常规中药和针灸作为艾司唑仑替代治疗手段失眠的随机对照研究

【作者】 Shapour Badiee Aval Baghyahi；

【导师】 高颖；

【作者基本信息】 北京中医药大学 ， 中医内科学， 2010， 博士

【摘要】 研究背景：失眠是临床上常见的一个症状,可以导致许多问题并影响到人们的生活。目前,临床内科医生和患者都在寻求一种有效果方法,特别是中药和针灸,治疗失眠以降低西药带来的副作用。研究设计：研究分为两部分。第一部分是一个横断面研究,在113个失眠患者中调查失眠严重程度指数量表(中文版)的信度和效度。第二部分是一个临床随机对照试验,符合纳入和排除标准的60名失眠患者被随机分为两个组,一组的治疗方案是“针灸加口服艾司唑仑”,另一组的治疗方案是“中药加医生管理下的口服艾司唑仑”,治疗失眠3周后,我们比较作为艾司唑仑的替代治疗手段的两种中医治疗方案的有效性,应用失眠严重程度指数量表(ISI)的变化作为衡量有效率的指标,它们包括：入睡时间,日常功能障碍,睡眠中干扰,睡眠持续时间,夜间做梦,口服艾司唑仑的剂量,停止治疗1个月后的复发率。研究结论：横断面研究中,在量表的信度分析方面,试验组、对照组及全体患者中文版失眠严重程度指数量表(C-ISI)的克朗巴赫α系数分别为0.72,0.75和0.91。重测信度中,前后两次的C-ISI的条目得分和总分有着显著的相关性。试验组的C-ISI条目得分和总分的平均秩比对照组的显著增高,在试验组中呈现出低睡眠质量。在量表的效度分析方面,中文版失眠严重程度指数量表(C-ISI)和中文版匹兹堡睡眠质量指数量表(C-PSQI)在相关条目和总分上存在着显著的相关性。在临床试验部分,我们发现治疗后“中药加医生管理下的口服艾司唑仑”组和“针灸加口服艾司唑仑”组在治疗效果(P>0.05),失眠严重程度指数量表(ISI)的改变(P>0.05),睡眠持续时间的变化(P>0.05),睡眠中干扰的变化(P>0.05),入睡时间的变化(P>0.05),日常功能障碍(P>0..05)等方面均无显著性差异,然而,“中药加医生管理下的口服艾司唑仑”组在夜间做梦的变化(P<0.05),口服艾司唑仑的剂量(P<0.05)及停止治疗1个月后的复发率(P<0.001)方面呈现显著的疗效。此外,“针灸加口服艾司唑仑”组的失眠严重程度指数比“中药加医生管理下的口服艾司唑仑”组在治疗1周后的下降程度要快。结论：“中药加医生管理下的口服艾司唑仑”,和“针灸加口服艾司唑仑”两组并无显著的差异,但是在“降低夜间做梦”,“减少口服艾司唑仑剂量”及“降低复发率”方面中药加艾司唑仑组比针灸加艾司唑仑组更具有治疗效果。更多还原

【Abstract】 Background:Insomnia, either as a symptom or as a disorder is a common complaints in clinic, and can cause many problems that affects on people’s life. These days, there is an increasing trend in patients and physicians to treat it by complementary medicine, especially Chinese herbs and acupuncture to reduce the dosage and side effects of western medicine drugs.Study design:This study consists of two parts. One is a cross sectional study in which we briefly investigate the reliability and validity of Chinese version of insomnia severity index scale in 113 patients with insomnia. In the second part of this study which is a randomized clinical trial in 60 patients with insomnia who had our inclusion and exclusion criteria, we compared the efficacy of two different Chinese medicine methods as the complementary medicine with estazolam including "Acupuncture plus oral estazolam" and "Chinese herb with administration of oral estazolam" in the treatment of insomnia for 3 weeks.we compared the effective rate.lSI change, changing in sleep parameters after 3 weeks treatment course, including:sleep latency, Day dysfunction, sleep disturbance, sleep duration, night dream, usage of estazolamm, and relapse rate after one month stopping the treatment.Results:in the cross sectional study, Cronbach-a coefficient of C-ISI (Chinese version of Insomnia severity Index) for the clinical group, control group and both of them was 0.72,0.75 and 0.91 respectively. The C-ISI component and total scores in test were significantly correlated with their related components and total scores in re-test (P<0.05). Mean Ranks for All C-ISI components, total score were significantly higher in clinical group than control group that presents low sleep quality in clinical group. There are Significant correlations between C-ISI component and total scores and C-PSQI components and Total scores in related Items.In the clinical trial part, we found "Chinese herb with administration of oral estazolam" and "Acupuncture plus estazolam" had no significant difference in Treatment effect (P value>0.05), ISI change (P value>0.05), sleep duration change (P value>0.05), sleep disturbance change (P value>0.05), sleep latency change (P value>0.05), day dysfunction (P value>0.05) after treatment. While "Chinese herb with administration of oral estazolam" was significantly more effective in night dream change (P value<0.05), using of estazolam (P value<0.05), relapse rate after one month (P value<0.001).in using "Acupuncture plus estazolam" severity of insomnia index has decreased quicker than" Chinese herb with administration of oral estazolam" after Ithweek treatment.Conclusion:Although there is no significant difference between" Chinese herb with administration of oral estazolam" and "Acupuncture plus estazolam", using herb plus estazolam is more effective than applying acupuncture plus estazolam in "decreasing of night dream"," reducing the usage of estazolam" and "relapse rate"更多还原