score,modified Kupperman score,and TCM syn-drome score of the Bushen Huoxue Recipe group and Climen group were significantly decreased(P<0.01).Bushen Huoxue recipe could reduce the level of follicle-stimulating hormone(FSH),increase the level of estradiol(E2)(P<0.01),and there was no significant difference in the level of luteinizing hormone(LH)(P>0.05).After treatment,the levels of FSH and LH were decreased and the levels of E2 were increased(P<0.01).Compared with the two groups after treatment,the total ef-fective rate of PSQI score of the Bushen Huoxue Fang Group and Climen group was the same,and there was no significant differ-ence(P>0.05).The significant effective rate of the Bushen Huoxue Fang Group was higher than the Climen group,and the difference was statistically significant(P<0.05).The effect of the Bushen Huoxue Fang Group in reducing TCM syndrome score was better than the Climen group,The effect of raising E2 level was better than that of the Chinese medicine group(P<0.05).Conclusion Bushen Huoxue decoction has a significant effect on perimenopausal sleep disorder,is safe and has no adverse reac-tion,has a significant effect on mild and moderate sleep disorder,and has a lower dependence on sedatives and sleeping pills than that of the Climen group(P<0.05);Climen can maintain menstruation,regulate the hormone level in perimenopause,a

关 键 词：补肾活血方 克龄蒙 围绝经期睡眠障碍 临床研究 

分 类 号：R256.23[医药卫生—中医内科学] R271.11[医药卫生—中医学]