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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 of the Efficacy and Safety of Deep Transcranial Magnetic Stimulation in the Treatment of Depression

【作者】 杨丽

【导师】 王学义;

【作者基本信息】 河北医科大学 , 精神病与精神卫生学(专业学位), 2023, 硕士

【摘要】 目的:探讨深部经颅磁刺激(Deep transcranial magnetic stimulation,d TMS)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2组:d TMS联合药物组28例,重复经颅磁刺激(Repetitive transcranial magnetic stimulation,r TMS)联合药物组28例。两组均在药物治疗基础上使用d TMS或r TMS,每周5次,共治疗2周。在基线及治疗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,匹兹堡睡眠质量指数量表(Pittsburgh sleep quality index,PSQI)评估睡眠质量,32项轻躁狂症状清单(32-item hypomania checklist,HCL-32)评估疗后的转躁风险。以HAMD17、HAMA和PSQI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:两组基线HAMD17、HAMA、PSQI评分差异无统计学意义(均P>0.05)。治疗2周结束时,d TMS组HAMD17减分及减分率高于r TMS组,差异有统计学意义(t=3.27,P=0.02;t=2.11,P=0.04),d TMS组HAMA减分及减分率高于r TMS组,但差异无统计学意义(t=1.03,P=0.31;t=0.76,P=0.45),两组PSQI减分及减分率差异无统计学意义(均P>0.05)。d TMS组和r TMS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(χ2=0.93,P=0.34)。d TMS组不良事件发生率为14.3%(4/28),r TMS组为7.1%(2/28),2组不良事件发生率差异无统计学意义(χ2=0.19,P=0.67),治疗中发生的主观不适在治疗结束3天内均可自行缓解,且无轻躁狂或躁狂发生。结论:两种经颅磁刺激(Transcranial magnetic stimulation,TMS)方案辅助治疗抑郁症的抑郁焦虑情绪安全有效,且辅助d TMS较r TMS更能显著改善抑郁症状。两种TMS联合药物治疗能有效改善患者的睡眠质量,但对睡眠的改善无显著差异。

【Abstract】 Objective:To investigate the efficacy and safety of Deep Transcranial Magnetic Stimulation(d TMS)as an adjunctive treatment for depression.Methods:From May 2021 to June 2022,56 patients aged 18-60 years 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.All patients were divided into 28 patients in the d TMS combined with drug treatment group and 28 patients in the repetitive transcranial magnetic stimulation(r TMS)combined with drug treatment group according to the random number table method.Both groups were treated with d TMS or r TMS on a pharmacological basis,5 times a week for 2 weeks.At 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.The Pittsburgh sleep quality index scale(PSQI)was used to assesses sleep quality and the 32-Item hypomania checklist(HCL-32)was used to assess the risk of mania after treatment.The reduction and reduction ratio of HAMD17、HAMA and PSQI were used as the primary assessment indexes,and the HAMD17response rate,adverse events and the risk of tranquilization were secondary assessment indexes.Differences in efficacy were compared using independent samples t-test and chi-square test.Results:No significantly differences in HAMD17、HAMA、PAQI scores between the 2 groups at baseline(P>0.05).At the end of 2nd week of treatment,The reduction and reduction ratio of HAMD17 was higher in the d TMS group than in the r TMS group,and the difference was significant(t=3.27,P=0.02;t=2.11,P=0.04).The reduction and reduction ratio of HAMA was higher in the d TMS group than in the r TMS group,but the difference was not significant(t=1.03,P=0.31;t=0.76,P=0.45).The HAMD17 response rates were52.2%(12/23)and 38.5%(10/26)in the d TMS and r TMS groups,respectively,with no significant difference(χ2=0.93,P=0.34).The overall incidence of adverse events was 14.3%(4/28)in the d TMS group and 7.1%(2/28)in the r TMS group,with no significant differences between the two groups(χ2=0.19,P=0.67).All subjective discomforts during the treatment automatically resolved within three days of the end of treatment,and no mania was reported.Conclusions:As the adjunctive treatment,both Transcranial magnetic stimulation(TMS)protocols are safe and effective in relieving the depressive and anxious symptoms of depressive disorder,and the adjunctive d TMS seems better in treating depressive symptoms than r TMS.The two TMS combined with pharmacological treatment were effective in improving patients’sleep quality,but there was no significant difference in the improvement of sleep.

  • 【分类号】R749.4
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