逐瘀疏肝汤为主治疗围绝经期焦虑抑郁状态随机对照临床研究

Randomized controlled clinical study of perimenopausal anxiety/depression treated by Zhuyu Shugan Decoction

目的:探讨纯中药逐瘀疏肝汤为主治疗围绝经期焦虑抑郁状态的有效性及远期疗效。方法:采用随机对照的方法,将符合纳入标准的62例围绝经期焦虑抑郁状态患者按照1∶1的比例,随机分配到治疗组和对照组。治疗组采用中药逐瘀疏肝汤为主方,加减治疗。对照组采用抗抑郁药氟哌噻吨美利曲新片(黛力新)结合激素替代疗法治疗。分别于治疗前、治疗2个月、治疗3个月、停药6个月,应用、改良绝经综合征症状评定量表(改良kupperman)、汉密顿抑郁量表17项版(HAMD-17)、汉密顿焦虑量表(HAMA)评分。并于治疗3个月结束时,根据《中医病证诊断疗效标准》评定疗效。结果:治疗2个月、治疗3个月、停药6个月时,两组改良kupperman总分均有明显下降(P<0.01),且治疗组显著低于对照组(P<0.05,P<0.01)。两组于治疗2个月、治疗3个月,HAMD-17、HAMA评分均较治疗前明显下降(P<0.01)。停药后6个月,两组HAMD-17、HAMA评分均有不同程度的回升,治疗组显著低于对照组(P<0.05)。治疗组与对照组均有明显疗效,但两组比较,差异无统计学意义。结论:逐瘀疏肝汤为主治疗围绝经期焦虑抑郁状态的疗效与西药抗抑郁剂结合激素替代疗法的效果相当。对围绝经期综合征的症状改善明显,且远期疗效优于西药抗抑郁剂结合激素替代疗法。

Objective： To explore the effectiveness and long-term effect of pure Chinese herbal medicine Zhuyu Shugan Decoction in the treatment of perimenopausal anxiety/depression. Methods： A randomized controlled method was used. Sixty-two patients with perimenopausal anxiety/depression were randomly assigned to the traditional Chinese medicine treatment group and the western medicine control group according to the proportion of 1∶1. The traditional Chinese medicine treatment group was treated with Chinese herbal medicine Zhuyu Shugan Decoction, and the decoction was added and subtract. The western medicine group was treated with antidepressants Deanxit（Flupentixol and Melitracen Tablets） combined with hormone replacement therapy. Before and after treatment at the end of the 2 month, 3 months, 6 months after withdrawal, the Hamilton Depression Scale 17 Edition（HAMD-17）, Hamilton Anxiety Scale（HAMA）, improved Menopause Rating Scale（Kupperman） scores were adopted for assessment. At the end of the 3 months of treatment, the curative effect was evaluated according to the standard of TCM syndrome diagnosis. Results： At the end of 2 months, 3 months at the end of the treatment and 6 months after drug withdrawal, the total scores of the improved Kupperman were significantly decreased in the two groups（P〈0.01）. The treatment group was significantly better than the control group, and the difference was significant（P〈0.05）. In the two groups at the end of 2 months and at the end of 3 months, the scores of HAMD-17 and HAMA were significantly lower than before the treatment（P〈0.01）. However, there was no difference between the treatment group and the control group. Six months after drug withdrawal when pursued, scores of two groups on HAMD-17 and HAMA showed different degrees of recovery, but the treatment group was significantly lower than the control group, after statistical treatment, there were significant differences（P〈0.05）. There was significant effect in the treatment group and the control group, but there was no significant difference between the two groups. Conclusion： Zhuyu Shugan Decoction＇s effect for climacteric anxiety/depression is similar to that of western medicine antidepressant combined with hormone replacement therapy. The symptoms of perimenopausal syndrome are improved obviously and the long-term effect is superior to western medicine antidepressant combined with hormone replacement therapy.