【摘要】 目的：评价五行音乐疗法治疗原发性失眠(Primary Insomnia, PI)轻症的临床疗效及安全性。方法：选取2019年5月至2021年12月福建省中医药科学院综合门诊部和福建中医药大学附属第二人民医院失眠专科收治的PI轻症患者60例作为研究对象，按随机数字表法分为观察组和对照组，每组30例。对照组予中药复方口服治疗，观察组在中药治疗的基础上配合五行音乐疗法。2组患者均治疗1个月，比较治疗前、治疗后以及随访1个月的匹兹堡睡眠质量指数(PSQI)、睡眠日记、失眠严重程度指数(ISI)和SF-36生命质量调查问卷，观察安全性及不良反应发生情况。结果：观察组患者在治疗后及随访1个月PSQI和ISI评分均明显优于对照组(P<0.01),但2组患者治疗后及随访1个月睡眠日记相关参数比较差异均无统计学意义(P>0.05);在SF-36生命质量平衡方面，观察组治疗后生理功能(PF)、生理职能(RP)、一般健康状况(GH)、精力(VT)、社会功能(SF)、情感职能(RE)和精神健康(MH)均高于对照组(P<0.05和P<0.01),而躯体疼痛(BP)与对照组比较差异无统计学意义(P>0.05),观察组随访1个月RP、GH和VT均高于对照组(P<0.05和P<0.01),而PF、BP、SF、RE和MH与对照组比较差异无统计学意义(P>0.05)。2组患者治疗均具有较好安全性，均未见明显不良反应。结论：中医五行音乐疗法治疗PI轻症患者可改善睡眠质量，提升生命质量，具有良好的远近期疗效，且操作简便，安全性良好，值得临床进一步推广应用。更多还原

【Abstract】 Objective:To evaluate the clinical efficacy and safety of five-element music therapy in the treatment of mild primary insomnia(PI).Methods:A total of 60 patients with mild PI treated from May 2019 to December 2021 was randomly divided into two groups with 30 patients each.The control group was treated with traditional Chinese medicine, and the treatment group was treated with traditional Chinese medicine combined with five-element music therapy.Both groups were treated for 1 month.Pittsburgh sleep quality index(PSQI),sleep diary, Insomnia Severity Index(ISI) and SF-36 quality of life questionnaire were compared before treatment, after treatment and 1-month follow-up.Safety and adverse reactions were observed.Results:Compared with the control group, the PSQI and ISI scores of the treatment group decreased significantly after treatment and 1 month of follow-up(P<0.01),while in terms of sleep diary related parameters, there were no significant difference in the two groups(P>0.05).In terms of SF-36 quality of life scores, physiological function(PF),role-physical(RP),general health status(GH),Vitality(VT),social function(SF),role-emotional(RE) and mental health(MH) were significantly improved in the treatment group after treatment than the control group, but there was no significant difference in BP in two groups(P>0.05).Compared with the control group, RP、GH and VT of the patients in the treatment group were significantly increased after 1 month of follow-up(P<0.05 and P<0.01),while there were no significant difference in PF、BP、SF、RE and MH between the treatment group and the control group after 1 month of follow-up(P>0.05).Both groups had good safety, and no obvious adverse reactions were observed.Conclusion:The five-element music therapy can improve the sleep quality and life quality of the patients with mild PI.It has good short-term and long-term curative effect, simple operation, good safety, and is worthy of further clinical application.更多还原