交泰丸治疗围绝经期心肾不交型失眠随机双盲对照临床研究

Double-Blind Randomized Controlled Study on Jiaotai Pills for Insomnia of Non-Interaction Between the Heart and the Kidney Type in Perimenopausal Period in Clinic

目的:观察交泰丸治疗围绝经期心肾不交型失眠的临床疗效及安全性。方法:采用随机、双盲、安慰剂对照临床试验研究设计,纳入32例心肾不交型失眠的围绝经期女性,将其随机分为2组各16例。对照组予安慰剂治疗,观察组予交泰丸颗粒剂治疗,疗程为1周。比较2组患者治疗前后匹兹堡睡眠质量指数(PSQI)、改良Kupperman量表评分、中医证候积分以及血清褪黑素、腺苷、卵泡刺激素(FSH)含量的变化情况。结果:治疗后,观察组PSQI、改良Kupperman量表评分、中医证候积分均较治疗前明显降低,差异均有统计学意义(P<0.05),且PSQI、改良Kupperman量表评分、中医证候积分均低于对照组,差异均有统计学意义(P<0.05)。治疗后,观察组血清褪黑素及腺苷较治疗前明显增加,差异均有统计学意义(P<0.05),观察组血清褪黑素及腺苷增加水平明显优于对照组,差异均有统计学意义(P<0.05)。2组卵泡刺激素(FSH)治疗前后比较及组间比较,差异均无统计学意义(P>0.05),2组患者均未出现与治疗相关的不良反应,且患者的血常规、肝肾功能等指标均未见明显异常。结论:交泰丸治疗围绝经期心肾不交型失眠疗效良好,可改善临床症状和提高血清褪黑素及腺苷含量,具有良好安全性。

Objective:To observe the clinical effect and safety of Jiaotai pills for insomnia of non-interaction between the heart and the kidney type in perimenopausal period. Methods:A randomized, double-blind, placebo-controlled clinical trial design was adopted. A total of 32 cases of perimenopausal women with insomnia of non-interaction between the heart and the kidney type were randomly divided into two groups, with 16 cases in each group. The control group was treated with placebo, and the observation group was treated with granules of Jiaotai pills. Both groups were treated for one week. Before and after treatment, the changes of the scores of Pittsburgh Sleep Quality Index(PSQI), modified Kupperman scale,Chinese medicine syndromes,and the levels of melatonin,adenosine and follicle-stimulating hormone(FSH) in serum in the two groups were compared. Results: After treatment, the scores of PSQI, modified Kupperman scale and Chinese medicine syndromes in the observation group were significantly decreased,differences being significant(P<0.05),and the scores of PSQI, modified Kupperman scale and Chinese medicine syndromes in the observation group were lower than those in the control group, differences being significant(P<0.05). After treatment,the levels of melatonin and adenosine in serum in the observation group were significantly increased when compared with those in the control group, differences being significant(P<0.05), and the levels of melatonin and adenosine in serum in the observation group were significantly better than those in the control group, differences being significant(P<0.05). There was no significant difference in the comparison of FSH in the two groups before and after treatment and between the two groups after treatment(P>0.05). There was no treatment-related adverse reaction in the two groups, and no significant abnormality in blood routine, liver and kidney function and other indicators of patients. Conclusion:Jiaotai pills is effective in the treatment of insomnia of noninteraction between the heart and the kidney type in perimenopausal period, and can improve clinical symptoms and increase the levels of melatonin and adenosine in serum,with great safety.