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清心化痰方治疗痰热内扰型原发性失眠临床研究

Clinical Study on the Treatment of Primary Insomnia with Syndrome of Internal Harassment of Phlegm-Heat with Heart-Clearing and Phlegm-Resolving Formula
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摘要 目的:观察清心化痰方治疗痰热内扰型原发性失眠的临床疗效。方法:将74例痰热内扰型原发性失眠患者按随机数字表法分为对照组35例和观察组39例。对照组给予艾司唑仑片,观察组给予清心化痰方。比较两组的临床疗效及治疗前后匹兹堡睡眠质量指数(Pittsburgh sleep quality index, PSQI)、失眠严重程度指数(insomnia severity index, ISI)、广泛焦虑量表(generalized anxiety disorder 7,GAD-7)评分、疲劳严重程度量表(fatigue severity scale, FSS)评分、中医证候评分变化情况,记录两组患者用药起效时间及不良反应发生情况。结果:对照组有效率为80.00%,观察组有效率为89.74%,两组患者有效率比较,差异具有统计学意义(P<0.05)。治疗后,对照组睡眠质量、入睡时间及观察组睡眠质量、睡眠时间、睡眠障碍、日间功能障碍、PSQI总分等评分低于本组治疗前,治疗后,睡眠时间、睡眠障碍、日间功能障碍、PSQI总分低于对照组,差异具有统计学意义(P<0.05)。两组患者治疗后ISI、GAD-7、FSS及中医证候评分低于本组治疗前,且治疗后观察组低于对照组,差异具有统计学意义(P<0.05)。对照组服药起效时间短于观察组,差异具有统计学意义(P<0.05)。对照组头晕、药物依赖不良反应发生率高于观察组,差异具有统计学意义(P<0.05)。结论:清心化痰方治疗痰热内扰型原发性失眠,可缓解患者的失眠严重程度,提高睡眠质量,延长睡眠时间,减轻焦虑、疲劳等精神状态。 Objective:To observe the clinical efficacy of Heart-Clearing and Phlegm-Resolving Formula on primary insomnia with syn-drome of intermal harassment of phlegm-heat.Methods:A total of 74 patients with primary insomnia with syndrome of internal harassment of phlegm-heat were randomly divided into the control group with 35 cases,and the observation group with 39 cases respectively accord-ing to the random number table method.The control group was given Eszolam Tablets,while the observation group was given Heart-Clearing and Phlegm-Resolving Formula.Then the clinical efficacy and changes in Pittsburgh sleep quality index(PSQI),insomnia se-verity index(ISI),generalized anxiety disorder 7(GAD-7)score,fatigue severity scale(FSS)score,and TCM syndrome score before and after treatment between the two groups were compared.The onset time of medication and the occurrence of adverse reactions in the two groups were recorded.Results:The effective rate of the control group was 80.00%,while that of the observation group was 89.74%.The difference between the two groups was statistically significant(P<0.05).After treatment,the scores of sleep quality,time to fall asleep,and sleep quality,sleep time,sleep disorders,daytime dysfunction,and total PSQI in the control group and the obser-vation group were lower than those of the same group before treatment;The scores of sleep time,sleep disorders,daytime dysfunction,and total PSQI in the observation group were lower than those in the control group,and all the differences were statistically significant(P<0.05);The ISI,GAD-7,FSS,and TCM syndrome scores of the two groups were lower than those of the same group before treat-ment,and the observation group's above scores were lower than those of the control group,and all the differences were statistically sig-nificant(P<0.05);The onset time of medication in the control group was shorter than that in the observation group,and the difference was statistically significant(P<0.05).The incidence of dizziness and drug dependence adverse reactions in the control group was higher than that in the observation group,and the difference was statistically significant(P<0.05).Conclusion:In terms of primary in-somnia with syndrome of internal harassment of phlegm-heat,Heart-Clearing and Phlegm-Resolving Formula can alleviate the severity of insomnia,improve sleep quality,prolong sleep time,and alleviate mental states such as anxiety and fatigue.
作者 李文珊 吴晓晶 李淑芳 LI Wenshan;WU Xiaojing;LI Shufang(Yinchuan Hospital of Traditional Chinese Medicine Affliated to Ningxia Medical University,Yinchuan,Ningxia,China,750004)
出处 《河南中医》 2023年第10期1551-1556,共6页 Henan Traditional Chinese Medicine
基金 宁夏医科大学科学研究基金资助项目(XM2019197)。
关键词 原发性失眠 痰热内扰证 清心化痰方 艾司唑仑片 primary insomnia syndrome of internal harassment of phlegm-heat Heart-Clearing and Phlegm-Resolving Formula Eszolam Tablets
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