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作 者 ：叶人,袁拯忠,戴春秀,李伟,宋秀华,程志清,胡万华,林燕,王小云,孙书臣,何金彩

期 刊 ：中国中药杂志 2011年 36卷 16期 页码：2285.

关键词：亚健康失眠；睡眠卫生宣教；归脾汤；随机对照试验；中医；

Keywords:subhealthy insomnia, dormancy hygiene education, spleen-restoring decoction, randomized control trial, traditional Chinese medicine,

摘 要 ：目的: 评价归脾汤结合睡眠卫生宣教,以及归脾汤单独干预心脾两虚型亚健康失眠的临床疗效、安全性、依从性,评估中医特色睡眠卫生宣教在亚健康失眠干预中的作用。 方法: 研究设计采用多中心、单盲、随机对照研究设计,研究对象为107例心脾两虚型亚健康失眠受试者,随机分成归脾汤结合睡眠卫生宣教组(A组)52例和单纯归脾汤治疗组(B组)55例,比较2组有效率、PSQI评分、CGI评分、WHOQOL-BREF评分以及安全性。 结果: 2组有效率均为79.58％,组间比较未见显著性差异;A组治疗前后PSQI总分分别为(11.80±2.08)分和(6.78±2.84)分,B组治疗前后PSQI总分分别为(11.61±2.00)分和(6.73±2.27)分,2组治疗后均有明显改善(P<0.01); 2组治疗后CGI评分、WHOQOL-BREF评分也有改善(P<0.01);治疗后各指标组间比较差异无统计学意义,时间点与处理因素之间不存在交互作用;停药2周后与疗程结束时CGI比较,2组比较差异无统计学意义;组间比较差异无统计学意义。 结论: 归脾汤联合睡眠卫生宣教与单独归脾汤对心脾两虚型亚健康失眠的干预均有显著效果,且依从性及安全性高。归脾汤联合睡眠卫生宣教并未显示出比单独归脾汤治疗更好的效果。

Abstract:Objective: To appraise the clinical efficacy, safety and compliance of the intervention of spleen-restoring decoction combined with dormancy hygiene education and the intervention of spleen-restoring decoction alone on sub-healthy insomnia of deficiency of both the heart and spleen pattern. Method: Study design took multi-centers, blind and randomized control trial, 107 participants with sub-healthy insomnia of deficiency of both the heart and spleen pattern were assigned to A group (52 cases) which was treated with the intervention of spleen-restoring decoction combined with dormancy hygiene education and B group (55 cases) which was treated with the intervention of spleen-restoring decoction single, compared by efficacy, PSQI score, CGI score, WHOQOL-BREF score and security. Result: The efficacy of two group was 79.58%. There was no significant different between them. The PSQI scores before treatment was (11.80±2.08) and which afer treatment was (6.78±2.84) of A group. The PSQI scores before treatment was (11.61±2.00) and which afer treatment was (6.73±2.27) of B group. There was significant difference in PSQI scores both A group and B group after treatment (P<0.01); the results of CGI score and WHOQOL-BREF score before and after measurement showed the same as PSQI. There were no significant difference between two groups in all scors after treatment and there was no interaction between time pots and treatment factors . Withdrawal reaction analysis: comparing CGI after withdraw 2 weeks and at the end of treatment course, there was no significant difference between two groups . The same result was in comparison among groups. Conclusion: Both the intervention of spleen-restoring decoction integrating with dormancy hygiene education and spleen-restoring decoction had obvious clinical efficacy on treating subhealthy insomnia of deficiency of both the heart and spleen pattern, and had high compliance and safety. The intervention of spleen-restoring decoction integrating with dormancy hygiene education showed no better clinical efficacy than spleen-restoring decoction did.

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