六味地黄汤联合逍遥散加减治疗肾虚肝郁型围绝经期睡眠障碍临床研究

目的:评价六味地黄汤联合逍遥散加减治疗肾虚肝郁型围绝经期睡眠障碍的有效性和安全性。方法:受试者随机分为两组，试验组予六味地黄汤联合逍遥散加减口服；对照组予戊酸雌二醇联合地屈孕酮序贯口服。试验组以30 d为1个疗程，对照组以21 d为1个疗程，连续治疗3个疗程。观察两组治疗前后PSQI评分、Kupperman评分、中医证候积分、血清FSH、E₂及血尿常规、肝肾功和心电图等指标的变化。结果:试验组总有效率93.3%,对照组90.0%;两组均能明显降低PSQI、改良Kupperman和中医证候评分，在改善中医证候积分方面试验组明显优于对照组，差异有统计学意义(P<0.01)。对照组在减低Kupperman评分上优于试验组，差异有统计学意义(P<0.01)。两组对血清FSH水平均有下调趋势，均可上调血清E₂水平，对照组较试验组对血清E₂上调更明显(P<0.01)。结论:六味地黄汤联合逍遥散加减治疗肾虚肝郁型围绝经期睡眠障碍安全有效。

Clinical study on Liuwei Dihuang decoction combined with modified Xiaoyao powder in the treatment of perimenopausal sleep disorder of kidney deficiency and liver depression

Objective:To evaluate the efficacy and safety of Liuwei Dihuang decoction combined with modified Xiaoyao powder in the treatment of menopausal sleep disorders of kidney deficiency and liver depression.Methods:The subjects were randomly divided into two groups:the experimental group was given oral administration of Liuwei Dihuang decoction combined with Xiaoyao powder.The control group was given oral administration of estradiol valerate and dydrogesterone sequentially.Results:The total effective rate of the test group was 93.3%,and that of the control group was 90.0%.Both groups could significantly reduce PSQI,modified Kupperman and TCM syndrome scores,and the test group was significantly better than the control group in improving TCM syndrome scores,with significant differences.The control group was better than the test group in reducing the Kupperman score,and there was a significant difference(P<0.01).The serum FSH levels of the two groups both tended to be down-regulated,and both groups could up-regulate the serum E₂level.Compared with the experimental group,the control group had a more obvious up-regulation of serum E₂,and there was a significant difference(P<0.01).Conclusion:Liuwei Dihuang decoction combined with modified Xiaoyao powder is safe and effective in the treatment of perimenopausal sleep disorder of kidney deficiency and liver depression.