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作 者:张玉梅 喻娟 余倩 Zhang Yumei;Yu Juan;Yu Qian(Longhua Central Hospital,Shenzhen 518110,Guangdong,China)
出 处:《药物流行病学杂志》2020年第6期373-377,共5页Chinese Journal of Pharmacoepidemiology
摘 要:目的:观察心神安胶囊联合佐匹克隆治疗阴虚火旺型失眠症疗效及对患者多导睡眠图和血清5-羟色胺(5-HT)、可溶性白细胞介素2受体(SIL-2R)水平的影响。方法:阴虚火旺型失眠症患者86例随机分为观察组(n=43)与对照组(n=43)。对照组给予佐匹克隆片,观察组在对照组基础上加用心神安胶囊。治疗4周后评估两组临床疗效和药品不良反应;比较治疗前后两组患者中医症状积分、匹兹堡睡眠质量指数(PSQI)、多导睡眠图,以及血清5-HT、SIL-2R水平变化。结果:观察组总有效率95.35%,显著高于对照组的76.74%(P<0.05)。治疗后,两组中医证候积分及PSQI评分均较治疗前明显下降(P<0.05);总睡眠时间、深睡眠时间以及快速动眼期(REM)均较治疗前明显增加,入睡潜伏期时间、觉醒次数以及浅睡眠时间则较前明显缩短(P<0.05);血清5-HT水平较前明显上升,SIL-2R水平则较前明显下降(P<0.05);且观察组上述指标均优于对照组(P<0.05)。观察组药品不良反应发生率明显低于对照组(P<0.05)。结论:心神安胶囊联合佐匹克隆治疗阴虚火旺型失眠症疗效确切,能明显改善患者睡眠质量,缓解临床症状,降低不良反应发生率。Objective:To observe the effect of Xinshen’an Capsule combined with Zopiclone on Yin deficiency and fire flourishing type insomnia and its influences on polysomnography and 5-HT and SIL-2R levels.Methods:86 patients with Yin deficiency and fire flourishing type insomnia were randomly divided into observation group(n=43)and control group(n=43).The control group was treated with Zopiclone,and the observation group was treated with Xinshen’an Capsule on the basis of the control group.4 weeks after treatment,the clinical efficacy and adverse drug reactions of the two groups were evaluated;the scores of TCM symptoms,Pittsburgh sleep quality index(PSQI),polysomnography,5-hydroxytryptamine(5-HT)and serum soluble interleukin-2 receptor(SIL-2R)were compared before and after treatment.Results:The total effective rate of the observation group was 95.35%,which was higher than 76.74%of the control group(P<0.05).After treatment,the scores of TCM syndromes and PSQI score in the 2 groups were decreased significantly compared with those before treatment(P<0.05);the total sleep time,deep sleep time and rapid eye movement(REM)were increased significantly compared with those before treatment;sleep latency time,arousal times and shallow sleep time were shortened(P<0.05);the serum 5-HT level was significantly higher than before,while the SIL-2R level was significantly lower than before(P<0.05);and the above indexes of the observation group were better than those of the control group(P<0.05).The incidence of adverse drug reactions in the observation group was significantly lower than that in the control group(P<0.05).Conclusion:Xinshen’an Capsule combined with Zopiclone is effective in the treatment of Yin deficiency and fire flourishing type insomnia,it can significantly improve the quality of sleep in patients,relieve clinical symptoms and reduce the incidence of adverse reactions.
关 键 词:心神安胶囊 佐匹克隆 失眠症 阴虚火旺型 多导睡眠图 5-羟色胺 血清可溶性白细胞介素2受体
分 类 号:R749.4[医药卫生—神经病学与精神病学]
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