健康云耳机治疗轻、中度广泛性焦虑障碍的疗效和安全性对照研究

Comparative study on the effectiveness and safety of health cloud headphones in the treatment of mild and moderate generalized anxiety disorder

目的探索健康云耳机对轻、中度广泛性焦虑障碍患者的疗效和安全性.方法对解放军第九○四医院门诊符合DSM-5标准的100例轻、中度广泛性焦虑症患者,随机分成试验组和对照组,每组各50例.试验组采用健康云耳机治疗,药物组选用度洛西汀治疗,所有患者均接受为期8周的治疗,治疗前、治疗4周末、治疗8周末均采用汉密尔顿焦虑量表(HAMA)评估临床疗效,以不良反应评定量表(TESS)评价不良反应发生情况.结果两因素重复测量方差分析组内效应显示,组别和时间交互作用对HAMA量表精神性焦虑因子、躯体性焦虑因子及总分变化的影响差异均无统计学意义(F=2.360、0.539、2.402,P>0.05).组别因素对量表得分变化的主效应差异无统计学意义(F=0.033、1.111、0.482, P>0.05),而时间因素的主效应差异有统计学意义(F=133.260、52.091、121.092,P<0.001).进一步两两比较显示,治疗前与治疗4周末精神性焦虑因子、躯体性焦虑因子及总分变化,差异均有统计学意义(P<0.01);治疗4周末与8周末的得分变化差异均有统计学意义(P<0.05).试验组与对照组在有效率(88.9%比92.9%)和显效率(53.3%比66.7%)上,差异无统计学意义(χ2=0.410、1.606,P>0.05).试验组不良反应发生率低于对照组(χ2=4.960,P<0.05).结论初步研究表明健康云耳机治疗对轻、中度广泛性焦虑障碍患者的疗效与度洛西汀相当,能够明显改善患者症状,且安全性高.

Objectives To explore the effectiveness and safety of the health cloud headphones(HCH)in patients with mild and moderate generalized anxiety disorder(GAD).Methods A total of 100 mild and moderate GAD outpatients who met the DSM-5 diagnostic criteria for GAD were recruited and randomly assigned into the experimental group and control group,with 50 cases in each group.The experimental group was treated using HCH while the control group was treated using duloxetine.All patients received an 8-week treatment.The effectiveness was evaluated by Hamilton Anxiety Rating Scale(HAMA)and the safety of treatment was assessed by Treatment Emergent Symptom Scale(TESS)before the treatment,4 weeks into the treatment and at the end of the 8-week treatment.Results Two-factor repeated measure analysis of variance showed that there was no significant difference in the effects of group and time interaction on the HAMA scales of psychotic anxiety factors,somatic anxiety factors and total scores(F=2.360,0.539,2.402,P>0.05).There was no significant difference in the main effect of group factors on the change of scale scores(F=0.033,1.111,0.482,P>0.05),while the main effect of time factors was statistically significant(F=133.260,52.091,121.092,P<0.001).Further comparison between the two groups showed that there were significant differences in the changes of psychotic anxiety factors,somatic anxiety factors and total scores between before the treatment and 4 weeks into the treatment(P<0.01).There were significant differences in the scores between the 4 weeks into the treatment and at the end of the treatment(P<0.05).There was no significant difference between the experimental group and the control group in terms of effectiveness rate(88.9%vs 92.9%)and marked effectiveness rate(53.3%vs 66.7%)(χ2=0.410,1.606,P>0.05).The incidence of adverse reactions in the experimental group was lower than that in the control group(χ2=4.960,P<0.05).Conclusions The effectiveness of HCH in treatment of patients with mild and moderate GAD was similar to duloxetine,while the HCH therapy can improve symptoms with higher safety.