药食两用复方颗粒剂治疗心神失养型亚健康失眠的临床研究

Clinical Observation of Homemade Medicated and Dietary Compound Granules in Treating Sub-health Insomnia with Deficient Cultivation of Heart-spirit

【目的】观察自制药食两用复方颗粒剂作为保健食品治疗心神失养型亚健康失眠的临床疗效。【方法】将60例亚健康失眠患者随机分为治疗组和对照组各30例,治疗组给予药食两用复方颗粒剂(酸枣仁、党参、茯神、炙远志、玫瑰花、莲子心、红枣、龙眼肉等)治疗,对照组给予谷维素治疗,疗程均为半个月。分别于治疗前后观察2组患者匹兹堡睡眠质量指数量表(PSQI)及中医症候评分量表积分的变化情况,并评价2组的临床疗效。【结果】(1)治疗半个月后及停药半个月后,治疗组的疗效均优于对照组(P<0.05)。(2)治疗半个月后及停药半个月后,治疗组的PSQI总分、睡眠质量积分、入睡时间积分、睡眠障碍积分、日间功能障碍积分等均较治疗前显著降低(P<0.01);而对照组患者PSQI量表的各项评分均无显著改善(P>0.05)。治疗半个月后及停药半个月后,治疗组的睡眠质量积分、入睡时间积分、日间功能障碍积分及PSQI总分均显著低于对照组(P<0.01)。(3)治疗半个月后及停药半个月后,治疗组中医症候评分量表的中医症候总积分及多梦易醒、心悸健忘、神疲乏力、食少、面色少华、头晕目眩、腹胀便溏等各项积分均较治疗前显著降低(P<0.05或P<0.01)。【结论】自制药食两用复方颗粒剂能够有效提高患者的睡眠质量,缩短入睡时间,改善睡眠障碍,提高患者日间功能效率,整体改善患者的精神状态,并有短期疗效维持效果。

Objective To observe the clinical effects of the homemade medicated and dietary compound granules in treating sub-health insomnia with deficient cultivation of heart-spirit. Methods Sixty qualified patients were randomly divided into treatment group and control group,30 cases in each group. The treatment group was given homemade medicated and dietary compound granules（mainly composed of Semen Ziziphi Spinosae, Radix Codonopsis, Sclerotiium Poriae Circum Radicem Pini, Radix Polygalae, Flos Rosae Rugosae, Plumula Nelumbinis,Fructus Ziziphi Jugubae, and Arillus Longan）. The control group was given Oryzanol powder. The course of treatment lasted for half a month. Before and after treatment, the scores of Pittsburgh Sleep Quality Index（PSQI）and the traditional Chinese medicine（TCM）symptom rating scale were observed,and the clinical efficacy of the two groups were also evaluated. Results After treatment for half a month and after suspension of medicine for half a month,（1） the total effective rate of the treatment group was higher than that of the control group（P〈0.05）;（2） the total PSQI scores, sleep quality scores, falling asleep time scores, and daytime function disorder scores were decreased in the treatment group（P〈0.01 compared with those before treatment）, but the scores of each PSQI item in the control group stayed unchanged（P〈0.05）. The total PSQI scores, sleep quality scores, falling asleep time scores, and daytime function disorder scores of the treatment group were lower than those of the control group（P〈0.01）;（3）the total scores of TCM symptoms as well as the scores of dreaminess and susceptibility to awakening, palpitation and amnesia, lassitude and weakness,poor appetite,pale complexion,vertigo and dizziness,abdominal distension and loose stools were declined in the treatment group（P〈0.05 or P〈0.01 compared with those before treatment）. Conclusion Medicated and dietary compound granules are effective on improving sleep quality, shortening time to fall asleep, improving sleep disorder, increasing the efficiency of daytime function, improving patients＇ mental state entirely,and maintaining the short-term curative effect.