香芍颗粒治疗围绝经期女性情绪障碍的临床研究  

Clinical Study on the Treatment of Emotional Disorder in Perimenopausal Women with Xiangshao Granules

作　　者：唐瑞怡 王亚平 张绍芬 王汝芹 欧阳运薇 谢秀珍 刘红丽 吕淑兰[7] 史惠蓉[8] 张友忠[9] 谢梅青[10] 罗涌 陈蓉 郁琦 TANG Ruiyi;WANG Yaping;ZHANG Shaofen(National Clinical Research Center for Obstetric&Gynecologic Diseases,Department of Obstetrics and Gynecology,Peking Union Medical College Hospital,Chinese Academy of Medical Science,Beijing 100730,China;Departme nt of Obstetrics and Gyn ecology,Obstetrics&Gynecology Hospital of Fudan Un iversity,Shanghai 200090,China)

机构地区：[1]国家妇产疾病临床医学研究中心,中国医学科学院北京协和医院妇科内分泌与生殖中心,北京100730 [2]复旦大学附属妇产科医院妇产科,上海200090 [3]廊坊市中医医院妇产科,河北廊坊065000 [4]四川大学华西第二医院妇产科,四川成都610066 [5]山东中医药大学第二附属医院妇产科,山东济南250001 [6]厦门市妇幼保健院妇产科,福建厦门361003 [7]西安交通大学第一附属医院妇产科,陕西西安710061 [8]郑州大学附属第一医院妇产科,河南郑州450052 [9]山东大学齐鲁医院妇产科,山东疥南250012 [10]中山大学孙逸仙纪念医院妇产科,广东广州510120 [11]重庆大学附属三峡医院妇产科,重庆400030

出　　处：《实用妇产科杂志》2023年第3期210-216,共7页Journal of Practical Obstetrics and Gynecology

基　　金：国家自然科学基金(编号:81871141,82201781);中国医学科学院医学与健康科技创新工程项目(CIFMS)(编号:2020-I2M-C&T-B-040)。

摘　　要：目的:探索香芍颗粒治疗围绝经期女性情绪障碍的疗效和安全性。方法:本研究于2013年12月至2016年6月在全国11个中心进行,招募处于围绝经期并伴有情绪症状的患者300例,进行随机、双盲、安慰剂平行对照研究,患者随机进入研究组(香芍颗粒1袋,每日3次,150例)和安慰剂组(香芍颗粒类似物1袋,每日3次,150例)治疗8周,并通过汉密尔顿17项抑郁量表(HAMD)、汉密尔顿14项焦虑量表(HAMA)和Greene围绝经期量表评价患者的抑郁焦虑情况及围绝经期症状的变化。结果:完成至少4周随诊的276例(92.0%)受试者纳入分析,其中研究组136例,安慰剂组140例。治疗8周后研究组和安慰剂组HAMD及HAMA评分均显著降低(P<0.001),研究组的HAMD和HAMA评分显著低于安慰剂组(P<0.05)。与基线比较,HAMD和HAMA的评分减分率在研究组均高于安慰剂组(P<0.05)。研究组抑郁症状治疗总有效率67.6%,安慰剂组抑郁症状治疗总有效率53.6%,组间差异有统计学意义(P<0.05);研究组焦虑症状的治疗总有效率也优于安慰剂组(61.0%vs.44.3%,P<0.01)。治疗8周后,Greene量表评分的减分率及总有效率研究组优于安慰剂组(P<0.05)。两组雌二醇水平、卵泡刺激素水平及不良事件发生率差异无统计学意义(P>0.05)。结论:香芍颗粒对改善围绝经期情绪障碍有效,安全性好,无严重不良反应。Objective:To investigate the safety and efficacy of Xiangshao granules for treating emotio nal disorders in perimenopausal women.Methods:This study was conducted in 11 centers across the country from December 2013 to June 2016.300 perimenopausal womenwith emotional symptoms were recruited.This randomized,double-blind,placebo parallel control study was conducted for 8 weeks.The patients were randomly assigned to the study group(1 bag of Xiangshao granules,3 times a day,150 cases)and the placebo group(1 bag of Xiangshao granules analogues,3 times a day,150 cases).The Hamilton 17 depression scale(HAMD),Hamilton 14-item anxiety scale(HAMA)and Greene scale were used to evaluate the depression and anxiety of patients and the changes of menopausal symptoms.Results:276 subjects(92.0%)completed at least 4 weeks of follow-up,including 136 in the study group and 140 in the placebo group.After 8 weeks of treatment,the HAMD and HAMA scores of the study group and the placebo group decreased significantly(P<0.001),and the scores in the study group were significantly lower than those in the placebo group(P<0.05).Compared with baseline,HAMD and HAMA score reduction rates in the study group were higher than those in the placebo group(P<0.05).The total effective rate of depressive symptoms in the study group and placebo group was 67.6%and 53.6%,respectively.The difference between groups was significant(P<0.05).The overall response rate of anxiety symptoms in the study group was also better than that in the placebo group(61.0%vs.44.3%,P<0.01).After 8 weeks of treatment,the reduction rate and total response rate of Greene scale score were better in the study group than in the placebo group(P<0.05).There was no significant differenee between the two groups in estradiol and follicle stimulating hormone levels and the incidence of adverse events(P>0.05).Conclusions:Xiangshao granule is effective in improving emotional disorder during perimenopause,with good safety and no serious adverse reactions.

关 键 词：抑郁症状 焦虑症状 绝经 香芍颗粒 

分 类 号：R711.51[医药卫生—妇产科学]