中医心身同治方案治疗绝经综合征抑郁症状的随机对照研究  

Randomized controlled study of depressive symptoms in postmenopausal women using traditional Chinese medicines based on the regimen of psychosomatic mutual aid treatment

作　　者：杨洪艳[1] 王小云[1] 许英[2] 温泽淮[3] 张春玲 聂广宁[1] 成芳平[1] 

机构地区：[1]广东省中医院妇科,广州510120 [2]广东省深圳市中医院妇科,518000 [3]广州中医药大学DME教研室,广州510405 [4]香港仁济医院中医门诊

出　　处：《广东医学》2011年第16期2209-2211,共3页Guangdong Medical Journal

基　　金：国家"十一五"科技支撑计划项目(编号:2007BAI20B014)

摘　　要：目的探讨中医心身同治方案与替勃龙片加支持性心理疗法治疗绝经综合征抑郁症状的有效性和安全性。方法将伴抑郁症状的绝经综合征患者60例按随机数字表法分为观察组和对照组,每组30例。观察组给予协定处方免煎颗粒及替勃龙片安慰剂片,同时给予中医情志治疗方案;对照组给予替勃龙片及中药协定处方免煎颗粒安慰剂,同时给予支持性心理治疗方案。治疗疗程均为8周,随访4周。记录初诊、治疗第4、8周及随访各时点KI量表及SDS得分,治疗前后进行包括心率、血压,血、尿、便常规,肝、肾功能、血脂四项、心电图及妇科B超等安全性指标检测。结果两组均能改善绝经综合征患者躯体和轻中度的抑郁症状,两组比较差异无统计学意义。随访期观察组治疗效应持续,而对照组的抑郁症状反弹明显。观察组未发生与用药有关的不良事件,对照组发生与用药相关的不良事件7例。结论对于伴有轻中度抑郁症状的绝经综合征患者,中医心身同治方案具有稳定、持久、安全的疗效。Objective To evaluate the efficacy and safety of traditional Chinese medicines based on the regimen of psychosomatic mutual aid treatment and treatment with Tibolone tablets plus psychological intervention in treatment of depressive symptoms in postmenopausal women. Methods Sixty patients with menopausal decompression syndromes were enrolled and randomized into two groups： the experiment group （using Chinese medicines plus Chinese psychosomatic mutual aid treatment） and the control group （ using Tibolone tablets plus psychological intervention）. The relative placebos of Chinese Medicines and Tibolone tablets were given accordingly. The study was composed with 8 week treatment and the 4 week followup. Kupperman Index （KI） and self- rating depression scale （SDS） were adopted as the final evaluation standards. The side effects were also evaluated using experimental parameters. Therapeutic efficacy and side effects were assessed at baseline, 4th and 8th week during treatment, and during the follow - up. Results Somatic symptoms and mild to moderate depression symptoms were alleviated in both groups, without significant difference. The beneficial effects continued in the experiment group, although rebound occurred in the control group during the follow - up. There was no side effect recorded in the experiment group. However, 9 cases in the control group were reported with side effects. Conclusion Chinese medicines based on the regimen of psychosomatic mutual aid treatment shows stable, continuous and safe therapeutic effects on the menopausal syndrome with mild to moderate depression symptoms.

关 键 词：绝经综合征 中医心身同治 随机对照试验 

分 类 号：R749.3[医药卫生—神经病学与精神病学]