深部经颅磁刺激治疗抑郁症疗效及安全性的探索性随机对照研究

An exploratory randomised controlled study on the efficacy and safety of deep transcranial magnetic stimulation in the treatment of depression

目的探讨深部经颅磁刺激(deep transcranial magnetic stimulation,dTMS)辅助治疗抑郁症的疗效及安全性。方法招募2021年5月至2022年6月河北医科大学第一医院精神卫生中心18~60岁,符合国际疾病分类第10版(International Classification of Diseases,ICD-10)抑郁症诊断标准的患者56例,按随机数字表法分为dTMS联合药物治疗组(dTMS组,28例)和重复经颅磁刺激(repetitive transcranial magnetic stimulation,rTMS)联合药物治疗组(rTMS组,28例)。2组均在药物治疗基础上使用dTMS或rTMS,每周5次,共治疗2周。在基线及治疗第2周末,采用17项汉密尔顿抑郁量表(Hamilton Depression Rating Scale,HAMD17)及汉密尔顿焦虑量表(Hamilton Anxiety Rating Scale,HAMA)评估患者的抑郁、焦虑症状,采用32项轻躁狂症状清单(32-Item Hypomania Checklist,HCL-32)评估治疗后的转躁风险。以HAMD17及HAMA的减分及减分率为主要评估指标,HAMD17反应率、不良事件及转躁风险为次要评估指标。使用独立样本t检验、卡方检验等比较疗效差异。结果2组基线HAMD17和HAMA评分差异无统计学意义(P>0.05)。治疗第2周末,dTMS组HAMD17减分及减分率高于rTMS组,差异有统计学意义(t=3.27,P=0.02;t=2.11,P=0.04),dTMS组HAMA减分及减分率有高于rTMS组趋势,但差异无统计学意义(t=1.03,P=0.31;t=0.76,P=0.45)。dTMS组和rTMS组HAMD17反应率分别为52.2%(12/23)和38.5%(10/26),差异无统计学意义(χ^(2)=0.93,P=0.34)。dTMS组不良事件发生率为14.3%(4/28),rTMS组为7.1%(2/28),2组不良事件发生率差异无统计学意义(χ^(2)=0.19,P=0.67),治疗过程中发生的主观不适在治疗结束3 d内均可自行缓解,且无轻躁狂或躁狂发生。结论2种经颅磁刺激方案辅助治疗抑郁症的抑郁焦虑情绪安全有效,且辅助dTMS较rTMS更能显著改善抑郁症状。

Objective To investigate the efficacy and safety of deep transcranial magnetic stimulation(dTMS)as an adjunctive treatment for depression.Methods From May 2021 to June 2022,56 patients aged 18-60 who met the diagnostic criteria in the International Classification of Diseases(ICD-10)for depression were recruited from the Mental Health Center of the First Hospital of Hebei Medical University.According to the random number table method,they were divided into dTMS combined with the drug treatment group(dTMS group,n=28),and the repetitive transcranial magnetic stimulation(rTMS)combined with the drug treatment group(rTMS group,n=28).Both groups received dTMS or rTMS based on drug therapy,5 times weekly for 2 weeks in total.At the baseline and the end of 2nd week of treatment,the Hamilton Depression Rating Scale(HAMD17)and Hamilton Anxiety Rating Scale(HAMA)were used to assess patients′depression and anxiety symptoms,and the 32-Item Hypomania Checklist(HCL-32)was used to assess the risk of mania after treatment.The reductions on HAMD17 and HAMA were the primary assessment,and the treatment response rate in HAMD17,adverse events and the risk of switching to mania were also assessed.The efficacy was compared between the two groups by using independent samples t-test and chi-square test.Results There was no significant difference in baseline HAMD17 and HAMA scores between the two groups(P>0.05).At the end of 2nd week of the treatment,The HAMD17 reduction and the reduction rate were higher in the dTMS group than in the rTMS group(t=3.27,P=0.02;t=2.11,P=0.04).The HAMA reduction and the reduction rate showed a trend favouring the dTMS group,but the difference was insignificant(t=1.03,P=0.31;t=0.76,P=0.45).The treatment response rates on the HAMD17 assessment were 52.2%(12/23)and 38.5%(10/26)in the dTMS and rTMS groups,respectively.However,the difference was not statistically significant(χ^(2)=0.93,P=0.34).The overall incidence of adverse events was 14.3%(4/28)in the dTMS group and 7.1%(2/28)in the rTMS group,with no significant differences between the two groups(χ^(2)=0.19,P=0.67).All subjective discomforts during the treatment automatically resolved within three days,and no mania was reported.Conclusion As the adjunctive treatment,both TMS protocols are safe and effective in relieving the depressive and anxious symptoms of depressive disorder,and the adjunctive dTMS seems better in treating depressive symptoms than rTMS.