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中文摘要: 目的：观察镇惊定志合剂治疗心胆气虚型失眠的临床疗效。 方法：采用随机双盲安慰剂对照的研究方法,以心胆气虚型失眠患者为研究对象；将72例患者随机分为治疗组(36例)服用镇惊定志合剂和对照组(36例)服用镇惊定志合剂安慰剂,疗程共4周。观察治疗前后两组患者匹兹堡睡眠指数量表(PSQI)积分、SPIEGEL量表积分、中医证候分级量化表积分及CPC睡眠质量测评结果变化情况。 结果：治疗后,治疗组PSQI量表积分、SPIEGEL量表积分、中医证候分级量化表积分均较治疗前明显降低(P<0.05),且低于对照组(P<0.05)；对照组各积分降低无显著差异(P>0.05)。治疗后,治疗组心肺耦合技术(CPC)睡眠监测结果明显改善(P<0.05),对照组改善不明显(P>0.05),治疗组的改善明显优于对照组(P<0.05)。 结论：镇惊定志合剂治疗心胆气虚型失眠疗效良好,可改善临床症状和提高睡眠质量。
Abstract: Objective:To observe the clinical efficacy of Zhenjing Dingzhi Mixture in the treatment of insomnia with qi deficiency of heart and gallbladder. Methods: Based on the randomized,double-blind and placebo-controlled trial for patients with insomnia of qi deficiency of heart and gallbladder,72 patients were randomly divided into the treatment group and control group,36 cases in each group. The treatment group was treated with Zhenjing Dingzhi Mixture and the control group was treated with placebo,with a course of 4 weeks. The Pittsburgh sleep quality index(PSQI)score,SPIEGEL scale score,Chinese medical syndrome grading scale score and cardiopulmonary coupling(CPC)sleep quality assessment in both groups were observed and compared before and after treatment. Results: After treatment,the PSQI scale score,SPIEGEL scale score and Chinese medical syndrome grading scale score were obviously decreased in the treatment group(P<0.05),and these scores in the treatment group were lower than those in the control group(P<0.05)；but there were no significant differences on these scores in the control group between treatment before and after(P>0.05). After treatment,the results of CPC sleep quality assessment were obviously improved in the treatment group(P<0.05),and there were no obvious improvement in the control group(P>0.05),the improvement in the treatment group was better than that in the control group(P<0.05). Conclusion: Zhenjing Dingzhi Mixture shows good efficacy in the treatment of insomnia with qi deficiency of heart and gallbladder,which can improve the clinical symptoms and enhance the sleep quality.
keywords: insomnia syndrome of qi deficiency of heart and gallbladder Zhenjing Dingzhi Mixture randomized,double-blind and controlled trial
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