中医综合干预模式对肝肾阴虚型围绝经期患者睡眠质量影响的多中心随机对照研究

Effect of comprehensive intervention mode of TCM on sleep quality of perimenopausal patients with liver and kidney Yin deficiency:A multi-center,randomized,controlled study

目的探讨中医综合干预对社区肝肾阴虚型围绝经期综合征患者睡眠质量的影响。方法从上海市嘉定区6个社区卫生服务中心各纳入30例肝肾阴虚型围绝经期综合征患者,均于2016年2—8月入组。将患者随机分为干预组和对照组,每组90例。对照组在常规治疗基础上为患者建立个人档案,进行心理疏导,并每月对患者进行1次健康宣教;干预组在对照组治疗基础上给予中医综合疗法干预,包括口服中药、针刺、耳穴及八段锦。2组疗程均为3个月。观察2组干预前后匹兹堡睡眠质量指数(PSQI)评分变化,统计2组临床疗效及睡眠障碍情况。结果疗程结束后,对照组的睡眠质量、入睡时间条目得分均明显低于干预前(P均<0.05),催眠药物得分明显高于干预前(P<0.05),总分及其他条目得分无明显变化(P均>0.05);干预组的催眠药物条目得分无明显变化(P>0.05),总分及其余条目得分均明显低于干预前(P均<0.05);干预组的PSQI总分及睡眠质量、入睡时间、睡眠时间、睡眠效率、睡眠障碍、催眠药物、日间功能障碍条目得分均明显低于对照组(P均<0.05)。对照组总有效率为4.55%、睡眠障碍率为98.48%,干预组总有效率为80.65%、睡眠障碍率为64.52%,2组比较差异均有统计学意义(P均<0.05)。结论中医综合干预模式能明显改善肝肾阴虚型围绝经期综合征患者的睡眠质量,值得推广应用。

Objective It is to explore the effect of comprehensive intervention of traditional Chinese medicine on sleep quality in patients with perimenopausal syndrome of type of liver-kidney yin deficiency. Methods Thirty patients with perimenopausal syndrome of type of liver-kidney yin deficiency were enrolled in 6 community health service centers in Jiading District of Shanghai. All patients were enrolled in the group from February to August of 2016. The patients were randomly divided into intervention group and control group,with 90 cases in each group. The patients in the control group were established personal records on the basis of routine treatment,and given psychological counseling,and given one-time health education in each month; the intervention group was given comprehensive interventions of traditional Chinese medicine on the basis of the treatment of the control group,including oral Chinese medicine,acupuncture,ear acupuncture and Baduanjin. Both groups were treated for 3 months. The changes of Pittsburgh Sleep Quality Index（ PSQI） scores before and after intervention were observed in the two groups,and the clinical efficacy and sleep disorders in the two groups were evluated. Results After the end of treatment,the scores of sleep quality and sleep time in the control group were significantly lower while the scores of hypnotic drugs were significantly higher than that before intervention（ P〈0. 05）,the changes of total scores and the scores of other items were not significant（ P〉0. 05）. There was no significant change in scores of hypnotic drugs in the intervention group（ P〉0. 05）,scores of total scores and other items were significantly lower than before intervention（ P〈0. 05）; total scores of PSQI and the scores of sleep quality,sleep time,sleep time,sleep efficiency,sleep disorders,hypnotic drugs,and daytime dysfunction were all significantly lower in the intervention group than those in the control group（ P〈0. 05）. The total effective rate was 4. 55% while the sleep disorder rate was 98. 48% in the control group,The total effective rate was 80. 65% in the intervention group and 64. 52% in the sleep disorder. There was significant difference between the two groups（ P〈0. 05）. Conclusion Comprehensive intervention model of traditional Chinese medicine can significantly improve the sleep quality of patients with perimenopausal syndrome of type of hepatic and kidney yin deficiency. It is worthy of popularization and application.