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袁拯忠,叶人,王小云,孙书臣,宋秀华,林燕,李伟,胡万华,何金彩,戴春秀,程志清.天王补心汤结合睡眠卫生宣教对阴虚火旺型亚健康失眠的干预作用[J].,2011,31(5):618-621
天王补心汤结合睡眠卫生宣教对阴虚火旺型亚健康失眠的干预作用
Intervention of Tianwang Buxin Decoction Combined with Dormancy Hygiene Education for Treatment of Sub-healthy Insomnia Patients of Yin Deficiency Fire Excess Syndrome
  
DOI:
中文关键词:  亚健康失眠  睡眠卫生宣教  天王补心汤  随机对照试验
英文关键词:sub-healthy insomnia  dormancy hygiene education  Tianwang Buxin Decoction  randomized control trial
基金项目:“十一五”国家科技支撑计划资助项目(No.2006BAI13B06)
Author NameAffiliation
YUAN Zheng-zhong 温州医学院附属第一医院中医科 
YE Ren 温州医学院附属第一医院中医科 
王小云 广州中医药大学 
孙书臣 中国中医科学院广安门医院 
宋秀华 温州医学院附属第一医院睡眠中心 
林燕 温州医学院附属第二医院 
李伟 温州医学院附属第一医院睡眠中心 
胡万华 浙江省温州市中医院 
何金彩 温州医学院附属第一医院睡眠中心 
DAI Chun-xiu 温州医学院附属第一医院中医科 
程志清 
浙江中医药大学
 
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中文摘要:
      目的评价天王补心汤结合睡眠卫生宣教以及天王补心汤单独干预阴虚火旺型亚健康失眠的临床疗效、安全性、依从性。方法采用多中心、单盲、随机对照研究设计,研究对象为101例阴虚火旺型亚健康失眠受试者,随机分为天王补心汤结合睡眠卫生宣教组(治疗组)50例和单纯天王补心汤治疗组(对照组)51例,比较两组有效率、匹兹堡睡眠质量指数(Pittsburgh sleep quality index,PSQI)评分、临床医生总体印象(clinical global impression-improvement,CGI)评分、WHO生活质量测定量表(quality of life made by WHO,WHOQOL-BREF)评分以及安全性。结果治疗组有效率(68.08%)低于对照组(75.00%),但差异无统计学意义;治疗组治疗前后PSQI评分分别为(12.00±2.25)、(7.55±2.91)分,对照组治疗前后PSQI评分分别为(11.68±2.21)、(7.16±3.13)分,两组治疗后均有明显改善(P<0.01);两组治疗后CGI评分、WHO-QOL-BREF评分也有改善(P<0.01),治疗后各指标两组间比较差异无统计学意义。两组停药2周后与疗程结束时CGI比较,差异无统计学意义(P>0.05),两组间比较差异无统计学意义(P>0.05)。结论天王补心汤联合睡眠卫生宣教与单纯天王补心汤对阴虚火旺型亚健康失眠的干预均有显著效果,疗效相当,且依从性及安全性高。
英文摘要:
      Objective To assess the clinical efficacy,safety and compliance of Tianwang Buxin Decoction (TWBXD) combined with dormancy hygiene education (DHE) and TWBXD alone in treatment of sub-healthy insomnia patients of yin deficiency fire excess syndrome. Methods The multi-centered,single blinded randomized clinical trial design was adopted. One hundred and one sub-healthy insomnia subjects of yin deficiency fire excess syndrome were randomly assigned to two groups. The 50 in the treatment group were treated by combined treatment with TWBXD and DHE,while the 51 in the control group were treated with TWBXD alone. The therapeutic efficacy,Pittsburgh sleep quality index (PSQI)score,clinical global impression-improvement(CGI) score,quality of life made by WHO (WHOQOL-BREF) score,and safety in the two groups were compared. Results The effective rate in the treatment group was 68.08%,lower than that in the control group (75.00%),but the difference between them was statistically insignificant. The PSQI score in the treatment group were reduced from 12.00±2.25 to 7.55±2.91 (P<0.01). It was reduced from 11.68±2.21 to 7.16±3.13 in the control group (P<0.01). The improvement of CGI score and WHOQOL-BREF score was also shown in the two groups after treatment (P<0.01). No significant difference was shown in each index between the two groups. There was no significant difference in CGI between two weeks after drug withdrawal and by the end of the therapeutic course in the same group (P>0.05). There was no statistical significance in inter-group comparison (P>0.05). Conclusion Significant effect was achieved by TWBXD combined with DHE and by TWBXD alone. Their efficacies were equivalent,with high compliance and safety.
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